Beyond Consent: a Relational Model of Community Authorization for Genetically Modified Mosquito Trials in Developing Countries

Beyond Consent: A Relational Model of Community Authorization for Genetically Modified Mosquito Trials in Developing Countries

Lara Zahabi, BSc, MD, MHSc

A thesis submitted in conformity with the requirements for the degree of Doctor of Philosophy

Institute of Medical Science/Collaborative Program in Bioethics

University of Toronto

Beyond Consent: A Relation Model of Community Authorization for Genetically Modified Mosquito Trials in Developing Countries

Lara Zahabi

Doctor of Philosophy

Institute of Medical Science/Joint Program in Bioethics

University of Toronto

2014

Abstract

This thesis provides the first empirical explanatory theory for community authorization for Genetically Modified Mosquito (GMM) trials. Although this theory was developed in the context of GMM trials, it can apply to other endeavors, research or not, where whole communities might be affected. As GMM make their way from laboratories to villages of developing countries to test their effectiveness in controlling vector-borne diseases, community authorization emerges as a critical and urgent, yet undefined, mechanism of protection and respect for communities who might be affected by research and its outcomes.

Following a constructivist Grounded Theory approach, I analyzed three prominent GMM trials from Mexico, the Cayman Islands, and Malaysia. Nineteen (19) interviews and two hundred and forty nine (249) documents were analyzed in order to uncover the substantive and procedural aspects of authentic and sufficient community authorization for research, as well as the factors that affect such authorization.

This interdisciplinary bioethics thesis supports a relational notion of community authorization, as a continuous state of ongoing, maintenance-dependent, approval for research from inception through all stages. Enabled by successful relationships between researchers and community groups and individuals, this state manifests in formal and informal ways at all levels of the community; institutional, national, regional, local, and even individual, and involves authorities,

ii both official and traditional, and publics alike. The state of authorization manifests in reciprocity, or the fulfillment of commitment to promote mutual interests.

The findings challenge current conceptions of research participants as well as consent, and consequently current practices of research appraisal. Future research is needed to provide researchers, research ethics boards, and regulatory agencies with standardized tools to gauge the conduct of research in relationship to the community.

The elements of this theory, as well as its reliability, applicability and generalizability, need to be tested and refined in future empirical work in multiple contexts and different fields.

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Acknowledgments

I would like to express my deepest appreciation to all of those who have helped and supported me during my graduate study program. Their support, understanding, and encouragement have provided me the possibility to complete this work.

Foremost is my husband and best friend Samer Bekdash, who unreservedly supported me through all the endless demands of my studies. His love was a constant source of comfort and his selfless care has given me wings to follow my dreams and ambitions, even at the expense of his own sometimes. I am ever blessed to have him as a partner, best friend, and mentor.

I am indebted to my supervisor Jim Lavery and my dissertation advisory committee members, Peter Singer and Ross Upshur, who have guided me throughout the program with their bright minds and valuable experiences and knowledge. Each one of them has been an inspiration to me in a different way, and their complementary contributions have brought me to this successful stage, and remain with me as long-life gifts. I am grateful to Jim for supporting me since I was a student in the Master’s program and throughout the process, and for his valuable guidance and constant encouragement. From him I will always learn intellectual humility. From Peter, I will always learn strategic thinking, and that with faith, will, and determination, one can truly make a difference in the world. From Ross, who was my first inspiration to join a PhD program in bioethics, I will always learn logic and critical thinking.

I would also like to express my sincere gratitude to Halla Thorsteinsdóttir for her valuable comments and support in both my thesis finalization as well as my doctoral qualifying exam. In both times, she generously accommodated my tight timelines, and provided the most appreciated feedback. I am also thankful to Barbara Secker, Bernard Dickens, and Peter Newman for reviewing my research proposal and providing critical insights that shaped every aspect of my research. I would also like to thank Peter Newman and Derek Jones for serving as reviewers on my final thesis examination.

I am grateful to Vasundara Venkateswaran for all her guidance and encouragement to successfully complete my program requirements, as well as to Mingyao Liu and Howard Mount iv from the Institute of Medical Science.

I am indebted to Janine Ramsey and her warm hospitality in Tapachula, for generously sharing her considerable expertise and donating her precious time to support my research. Her insightful comments and experiences form in fact the basis of my research. My appreciation also goes to Ana Laura Pacheco, Abraham Marcoschamer, and Claudia Ytuarte, for all their insights that provided depth to this thesis and for their hospitality and generosity in donating their time to support my field visits. I am also thankful to Luca Facchinelli, Laura Valerio, Sergio Meneses, and Guillermo Bond for all the support they offered me in Tapachula. I am also sincerely grateful to Don Martimiano Matute, Don Leobardo Àlvarez, and the men and women of Río Florido, who kindly received me in their community and opened their homes for my research, as well as donated their precious time to answer my questions and share their experiences. I would also like to express my gratitude to Sunita Bandewar and Renaud Boulanger for their scholarly inputs throughout my research study. I am also thankful to Stephanie James, Anthony James, Scott O’Neil, Bart Knols, and Darlene McNaughton for all the insightful discussions we had, and that have affected my research one way or another.

I am deeply thankful to those who supported this research project by offering logistic or financial support, in particular the Grand Challenges in Global Health Initiative, the Institute of Medical Science at the University of Toronto, Abdallah Daar, Andrew Taylor, and Deepa Persad. I wish to thank the many other faculty members at the University of Toronto under whom I have been privileged to study and who have contributed tremendously to my learning.

Last but not least, I am ever grateful to my family and friends who have been extremely understanding and supportive, offering encouragement and accommodating my demanding schedule and occasional lack of attention to their needs. In particular, I am ever indebted to my mother, Samiramiss and my brother Sobhi, without whom I wouldn’t have reached this point in my life. I am also deeply thankful to Rasha Elendari, for accompanying me in my thesis writing journey, holding my hand and pushing me forward right when I needed it. I would also like to thank Ibrahim El-Ekawi for giving me a small tip that made a big difference in translating the documents from Malaysian and Chinese.

Table of Contents

Acknowledgments ...... iv

Table of Contents ...... vi

List of Tables ...... xiv

List of Figures ...... xv

List of Appendices ...... xvi

CHAPTER 1 Introduction ...... 1

1 Purpose ...... 1

2 Overview ...... 1

3 Thesis Organization ...... 8

Part I Literature Review ...... 11

CHAPTER 2 Dengue and Genetically Modified Mosquitoes ...... 12

1 The Global Burden of Dengue ...... 12

2 Dengue: Treatment and Prevention ...... 14

3 The New Era of Disease-Vector Control ...... 16

4 Summary ...... 18

CHAPTER 3 Ethical, Social, and Cultural Aspects of GMM Research ...... 20

1 Risks and Potential Benefits ...... 21

2 Autonomy ...... 23

3 Summary ...... 30

CHAPTER 4 The Individual, Community, and GMM trials ...... 32

1 Individuals, Community, and Decision-Making ...... 33 1.1 Principlism and The Individual ...... 33 1.2 Beyond Informed Consent: Communitarian Bioethics ...... 36

2 Towards a Constructivist Approach: Responsive Communitarian Bioethics ...... 40 vi

3 Models of Community Approval for Research from Aboriginal Communities ...... 44

4 Summary ...... 47

CHAPTER 5 Methodology ...... 49

1 Purpose of the Study ...... 50

2 The Use of an Empirical Approach ...... 50

3 Grounded Theory ...... 53

4 GT Methods ...... 56 4.1 Concurrent data collection and analysis, and constant comparison ...... 57

5 Features and Type of My Theory ...... 57

6 Research Design ...... 58 6.1 Cases ...... 58 6.2 Research Questions ...... 60 6.3 Units of Analysis ...... 60 6.4 Cross-Case Comparison: The Case-Study Approach ...... 61

7 Ethical Considerations ...... 62

8 Summary ...... 64

Part II: Caged-Field GMM Trials in Mexico: A Successful Example ...... 65

CHAPTER 6 Mexico Case Study Methods ...... 66

1 Research Questions ...... 66

2 Units of Analysis ...... 66

3 Data Collection ...... 68 3.1 Sampling ...... 68 3.2 Sample Size: ...... 70 3.3 Recruitment ...... 70 3.4 Data Sources ...... 71 3.4.1 Interview Transcripts ...... 71 3.4.2 Documents ...... 73 3.4.3 Direct Observation ...... 73 3.4.4 Field Notes and Memos ...... 73 vii

4 Data Management ...... 74

5 Data Analysis ...... 74 5.1 Initial Analysis (Coding) ...... 75 5.2 Intermediate Analysis ...... 76 5.3 Advanced Analysis ...... 78

6 Summary ...... 78

CHAPTER 7 Case Study Research Context ...... 80

1 The Trials ...... 80

2 Field Trials Site ...... 81 2.1 Scientific Criteria ...... 82 2.2 Regulatory and Administrative Capacity ...... 83 2.3 Community Engagement and Authorization ...... 84

3 Geographical and Political Context ...... 86 3.1 Chiapas ...... 87 3.1.1 Agriculture and Genetic Modification in Chiapas ...... 87 3.2 Tapachula ...... 89 3.3 Ejidos ...... 90 3.3.1 Land Privatization and Ownership in Ejidos ...... 92 3.4 Río Florido ...... 93

4 Social Context ...... 94 4.1 Macro Community: ...... 97 4.2 Micro Community ...... 100

5 Summary ...... 101

CHAPTER 8 Researchers and the Community: A Successful Relationship ...... 103

1 Mapping Stakeholders ...... 103

2 Priming Relationships ...... 106 2.1 Establishing Initial Comfort ...... 109 2.1.1 Comfort with the Team ...... 109 2.1.2 Comfort with the Research Risks ...... 113 2.2 Development of Interest and Hope: Commitment to Benefits ...... 114

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3 Defining and Negotiating ...... 115

4 Developing Relationships ...... 117 4.1 Inter-institutional Relationships ...... 119 4.2 Inter-personal relationships ...... 121

5 Maintaining Comfort and Generating Satisfaction ...... 123 5.1 Maintaining a positive and committed attitude ...... 125 5.1.1 Humility ...... 126 5.1.2 Faithfulness: Honesty and Transparency ...... 126 5.1.3 Consistency ...... 127 5.1.4 Immersion in the Community: Familiarity, Presence, and Closeness ...... 127 5.1.5 Reliability: Responsibility and Responsiveness ...... 129 5.2 Following an inclusive, incremental, and iterative course ...... 130 5.2.1 Inclusive and contiguous ...... 130 5.2.2 Incremental and cumulative ...... 131 5.2.3 Iterative and continuous ...... 132 5.3 Demonstrating commitment to promoting community interests ...... 132 5.4 Demonstrating Respect ...... 134 5.4.1 Taking the community into account ...... 134 5.4.2 Respecting hierarchies, protocols, and norms ...... 137 5.4.3 Valuing regular members of the community and not only authorities ...... 137 5.5 Maintaining a conversation ...... 138 5.5.1 Describing ...... 140 5.5.2 Explaining ...... 140 5.5.3 Updating ...... 141 5.5.4 Empowering ...... 142 5.5.5 Eliciting ...... 142

6 Summary ...... 143

CHAPTER 9 Community Authorization: A Multi-Component Phenomenon ...... 144

1 Formal Approval ...... 144

2 Informal Approval ...... 149 2.1 Absence of Antagonism ...... 152 2.2 Expressing Satisfaction and Favor ...... 154

2.3 Embracing the Project ...... 155 2.3.1 Welcoming the Project into the community ...... 155 2.3.2 Supporting the Project ...... 156

3 Summary: ...... 159

CHAPTER 10 Community Authorization: An Experiential State ...... 161

1 Authorization is a state ...... 161 1.1 Conditionality ...... 162 1.2 Revisability and Fragility ...... 163 1.3 Non-Universality ...... 165

2 Authorization is a Process ...... 165

3 Authorization is Responsive and Interactive ...... 167

4 Summary ...... 168

Part III The Release of Genetically Modified Mosquitoes in the Cayman Islands and Malaysia: Case Studies ...... 169

CHAPTER 11 Methods ...... 170

1 Research Questions ...... 170

2 Units of Analysis ...... 171

3 Data Collection ...... 171 3.1 Sampling ...... 172 3.2 Sample size ...... 173 3.3 Data ...... 173

4 Data Management ...... 174 4.1 Translation ...... 174 4.2 Data Storage and Organization: ...... 174

5 Data Analysis ...... 174

6 Summary ...... 175

CHAPTER 12 The Surprising Release of Genetically Modified Mosquitoes in the Cayman Islands ...... 176

1 Context and Background ...... 176

2 Authorization Processes ...... 180 2.1 Regulatory Approval ...... 180 2.2 Community Reactions Towards the Trials ...... 182

3 On What Basis Were the Trials Conducted? ...... 186 3.1 What is the Needed Scope of Engagement? ...... 186 3.2 What Constitutes Authorization and Who Should Be Involved? ...... 193

4 What Assumptions Influenced These Judgments? ...... 198

5 Summary ...... 201

CHAPTER 13 The Release of Genetically Modified Mosquitoes in Malaysia: A Bumpy Journey ...... 202

1 Context ...... 202 1.1 GMM Trials in Malaysia ...... 203 1.2 Regulatory System in Malaysia ...... 206

2 Authorization Processes ...... 208 2.1 Official Authorities ...... 208 2.1.1 Macro Level: Regulatory Approval ...... 208 2.1.2 Micro Level: Bentong Council ...... 210 2.2 The Public ...... 212

3 Public Opposition ...... 218

4 Decoding Judgments: Implications for Community Engagement and Community Authorization ...... 222 4.1 Community Authorization ...... 224 4.1.1 Opposition ...... 226 4.2 Community Engagement ...... 231 4.2.1 Who is the Relevant Community, and What Constitutes Expertise to Participate ...... 235

5 Summary ...... Error! Bookmark not defined.

Part IV Discussion and Conclusions ...... 240

CHAPTER 14 The Social Process of Community Authorization ...... 241

1 Process of Judgments-Development ...... 242 1.1 Stage 1: Comfort, Anxiety, and Openness to Risk ...... 242 1.2 Stage 2: Constant Assessment, Judgment Formation, and Action ...... 248

2 The Role of Narratives, Affect, and Confidence in the Assessment of Research: discussion from the literature ...... 251 2.1 Narratives ...... 251 2.2 Affect ...... 254 2.3 Confidence, Trust, and Action ...... 258

3 Summary ...... 262

CHAPTER 15 Porcedural and Substantive Aspects of Community Authorizations ...... 263

1 Admission ...... 263 1.1 Research collaboration agreement ...... 265 1.2 Regulatory approval ...... 266 1.3 Approval from authorities at meso-community level when prescribed by jurisdiction ..... 267 1.4 Consent from local community authorities to admit the trials into their communities ..... 267

2 Reinforcement and Maintenance ...... 268

3 Summary ...... 271

CHAPTER 16 Implications and Conclusion ...... 272

1 Community Authorization Theory ...... 273

2 Lessons and Recommendations ...... 275 2.1 Community Authorization includes but is not limited to ‘consent’ ...... 275 2.1.1 Implications for Bioethicists ...... 275 2.1.2 Implications for Policy Makers/Regulators/Research Ethics Committees ...... 277 2.1.3 Implications for Researchers ...... 278 2.2 Community Authorization is a multilevel phenomenon ...... 278 2.2.1 Implications for Researchers: ...... 279 2.2.2 Implications for regulators/research ethics committees ...... 280 2.3 CA is a relational process not a procedural milestone ...... 280 2.3.1 Implications for Researchers ...... 282 2.3.2 Recommendations for Regulators/Research Ethics Committees ...... 283 2.4 ESC aspects should be given the same importance as the technical aspects of research ... 284

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3 Implications for Communities ...... 286

4 Generalizability of my findings ...... 287

5 Areas for future research ...... 288

6 Limitations of this study ...... 288

7 Conclusion ...... 290

Bibliography ...... 292

Appendices ...... 354

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List of Tables

Table 9.1 Formal Approval (Decisions) p.145

Table 9.2 Dimensions of Formal and Informal Approval p.160

Table 12.1 Needed Scope of Engagement from the Community’s Perspectives p.193

Table 12.2 The Meanings of Authorization from Different Perspectives p.198

Table 14.1 Community Expectations p.247

Table 14.2: Affective states in the three settings p.255

Table 15.1 Admission Stage of Approval p.265

Table 15.2 Reinforcement and Maintenance Stage of Approval p.271

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List of Figures

Figure 7.1 Schematic representation of the Project regulatory structure p.84

Figure 7.2 Geographical Location of Río Florido p.86

Figure 7.3 Geographical Location of Río Florido p.86

Figure 7.4 Soconusco Region p.89

Figure 7.5 Community Levels p.96

Figure 8.1 Priming and Openness p.109

Figure 8.2 Comfortometer p.118

Figure 12.1 Map of Grand Cayman island p.178

Figure 13.1 Bentong, Pahang, Malaysia p.205

Figure 13.2 Release site in Bentong p.206

Figure 13.3 Regulatory Approval Process for GMO Release p.207

Figure 13.4 Flowchart of the biosafety regulatory process, public engagement and approximate time frame p.210

Figure 13.5 Community Authorization from the Regulators’ Perspectives p.215

Figure 13.6 Community Authorization from the Community’s Perspectives p.226

Figure 13.7 Considerable Community Opposition p.231

Figure 13.8 Perspectives on Community Engagement p.235

Figure 14.1 Judgments and narratives development p.250

List of Appendices

Appendix 1: Definitions p.354

Appendix 2: University of Toronto Research Ethics Approval p.355

Appendix 3: Ethics Approval National Institute of Public Health (Comisión de Investigación, Instituto Nacional de Salud Pública) p.356

Appendix 4: Invitation Letter p.357

Appendix 5: Study Information Sheet p.359

Appendix 6: Consent Form p.365

Appendix 7: List of Interviewees p.368

Appendix 8: Community Engagement Mexico p.370

Appendix 9: Relational Model/Roadmap p.371

Appendix10: Authorization Procedural Milestones (Mexico) p.372

Appendix 11: Procedural and Substantive Aspects of Community Authorization

(Mexico) p.373

xvi 1

CHAPTER 1 Introduction

This thesis is an empirical bioethics research study. It addresses an important aspect of research ethics related to trials using genetically modified mosquitoes, by elucidating the meaning of community authorization for such trials. Specifically, this thesis attempts to uncover the substantive and procedural elements that constitute authentic and sufficient authorization from local communities for trials involving genetically modified mosquitoes (GMM) to begin and proceed in developing countries, as well as the factors that affect such authorization. This interdisciplinary bioethics thesis draws on different relevant fields of social enquiry, such as medical anthropology, social psychology, moral philosophy, and public policy, as well as on public health, global health, and medical science.

1 Purpose

The purpose of this thesis was to build an explanatory grounded theory of community authorization for GMM trials. It therefore aimed to answer the following research question

“What constitutes community authorization to begin and proceed with caged-field or open release GMM trials”?

The development of this theory focused on three main aspects of the authorization phenomenon: 1) the meaning of authorization for such trials from different perspectives, 2) the kinds of formal and informal actions that were taken by different groups of the community to signify authorization, and 3) the factors that affected these actions.

2 Overview

To achieve the study purpose and explore the substantive and procedural aspects of community authorization for GMM trials, I investigated three leading trials testing GMM for the control of Dengue from Mexico, Malaysia, and the Cayman Islands. The case study from Mexico (Chapters

6-10) is the core of my research, as it is the basis for the generation of concepts, categories and hypotheses, derived from in-depth investigation through fieldwork. It is therefore the ‘major’ case study, and it can serve independently as a research study. The two cases from the Cayman Islands (Chapter 12) and Malaysia (Chapter 13) on the other hand did not involve any fieldwork, and data were limited to publicly available sources. While these two cases were not independently sufficient to provide the core concepts of the theory of community authorization, cross comparisons with their data enabled verification and enrichment of the theoretical framework generated from the major case study. They are therefore considered minor case- studies.

As GMM make their way from laboratories to villages of developing countries to test their effectiveness in controlling vector-borne diseases (Chapter 2), community authorization emerges as a critical and urgent ethical question (Chapter 3). In this research study I explore community authorization for GMM trials through focusing on a specific application of GMM for Dengue control. Nonetheless, the results are generalizable to all GMM trials, as well as to other types of research or even applications with potential to impact whole communities indiscriminately (Chapter 16). Over the past three years, Dengue-specific GMM were released in the Cayman Islands (Harris et al., 2012), Malaysia (Lacroix et al., 2012), and Brazil (Ministério da Ciência Tecnologia e Inovação, 2012), while other countries such as Panama, India, and the United States are preparing for releases (Nightingale, 2010; Urquhart, 2012). Mexico on the other hand has only conducted caged-field trials of GMM (Ramsey et al., 2014). Calls for community engagement and the need for ‘consent’ or ‘authorization’ from the involved communities as key requirements for the ethical conduct of research were raised even before any trials were initiated (Kilama, 2005, 2010; Knols and Scott, 2003; Lavery et al., 2008; Macer, 2003, 2005; Tindana et al., 2007; Touré and Manga, 2006).

Unfortunately, empirical research shedding light on what constitutes community authorization for research in developing countries is still lacking (Chapter 3), and guidelines to help investigators ethically and effectively steer intervention studies such as GMM trials where whole communities may be affected (Chapters 3) are yet to be developed. The science of community engagement in health research is still immature (Newman, 2006), and little is known about the engagement, participation, and decision-making processes of involved communities in the context of large-scale science and technology research, especially in developing countries.

Specifically, there is no formal agreement on what community authorization is, what constitutes sufficient authorization, and what are the variables and factors that are related to authorization in this type of trials. Moreover, divergent theoretical views in bioethical doctrines lead to different and sometimes conflicting meanings for community authorization and do not offer much help in elucidating the concept, necessitating an empirical approach grounded in the lived experiences of communities with GMM trials. (Chapter 4). Investigators are then left to trial and error (Kilama, 2005) while navigating a process that is seen as “mind-boggling” (Kilama, 2010). Therefore, an explanatory and contextually situated empirical theoretical account to explore the substantial and procedural aspects of the social phenomenon of authorization is highly needed and is the primary intention of this research study (Chapter 5).

Unfortunately, the high price of ‘error’, and consequently the ethical necessity of community authorization have been highlighted in responses to recent releases of GMM in the Cayman Islands and Malaysia (Enserink, 2010; Reeves et al., 2012; Science/AAAS, 2010). In November 2010, the British biotechnology company Oxitec (Oxitec, n.d.) announced that its researchers carried out the world’s first release trial with GMM in the Cayman Islands in the fall of the previous year, surprising opponents of GMM as well as researchers in the field of genetic vector control (Enserink, 2010). Commentators, researchers, and communities alike, criticized the release in the Cayman Islands, as will be discussed in Chapter 12, on the basis that the local community was not even informed (Canadian Press, 2010; Cayman 27, 2010b; Cayman News Service, 2010c; Enserink, 2010; Science/AAAS, 2010), and hence felt exploited and disrespected. In Malaysia on the other hand (Chapter 13), while the community was briefly consulted, researchers were criticized for failure to attain sufficient authorization from the community (Malaysian NGOs, 2010). There, trial opponents as well as the researchers reiterated the calls for guidelines for effective community engagement as well as procedures to develop community authorization:

“There is a dire need for… further means of ensuring meaningful and effective public participation” (Idris, 2010c)

“There is also a need to put in place a serious and proper prior informed consent regime, especially considering that the whole world will be looking to the Malaysian experience as a model” (International NGOs, 2010)

“An international guidance on public engagement would definitely assist researchers and regulators of future releases... In the meantime, countries planning GM releases should establish a working group to develop models for effective stakeholder or community engagement from an early stage” (Subramaniam, 2012)

Researchers have ethical obligations towards persons who might be adversely affected by the conduct of research. These obligations include minimizing risks and maximizing benefits, as well as respecting persons by respecting their autonomy to decide after due consideration whether they accept to be enrolled in the research and hence be exposed to its risks. Traditionally, research ethics focus on the protection and respect of individuals who would be considered research subjects, and operationalize researchers’ obligations in the processes of “informed consent”, which aim to ensure that individuals are exercising their autonomy by participating willingly in research and are fully informed about the research and about their rights, including their right to withdraw (Chapters 3 and 4). Environmental trials, i.e. trials in which the intervention affects the environment and hence the community as a whole and not just individual research participants such as GMM trials, present a new set of ethical considerations. Although not every person in the community would be considered a research subject (Chapter 3, McRae et al., 2011a, 2011b), all individuals in host communities have legitimate interests in the outcomes of the research, and might be directly or indirectly affected by its conduct and outcomes (King et al., in press). What then are the researchers’ ethical obligations towards these individuals as well as towards the community as a whole?

Community authorization for research is proposed as a mechanism of protection as well as a demonstration of respect for communities who might be impacted by research and its outcomes (Zahabi-Bekdash and Lavery, 2010), by allowing community members to participate in governing endeavors that might affect their interests and well-being. The ethical necessity of community authorization stems from the recognition of ‘community’ as more than a simple aggregate of individuals, but as an interdependent systems of persons, their relationships, shared values, and shared interests, and the recognition that a community could be harmed as a collectivity even when its individuals are protected or are not ‘individually’ affected (Lehrman, 1997, Weijer, 1999). As such, communities are ethical entities that are worthy of ethical consideration separate from that of its individuals (Eichbaum, 2012) and consequently entitled to respect (Levine, 1982, Weijer, 1999, Weijer and Emanuel, 2000).

In contrast to conventional research ethics models and methodologies where individuals decide through informed consent whether to use or not individual-based tools such as an insecticidal mosquito coil or bed net (Knols and Scott, 2003), a communal consent is thought to be a process in which the community decides collectively, after appropriate information and due consideration, whether to participate in the research (Lavery et al., 2008). Unfortunately, little is known about this phenomenon, and about the relationship between consent and authorization. Community engagement in global health research as a field is still immature, and little empirical evidence is available to illuminate our understanding about the engagement, participation, and decision-making processes of involved communities in the context of large-scale science and technology research, especially in developing countries. In fact, there is still considerable debate about what is meant by a community decision to participate in research (Senituli and Boyes, 2007), and investigators are challenged by questions about the meaning of consent in communities that are largely unfamiliar with vector biology, genetic modification and often the role of mosquitoes in transmitting disease (Marshall and Taylor, 2009).

In addition to being an ethical necessity for the conduct of research, community authorization is also an ethical necessity for ensuring that potentially beneficial and life-saving technology would not be rejected (Berndtson et al., 2007; Singer et al., 2007; Tindana et al., 2007). Each year, approximately 390 million cases of Dengue occur (Bhatt et al., 2013), leading to hundreds of thousands of cases of Dengue Hemorrhagic Fever, with a fatality reaching up to 5% (CDC, n.d.). With no effective antiviral agents (WHO, 2009) or successful vaccines (Halstead, 2012), and with unsuccessful vector control to date (WHO, 2009), novel strategies that are safe, effective, efficient, and selective are needed (Touré et al., 2003). GMM offer a promise in the war against Dengue. Different strains of GM Aedes aegypti, are being developed and tested in field cages or through open air releases, as I mentioned before, to assess their effectiveness and safety in controlling the Dengue mosquito vector. These strains are either less capable of carrying the Dengue virus and are designed to replace local populations of Aedes mosquitoes, or they are sterile and designed to deplete the local populations (Alphey and Andreasen, 2002; James, 2011; Thomas et al., 2000), thus decreasing transmission in both cases.

In light of the aforementioned, an explanatory and contextually situated theoretical account of the social phenomenon of authorization is crucially needed. This empirical bioethics thesis aims to address this gap in knowledge, by building a grounded (Charmaz, 2006; Glaser and Strauss,

1967) middle-range (Chinn and Kramer, 1999; Merton, 1968) theory of community authorization for GMM trials (Chapter 5). In order to answer this question, I have looked at how three different communities interacted with three prominent GMM trials, in Mexico (Chapters 7-10), the Cayman Islands (Chapter 12), and Malaysia (Chapter 13), and how authorization, or lack of, was manifested in each of these settings. I consequently used these insights to develop my theoretical account (Chapters 14-16). In order to explore the substantive and procedural aspects of the authorization phenomenon, personal perspectives and experiences of various stakeholders were elicited in interviews or collected from openly available sources. I have followed the grounded theory methodology (Chapter 5) to use these insights for the construction of the theory.

While no differentiation has been made between consent and authorization in the relevant literature on ethical issues related to GMM trials, where both terms have been sometimes used interchangeably to mean permission or approval for research, I use the two concepts differently (Caulfield et al., 2003). Consent has been associated in both bioethics and tort law with a specific application of permission to mean the expressed provision of approval in the form of agreement, and I use it in this sense. It is procedural, formal, and consists of a discrete expressed decision. However, following a grounded theory approach, where meanings are drawn from the data rather than from a priori definitions or understandings, I chose to look for a broader concept that might encompass different forms of permission or approval, and which might include but is not limited to consent. I use community authorization to embody this concept. While most commentators call for community consent for GMM research, and often use the term to refer to permission from community representatives, my theory in fact argues that community authorization for research involves more than just community consent, and hence I titled my thesis “Beyond Consent: A Relational Model for Community Authorization for GMM trials”.

Rather than a one-time decision or an agreement, ‘Community Authorization’ appeared to be a continuous state of ongoing and maintained approval for the trials from inception through all stages of the research. Enabled by successful relationships between researchers and community groups and individuals, this state manifests in a continuous manner in formal and informal ways at all levels of the community; institutional, national, regional, local, and even individual. Community authorization passes through, or involves, two stages of approval. The first consists of all the formal decisions to admit the research to the community, while the second stage involves the formal decisions and informal actions at the host community level, by authorities,

7 traditional or moral leaders, as well as groups and individuals, that maintain and reinforce the initial approval. The state of authorization is manifested in reciprocity, or the fulfillment of commitment to promote mutual interests.

My theory of community authorization was developed to provide guidance for researchers, regulatory agencies, funders, as well as communities, testing GMM to deal with the globally threatening epidemics of Dengue, an acute systemic viral infection transmitted between humans by Aedes mosquitoes, and the world’s fastest growing vector borne disease (Bhatt et al., 2013; CDC, n.d.; WHO, 2009). Nonetheless, the findings of my research can be applicable to other vectors trials, or other types of research in which whole communities can be affected (Chapter 16).

This thesis provides a valuable starting place for prospective interdisciplinary cooperation and deliberations aimed at developing detailed guidelines on community engagement and community authorization for investigators, funders, regulatory authorities, research ethics committees, as well as communities. The findings dictate that funders have to allow budget and time provisions in research proposals, and to have the needed capacity to assess how researchers will attend to ethical, social, and cultural issues related to research. Regulators and research ethics boards have to develop new ways of conceptualizing consent and community approval, and new ways of approving and overseeing projects, such as issuing approval in different stages based on evidence of community ongoing approval. One way is to adopt a multi-stage approval system that takes into consideration regularly the quality of the relationships between the researchers and the community as well as the community’s perspectives about the research. Finally, researchers have to integrate themselves from day one as neighbors and as partners in the communities that will host their research, and work hard towards developing respectful and equitable relationships with authorities, leaders, and publics alike. Future research is needed to provide researchers as well as research ethics boards and regulatory agencies with standardized tools to gauge the conduct of research in relationship to the community. The reliability, applicability and generalizability of this theory need to be tested and refined in future empirical work in multiple contexts and different fields.

My research project was funded by the Ethical, Social and Cultural (ESC) Program for Global Health (Lavery et al., 2013), a program funded initially through the Grand Challenges in Global

Health Initiative (GCGH), a partnership between the Bill and Melinda Gates Foundation (BMGF), the Foundation for the National Institutes of Health, The Wellcome Trust, and the Canadian Institutes of Health Research (GCGH, 2010). The GCGH was created to identify and solve the most significant “bottlenecks” in science and technology in order to help address the most critical health problems in the developing world (Varmus et al., 2003). This study is part of a global 10-case-study series that is being conducted by the ESC Program to improve the current knowledge base about what constitutes effective community engagement in global health research (Berndtson et al., 2007; Tindana et al., 2007).

3 Thesis Organization

This thesis is divided into 4 main parts following this first chapter, which provides an overview of the thesis. These parts respond to the criteria that Miller and Wendler (2006) proposed for empirical bioethics: “The potential value of this research depends on the ethical significance of the questions asked, the suitability of the methods to answer the questions, and interpretation of the ethical import of the findings”. Part I presents the relevant literature review. In Parts II and III, I present the data in a descriptive narrative story about community authorization (Corbin and Strauss, 1990) from the three case-studies, while Part IV presents a cross-case comparison with the ensuing final theory of community authorization and a discussion of its implications.

The first part, Part I, provides a literature review, and consists of four chapters. The first one in this section, Chapter 2, provides an overview of Dengue’s global burden, and the challenges associated with its prevention. In Chapter 3, I explore the ethical, social, and cultural issues associated with GMM experimentation, and stress the ethical necessity of community authorization for such trials, but conclude that a knowledge gap exists in this regard. In Chapter 4, I explore the bioethical models that could illuminate my research questions and draw insights from them. This task proved useful to build the significance of my research question from a theoretical perspective, as well as to show that an empirical approach is needed to fully elucidate community authorization. I also review one established application of community authorization for research from the context of Aboriginal communities. In Chapter 5, I present the methodological underpinnings that guided my research. Here I also provide justifications for my use of a constructivist grounded theory methodology in a case-study approach.

Part II is the first part of results and consists of five interrelated chapters, dedicated to the Mexico case study, which is an in-depth research project conducted in the city of Tapachula in Chiapas, Mexico. In the first chapter of this part, Chapter 6, I present the methods I used for data collection and analysis for this case. In Chapter 7, I present the socio-political context of the trials, where I also describe the structure of the community and the different social units constituting the different levels of community. In Chapter 8, I describe the social processes that were involved in the interactions between the GMM trial team and the community and examine how certain social processes and interactions were facilitative and conducive for community authorization for the trials to begin and to proceed. In Chapter 9 I describe the transactions that constituted the phenomenon of authorization, and in the last chapter, Chapter 10, I discuss the characteristics of this phenomenon.

Part III consists of three chapters in which I present the findings of the two case studies from the Cayman Islands and Malaysia. In the first chapter of this section, Chapter 11, I present the methods that I have used in these two cases. Both cases depend on openly available documents, retrieved from newspapers, magazines and journals, organizational and personal websites, as well as blogs, forums, and other social networking pages. Chapter 12 presents the findings of the case study from the Cayman Islands, while Chapter 13 is dedicated to the case study from Malaysia. In these two chapters I review the authorization processes that the trials passed through in both settings, and elicit the assumptions about the meanings of community, community engagement, and authorization from multiple perspectives.

Part IV consists of five chapters in which I examine the findings of this thesis in light of available literature and discuss the implications of my research for the field of global health. The first two chapters of this part, Chapters 14 and 15, present the cross-case comparison. In the first chapter, Chapter 14, I explore the factors that led to different responses from the three communities towards the GMM trials, and argue that the difference in responses can mainly be attributed to differences in the approaches to the interactions with the community. I also draw insights from the comparison to develop the ‘social process’ of community authorization and show that comfort and confidence, or lack of, lie at the basis of judgments-development, which follow certain patterns of narrative formation. Comfort and confidence are in turn contingent on the satisfaction of community expectations. In Chapter 15, I compare the perspectives on the authorization from the three settings, and hence draw insights to develop an explanatory theory

10 of community authorization for these trials, which I present in Chapter 16, where I also I discuss the implications of the findings from this research for global health research ethics, funders, policy makers and regulators, as well as researchers. This chapter also discusses the limitations of this study, and points to consider in further research.

Part I Literature Review

In this part, which consists of three distinct chapters, I present the literature review pertaining to my research. In the first chapter of this part, Chapter 2, I provide an overview of Dengue, its global burden, its prevention and treatment, and the challenges that the world is facing with regards to its control. I then briefly describe the use of GMM as new strategies for Dengue control. In Chapter 3, I provide an overview of the ethical, social, and cultural challenges associated with GMM research, and focus on community authorization for research as one of the most pressing and challenging issues. In Chapter 4, I present a brief review of the bioethical doctrines that could illuminate the discourse on research in communities and that are relevant to the concept of community authorization, then give a brief overview of models of community approval for research with aboriginal communities. In the last chapter of this part, Chapter 5, I present the methodological considerations that guided the methods I used in this research, and which I describe in chapters 6 and 10.

CHAPTER 2 Dengue and Genetically Modified Mosquitoes

This chapter provides a background review of dengue fever and the challenges related to its prevention. I start by providing an overview of the impact of dengue fever globally, and then review the treatment and prevention modalities with a focus on the new technologies for vector control, namely genetically modified mosquitoes.

1 The Global Burden of Dengue

Since the 1970s, the world has been witnessing a resurgence of arthropod vector-borne infectious diseases such as Malaria, Dengue, Yellow fever, Chagas and others (CDC, n.d.; Gubler, 2004). Vector-borne diseases account for one-sixth of the world’s infection-associated DALY (disability-adjusted life year) estimate, and more than 90% of this number is due to mosquito- borne pathogens (McGraw and O’Neill, 2013). In this thesis I will focus on Dengue for the following reasons, which I will also explain in more detail later in this chapter: 1) Dengue’s incidence is increasing at alarming rates (Bhatt et al., 2013; Guha-Sapir and Schimmer, 2005; WHO, 2009), 2) It is caused by daytime biting mosquitoes, and therefore prevention using bed nets is not possible, as is the case for Malaria (McGraw and O’Neill, 2013), 3) While prophylaxis is effective in preventing Malaria, none exist to prevent Dengue, 4) Dengue, like Malaria, still does not have an approved effective vaccine, though Malaria’s experimental vaccine is at more advanced stages than Dengue’s, which is anticipated in the next 5-7 years (Swaminathan et al., 2010; Gubler, 2011; Coller and Clements, 2011; Halstead, 2012), 5) Dengue’s presenting symptoms are highly non-specific and influenza-like, making its early diagnosis a challenge (Tang and Ooi, 2012), 6) No effective antiviral treatment exists for Dengue, unlike Malaria (WHO, 2009). Even though I focus on Dengue, my research findings are not specific to Dengue, but would apply to all other modified vector trials, as well as to other types of large-scale research where whole communities might be affected (Chapter 16).

Dengue fever is an acute systemic viral infection that is transmitted between humans by Aedes mosquitoes, and causes fever, headache, muscle and joint pains, and skin rash. In some cases it can develop into the life-threatening dengue hemorrhagic fever, characterized by bleeding, low levels of blood platelets, and blood plasma leakage. Dengue shock syndrome is the most severe manifestation characterized by hypovolemic shock and organ failure, including encephalopathy (Tang and Ooi, 2012).

Dengue is the world’s fastest growing vector borne disease with a global distribution comparable to that of Malaria (CDC, n.d.; WHO, n.d.), threatening more than one-third of the world’s population (CDC, n.d.; WHO, 2009, n.d.), and is endemic in more than 110 countries (Ranjit and Kissoon, 2011). The disease has spread in recent years from South East Asia to China, countries in the Pacific Ocean, South America and the Caribbean, and has even caused outbreaks in the tropical and subtropical United States (Gubler, 2010; Morens, 2009). Dengue today threatens other temperate zones in the continental US (Morens, 2009) and might pose a threat to Europe (Reiter, 2010). Recent reports showed increased incidence of Chikungunya infection in the Carribean and the Americas including the US (Weintraub, 2014), which is carried by A. aegypti, the same mosquito that carries Dengue, indicating that Dengue could also be on the rise in these new areas.

The incidence of dengue fever has increased 30 fold over the last three decades and more than a thousand fold in the last sixty years (WHO, 2009) as the number of cases of Dengue infection reported to the WHO increased from 908 cases in the 1950s to 968,564 cases in the early 2000s (WHO, 2009). The actual incidence is estimated to be much higher however, since most of the cases were not reported and more than 20 endemic countries do not actually report to the WHO (Bhatt et al., 2013). While the WHO estimates that each year up to 100 million cases of Dengue Fever occur globally, the actual annual incidence is estimated to be up to 390 million cases, making Dengue the most common vector-borne disease in the world (Bhatt et al., 2013). Dengue infections lead annually to hundreds of thousands of cases of Dengue Hemorrhagic Fever (DHF), a lethal complication of Dengue, and up to half a million hospitalizations with a case fatality rate reaching up to 5% (CDC, n.d.; WHO, 2009). Without proper treatment, DHF fatality rates can exceed 20% versus 1% with optimal treatment (WHO, 2009). While the global case fatality rate has declined recently to less than 1% (Guha-Sapir and Schimmer, 2005), mortality remains high because of the high incidence rates. Moreover, disaggregate data reveal a different picture with

14 rates significantly varying between countries, provinces, or even hospitals (Guha-Sapir and Schimmer, 2005). For example, fatality rates range between 0.5% and 13% across different provinces in Vietnam (Pinheiro and Corber, 1997), and have been reported as high as 40% in Thailand (Tassniyom et al., 1993). The disease burden of Dengue is high and is estimated to be 1300 disability-adjusted life years per million population (Guzman et al., 2010), which is similar to the disease burden of other childhood and tropical diseases, including tuberculosis (Gubler and Meltzer, 1999). As the disease tends to occur in epidemics disrupting whole communities, its economic and social impacts are also enormous (Gubler, 2002).

Unfortunately, Dengue is still a neglected tropical disease (WHO, 2009). As a response to its global public health threat, the 2002 World Health Assembly Resolution WHA55.17 urged greater commitment to dengue among Member States and WHO, and stated that Dengue is a disease with the potential to cause a public health emergency of international concern (WHO, 2006).

2 Dengue: Treatment and Prevention

Dengue fever is caused by four serotypes of the Dengue Virus (DEN-V), arboviral flaviviruses that are primarily transmitted to humans through the infected bites of Aedes mosquitoes, particularly A. aegypti. This daytime biting species is a very efficient epidemic vector because of its close association with humans in urban settings, and its blood feeding behavior (Gubler, 1998a).

To date, there are no licensed antivirals that can be used to treat or prevent Dengue, and treatment remains limited to the management of symptoms (WHO, 2009). Similarly, there are no approved vaccines despite on-going research (Halstead, 2012). This task has proven to be a challenge due to the complexity and the uniqueness of Dengue and its pathogen-host interaction. To start with, the presence of four closely related serotypes necessitates a tetravalent vaccine that is effective against all four types. Moreover, the DENV-host interaction of infection is complex with severe disease being a consequence of sequential dengue infection, viral immune evasion, host antibody enhancement, host immune activation, and genetic predisposition (Thomas and Endy, 2011). Finally, there is a lack of laboratory animal models available to test immune responses to potential vaccines (Thomas and Endy, 2011).

In the absence of effective vaccines, prevention efforts focus on controlling A. aegypti, the mosquito vector that transmits dengue (WHO, 2009). Unfortunately, traditional and available control methods are inadequate, raising the need for new effective ones (Gubler, 2004; Mohammadi, 2010). These traditional methods focus primarily on eliminating mosquito habitats, through emptying natural or artificial water containers where the mosquito can lay eggs (oviposit), or by adding insecticides or biological control agents to these areas (Reiter, 2007). Large scale spraying with insecticides used to be the standard procedure until the 1970s (Gubler, 2005). However, chemical control is increasingly restricted due to its environmental effects, potential human toxicity (Bishopp, 1945; Cox et al.; 2005; Longnecker et al.; 1997), and its non- specific effect causing mortality in non-target organisms, in addition to increased insecticide resistance in many mosquito species (Denholm et al., 2002; Hemingway and Ranson, 2000; Weill et al., 2003). Following the banning of DDT in 1972, mosquito populations quickly rebounded, and unfortunately, effective disease-vector control has been unsuccessful to date, particularly in developing countries (Gubler, 1998b). The reasons for this dramatic global resurgence of epidemic dengue fever are not fully understood (Gubler, 2004). First, it is expected that populations’ explosive growth in urban centers in developing countries was a major driving force (Gubler, 2004). Moreover, migrations, including tourism, and prevalent modern transportation methods, also contributed to secondary transmission (Gubler, 2004; Wilder-Smith and Gubler, 2008). Other major factors include the development of insecticide resistance by the vectors (Denholm et al., 2002; Hemingway and Ranson, 2000; Weill et al., 2003), poor knowledge of the biology of vectors, and inappropriate implementation strategies and failed public health policy (Gubler, 2005). For instance in the Americas, despite guidance and help by the Pan American Health Organization (PAHO) and the US Centers for Disease Control (CDC) to develop prevention and control plans, the response to vector-borne disease epidemics was to apply adulticides, agents that kill adult mosquitoes, via ultra-low-volume sprays, a method that is inexpensive but has little or no effect on disease transmission (Castle et al., 1999; Gubler, 1989)

With ineffective control methods and poor capabilities for mosquito control in endemic areas, it is anticipated that the dengue fever epidemic will “continue unabated for the foreseeable future” (Gubler, 2004). Novel strategies that are selective, targeted, and site-specific and that take into consideration the biology of vector-pathogen-human interactions are deemed necessary (Gubler, 2004; Mackenzie et al., 2004; Mohammadi, 2010; Touré et al., 2003). Innovative vector-control

16 tools such as genetically, biologically, or chemically modified mosquito vectors, which have a reduced ability to carry or transmit pathogens, offer hope to move into a new era of disease- vector control.

3 The New Era of Disease-Vector Control

Today, mosquitoes that are less capable vectors of infectious diseases are on their way from laboratories to villages of developing countries. Biological control of A. aegypti by introducing into its gut an intracellular symbiotic bacterium, Wolbachia, has proven effective in suppressing target mosquito populaiton (Hoffmann et al., 2011; McGraw and O’Neill, 2013; Moreira et al., 2009; Walker et al., 2011). The introduction of Wolbachia to mosquitoes can affect their lifespan and suppress the replication of several viruses. It is even being investigated in Anopheles mosquitoes in attempts to control the transmission of the Malaria parasite (Plasmodium genus) (“Modulating malaria with Wolbachia.,” 2013)

Although issues related to community authorization for mosquito trials have also been important in biological control research (McNaughton, 2012; McNaughton and Duong, 2014), the case studies in this thesis are limited to GMM trials, based on a strategic decision. First, biological control with Wolbachia and GMM are two completely distinct applications, even though both deal with modification of mosquitoes in the hope of controlling Dengue. Wolbachia infection is naturally found and inherited in up to 75% of insects (Hoerauf and Rao, 2007), and the introduction of the bacterium to the mosquito does not alter its nature or genetic profile, as GMM does. Consequently, the concerns associated with both approaches were expected to be different, and the ESC issues associated with research could also be different. On the other hand, there’s a long history of genetic modification and a broad experience with public reactions and debates related to GMOs use and experimentation. Genetic modification has been associated in the conscience of publics all around the globe with heated debates that are emotionally charged and value-laden, and is hence expected to encounter more resistance than biological control applications. In this regard, comparison between the experiences of the two approaches risks associating biological control with GM in uninformed communities, and hence creating unnecessary tension or confusion for stakeholders. For all of these reasons, comparison of experiences between GMM and biological control trials was deemed inappropriate, and I decided

17 to keep the discussion limited to the more contentious GMM trials, where interactions with communities have, to date, been more complicated.

Genetic modification applications seek to manipulate, replace or suppress local populations of mosquitoes. Manipulation or replacement technologies, such as homing endonuclease and Medea-based gene drive, are aimed at reducing the mosquitoes’ ability to transmit disease, but have been criticized for introducing new genes or systems of genes that are reproducible to the ecosystem (Alphey and Andreasen, 2002; Thomas et al., 2000). Suppression technologies on the other hand, produce and use GMM that are not expected to reproduce, by being either sterile or producing a progeny that is destined to die, and so cannot reproduce the mutated genome and remain biologically contained. These suppression techniques have been criticized however for the potential of eradicating species and creating an ecological vacuum that might invite other species and pests to migrate in. One of the most successful suppression control strategies is the Sterile Insect Technique (SIT) (Dyck et al., 2005). This approach, which renders the male insect sterile, typically using irradiation, has been used since the 1950s to eradicate several pests and disease vectors. Using this strategy, overwhelming numbers of sterilized male mosquitoes are released into the environment to compete with wild males to mate with wild female mosquitoes. Since the released males are sterile, mating will not result in any offspring, thus reducing the next generation’s population. The SIT is considered a safe technique, as it is only the female mosquito that bites for food meals, and therefore there is no increased risk of bites or disease transmission by releasing sterile male mosquitoes only. However, irradiation was found to weaken the mosquitoes and hence affect their mating competitiveness in the wild, which can render the technology ineffective.

The establishment of caged-field and environmental release trials of genetically modified insects mark important milestones in the evolution of vector control research and in the war against vector-borne diseases. RIDL Ae. Aegypti GMM strains have been for some years under investigation in caged-fields as well as in open-release trials. Caged-field trials constitute an intermediate research stage between the laboratory and an open release, where a more realistic assessment of the characteristics of modified mosquitoes can be obtained in contained settings in the wild. The potential risks associated with this type of research are mainly related to accidental release and consequent possible dispersal. Open release trials on the other hand, are environmental release of the modified mosquitoes in large numbers, and are usually performed

18 after a risk assessment has been performed and the efficacy of the modified mosquitoes has been proven in the caged-field trials. In the following section, I will elaborate on the ethical, social, and cultural issues associated with GMM experimentation.

GMM carrying a dominant lethal (RIDL) gene are one promising control strategy that is derived from SIT and is currently under investigation for the control of Dengue (Alphey and Andreasen, 2002; Thomas et al., 2000; Wise de Valdez et al., 2011). RIDL is a genetic strategy that uses modern recombinant DNA technology to produce genetically modified mosquitoes homozygous for a repressible dominant lethal gene or genetic system. When RIDL males mate with wild females, their progeny would die unless tetracycline is added to their diet (Alphey and Andreasen, 2002; Thomas et al., 2000). Oxitec developed a genetically modified Aedes aegypti strain (labeled OX513A) with RIDL technology, which was deemed to be sterile, and was tested in release trials in the Cayman Islands, Malaysia, and Brazil. When male OX513A mate with local wild type females, the offspring cannot survive into adulthood, leading therefore to a reduction in the overall A. aegypti population, and supposedly Dengue infection cases (Alphey and Andreasen, 2002; Thomas et al., 2000; Wise De Valdez et al., 2011). I will provide a brief update about how the research has unfolded in each of the settings of my case studies in the respective chapters. A proposed trial of OX513A in Key West, Florida (USA), scheduled initially for January 2012, was cancelled because of opposition of local residents who collected a petition with 100,000 signatures to stop the release (Maxmen, 2012). The release of GMM mosquitoes is also being evaluated in France, Guatemala, India, Malaysia, Mexico, Panama, Philippines, Singapore, Thailand, the USA, and Vietnam (Reeves et al., 2012).

4 Summary

In this chapter, I presented the worsening impact of Dengue globally, and the challenges associated with its control. Dengue, a still neglected tropical disease, is the world’s fastest growing vector borne disease threatening more than one-third of the world’s population and is endemic in more than 110 countries. In the absence of licensed effective vaccines or antivirals that can be used to treat or prevent Dengue, prevention efforts focus on controlling A. aegypti, the mosquito vector that transmits dengue. Unfortunately, traditional and available control methods are inadequate. Today, modified mosquitoes that are less capable vectors of infectious diseases are on their way from laboratories to villages of developing countries. Genetic

19 modification applications seek to manipulate, replace or suppress local populations of mosquitoes, and offer a promise for the control of Dengue. GMM A. aegypti have been tested in caged-field trials in Mexico and in release trials in the Cayman Islands, Malaysia, and Brazil. Further releases also being evaluated in France, Guatemala, India, Malaysia, Mexico, Panama, Philippines, Singapore, Thailand, the USA, and Vietnam. In the next chapter, I review the ethical, social, and cultural challenges associated with GMM research, with a focus on community authorization as one of the most pressing and challenging issues.

CHAPTER 3

Ethical, Social, and Cultural Aspects of GMM Research

In the previous chapter, I presented the worsening global burden of Dengue and provided a brief overview of the scientific advancements in the field of vector control, where GMM A. aegypti presents itself as a promising option currently undergoing investigation. In this chapter, I briefly present the ethical, social, and cultural (ESC) issues associated with GMM research, emphasizing on the need for community authorization for such research, and highlighting thus the significance of my study. While there is some ethical debate over the use of biotechnology for public health advancement and vector control rather than implementing conventional measures (Curtis, 2000; Birn, 2005), there is now wide agreement on the benefit and promise of genomics as a major strategy in the future (James et al., 2001) and hence I will not address this debate in this chapter. ESC issues related to GMM trials can be divided into four categories: 1) Intrinsic issues related to the technology itself, 2) issues related to impacts on the environment, 3) issues related to public health impacts, and 4) issues of political, economic and social nature. Intrinsic ethical issues include ideological concerns about manipulating and controlling nature, such as introducing or creating genes that do not naturally occur (Macer, 2003), or altering the “telos” of the animals (Munro, 2001). Other issues are related to animal welfare and animal rights. For instance there are concerns about manipulating living organisms as means to the ends desired by humans, and without considering the interests of these animals (Macer, 1989, 2005). The other three categories of ESC issues are related to researchers’ ethical obligations to minimize risks, maximize benefits, and respect and safeguard participants’ autonomy and right of self-determination. In the first part of this chapter, I briefly review some of the most important ESC issues associated with GMM research before turning my attention to focus on community authorization as one of the most challenging issues, and which will be the focus of the second part of this chapter.

In GMM trials, as in most environmental research, risks and benefits are collectively and unavoidably shared by the whole community. The shift from research on individuals-based intervention tools for vector control, such as the use of larvicides in water containers or mosquito bed nets, to community-wide application, such as GMM caged-field or release trials, requires

21 therefore greater attention to the ethical, social, and cultural (ESC) aspects and implications of research for involved communities and not only for individuals (Emanuel et al., 2004; Kilama, 2005, 2010; Knols and Scott, 2003; Lavery et al. 2003, 2008; Macer, 2005; Newman, 2006; Singer et al., 2007; Tindana et al., 2007; Touré and Manga, 2006; Toure et al., 2003; WHO - TDR, 2000; Zahabi-Bekdash and Lavery, 2010, Resnik, 2014). Unfortunately, empirical research assessing such communal ESC issues is still lacking. Moreover, although there are many international ethical guidelines and policies governing clinical research and trials, there is paucity of those that effectively guide investigators to steer intervention studies where whole communities may be affected such as trials on GMM (Kilama, 2005; Macer, 2005; Toure et al., 2003). Consequently, scientists working on new GMM technologies are reaching out to experts from different disciplines for advice and counsel on safe, ethical and regulated applications of their technologies in ways that are also mindful of communities (James, 2011), but have been largely left to trial and error (Kilama, 2005, 2010). Alas, the costs of error could be very high, as communities could be exploited, harmed, disrespected, and their interests could be compromised, as I will illustrate in this chapter.

In the following chapter, Chapter 4, I will present a theoretical discussion of the bioethical doctrines that are relevant to the concept of community authorization.

1 Risks and Potential Benefits

There is a wide agreement in most if not all of national and international guidelines on the ethical obligations of researchers to uphold the basic commitment to safeguard the rights, safety, and wellbeing of the research participants (Muthuswamy, 2013). Minimizing risks and maximizing benefits for research participants are two major tenets to uphold this commitment, and remain at the core of ethical assessment of all research trials. In this brief and non-exhaustive section I provide a summary of the most important risks and potential benefits that could be associated with GMM trials, and measures suggested or required to optimize the risk/benefit balance.

The most important potential benefit of successful GMM trial would be the production of effective, safe, and cost-efficient tools for vector-control. Public health benefits could also be compounded by decreased insecticide use. These advancements wouldn’t only help in promoting public health locally and globally, but would also have economic benefits to countries using the

22 technology, taking into consideration the high costs of current ineffective vector control programs as well as of Dengue treatment and loss of productivity. Moreover, it could be argued that host communities could benefit from post-production profit sharing, and through building their knowledge economies.

On the other hand, the concept of risk is generally understood to refer to the combination of the probability and magnitude of a future harm. There are myriad risks that are associated with GMM research. However, although many risks can be identified the magnitude and likelihood of these risks remain unknown, and many other risks remain undetermined. Risks could be of environmental, public health, social, economic, or political nature. Environmental ESC issues concern the risks of GMM on other species and the ecosystem. These include concerns about interbreeding and hence horizontal gene transfer to other species, impacts on non-target predator species (Resnik, 2014) and affecting the ecological food chain, and hence creating ecological vacuum by eliminating the target mosquito population and inviting other non-native species to fill in. Public health risks on the other hand include the horizontal transmission of the mutated genes to humans, increased transmission of other diseases (Marshall and Taylor, 2009), or increased virulence of the Dengue pathogens (James et al., 2011).

Research risks of political, social, and economic nature are now being increasingly recognized and included in risk assessments. For example, shifts in public health budgets and agendas can occur because of misunderstandings of the role and scope of the GMM research leading to depriving host communities from essential services such as medical treatment for Dengue or mosquito control and waste disposal mechanisms. Moreover, residents of the areas where research is undertaken might be stigmatized for being ‘infested’ with Dengue or in contact with GM ‘creatures’, and possibly, their crops would be avoided for fear of contamination or their areas would be avoided (travel and tourism). Social and political disruption might also occur. For example, some households might feel left out if they were not chosen for experiments. Or, trust in community leaders might be jeopardized if these leaders approve the trials while some families are opposed to them.

The first consideration in the assessment of risks and potential benefits concerns whether the host community for the trials is appropriate, that is where Dengue is a major public health problem and where the use of the technology would be accepted for Dengue control (Lavery et al., 2008).

In other words, the research should be relevant and expected to produce important social benefits that would outweigh any potential harms (Macer, 2005; Resnik, 2014). For instance, it was argued that selecting Key West, Florida as a study site for the release of GMM was not appropriate because Dengue was not a significant public health issue (Resnik, 2014). Similarly, the Cayman Islands did not have a significant Dengue incidence at the time of the trials (Chapter 12). Lavery et al. (2008) provide a detailed list of ethical, social, and cultural considerations for site selection for GMM trials, and includes the regulatory requirements that need to be in place to maintain protections and overview for host communities.

In addition to scientific criteria related to local mosquito epidemiology and feasibility of the trials, appropriate site selection should also aim for geographical isolation in order to localize harms or ‘adverse effects’ of research (Core Working Group on Guidance for Contained Field Trials, 2008). Moreover, impacts can be minimized by conducting pilot studies, starting in caged-fields, then in small open releases, before attempting riskier and larger trials (Core Working Group on Guidance for Contained Field Trials, 2008; James et al., 2011).

Other suggested safeguards include regular monitoring of participants and offering free treatment in case of disease outbreaks (Resnik, 2014) as well as putting in place contingency plans for mitigating adverse events (Kilama, 2010).

2 Autonomy

Respecting research participants’ autonomy is recognized as a manifestation of their right and entitlement not to be treated as means to an end. Informed consent for research has been traditionally recognized as one of the most important safeguards for protecting participants and for respecting their autonomy. One of the most critical and challenging ESC issues associated with GMM research involves the types of consent and authorization processes that are required from the community for GMM trials to ethically proceed (Macer, 2005; Kilama, 2010; Lavery et al., 2008; Zahabi-Bekdash and Lavery, 2010). Kilama describes the “The consent process in such studies… [as] mind-boggling” (Kilama, 2010). Many questions challenge researchers, as well as overviewing agencies, including who would be considered research participants, who would need to provide approval for trials, and how would approval be operationalized.

The questions “what constitutes community authorization to begin and proceed with GMM trials” is partly answered, as it is widely recognized and legally required in many countries that a formal regulatory approval, establishing biosafety and biosecurity, be secured from the relevant governmental agencies before any vectors field research could begin, especially before any potential release (Beech et al., 2011; Touré et al., 2003). Nonetheless, the reactions to the release of GMM in the Cayman Islands (Chapter 12) clearly demonstrate that a regulatory approval from the government was not sufficient to warrant conducting the trials, and that some form of approval from the rest of the community was also needed (Cayman News Service, 2010c; Enserink, 2010; Science/AAAS, 2010).

Ethical considerations related to the conduct of research traditionally focus on the protection of individuals who would be considered “human research subjects”. The International Ethical Guidelines for Biomedical Research Involving Human Subjects as well as International Ethical Guidelines for Epidemiological Studies by the Council for International Organizations of Medical Sciences (CIOMS), define research as any study that manipulates an individual's social or physical environment, and implicitly consider that individuals who may be directly affected by public health interventions that manipulate the environment are considered human research subjects. The CIOMS guidelines state:

“Research involving human subjects includes: studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures… Research involving human subjects may employ either observation or physical, chemical or psychological intervention… The research may be concerned with the social environment, manipulating environmental factors in a way that could affect incidentally-exposed individuals” (CIOMS, 2002)

Accordingly, all individuals living in the vicinity of a trial field in the host community would be required to provide informed consent to authorize the trial. Recent scholarship however explains the historical conditions that led to the use of the environmental manipulation clause and recommends a narrow reading where an individual would be considered a research subject only if the environmental manipulation is “designed to produce a direct effect on that individual” (McRae et al., 2011a, 2011b), that is if the individual is “subjected to an action by the investigator” (National Bioethics Advisory Commission, 2001). This is in line with the definition

25 of the Common Rule, or the US Federal Policy for the Protection of Human subjects, where human subjects are the individuals about whom an investigator conducting research obtains data through intervention or interaction or collects identifiable private information (CFR - “United States Department of Health and Human Services,” 2005). In GMM trials, it was argued that examples where informed consent would be needed from individuals include Mark-Release- Recapture experiments where mosquitoes marked with a fluorescent marker are released in individual homes and then mosquito collection is conducted after a period of time to track movement patterns and estimate survival rates or other factors (King et al., in press; Resnik, 2014).

Nonetheless, how can researchers protect as well as respect the autonomy of other individuals in the community who are not considered research subjects even if they can be affected by the research? Since the GMM trials are conducted at the community level, it is impossible to allow individual members of the community to exercise their autonomy to participate or withdraw from research. In these cases, “individuals cannot act independently” and “the autonomy principle is lost” (Edwards et al., 1999). McRae et al (2011b) provide a reasoning with relation to cluster-randomized trials, and resort to the provisions for a waiver of consent found in many research ethics guidelines (CIOMS, 2002; Department of Health and Human Services, 2005; National Health and Medical Research Council et al., 2007, TCPS, 2010) to conclude that a research can ethically proceed without the consent of all potentially affected individuals only if it involves no more than minimal risks, and will not adversely affect the rights and welfare of the subjects. They also allude to the condition of approval from “gatekeepers” or representative bodies, found in the United Kingdom Medical Research Council guidelines on cluster randomized trials (Medical Research Council (UK), 2002). Resnik (2014) suggests two related scenarios to deal with this issue. The first is to enroll everyone in the community in the trials as research subjects, and thus secure informed consent from all individuals. However, he admits that this option is not logistically feasible and may not even be possible. Therefore he recommends that if public health benefits are important enough to impose the research risks on individuals without their “informed consent”, for example if the disease is a major public health issue in the area, then the research can proceed if these conditions are met: Researchers should 1) obtain approval from political leaders, public health agencies and other relevant bodies, 2) inform the community about the trials through media, 3) provide basic information about the

26 study along with contact information, and 4) make treatment available for research related diseases (Resnik, 2014).

Three intrinsic problems can be found in these analyses. First, risks’ probabilities and magnitudes remain a speculative exercise in these trials, and hence an objective risk/benefit analysis cannot be confidently attained to warrant imposing the research risks on the host community. Second, these analyses may represent too “technical” an analysis of the prevailing research ethics standards, and thereby dilute the spirit of informed consent requirements (King et al., in press), which relates more to respect of persons than to legal requirements. Third, they adopt a parochial view that focuses on individuals and overlooks the interests of the community as a whole (Chapter 4). Nowadays, there is an increased recognition of communities as ethical entities entitled to be respected and protected from harm (Levine, 1982, McCarthy, 1993, Weijer, 1998, 1999, Weijer and Emanuel, 2000). Consequently, communities are accorded a moral status whereby their wishes and interests must be taken seriously (Weijer, 1999). Communities can be harmed as collectivities (Lehrman, 1997, Weijer, 1999, Weijer and Emanuel, 2000), even when individuals are not ‘individually’ affected, and hence are entitled to certain protections (Chapter 4). "It is the group's collective autonomy that is challenged if researchers, with the informed consent of only a few individuals in the group, can probe for information about the whole group" (Greely, 1997: 1431).

Before I discuss the literature pertaining to community authorization, it is important to explore what is meant by ‘community’. The meaning of community challenges many researchers in community-based research enterprises. The lack of an accepted and unified definition of community has even been suggested as an obstacle to realizing the benefits of participatory approaches in health research; different collaborators can result in contradictory or incompatible assumptions and input, and inappropriate representation can inter alia undermine the legitimacy and the local acceptance of research results. Nonetheless, as I will explain below, scholars are moving into more holistic definitions that reflect the complexities of modern communities, that are at the same time workable in research settings. Literature review of more than 154 early community definitions in social sciences revealed geographic area, social interactions and common ties as shared essential elements of community life (Hillery, 1955; Willis, 1977). Shared actions and political responsibility were also implicated as defining characteristics of a community (McKeown, 1987; Patrick and Wickizer, 1995).

Brunger and Burgess (2000) argued against defining community by a single characteristic and are in favour of a continuum based on the use of multiple criteria. MacQueen et al for example, through a case study in which they interviewed 108 individuals belonging to four different groups on the meaning of community, defined community as a “group of people with diverse characteristics who are linked by social ties, share common perspectives, and engage in joint action in geographical locations or settings” (MacQueen et al., 2001). Etzioni considers that in modern times the term ‘community’ has become more holistic and has expanded to encompass individuals tied together by shared identity, ethnicity, race, religious, background, or sexual orientation among others, and who can belong to different communities concurrently (Etzioni, 2011a, 2011b). Communities can also be nested within more encompassing communities, such as local ones within the national one (Etzioni, 2011a, 2011b). In the context of healthcare and health research, Patrick and Wickizer (1995) offered a working definition of community, as the “entire complex of social relationships in a given locale, and their dynamic interaction and evolution in working toward [the] solution of health problems”. This definition provides a guiding principle for identifying relevant stakeholders. Brunger and Weijer (2006) focused this definition with relation to research, and considered that a community consists of all those individuals who share identified risks and/or will benefit from the outcome of the proposed research, but clarified that it is not a pre-existing entity but rather takes form progressively and evolves continuously in response to research. Lavery et al. (2010) coalesced these concepts and asserted that a community is the collection of all individuals and organizations that hold legitimate interests in the conduct and/or outcomes of a given study (King and Kolopack, 2013, King et al., in press, Lavery et al., 2010). These may include various community leaders in the neighbourhoods and communities who agree to host the trials and who may have stewardship interests; local, regional, and national official authorities, which may have a responsibility to promote public health or develop research capabilities nationally or locally, residents who open their homes to facilitate the conduct of the trials have clear privacy and safety interests; and homeowners in neighbourhoods adjacent to release sites who may have concerns about their safety or about the impact on their property values. Other potential interest- holders include members of the scientific community, and NGOs or individual citizens opposed to, or wary of, these new technologies (King et al., in press).

Some of the initial discussions of the ethics of research involving GM insects have emphasized the consent of the participating communities as a key requirement for the ethical conduct of research (Enserink, 2010; Kilama, 2005, 2010; Knols, and Scott, 2003; Lavery et al., 2008; Macer, 2005; McNaughton, 2012; Resnik, 2014; Tindana et al., 2007a; Touré and Manga, 2006; Zahabi-Bekdash and Lavery, 2010). The need for authorization from host communities in addition to regulatory approval has been demonstrated in examples from GM research around the world, as I will explain below and in subsequent chapters. In contrast with existing and standard consent procedures where individuals decide whether or not to use individual-based tools such as an insecticidal mosquito coil or bed net (Knols and Scott, 2003), a community consent is thought to be a process in which the community decides collectively, after appropriate information and due consideration, whether to participate in the research (Lavery et al., 2008). There is still considerable debate however about what is meant by a community decision to participate in research (Senituli and Boyes, 2007). International research ethics guidelines remain ambiguous about the kinds of collective formal and informal authorization processes that are required from local communities for research to be undertaken ethically, and about their timing, extent, and procedures (Macer, 2005). For instance, the international guidelines for Ethical Review of Epidemiological studies (WHO, 2008), recognizing the difficulty of obtaining individual informed consent in such studies and in the absence of empirical evidence or established guidance, allows for ‘flexibility’, providing investigators with little practical guidance and leaving them to trial and error (Kilama, 2005). Investigators are also challenged by questions about the meaning of informed consent in communities that are largely unfamiliar with vector biology, genetic modification and often the role of mosquitoes in transmitting disease (Marshall and Taylor, 2009). Kleinman (1999) suggested that processes for seeking community ‘consent’ need to be developed for each community, while Greely suggested that consent should be sought from “[C]ulturally appropriate authorities within the community, where such exist, or through consensus of the entire community, where there are no relevant authorities (or where a consensus is the culturally appropriate authority)” (Greeley, 1997: 1431).

‘Authorization’ for research embodies communities’ entitlement of self-determination, and hence enables host communities to protect their interests and values from being compromised due to research harms. Community consent was thought to add extra protections to vulnerable communities in situations when the results of a research projects may have implications for

29 everyone in a community and not just those individuals who participated in the research as subjects (Foster et al., 1999). Inability to secure authorization for research could result in many ethical, social, and cultural (ESC) problems. First, the possibility of abuse and exploitation can never be overlooked, especially in developing countries where regulations might not be in place to protect individuals and their communities. Even with good intentions, failure of projects to get authorization from involved communities in the absence of requirements for authorization in international and national ethical guidelines can set precedents for other abusive projects to take advantage of vulnerable communities in places where oversight is lacking. Moreover, to conduct a trial without the community’s authorization, is forcing that community to be subject to risks, and disrespecting its members’ rights of self-determination.

These concepts permeated the literature following the previously unannounced release of GMM in the Cayman Islands (Chapter 12). A surge of papers and articles immediately appeared, criticizing the scientists responsible for the releases for not engaging the local communities, and calling for empirical research to guide scientists on how to inform, communicate with, consult, and “win the hearts and minds” of local communities (Enserink 2010). These articles appeared in peer-reviewed journals such as Science and Nature (Enserink 2010, Subbaraman 2011), local media expressing the position and opposition of local community groups (Cayman 27, 2010b), and websites of global non-governmental organizations and advocacy groups (Nightingale, 2010; Wallace, 2010). Similar accusations of disrespect and colonialism faced a related GMM project in Malaysia, conducted by Oxitec and the Malaysian Institute of Medical Research (Chapter 13). While the community was aware of the project, community groups criticized the project for not gaining their consent (CAP and SAM, 2010; Malaysian NGOs, 2010). The message in both contexts was unified: The international scientific community, as well as local and regional communities and groups, did not criticize the science or the research itself, but criticized and opposed the manner in which the public and community engagement was handled.

Finally, the lack of authorization could be one of the most important challenges for successful application and implementation of potentially beneficial and life-saving technology. (Berndtson et al., 2007; Daar et al., 2007; Singer et al., 2007). Even with great scientific success, programs could fail if the needed relationships are not formed with the community (McGraw and O’Neill, 2013). An example is an earlier incident in the early 1970s, when WHO carried out releases of

SIT mosquitoes in Delhi, India. Opposition and accusations of imperialism arose by the unengaged community because of inaccurate reports by the media, leading to prematurely terminating the promising programme (Curtis and Von Bostel, 1978). Also, as I will explain in more detail in Chapter 13, local opposition in Malaysia to the proposed GMM release by the Malaysian Institute of Medical Research and Oxitec, delayed regulatory approval and complicated the release, even when the trials were undertaken in collaboration with the government (AFP, 2011). The recent developments for the proposed trials in Florida, USA are another example (Maxmen, 2012). On the other hand, unsuccessful experiences in one setting have the potential of impacting negatively the way other communities perceive GMM research

“[Guy Reeves from the Max Planck Institute for evolutionary biology] so vehemently opposes Oxitec's rash field trials: He believes they could trigger a public backlash against this relatively promising new approach, thereby halting research into genetic modification of pests before it really gets off the ground. He's not alone in his concerns. "If the end result is that this technology isn't accepted, then I've spent the last 20 years conducting research for nothing," says Ernst Wimmer, a developmental biologist at Germany's Göttingen University and one of the pioneers in this field” (von Bredow, 2012).

3 Summary New GMM technologies aimed at controlling the Dengue scourge are associated with many intrinsic and extrinsic new ethical, social, and cultural challenges. Extrinsic issues are related to researchers’ ethical obligations to safeguard the rights, safety, and wellbeing of research participants and were the focus of this chapter. One of the most pressing and challenging ESC issues involves the authorization processes needed from involved communities to ethically begin and proceed with GMM trials. To overlook or forego this crucial aspect undermines the fundamental principles of protection and respect at the core of any scientific endeavor, and risks harming communities directly or indirectly. Moreover, the lack of authorization could be one of the most important challenges for successful application and implementation of potentially beneficial and life-saving technology.

The need for authorization from host communities in addition to regulatory approval has been demonstrated in examples from GM research around the world. International research ethics

31 guidelines remain ambiguous however about the kinds of collective formal and informal authorization processes that are required from local communities for research to be undertaken ethically, and about their timing, extent, and procedures.

CHAPTER 4 The Individual, Community, and GMM Trials

In this chapter I elicit the literature on bioethical theoretical models that could provide background information relevant to GMM trials. I do this task for two reasons. The first reason is to build the case for the significance of my research question from a bioethical perspective. The second is to show that while some ideologies give more attention than others to communities in research, and while we can draw a lot of insights from these ideologies, none of the available bioethics models fully answers my research question, or provides practical guidance, and therefore an empirical rather than a theoretical approach is the most appropriate, as I will explain in the following chapter, Chapter 5. In the spirit of a Grounded Theory approach, literature review done for this chapter was initiated after the data analysis was completed and the empirical account of authorization was built.

The key problem I address in this thesis is to help shed light on what it might mean for communities to authorize, in an ethically meaningful way, the introduction of GMM. At the core of this problem lie two important questions. The first revolves around who would be considered the moral agent to make such ethical decisions, the individual, the community as a whole (although this concept is not well defined), or a combination of constituents. This question remains one of the main disagreements between models upholding universalism or those upholding relativism, namely individual liberalism and communitarianism respectively, as I will explain in this chapter. The second question involves the procedures that need to be followed and the actions that need to be taken or accomplished to reach and signify authorization. This question is one of the most important practical challenges to researchers working with communities.

This chapter consists of three parts. The first two parts are a conceptual discussion, while the third and last part presents a pragmatic application of community authorization for research from the context of Aboriginal communities. In the first part, I explore the two major thought movements that guide modern bioethics and that are relevant to my research question, liberalism and communitarianism. In the second part of the chapter, I explore a liberal communitarian perspective, which balances individual rights with those of the community, and at the same time

33 provides a tool for deliberative decision-making and consensus building processes, which might prove valuable for community authorization for GMM. In the third part, I review the main and probably only established application of research ethics in the context of communities, where I review the models developed for ethical research in aboriginal communities and look for insights applicable for GMM trials.

1 Individuals, Community, and Decision-Making

In this first part of the chapter, I explain the theoretical underpinnings of the two major bioethics ideologies or models that could be helpful for my research on authorization, namely principlism and communitarian bioethics. I show that paradigmatic differences lie at the heart of the debate over who can and should make decisions about science and technology, contrasting individual consent with a community authorization. I also explore how these two models might illuminate our thinking about community authorization.

Current times have witnessed a shift in bioethical discourse from the application of philosophical theories to framing ethical issues through political theories with bioethicists often labeled “liberal” or “communitarian”, based on their views of the relationships between the individual and community (Sutrop, 2011). The divergence between the two ideologies is summarized by philosopher and bioethicist Mark Kuczewski: “Liberal individualism presupposes that the individual is the original and primary unit of social organization, and that liberties enable the individual to determine and pursue his own vision of the good life. This volitional view of the person is in sharp contrast to the communitarian’s cognitivist view of the person, which understands the good as something that is discovered or apprehended in communal dialogue” (Kuczewski, 2009). Before I turn my attention to the communitarian view of the relationship between the individual and the community, and hence the role that each can play in authorizing research trials, I will provide a quick overview of principlism and explain why it might not be a useful approach for authorizing GMM trials, especially in developing countries.

1.1 Principlism and The Individual

Liberalism enjoyed a long period of dominance in bioethics, manifested in principlism, or the four-principle approach. This approach has been one of the most widely used methodological

34 tools for the resolution of ethical dilemmas in the modern bioethical arena, as a set of clear and simple middle-level principles of more pragmatic utility than high-level moral theories such as deontology or utilitarianism (Callahan, 2003a). Its historical roots started in the wake of the outrage at the discovery of Nazi doctors trials, which led to the creation of the Universal Declaration of Human Rights and the Nuremberg Code. The aim was to make “transcultural, transnational, and transtemporal moral and legal judgments” (Baker, 2001).

With the news of the U.S. Public Health Services Syphilis trials in Tuskegee, these codes were deemed insufficient to protect human subjects from coercion and abuse for the sake of the public interest, especially in an era of cold war realism and push for science and technology development. The outrage caused by the news of Tuskegee, coupled with the environment of the liberation and civil rights movements in the 1960s and early 1970s, fueled and energized politically and intellectually a bioethics model that was intended to empower patients against paternalistic Hippocratic medicine, and afford the highest respect to the autonomy and privacy of every individual (Reich, 1995; Tauber, 2005). The Belmont report was published in 1979 (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978), with its three basic principles: Respect for persons, beneficence, and justice. These principles were featured with some modification and addition in the Beauchamp and Childress’ seminal book in bioethics, “Principles of Biomedical Ethics” published in the same year (Beauchamp and Childress, 1978, 2013). Now in its seventh edition, the book defines the model that dominated biomedical ethics teaching and practice, and present the four most famous principles: respect for autonomy, beneficence, non-maleficence, and justice. The moral and legal implications of the four-principle approach were an overemphasis on the requirement of informed consent. Consequently, the requirement of informed consent was codified as the most important principle in various international documents, such as with the Belmont report, the WMA Helsinki declaration and the Oviedo convention, and reaching a recent international document, the UNESCO declaration on Bioethics and Human Rights (UNESCO, 2005).

In application, the principlist approach implies that as researchers pilot new treatments or technologies, individuals must be able to give their free and informed consent to obtaining the potential benefits and being subject to potential harms by participating in research. The central question that bioethicists ask regarding any proposed technology is whether it will cause some obvious injury to identifiable parties who have not given full and free informed consent, in which

35 case the technology must be regulated. Theoretically, if harms are not significant or are justifiable, and full and free informed consent to research can be given, then the technology can proceed. However, as subjects might not be capable to evaluate the technical information that goes into a risk-benefit analysis, the regulatory bodies and overviewing committees would aim to enhance the potential subject’s autonomy by ensuring that the scientific basis of the research is sound and the information provided to individuals is clear and complete (Kuczewski, 2002).

With respect to GMM trials, this approach suggests that if regulatory agencies authorized the research based on favorable risk-benefit calculations, the next step would be to seek informed consent from affected individuals. Theoretically, all individuals living in the vicinity of a trial site are compellingly affected by the research (although the boundaries of the vicinity could also be contested). In the previous chapter however I briefly presented the current discussion in bioethical spheres about this issue where only individuals in whose homes experiments are conducted (such as Mark-Release-Recapture experiments), or from whom biological or social information is withdrawn, are considered human subjects of research and hence need to provide informed consent. Extension of liberal democratic processes also implies two scenarios. The first is based on the assumption that elected officials represent the population and can take such decisions in proxy, and hence a regulatory approval supplemented by consent from community leaders might be considered sufficient. This view is encountered in most contemporary bioethics views on the topic of GMM (Macer, 2003, 2005; Resnik, 2014, Touré et al., 2006). The second scenario would call for public votes or referenda on the proposed technology or trial (Kilama, 2005). In following sections, I will argue from a theoretical perspective that both these scenarios are not appropriate for authorizing GMM trials that could affect the whole community.

Modern bioethics has been criticized of misguidedly “absolutizing” and prioritizing the respect for individual autonomy and freedom of choice as the most important universal ethical principle at the cost of other important principles, while relegating responsibility to each other, solidarity, and equity to the background (Callahan, 2003a; Campbell and Lustig, 1994; Engelhardt, 2005; Hellsten, 2008; Kuczewski and McCruden, 2001; Sakamoto, 1999; Sutrop, 2011). Several critics have convincingly shown that the major mistake of liberal bioethics has been too narrow an understanding of merely individual liberty or self-determination (Sutrop, 2011). This conception of autonomy ‘rests on a picture of the person as a separate being, with a distinctive personal point of view and an interest in being able securely to pursue his or her own conception of the

36 good’ (Blustein, 1993), which is seen as a false conception of human beings as “unencumbered” and independent selves, disregarding the moral importance of commitments and obligations that arise from shared history, values, and communal ties (MacIntyre, 2007; Sandel, 1984).

Beauchamp and Childress in fact emphasize that the principle of respect for autonomy is not absolute, but “has only prima facie standing and can be overridden by competing moral considerations”, such as those based on harm to others or the community (Beauchamp and Childress, 1978, 2013). Childress describes the principle as limited, as it does not disregard the influence of authority and tradition on personal decisions, and is rather a “principle of obligation”, because it calls to respect the autonomy of others (Childress, 1990). Gauthier states that respect for autonomy, within the limits described above, is a fundamental component of a pluralistic democratic society. He adds that the exercise of self-determination should be guided by an internalized sense of moral responsibility, that serves the important purpose of calling our attention to our effects on the world, our obligations towards others, [and that] also acts in harmony with and to further the community’s interests and goals” (Gauthier, 2000). To be morally responsible is to be responsive to the world, to the community in which we are members, and to our relationships, obligations, and the outcomes of our choices and actions on others in that community (Gauthier, 2000; Nussbaum, 1990). Many theorists actually believe that communities need more than individual autonomy for the flourishing of the common as well as the individual good, but the solution is not to abandon the autonomy discourse totally, but to make it only a part of the discourse (Murray, 1994).

1.2 Beyond Informed Consent: Communitarian Bioethics

Principlism, dominant in American bioethics, has been found by some commentators to be too parochial to be of use on a global level (Baker, 2001). It has been criticized for not being sensitive to different cultural, economic, social, and morally relevant perspectives from different contexts, disregarding familial and communal human relationships, and overemphasizing instead individual rights (Levine, 1988).

Many scholars have consequently called for the inclusion of respect for communities as a fundamental ethical principle that has been overlooked by the individualist approach (Levine, 1982, 1988; McCarthy, 1993, Weijer, 1998, 1999, Weijer and Emanuel, 2000) etc). Weijer et al. explain that the principle of respect for communities requires researchers to respect the values

37 and interests of the community in research, and to protect the community from harm when possible (Weijer et al., 1999). Many societies in Africa, Asia, and Latin America, place the person’s close environment, in particular the family, and sometimes even the whole community at the core of decision making (Fan, 1998; Fan, 1997; Finkler, 2008; Sakamoto, 1999). In most of these countries, individuals do not practice self-determination in the same way as promoted by the individualist Western medical ethics. Instead, the decision-making is based on values of social responsibility, solidarity, and egalitarianism (Fan, 1998; Hellsten, 2008; Sakamoto, 1999). It follows that the family as a whole, even the extended, and in some cases the whole community is expected to be part of decision-making (Fan, 1998; Finkler, 2008; Hardwig, 1990; Yu and Fan, 2007). These collective decisions are influenced by two considerations. On the one hand, the whole community has the obligation to care for the individual, including helping in taking decisions, and on the other, the common good has to be preserved (Fan, 1998).

The notion of the common good is at the heart of Communitarianism. Communitarianism is founded on Aristotelian virtue ethics and holds that “the whole is of necessity prior to the part” (Aristotle, 1996). It is a model of political organization that stresses social ties of kinship and a sense of common purpose and tradition (Blackburn, 1996), prioritizes the role of the community and social context in all decisions and choices (Kuczewski, 1997), and implies that public policies should be based on communal values, the common good, social goals, traditional practices and the cooperative virtues (Beauchamp, 1994) which would be determined by deliberation and consensus (Kuczewski, 1997).

The common good, which pertains to the ‘whole’ refers to “a good proper to, and attainable only by the community, yet individually shared by its members” (Dupre, 1993). It refer to those goods that serve as shared assets for a given community, such as preserving monuments, protecting the environment, and promoting public health (Etzioni, 2011a). Contributions to the common good often offer no immediate benefits to any one individual, and it’s often impossible to predict who will benefit from them in the long run (Etzioni, 2011a). Samuelson’s (1954) classical definition provides a similar but more pragmatic conceptualization of the concept of common good, by referring to two criteria:1) the benefits of public goods are “nonrivalrous in consumption”, that is one person or group’s use does not preclude another’s, and 2) they are “nonexcludable”, that is no one can be exluded (Knoppers, 2005, Samuelson, 1954, Sandler, 1997). The common good is therefore at once communal and individual, it is not the sum of individual goods, but rather

38 transcends the goals and purposes pursued by people in their interpersonal and social relationships.

We can infer that all benefits resulting from GMM trials, such as protection from vector-borne diseases would add to the common good in a nonrivalrous and nonexcludable way, while most harms would impact it negatively. Thorsteinsdóttir et al (2003) in fact argue that GMM can even be considered global public goods, in the sense that they posses properties of ‘publicness’ (being public) across national boundaries (Kaul et al., 1999). The incidence of vector-borne diseases would be expected to be reduced both in the region where the trials are conducted as well as in other regions to which the mosquitoes spread. Others have also argued that the global public good concept may be most useful applied to just two aspects of health, research and development, and communicable disease control (Smith et al., 2003; Smith and MacKellar, 2007). GMM trials belong to both aspects. Nonetheless, it is logical to assume that benefits and harms are expected to be mostly experienced in host communities, and even here some harms could affect certain groups of individuals more than others. For example, should there be any regional or international aversion of agricultural produce from the community because of the presence of GMM, farmers would be affected most.

Callahan uses an interesting metaphor that he borrows from ecology, and with which scientists working on GMM are most familiar. When a new species is introduced into the environment, the central issue is not how well it will individually flourish, but what it will do to the network of other species. Similarly, communitarianism has at its core the view that the individual is embedded in a context of social and cultural relationships and interdependence, but never an insulated person (Callahan, 2003a; Gostin, 2002; Ogunbanjo and Knapp van Bogaert, 2005). Individuals rely on others for health and security, and gain value from being a part of a well- regulated society that seeks to promote common good and prevent common risks (Gostin, 2002). Emanuel asserts that “communitarianism [is] a philosophy that incorporates the truths of utilitarianism and liberalism, but transcends both by arguing that ethical problems can be resolved only by accepting a public conception of the good life while rejecting the conception of the good particular to utilitarianism” (Emanuel, 1987). It is set in contrast to the social contract model that regards society as a cluster or aggregate of individuals who determine the governing principles of the political order of their choice based on contracts establishing rights and obligations (Gyekye, 1997). The welfare of the society as a whole, encompassing the traditions,

39 practices, values, political institutions and culture commitments of a society, is the point of departure in any decision/choice consideration (Callahan, 2003a).

Communitarianism therefore implies a social rather than individual starting point for ethical analysis, and ascribes great importance for substantive reflection about ends and goals (Callahan, 2003a). Communitarians hold that while liberal individualism is a valuable part of human culture, communitarianism should be allowed the “opening bid”, that is the first ethical questions always to be raised should concern the potential societal and cultural impact and meaning of a possible decision, even in cases that seem to affect individuals only (Callahan, 2003b). Based on the above, and since the community is not simply an aggregate of individuals but a network of interrelated and interacting relationships, a communitarian would consider that community authorization for research is not a sum or collection of individual informed consents, nor the totality of votes and referenda.

Callahan summarizes the communitarian perspective on the introduction of new technologies or the deployment of old ones by its predilection to ask first the question “what will the technology mean for all of us together” or for the whole community. Such an approach is thought to turn upside down the working presumption of liberal individualism, especially when new technologies are evaluated and before hard evidence is available for any potential harms. The next questions will turn to individuals addressing the technology’s meaning for them, and 1) whether the technology is sufficiently compatible with the common good and adds to it positively through its potential benefits to permit its use, and 2) if not, whether it should be nonetheless permitted on the premises that a good society may occasionally tolerate potential harms to itself for the sake of accommodating the special needs of some of its members (Callahan, 2003a).

When biomedical developments, theoretical or applied, are expected to affect the welfare of the community as a whole, then it is appropriate and required to initiate a communal discussion of the common good. Inclusivity and democratic participation are key (Callahan, 2003a). “Only if we believe that there will be no socially coercive or inadvertent culture-shaping consequences of present and forthcoming medical technologies can we deny the need to take common, and not just individual, responsibility for the deployment of a bio-medicine that can change just about everything in our lives” (Callahan, 2003a). Some even argue that informed consent procedures

40 are inapplicable whenever the benefits to be provided are public goods (O’Neill, 2004). Greely (1997), writing in the context of genetics research, argues that when research is about groups or affects groups, the notion of individual autonomy is “artificial”.

Authoritarianism however is a major criticism against communitarianism and the greatest fear of liberal individualism (Etzioni, 2011a) in addition to moral relativism (which I will not cover in this chapter). It is feared that “shifting the focus toward community often leads to the abandonment or restriction of respect for individual autonomy and overemphasis on the common good” (Sutrop, 2011). Beauchamp and Childress caution against the control by influential groups or governments under the pretext of communal values, and consider that the major reason for the prominence of the individual rights is that they “stand as a shield against communal intrusion by governments” (Beauchamp and Childress, 1978, 2013). An important task is to carefully analyze who is defining the public interest or the common good, and to show that giving a high value to public interests or the common good, can take place without the cost of violating individual autonomy or individual protections. “It is arguably neither morally nor practically feasible to expect individuals to show solidarity in the absence of such protections” (Sutrop, 2011). Would it be acceptable for example for community representatives or official authorities to make decisions to sanction GMM trials based on their own interpretations about and views for the common good? When GMM trials are approved, what are the implications to those individuals who are opposed to the introduction of GMM into the environment, and feel coerced by the majority? Also, would individuals feel obliged to facilitate the trials, such as accepting the use of their homes for mosquito collection or release, because the community as a whole authorized it?

Unfortunately, the classic conception of communitarianism doesn’t provide solution to these potential problems. In fact, communitarianism can lead to a similar unwanted outcome of liberalism, by imposing an ethic on an unwilling minority by the majority.

2 Towards a Constructivist Approach: Responsive Communitarian Bioethics

In the first part of this chapter, I explored the two major bioethical doctrines that could be relevant to authorization for GMM trials, as well as other research that involves the whole community, namely Principlism and Communitarian Bioethics. I also showed that both

41 ideologies have shortcomings when it comes to balancing the respect and protections to both individuals and their communities. In this part, I present a third approach, the responsive or liberal communitarian bioethics. I draw mostly in this part on the work of Amitai Etzioni ( Etzioni, 1998, 1999, 2011a, 2011b; Etzioni, Bader, and Communitarian Network, 2003) and Mark Kuczewski (Kuczewski, 1997, 2001, 2002, 2009).

As suggested by the previous discussion, a balance between autonomy and social or community control is seen as essential by many commentators (Gaylin and Jennings, 1996). Responsive or Liberal Communitarianism aims to achieve this balance, by adding the concern for the common good to the already existing core values of liberties on which western bioethics draws, and seeking to balance autonomy with the concern for the common good, without a priori privilege of either of these two core values (Communitarian Network, 2010; Etzioni, 2011a). A responsive communitarian reading of bioethics implies that autonomy should be given the right of way when individual sacrifices are substantial in return of minor gains to the common good, while policies or decisions should lean in the opposite direction if the gains to common good are substantial and the sacrifice of autonomy is minimal (Etzioni, 1999).

Evanoff suggests a similar approach that he calls constructivist (Evanoff, 2001), and which draws on Habermas’ discourse ethics and his concept of communicative rationality (Dryzek, 1994; Evanoff, 2004). It holds that both knowledge and values are neither subjective nor objective, but are the product of inter-subjective agreements both within and between cultures about how reality will be described and acted in (Evanoff, 2001, 2004). According to this view, a moral claim can be considered justified, or legitimate, only if everyone who is affected by and has legitimate interests in the decision has the opportunity to participate in the process by which the decision is made (Habermas, 2001). It follows then that decisions having consequences only on the individual, should be taken only by the individual, whereas the scope of decision-making expands to include others, even if it’s the whole community or society, when individual decisions can have consequences on those others. Consequently, when consequences can cross national boundaries, like global warming or genetically modified mosquitoes, cross-cultural dialogue is a necessity. This is what Habermas coins ‘communicative action’ (Evanoff, 2004; Habermas, 2001).

Responsive, or liberal, communitarianism is a political ideology that aims to provide individuals

42 and communities with procedures and criteria to work out and balance personal decisions and public policies, especially in the face of conflicting values or interests (Etzioni, 2011a). This model rests on the idea that people in a society can reason together, and even reach agreement and shared visions, or consensus, even if their traditions do not completely coincide (Kuczewski, 1997, 2001). Often, many “bioethicists embrace consensus as the telos or goal of their efforts … as it makes potentially controversial and divisive issues manageable within a pluralistic society” (Kuczewski, 2002; Moreno, 1995). This strand of communitarianism suggests making moral judgments and decisions through moral dialogues. “Examinations of actual processes of consensus building, especially when they concern normative matters, show that individual preferences and judgments are largely shaped through interactive communications about values, that is through moral dialogue that combine passion with normative arguments and rely on processes of persuasion, education and leadership. Moral dialogues focus more on values that on facts” (Etzioni, 2011a) and depend on moral suasion that is built on trust and respect for others (Kuczewski and McCruden, 2001). Instead of attempting to persuade everyone, the liberal communitarian aims to attain considerable overlap in viewing and addressing the problems at hand. By including a wide variety of voices, one hopes to advance the common good by broadening the range of concerns and goods that are taken into account, and hence find more areas of values overlap (Kuczewski and McCruden, 2001)

Communitarian moral dialogues differ significantly from the ‘rational democratic deliberations’ with which science and technology sphere are familiar especially in Europe. The term rational implies that the deliberations are based on empirical findings and logical conclusions, and the term democratic implies that the results reflect the preference of the electorate (Fleck, 2007). In contrast the moral dialogues are concerned with values and help shape rather than reflect people’s preferences. These dialogues would be highly relevant to matters where facts are not fully available, and where uncertainty is high (Etzioni, 2011a), such as in GMM trials. It is hoped that through these dialogical processes, large areas of agreement can be reached under the proper circumstances. These include a “commitment to deliberate together rather than caricaturing the opposition or trying to exclude traditions from the public arena” (Kuczewski and McCruden, 2001).

This conception of communitarianism has at its core two elements. The first is the belief that average people have some moral sensibility that can form a basis for moral discourse. This is

43 what liberal communitarians call common morality, which is the amalgam of values, beliefs, and preferences that are more or less shared among people (Kuczewski, 2009). The second element is the belief that people do not come to discussions with preformed choices. Through dialogue and deliberating about their values, experiences, feelings, aspirations, and perspectives, they can help each other form this moral sense, or common morality, and form opinions and choices (Moreno, 1995).

The common morality supplies the matter that gets appropriated and refined through deliberation, but does not dictate a particular solution (Kuczewski, 2009). “What presents itself as a viable option is at least in part a product of the many intersecting communities in which we are immersed. Through these processes we as particular persons and as communities come to appropriate, refine, and redefine our traditions and their values. At our best, we deliberate together about things that affect us individually as well as those that affect us collectively” (Kuczewski, 1997). As such, communitarians stress on fostering the communal life of deliberation (Emanuel, 1991) rather than sorting out the elements of deliberation. It is up to the community also to decide on which elements and which values take precedence and priority in the deliberative processes. For instance, values such as beneficence, manifested in the direct and indirect benefits of technologies, may have a “deeper hold on the common allegiance and form a more foundational role in the deliberative life of the community”, while at other times, risks of harms could take that role (Kuczewski, 2009). A priori decisions by researchers or policy makers on which elements should be privileged to form the basis of deliberation, are therefore against the spirit of responsive communitarianism.

From a utilitarian perspective, the consensus model proposed by responsive communitarians acknowledges and addresses two major challenges with democratic deliberative approaches (Kuczewski, 2009). These are the impossibility of active deliberative involvement of each person in the community in each important decision, and the increased potential for influence by media, propaganda and special interest groups. Kuczewski posits that the consensus is one of values, which would elicit assent upon reflection. Reflection in this regard is not expressing opinions, as opinions could be reflections of misinformation and could be swayed by sensational media, but rather is sifting through the arguments and drawing upon lived experiences, and asking oneself “what would I think if I thought about it… as it affects me and my community” (Kuczewski, 2002, 2009). To ensure that the consensus is not a balancing of opinions but is actually a

44 consensus of values, Kuczewski stresses the role of social scientists and bioethicists, to help decision-makers “go below the surface of the opinions and make sure that the relatively stable values of the society, not uninformed impulses are reflected in the consensus” (Kuczewski, 2002). It is also assumed that participants in such processes will feel a sense of ownership of the conclusions and hence be unlikely to be easily swayed by the media or other advocacy groups (Kuczewski, 2009). Social scientists can also help in finding new means of communal deliberation in large societies, such as the growing virtual communities, as well as fostering such mechanisms (Kuczewski, 2009). As I will explain in coming chapters, the experiences from Mexico support this liberal communitarian view, where the community developed its judgments over time, and through communal discussions.

3 Models of Community Approval for Research from Aboriginal Communities

Research in the context of Aboriginal communities, provides the most useful and probably the only established experiences with community approval for research. In this section, I provide an overview of these experiences. I acknowledge however that aboriginal communities represent a special niche for research ethics, as aboriginal communities often have many unique characteristics, such as geographical localization, cultures and norms that are distinct from dominant national ones, political sovereignty and identified moral leadership, norms of collective decision-making, and sense of cohesion and strong community ties. However, I believe that it is important to be familiar with these workable models, as we can derive many insights, especially on the pragmatic side. In fact, my research shows that experiences from developing countries are not very different from those in Aboriginal settings (Chapter 16).

In their report about issues of group, community, or First Nation consent in health research, Kaufert et al. (2004) found that many national indigenous organizations in Canada, the U.S.A, Australia, and New Zealand, developed guidelines for scientific research based on indigenous values, particularly the moral significance of the community as a distinct entity from the individual. The core principle in all indigenous codes and regulations is that the community must give consent to research, and not just the individual. Moreover, all of these ethical codes emphasize the importance of trust, reciprocity, and respect for local knowledge, in the context of

45 developing relationships between researchers and the community (Freeman, 2003b; Kaufert et al., 2004; NHMRC, 1998). In fact all of these guidelines emphasize the notion that community consent reflects relationships involving a continuous process, and therefore consent is also seen as a continuing process, rather than a onetime event (Kaufert et al., 2004)

Many Aboriginal communities and Aboriginal Research bodies emphasize a participatory action research framework (Innuit Tapirisat of Canada, 1993; Masuzumi et al., 1993; Schnarch, 2004) whereby their communities can be involved in all stages of research as active partners (TCPS, 2010) and can own and benefit from the research results (Kaufert and Glass, 2002). For example, the frameworks proposed by the First Nations and Inuit Regional Health Survey Project (Code of Research Ethics, 1997), stress mutual commitment to the principles defined as OCAP (Ownership, Control, Access and Possession) as the basis for self-determination in research (Snarch, 2004). In this paradigm, researchers have obligations to consult key stakeholders in the community, as well as communicate with the whole membership. This process is maintained throughout all phases of the research, and is thought to create a dual cycle of data collection and community learning, providing a more accurate and authentic reflection of the reality of community life (Natpracha and Stevens, 1990).

Many found that one meaningful process for eliciting community consent is to set up community review boards (Burgess and Brunger, 2000; Foster et al.1999; Greely, 1997; Weijer et al., 2000; Weijer, 1999a; 1999b; 1999c). The objective of community review is to promote dialogue between researchers and community members to allow both sides to identify risks, especially those that could only be considered by the community, and define ways of managing risks from inside the community (Burgess and Brunger, 2000; Juengst, 1998b). Community review was also found to be a spectrum of different activities that vary between communities, depending on the pre-existing collective decision-making processes. These activities include “holding informal discussions with members of a community, involving community members in the planning stages of research, asking the community to participate in the evaluation of human subjects’ protections, and negotiating formal agreement with the community” (Foster et al., 1999:1723).

Some argued that in large culturally heterogeneous or geographically dispersed populations (including urban indigenous communities), community review might be impractical (Juengst, 1998b). While recognizing the problems of generalizing their observations to larger

46 geographically dispersed communities, Foster et al. (1999) found that community review can still take place in populations lacking recognizable leadership structures. In the two communities they researched in their case studies: “consensus was reached within private social units, not through political organizations or established moral leaders. In this way, a number of private social units and their members were involved in reviewing the implications of genetic research. This broader engagement of community members is preferable to reliance on a small number of leaders who may have individual agendas that fail to reflect the full range of community concerns. When political organizations and their leaders were involved, their role was to formally ratify the consensus reached by the private social units, not to shape it. Thus our experiences suggest that community review can take place in populations lacking established, inclusive political organizations and readily identifiable leaders (Foster et al., 1999: 1722).

There are many workable models of community consent from aboriginal communities (Kaufert et al., 2004). In the rest of this section, I will give few examples that could offer some important operational insights. This overview is not exhaustive, as it only aims to provide some background information.

The Inuit Tapirisat of Canada (ITC) Background Paper on Negotiating Research Relationships in the North (Inuit Tapirisat of Canada, 1993) and Dene Tracking: A Participatory Research Process for Dene/Métis Communities (Masuzumi et al., 1993) are two frameworks developed by regional aboriginal organizations in Canada. Both frameworks were drafted as discussion papers or proposals for an alternative process of ethical review and community collaboration for the research process. Rather than emphasizing principles or detailed guidelines for monitoring and enforcement, these frameworks propose templates for community consent in the form of mutually binding negotiated arrangements between the researcher and the community, outlining their reciprocal obligations. The proposed models extend to include all parties involved in the research project by having each specify their understanding of the research plan and mutual obligation at every stage of the research program. The ITC process includes the agreement and understanding of: scope and purpose; methods; provisions for community participation and skill transfer; data ownership and access to research results; confidentiality; dissemination strategy and media relations, and commitment to disclose all sources of support. Moreover, re-negotiation of the objectives and methods, as well as of the consent agreement may occur throughout the duration of the project (Inuit Tapirisat of Canada, 1993). Similarly, in Australia, the 1998

Consultation Draft Statement of the Australian Health Ethics Research Committee called for specification arrangements to address community issues involving a process of respectful negotiation (NHMRC, 1998).

Also in Australia, guidelines developed for research conducted among Koori indigenous communities of Northeast Victoria and New South Wales (Henderson et al., 2002) stipulate that each proposed project must have initial consent from the Board of Directors of the Koori community organization, and researchers must hold meetings to explain the proposed research and gain wider community approval. These guidelines also stress on the participatory research framework, whereby communities are continuously involved in all phases of the research from design, fieldwork and ownership of the research product. The community also would nominate a local community representative to monitor compliance with the guidelines and maintain a continuous liaison with the researchers. Additionally, it is recommended that the external ethics review committee approving the research include at least two Koori individuals, whose is to maintain oversight and “…assess the need for referral to a Koorie community group” (Henderson et al., 2002).

4 Summary

In this theoretical chapter I have examined the application of the two major bioethical paradigms that are relevant to the issue of authorization for GMM trials, Liberal Principlism and Communitarian Bioethics. Liberal Principlism has been criticized for disregarding familial and communal human relationships, and overemphasizing instead individual rights. Nowadays, there is an increased recognition of communities as ethical entities entitled to be respected and protected from harm. Many scholars have consequently called for the inclusion of respect for communities as a fundamental ethical principle that has been overlooked by the individualist approach. Communitarianism on the other hand prioritizes the role of the community and social context in all decisions and choices and implies that public policies should be based on communal values, the common good, social goals, traditional practices and the cooperative virtues. This paradigm has been criticized however for facilitating authoritarianism and the control by influential groups or governments under the pretext of communal values, and infringing on the rights and autonomy of individuals. A responsive, or Liberal, Communitarian approach builds on the merits of both paradigms, to ensure the liberties and autonomy of the

48 individual while acknowledging and fostering communal ties and the common good. The consensus model proposed by some responsive communitarian thinkers might prove helpful in the field of GMM research. Guidelines for research in Aboriginal communities are in line with this view. However, the success of such mechanisms in navigating controversial bioethical issues such as GMM trials, as well as their role in authorization processes, remain an empirical question that is beyond the scope of this thesis, as none of the studied programs in the three cases have followed this approach. I will refer to these ideas nonetheless in my discussion of the findings.

CHAPTER 5 Methodology

“A ‘good methodology’ is more a critical design attitude to be found always at work throughout a study, rather than confined within a brief chapter called ‘Methodology’” (Clough and Nutbrown, 2002:31)

Research decisions such as sampling choices, which data collection methods to use, how to use them, how to analyze information, and so on, “are often based on values and assumptions which influence the study, and as such need to be fully interrogated in order to clarify the research decisions which are made” (Clough and Nutbrown, 2002). I therefore dedicate this chapter to describing the guiding methodology I followed, in other words the set of principles and ideas that informed the design of my study (Birks and Mills, 2011), and which constitute the paradigmatic justifications for using the methods I have used, and which I describe in detail in chapters 6 and 11.

After stating the purpose of the study, I argue why an empirical approach to answering my research question is the most appropriate. I then present a discussion of the methodological approach that I followed, where I show that a symbolic interactionist approach to theory building by following the methods and procedures of a constructivist Grounded Theory approach was appropriate as it can culminate in a novel, testable, and rigorous theory that both fits the data and is useful when put in practice. I then present my research design, which includes my research questions, the cases I used for comparison, and the units of analysis, as well as the cross-case comparison approach. The specific methods followed for data collection and analysis in the Mexico case study are different than the ones I used for the Cayman Islands and Malaysia case studies, and therefore I report them separately in Chapters 6 and 11 respectively.

I drew on the work of Barney Glaser, Anselm Strauss (Glaser and Strauss, 1965; 1967), Juliet Corbin and Anselm Strauss (Corbin and Strauss, 2008; Strauss and Corbin 1990, 1998), and Kathy Charmaz (Charmaz, 2006).

1 Purpose of the Study

The purpose of this qualitative research project is to build a substantive middle-range theory of community authorization to begin and proceed with genetically modified mosquito vector trials. To achieve this purpose, I investigated three leading GMM trials dealing with Dengue vectors from Mexico, Malaysia, and the Cayman Islands as my case studies.

The development of this theory will focus on three main aspects of the authorization phenomenon: 1) the meaning of authorization for such trials, 2) the kinds of formal and informal actions that were taken by the community to signify authorization, and 3) the factors that affect these actions. In order to explore the substantive and procedural aspects of actions related to authorization, personal perspectives and experiences of various stakeholders were elicited for the Mexico case study, and publicly available information on the trials were sourced for the Cayman Islands and Malaysia case studies.

2 The Use of an Empirical Approach

In this section I argue why a theoretical approach based on high-level philosophical theory is not appropriate for my research study, and consequently why an empirical approach is the most appropriate.

As I showed in Chapter 4, liberal and communitarian approaches, the two most salient political philosophies in Bioethics, diverge on the question of who would be considered the moral agent to make ethical decisions in situations where the whole community could be affected, such as GMM trials, the individual or the community as a whole. Consequently, the substantive as well as the procedural aspects of community authorization for GMM trials would be different according to these two paradigms. Moreover, I have argued that while some theories give more attention to communities, their rights, and their roles in biomedical research, none provides concrete or successful advice on what needs to be actually done in these situations. Consequently, a theoretical approach to address my research question is not appropriate.

Arras argues in the Stanford Encyclopedia of Philosophy that the application of high theory in bioethical practice in medicine, research, and public health, is thwarted by many challenges. The first challenge is the absence of a “clear winner” among all the available theories to choose from, often with diverging and contradicting conclusions, and the absence of consensus on which theory should prevail (Arras, 2013). Moreover, it has been frequently argued that high level philosophical theories cannot be concretely and directly applied in real life complex situations of professional practice and public policy (Arras, 2013). Arras mentioned that Gutmann and Thompson have persuasively argued that “which ever theory we happen to embrace – whether it be any flavor of utilitarianism, contractarianism, or natural law – will eventually run out of gas before it reaches the level of concrete decision making required by practical ethics” (Gutmann and Thompson, 1998). He also used the example of the philosopher Norman Daniels, who spent several decades working on a theory of just health, and then acknowledged that “philosophical theory is not sufficiently fine-grained for such concrete policy making” (Daniels 1996, 2007). Moreover, while ideal political theory provides us with a description of what Arras calls “Paradise Island”, it is rarely helpful in common situations where non-ideal conditions prevail. He therefore concludes that non-ideal, mid-level theorizing is an appropriate approach of philosophical action in bioethics.

On the other side of the spectrum, movements such as casuistry, narrative ethics, and pragmatic bioethics, increasingly permeating bioethical discourse, stress that moral judgments depend on the particularities of moral situations (Arras, 1990, 2013; Jonsen, 1998; Jonsen and Toulmin, 1998). It has been argued that sound moral judgment is dependent upon the particularities of moral situations and their individuality and complexity (Dancy, 2006). In fact, the focus of bioethics started to drift away from a purely theory-driven approach, guided by high-level philosophical analysis, towards a moral theory that was more grounded in practical reality (Borry, Schotsmans, and Dierickx, 2005). An empirical approach to bioethics is characterized by having encounters with experience (Ives, 2008), as it involves taking into account actual experiences, meanings, and moral decisions to make bioethics more connected to real life situations (Musschenga, 2005), based on the idea that moral decision-making has more to do with “muddling through problems” rather than with rational problem-solving (Hoffmaster, 1992; Lindblom, 1959). Having ‘encounters with experience’ simply means understanding, as far as possible, “how an ethical problem affects peoples’ lives, how the problem is constructed and

52 negotiated, and how different resolutions might affect stakeholders in different ways” (Ives and Draper, 2009).

Empirical bioethics also aims to contribute to normative questions (Musschenga, 2005). It aims to combine the collection and analysis of empirical data with moral philosophical analysis, to make normative claims about practical issues (Dunn et al., 2012). Borry et al. consider that it has now entered mainstream thinking that “the use of empirical research in ethics could help translate more general and abstract principles into specific and action-driven directives and guidelines that are both morally justified and workable in practice” (Borry et al., 2005). Brody promotes this empirical approach to bioethics for its potential to “identify issues that actually arise and processes actually used for dealing with them, thereby suggesting where normative analysis is most needed. Moreover, it can contribute to that normative analysis by discovering relevant consequences which become the consequentialist component of that normative analysis” (Brody, 1990, 1993). I acknowledge the controversy regarding the link between empirical data and normative claims, that is moving from “is” to “ought” or the naturalistic fallacy, and hence I assert that my theory is an explanatory and descriptive one. However, the insights and understandings it offers could be used as the basis to develop normative claims such as guidelines (Chapter 16).

Middle-range theorizing in bioethics can be faithful to the aforementioned aims of empirical bioethics, as it is what Baier calls a “mosaic” approach to theory-building; It starts closer to the ground, by being connected to the context, and erects, brick by brick, theoretical structures with a scope limited to the social area of inquiry (Baier, 1994).

The science of community engagement in health research is still immature (Newman, 2006), and little is known about the engagement, participation, and decision-making processes of involved communities in the context of large-scale science and technology research, especially in developing countries. Specifically, there is no formal agreement on what community authorization is, what constitutes sufficient authorization, and what are the variables and factors that are related to authorization in this type of trial. Moral and political theories do not offer much help in elucidating the concept, necessitating an empirical approach grounded in the lived experiences of communities with GMM trials. Therefore, an explanatory and contextually situated theoretical account of the social phenomenon of authorization is highly needed and is the

53 primary intention of this research study. As a result of this discussion, I have decided to adopt an empirical approach to address my research question. In the following section I describe my methodological approach. In contrast with ideal theory, which provides us with an objective to aim at, but which is detached from reality and from context particularities, I built in this research study a middle-range non-ideal theory that takes into account the “messy realities on the ground in charting a practical course towards that objective” (Arras, 2013, Simmons, 2010).

3 Grounded Theory

In this thesis I have followed the “Grounded Theory” (GT) methodology for data collection, data analysis, and theory building. As I will explain in this section, and as I will later elaborate in Chapters 6 and 11, my theory is built from data by comparative analysis rather than being generated by logical deduction from a priori assumptions or theories. It is constructed from conceptual categories that are themselves generated from evidence (which is later used to illustrate the concepts) and that are consequently interrelated into hypotheses. Concepts are symbolic representations of abstract ideas, while hypotheses represent suggested relations between categories and their properties.

The GT approach, first developed by Barney Glaser and Anselm Strauss (Glaser and Strauss, 1967) provides a practical approach to construct theory from empirical data derived from case studies, as it consists of “systematic, yet flexible guidelines for collecting and analyzing qualitative data to construct theories ‘grounded’ in the data themselves” (Charmaz, 2006: 4). It refers to theory that is developed inductively and iteratively, through deriving from a set of data concepts and conceptual categories, and developing relationships between these categories. Grounded theory procedures are actually designed to develop a “well integrated set of concepts that provide a thorough theoretical explanation of social phenomena under study” (Corbin and Strauss, 1990). Glaser asserts that GT is not mere findings, but is rather an integrated set of conceptual hypotheses, which emerge during data analysis, get tested and refined through comparative and iterative analysis, and constitute the probability statements about the relationships between concepts (Glaser, 1998; Corbin and Strauss, 1990, 2008; Strauss and Corbin 1998).

The ultimate goal of GT is “generating more local, contextual theory that would as a consequence ‘work’ and also be of relevance to those being studied” (Pidgeon, 1996). Glaser and Strauss stress on the ‘fit’ of the theory and its ability to ‘work’ when put into use (Glaser and Strauss, 1965, 1967). By ‘fit’ they mean that the categories must be readily (not forcibly) applicable to and indicated by the data from the research, whereas a theory ‘works’ when it is meaningfully relevant and is able to explain the phenomenon under study (Glaser and Strauss, 1967). The latter concept, the ‘workability’ of the theory, will be discussed in Chapter 16. In a substantive grounded theory, the integral set of hypotheses is developed to account for much of the behavior and experiences seen in a substantive area. The hypotheses should fit in the data, and in so far as they do not, constant comparison and analyzing of the data modify them until they do (Glaser, 1998). By taking into account multiple experiences and perspectives, “GT focuses on variation, and elaborates complexity, seeking to show how social process makes meaning and how contextual conditions structure social process” (Jacobson, 2009). The result would be the construction of theory that is richer and more reflective of the context in which participants are situated (Charmaz, 2006; Corbin and Strauss, 1990, 2008; Glaser and Strauss, 1967; Mills et al., 2006a, 2006b; Pidgeon, 1996; Strauss and Corbin 1998).

This latter concept is evident in the contemporary paradigmatic shift in GT to interpretive constructivist GT, pioneered by Strauss (1987), who was later joined by Corbin (Corbin and Strauss, 1990, 2008; Strauss and Corbin, 1998), and championed by Kathy Charmaz (Charmaz, 2006). Over the past few decades, the GT method has witnessed an evolution in ontological and epistemological positions. Many researchers have adopted and adapted GT methodology, and several approaches to grounded theory procedures have been proposed (Birks and Mills, 2011). To choose between these different models, researchers must follow the research paradigm that is most congruent with their beliefs about the nature of reality as I will explain below. Nevertheless, engaging in any form of GT study requires the researcher to address a set of common canons, or essential methods: Initial coding and categorization of data, concurrent data generation and analysis and thus constant comparative analysis, writing memos, theoretical sampling, theoretical sensitivity, intermediate coding and identifying a core category, theoretical saturation and theoretical integration (Birks and Mills, 2011). I will describe these methods in Chapters 6 and 11.

Traditional GT, a post-positivist paradigm founded on critical realism (Annells, 1997; Harris, 2003), upholds one ‘real’ reality that exists in the social world and that needs to be discovered by the objective researcher, though it can only be imperfectly perceived (Lincoln and Guba, 2000). Constructivist GT on the other hand, positions the researcher as a partner in the research process, and advocates the interactive relationship between the researcher and research participants in co-constructing and reciprocal shaping of meanings and consequently theory, while acknowledging that theories are embedded in the multiple experiences and perspectives of the research participants as well as those of the researcher (Charmaz, 2006). Dunn and Ives (2009) see that having ‘encounters with experience’ and ‘grasping’ the meanings held by participants is an essential approach in empirical bioethics, and demands that the researcher plays an “active and reflexive role in stimulating and shaping an interpretative conversation through which the relevant ethical issues are identified, shared and understood by the researcher and participant” (Dunn and Ives, 2009). Ethical issues are identified or even produced through dialogue and interaction in the research interview, where the “researcher never simply ‘grasps’ meanings held by participants, but is involved actively in creating those meanings through the process of collecting and analyzing data” (Dunn and Ives, 2009). Theories themselves are in fact “interpretations made from given perspectives as adopted or researched by researchers” (Strauss and Corbin, 1998).

In this research project, I adopted a constructivist GT approach, for the following reasons. First, the concept of community authorization is a social construct that is affected by a myriad of contextual factors and might have different meanings to different people and communities. By following a constructivist approach, I was able to actively react to and work with data (Charmaz, 2006; Corbin and Strauss, 2008) as discussed above, to collaboratively negotiate and construct these different meanings (‘realities’) with my research participants. As an active partner in the co-construction of meanings and concepts, I was also enabled to integrate in the theory building process, analytic ethical dimensions that emanate from my previous experience and guided by my theoretical sensitivity.

In summary, I designed my research using a constructivist grounded theory approach, a methodology that guided the specific procedures that I have followed to collect my data, analyze them, and link them in order to produce my theory. In the following section, I will briefly review the essential methods of GT, and which I followed in the three cases.

Grounded theory methodology has been used in many disciplines such as sociology, nursing, public health, and even economics and marketing. It has also been widely used in empirical bioethics, because it offers way to explore the ethical meaning of social phenomena for people experiencing them, and to identify key social processes that shape the ethical aspects of these social phenomena. 4 GT Methods

Methods are the practical procedures used to generate and analyze data. Grounded theory methods consist of “systematic, yet flexible guidelines for collecting and analyzing qualitative data to construct theories grounded in the data themselves. The guidelines offer a set of general principles and heuristic devices rather than formulaic rules” (Charmaz, 2006:2). While all authors stress the flexibility of methods guidelines and the avoidance of prescriptions and packages in grounded theory (Birks and Mills, Charmaz 2006), there is a consensus that a set of essential methods, or canons, has to be followed for a study to be considered a grounded theory study (Bryant and Charmaz, 2007, Birks and Mills, 2011). These are: Initial coding and categorization of data, concurrent data generation and analysis and thus constant comparative analysis, writing memos, theoretical sampling, theoretical sensitivity, intermediate coding and identifying a core category, theoretical saturation and theoretical integration (Birks and Mills, 2011). Researchers can adopt and adapt these methods, and can draw from different authors and versions of GT to varying degrees in the application of these essential methods (Birks and Mills, 2011). The following excerpt by Schwandt efficiently describes the grounded theory data collection and analysis process in a nutshell (Schwant, 2001):

“Empirical indicators from the data (actions and events observed, recorded, or described in documents in the words of interviewees and respondents) are compared, searching for similarities and differences. From this process, the analyst identifies underlying uniformities in the indicators and produces a coded category or concept. Concepts are compared with more empirical indicators and with each other to sharpen the definition of the concept and to define its properties. Theories are formed from proposing plausible relationships among concepts and sets of concepts. Tentative theories or theoretical propositions are further explored through additional instances of data. The testing of the emergent theory is guided by theoretical sampling. Theoretical sampling means that the sampling of additional incidents, events, activities, populations, and so on is directed by the evolving theoretical constructs. Comparisons between

57 the explanatory adequacy of the theoretical constructs and these additional empirical indicators go on continuously until theoretical saturation is reached (i.e., additional analysis no longer contributes to anything new about a concept). In this way, the resulting theory is considered conceptually dense and grounded in the data.” (pp. 110-111).

1.1 Concurrent data collection and analysis, and constant comparison

The process of concurrent data collection and analysis is a fundamental aspect of grounded theory research (Glaser and Strauss, 1967, Charmaz, 2006; Birks and mills, 2011). Initial data collected through purposive sampling was coded and analyzed and then used to guide further sampling and data collection, as I will explain in Chapters 6 and 11. Constant comparison is part of this process. As new data is gathered, it was constantly analyzed and compared to previously analyzed data, in the aim of refining concepts and relationships. The cyclical or iterative nature of grounded theory continued until my theoretical account was fully built and integrated. Even as I was writing the thesis, my comparative analysis never ceased, and the theory kept on getting sharpened until the last day of writing.

5 Features and Type of My Theory

As I have explained in the previous section, my theory was built from data by inductive and comparative analysis rather than being generated by logical deduction from a priori assumptions or theories. It is constructed from conceptual categories that were themselves generated from evidence (which is later used to illustrate the concepts) and that were consequently interrelated into hypotheses.

The theory is therefore presented as a set of interrelated concepts, formulated into hypotheses that structure a descriptive and explanatory systematic view of the phenomenon of community authorization as a substantive, or empirical, area of sociological inquiry (Glaser and Strauss, 1965). This theory is considered a substantive ‘middle-range’ theory (Merton, 1968). According to Merton, middle-range theory construction starts with an empirical phenomenon in a substantive area of social enquiry (as opposed to a broad abstract entity like the social system) – in my case community authorization in the context of GMM trials – and abstracts from it to create general statements that can be concurrently and iteratively verified by data. The ideas of

58 middle range theory are simple yet general and are more than mere empirical generalizations. This type of theory falls between the “minor but necessary working hypotheses” of everyday life and the “all-inclusive grand theories” (Merton, 1968, p 5-10).

In this research study, I built a theory that offers an explanation of community authorization for research trials, and that has predictive values, and can be usable in practical applications (Chapter 16).

6 Research Design

In this section I present the overarching design for my research study, which will include the cases that I have studied, my research questions and units of analysis, as well as the cross-case comparison approach. The specific questions and objectives for each case study, as well as the specific methods for data collection and analysis, will be covered in Chapter 6 (Mexico) and Chapter 11 (Malaysia and the Cayman Islands)

6.1 Cases

The research project follows a multiple-case design, where three cases served the basis for cross- case comparison. The three cases are caged-field or open-field trials on genetically modified mosquitoes: A major case from Mexico, and two minor cases, from the Cayman Islands and Malaysia. The case study from Mexico is the core of the research, as it is the basis for the generation of concepts, categories and hypotheses. It is therefore the ‘major’ case study. In-depth research has been conducted in this case, which can serve independently as a research study. The two minor cases from the Cayman Islands and Malaysia on the other hand serve comparative purposes, as all of the data were gathered from open source material. These two cases are not independently sufficient to provide the core concepts of the theory. However, cross comparisons with their data enabled verification and enrichment of the theoretical framework generated from the major case study.

The three cases are: 1. Major Case: Genetic Strategies for Control of Dengue Transmission Program – Caged- field Trials

Major Institutions: University of California Irvine (USA) and Instituto Nacional de Salud Pública (Chiapas, Mexico)

Location: Tapachula, Chiapas, Mexico

2. Minor Case: Oxitec RIDL strain OX513A Open Field Trials

Major Institutions: Oxitec Limited (UK) and Mosquito Research and Control Unit (Cayman Islands)

Location: Grand Cayman, the Cayman Islands

3. Minor Case: Oxitec RIDL strain OX513A Open Field Trials

Major Institutions: Oxitec Limited (UK) and Institute of Medical Research (Malaysia)

Location: Bentong, Pahang State, Malaysia

As this research project explores community authorization in the context of genetically modified mosquito trials, it was logical to choose the most prominent trials that were being conducted in the world at the time of the conception of this research study (Mexico, Cayman Islands, and Malaysia), and which are very likely to be examined extensively by future investigators to draw insights on how they dealt with ESC issues such as community authorization. These cases are complementary, as they are situated in very different contexts, and different social approaches to community authorization were followed in Malaysia and the Cayman Islands in comparison with Mexico. The cross-case comparisons would therefore constitute the basis for a richer and more generalizable theory.

Moreover, as the ESC Program sustained a collaboration with the Mexican trial on a number of issues, we had a unique opportunity for collaboration with the investigators and for access to the trial, enhancing thus the feasibility and the potential of success for this research project.

6.2 Research Questions

The overall research question “What constitutes community authorization to begin or proceed with caged-field or open-release GMM trials” was established after meetings with the principal investigators of the above three projects and other mosquito trials around the world and determining that community authorization has been one of the most pressing ESC challenges. The lack of guidance about what constitutes authorization to begin and continue GMM trials presents an important ethical and practical challenge for investigators. In the absence of any coherent accounts of authorization for this context, an explanatory theory would offer a valuable starting place for investigators and communities to help them plan and structure their activities.

The specific questions that were addressed in this study are the following: 1) What does authorization mean in different settings and from different perspectives? 2) What are the actions that were involved, and what factors affected these actions? 3) What are the salient features of the authorization phenomenon across different settings, and what are the differences?

The specific case-related questions for Mexico, the Cayman Islands, and Malaysia, will be covered in Chapters 6 and 11 respectively.

6.3 Units of Analysis

Units of analysis are the major entities that were examined and analyzed to create rich descriptions and to get better understanding of the phenomenon under study. Typical units of analysis usually include individuals, social organizations, social artifacts, or social interactions. Specifying the units of analysis at the beginning of the research in an open and flexible way can guide the data collection as well as data analysis. This means that the units of analysis can be modified or supplemented if initial data gathering provides evidence for these units, or challenges their relevance for theory development.

The major unit of analysis in the three cases was judgments, which refer to conclusions formed after consideration. I have chosen judgments rather than decisions, keeping with an open grounded theory approach, as judgments include decisions, opinions, statements, or responses, and were made by different stakeholders including investigators, research institutes,

61 governmental agencies, authorities, and community representatives, groups, or members. Judgments were analyzed to look for patterns or differences, and to try to uncover the assumptions and the considerations that impacted them.

Specific decisions were selected based on the following characteristics: 1) Chronological/pivotal importance in the project development 2) Enabling a major step/milestone in the project

Other forms of judgments made by community members and representatives, such as opinions, reactions, responses, and actions were also identified and analyzed but no criteria were used to maintain a grounded theory open approach.

A minor unit of analysis was ‘interactions with the community’. The relationship between these interactions and community authorization was also analyzed, which helped me build the social process of the theory.

6.4 Cross-Case Comparison: The Case-Study Approach

I have designed my research as a multiple-case study, and conducted cross-case comparisons and analysis to both refine and test my emerging theory by analyzing three distinct but related cases.

Cross-case analysis has been used extensively in social sciences research, and is considered to enhance the researcher’s capacities to develop and refine concepts (Ragin, 1997), further articulate the concepts, hypotheses, or theories discovered or constructed from the original case (Khan and Vanwynsbergue, 2008), and even test theory (Eckstein, 2002).

Eisenhardt sees cross-case comparison as an essential strategy in building theories, as it helps to refine concepts, and categories, by looking for evidence for them across different case studies (Eisenhardt, 1989). Cross-case comparison can also help in testing the relationships between concepts and categories, by facilitating the comparison of similarities and difference in the events, activities, and processes that are the units of analyses in case studies (Khan and Vanwynsbergue, 2008). Moreover, cross-case analysis allows the researcher to compare cases from one or more settings, communities, or groups in order to highlight contextual factors that may have contributed to the outcomes of the case or have affected the relationships between the

62 concepts, and to construct an explanation as to why one case is different or the same as others (Khan and Vanwynsbergue, 2008).

In summary, the aims of the comparison were: 1) Identifying new concepts that might be unique to the context and using them to complement and refine previously established theoretical propositions and hence generate a richer theory 2) Refining existing categories generated from the original core case (Mexico) by expanding their properties and dimensions 3) Testing the links and relationships that were established in the original case between categories, and hence testing and refining the robustness of core theoretical propositions 4) Uncovering the underlying social process of community authorization 5) Studying how contextual factors might affect the emerging theoretical account by comparing outcomes in different research settings, enhancing thus the theory’s external validity and generalizability

7 Ethical Considerations

In this section I address the ethical considerations that are associated with the conduct of this research. Issues related to my results and their application in the field are incorporated in the section on the limitations of this study in Chapter 16.

Research Ethics approval:

Ethics approval for the my research study was part of cleaning 10 global case studies conducted by our ESC Program research team and has been obtained from the University of Toronto (Appendix 2). In Mexico, an approval from the research ethics committee at the National Institute of Public Health (Comisión de Investigación, Instituto Nacional de Salud Pública) was granted on January 26, 2011 (Appendix 3). As information for the minor cases in Malaysia and the Cayman Islands was gathered from publicly available sources, such as journals and the internet, there was no need to apply for local research ethics clearance.

Informed consent process:

Informed consent was sought from all participants with whom interviews were conducted in Mexico. All participants were provided with a formal invitation letter (Appendix 4), a study Information Sheet (Appendix 5) and a Consent Form (Appendix 6). These documents were translated into Spanish and were read to participants who have low levels of literacy, and their voluntary participation and the freedom to withdraw from the interview were stressed. Participants signed and dated the Consent Form before their participation in the study could proceed. Participants were also asked about their consent to use their responses in publications, and were also given the option to participate anonymously in the interviews.

Risks of participation:

The risks to participation in this study were thought to be minimal, if any. Taking part in the interviews was not reasonably expected to invoke emotional or psychological distress on the part of the participants.

On the other hand, this research project could have imposed certain risks on the field trials themselves and their community engagement programs and activities. These included disruption of timelines, posing burden and additional workload on local researchers and staff, and confusion in the community on the roles of different researchers (for instance, community members might have confused my role with that of social scientists associated with the trials community engagement programs).

To ensure that these risks were mitigated and that this research study was minimally disruptive, I have worked very closely with the main project team in Tapachula, and all research activities were planned in close coordination and collaboration with local site researchers and social scientists to be contextually and culturally sensitive. I have also explained my role, affiliation, and my research to all participants.

Compensation:

There was no financial remuneration or other compensation for participation in this study.

Privacy and confidentiality:

All collected data (audio recordings, interview transcripts, field notes, etc.) are stored securely on a password-protected computer and will be stored for a period of five years from the close of the study.

8 Summary

Empirical evidence about the engagement, participation, and decision-making processes of involved communities in the context of large-scale science and technology research, is still lacking, especially from developing country. Therefore, I set in this research study to build a substantive middle-range explanatory theory of community authorization for genetically modified mosquito vector trials using a constructivist grounded theory approach. The development of this theory focused on elucidating 1) the meaning of authorization for such trials to different stakeholders, 2) the kinds of formal and informal actions that were taken by community stakeholders to signify authorization, and 3) the factors that affected these actions. To achieve my goal, I followed a multiple-case design, where three cases served the basis for cross-case comparison; a major in-depth case study from Mexico, and two minor case studies from the Cayman Islands and Malaysia. In the three cases, my major unit of analysis was judgments, which included decisions and other actions with respect to the trials, while the minor unit of analysis related to the interactions between researchers and the community. Throughout my research, I concurrently and iteratively collected and analyzed data. The specific methods followed for data collection and analysis are described in Chapters 6 and 11.

Part II Caged-Field GMM Trials in Mexico: A Successful Example

This part of the thesis is an in-depth case study that I have conducted in Mexico, and consists of five chapters. For this case study, I collected data over three distinct visits to the field site in Mexico between 2009 and 2011, where I conducted interviews with key informants, and gathered documents from key research trial personnel. In the first chapter, Chapter 6, I present in detail the methods that I used for both data collection and analysis for this case study. In Chapter 7, I describe the socio-political context of the project and describe the characteristics of the community. In the third chapter of this part, Chapter 8, I describe the social processes that were involved in the interactions between the GMM trial team and the community and examine how certain social processes and interactions were facilitative and conducive for community authorization for the trials to begin and to proceed. In Chapter 9 I describe the formal and informal processes and social transactions that constituted the phenomenon of authorization, and in the last chapter of this part, Chapter 10, I discuss the characteristics of this phenomenon.

CHAPTER 6 Mexico Case Study Methods

In this section, I describe the methods I have followed in this case study. I start by stating the case specific research questions and its units of analysis, then I describe my data collection considerations and techniques. These include sampling, recruitment, and data sources. The final part of this chapter deals with data analysis, which proceeded in three phases; initial, intermediate, and advanced.

1 Research Questions

The research question “what constitutes community authorization to begin or proceed with caged-field or open-release GMM trials” is the overall research question that I aimed to answer through all three case studies. In this study I addressed specific questions that enabled me to understand authorization as it was manifested in this setting • What were the experiences of different community members with the trials? • What did approving the trials mean for different stakeholders? • What were the considerations involved in decisions and other judgments? • What did authorization for research involve at different stages of the trials?

2 Units of Analysis

As I explained in the previous chapter, the major unit of analysis in the three cases is judgments, which includes decisions and decision-making, opinions, actions, and reactions. Although decisions constituted the majority of the judgments I considered in my analysis, following an open grounded theory approach I wanted to explore if authorization involves more than decisions. In fact, after conducting the first set of interviews, it became obvious that different stakeholders express their approval differently, according to their status in the community and the interests they hold, and continued approval was manifested in support and assistance for the project, offered by both authorities as well as members of the public in the host community.

Decisions were selected based on their chronological or pivotal importance in the project development for enabling a major step or milestone for the trials, while other forms of judgments were freely identified from interviews. In other words, I specifically and actively asked about the different decisions taken in the lifetime of the project, while other forms of judgments were identified from interviews and followed up upon when brought up by interviewees. The minor unit of analysis is ‘interactions with the community’, and is used to assess the relationship between these practices and community authorization.

After the first 3 interviews in Mexico, the following decisions were found to have pivotal importance and were chosen as the core for subsequent data collection: 1. Decision of the local research institute to enter the research collaboration with the sponsoring organization 2. Regulatory approval to give clearance for the trials 3. Decision of the community assembly (council) in Río Florido (trial site) to sell the field site to the project for the construction of the trial cages 4. Decision of the assembly to permit the trials and admit the project to the community 5. Decisions by community members to allow researchers to conduct mark-releaserecapture trials 6. Decisions by the community assembly to permit research-related and community engagement activities

As I started conducting interviews and asking community members about their experience with the trials, many other minor personal decisions were identified, such as decisions of individuals to attend community talks given by the project team about the trials or about Dengue, or the comisariado’s decision to provide support for the project. These decisions and personal actions provided a lot of insight and furthered my understanding of what authorization might mean, and what factors led the community to authorize the trials. While decisions and decision-making processes were essential to uncover the phenomenon of authorization, other judgments made about the project and the trials, such as the community’s opinions about the researchers and the value of their work were of high importance as I explain in the coming chapters of this part.

3 Data Collection

In this section I explain my data collection considerations and assumptions, such as my sampling strategy, as well as my data collection procedures, where I detail my data sources and how I have gathered and used them.

3.1 Sampling

In this research project, I followed a theoretical sampling approach. Theoretical sampling, the process of data collection directed by evolving theory rather than by predetermined population dimensions (Strauss, 1987), is a pivotal strategy in GT (Charmaz, 2000). Using theoretical sampling, I have selectively chosen the cases and recruited the participants that were expected to yield the richest and most relevant data to build the properties of my emerging theory as I will explain in this section. To fulfill this task, I concurrently collected, coded and analyzed data in order to decide which data to collect next based on the emerging theoretical concepts and categories (Glaser, 1978). This task allows modifications and adjustments to be made to data collection in light of emerging findings.

In the initial stages of data collection researchers will “go to the groups which they believe will maximize the possibilities of obtaining data and leads for more data on their question. They will also begin by talking to the most knowledgeable people to get a line on relevancies and leads to track down more data and where and how to locate oneself for a rich supply of data” (Glaser, 1978, p45). This ‘selective’ sampling, or the identification of populations, settings, and participants prior to data collection (Schatzman and Strauss, 1973), is a common first step in GT studies. In fact sampling in GT is often sequential, beginning with selective sampling and moving into a more focused theoretical sampling when concepts begin to emerge (Draucker and Martsolf, 2007). Schatzman and Strauss (1973) suggest that after several observational visits to the sites, the researcher will know who and what to sample for the purpose of the study.

I have followed the approach outlined above, by following what Corbin and Strauss (Corbin and Strauss, 1990; 2008) recommend, that is to connect specific theoretical sampling strategies to the three stages of coding (explained in Data Analysis section). For instance, initial coding (or open coding) required open sampling, in which data were gathered to uncover as many relevant concepts and categories as possible. Selective sampling fell in this stage, where sampling was

69 done “purposefully, by choosing sites, persons, or documents deliberately to gain the maximum amount of data needed to unearth potential categories and their dimensions; systematically, by moving from one person to another on a list to uncover subtle differences; and fortuitously, by gathering data during field observations that were unexpected but are seemingly relevant to category development. Axial [or intermediate] coding requires relational… sampling, in which data are gathered to uncover and validate the relationships among categories that have been discovered. This type of sampling can also be done purposefully or systematically. Selective coding calls for discriminate sampling, in which data are gathered to verify the emerging theory and to further develop categories that have not been well saturated” (Draucker et al., 2007).

In the first stage of research, I have had multiple meetings with the principal investigators of leading modified mosquito trials in the world (Irvine, USA- 2007 and 2008; Cairns, Australia - 2009; Tanzania - 2009, and Tapachula, Mexico – 2010). Discussions with these key informants enabled me first to set the most relevant research question with regard to relationships with communities in global health research (the theme of case studies conducted by the ESC program), and second to purposefully select the cases from which the richest and most useful data can be drawn. Once the cases were selected, I started my data collection for the major case in Mexico. This endeavor started in an observational field visit to Tapachula (Mexico) in February 2010, during which I met extensively with the trial principal investigator, referred to from here on as the PI, the social scientist responsible for community engagement, and the entomologists working in the field. This phase of open sampling generated a large amount of data from interviews/meetings, documents, or direct observation, which provided me with deeper understanding of the trials and the social interactions that occurred with the community, as well as helped me identify the units of analysis and therefore focus my data collection.

As I was simultaneously collecting and analyzing data, categories and relationships between categories and concepts started emerging and called for further exploration in my subsequent visit to Tapachula. Consequently, I was able to identify with help from the PI a number of key informants to be interviewed in the following field visit to further explore the full range of pertinent information such as the previous and current community council leaders. In the final field visit, the interviews were selected to ‘uncover and validate the relationships among categories’, and also to verify the emerging theory, accomplishing thus relational and discriminate sampling as proposed by Corbin and Strauss (Corbin and Strauss, 2008). During

70 this visit, I interviewed the PI again, the project social scientist, the communications specialist, two women from the community (one of whom leads a local women organization and has helped setting up seminars and focus groups with her constituents), the current community council leader, an expert social scientist in community organization in Tapachula, a leader of a local civic society group, and a field researcher who had a pivotal role in establishing the project.

3.2 Sample Size:

The typical approach to determining the appropriate sample size for a grounded theory study necessitates that “theoretical sampling on any category ceases when it is saturated, elaborated, and integrated into the emerging theory” (Glaser 1992, p102). When no new or relevant data seem to emerge regarding a category, or when new data do not add to the properties or dimensions of the categories or the relationships between the categories, theoretical saturation is reached, and no more data collection is needed (Strauss and Corbin, 1998).

A total of 19 formal interviews were conducted for this case study. In the first field site visit, I have had extensive meetings with the PI and project social scientist, but these meetings were not done in the format of interviews. Hence while the insights drawn from these meetings were used to determine the case specific research questions and units of analysis, and to identify key informants for the next trips, there were no transcripts used for analysis. In my second field visit to Tapachula, 8 interviews were conducted with 6 key informants (3 interviews with the PI and 5 with other key informants). The third field visit yielded 10 interviews with 7 key informants (4 with the PI, and 6 with others). Some of the key informants from the third visit were also interviewed previously in the second visit. One final interview was conducted by teleconference using the online application Skype. This number of interviews was deemed sufficient as theoretical saturation was reached and no new information was being added. Appendix 7 provides a list of interviewees.

Six documents and 142 memos and field notes were also used for analysis.

3.3 Recruitment

In this case study I interviewed 11 individuals who had key roles in the project (some informants were interviewed more than once). Appendix 7 includes a list of all identifiable interview

71 participants. After identifying key informants to be recruited, the trials PI and anthropologist in Tapachula facilitated the contact with the interviewees, and scheduled the interviews with them after their approval and at a convenient location and time. Invitation letters (Appendix 3) were sent when possible, along with the study information sheet (Appendix 4) and a Consent Form (Appendix 5). Otherwise these forms were presented to the participant at the beginning of the interview. All of these forms were written in Spanish. Participants were also asked about their preferred language of communication, and when requested, interviews were conducted in Spanish with the help of a Spanish-speaking member of our ESC research team (Mr. Renaud Boulanger) or the PI of the trials. When interviews were conducted in Spanish, the interviewee’s permission for the presence of the translator was sought.

During the interview, the consent form was read and explained, and participants were provided with a copy that I also signed. The interviewees’ permission to use their name in transcripts, this thesis, and any other ensuing publication was also sought.

3.4 Data Sources

GT supports the use of multiple data sources in order to provide stronger substantiation of the emerging constructs and hypotheses as explained previously. Data were collected from separate sources depending upon availability and relevance to the units of analysis and I will elaborate on these sources in this section.

3.4.1 Interview Transcripts

The verbatim transcripts of 19 Interviews with 11 key informants were the main source of data for this case study. All interviews transcripts, totaling around 290 pages (Times New Roman font, size font 12, double-spaced), corresponded to 26 hours and 38 minutes of digitally recorded, face to face interviews (including one interview conducted with audio-video conferencing using Skype™), saved as mp3 files. Interviews conducted in Spanish were transcribed in Spanish first then translated by a professional translator in Mexico. All transcripts were saved as text files, then imported into Atlas.ti (described below). All quotes used in the analysis were drawn from these transcripts.

Semi-structured open-ended interviews were conducted with key informants in either English or Spanish (according to their preference), and were audio-recorded with the interviewee’ consent. An interview guide was prepared, but it was not religiously followed as it was only meant to be used a reference and provide general guidelines for the interview rather than a script. In fact, interviewers are discouraged from using interview guides to develop GT, as important information might be missed by using a structured format (Schwandt). Thus, I followed a flexible design and asked participants to begin by telling their own stories with the project. The first question with which I started all the interviews in the first stage of data collection was:

“Tell us what happened when you were first approached about the trials”

Or,

“Tell us about your experience with the trials from the beginning”

In this stage of data collection, I concluded all interviews by asking interviewees the following questions:

“If someone else comes with a new research project to the community, what would you like them to do? And what would you do differently?”

Later interviews were adapted to fit the needs of the emerging theory, and some questions were prepared before every interview to follow up on or explore specific issues, categories, or relationships discovered previously in interviews or through analysis. The interviews nonetheless followed a semi-structured format and specific questions were dictated by the participants’ answers and emerged during the interview itself.

Quotes used in this thesis will be identified with the interviewee’s function or professional position only if those individuals have consented to be identified in connection to their statements. I have decided to include name identifiers next to quotes when possible in order to make them more contextualized. Dr. Ramsey, the PI, was the core of the relationships with the community, and provided much of the background information about social interactions as well as detailed descriptions of the project milestones and timeline. Consequently, quotes derived from her interviews are disproportionally represented relative to other interviewees in this thesis.

All quotes used in this thesis are used verbatim (from English interviews, or as translated by the Mexican translator), and therefore might contain grammatical errors that were left unaltered.

3.4.2 Documents

Documents that were used for this study included activity reports written by the trial social scientists (Claudia Ytuarte and Anna Laura Pacheo), posters developed for the community, presentations by the PI or the social scientists for the community or for scientific meetings, and scripts of plays prepared by the trial team for the community schools.

3.4.3 Direct Observation

Although direct observation constituted a minor aspect of data collection, it did help however to provide many useful insights. Direct observation is watching interactions, including verbal communication and body language, in a non-intrusive way and without taking part. In this case, it provided major insights on the type of relationship between community members and the project team. For instance, after observing how they greeted each other, called each other on a first name basis or even using nicknames (like Laurita, or little Laura), joked with each other, and sometimes kissed each other on the cheek as is customary in rural Mexico between friends and family, it became obvious to me that the relationship formed is one of friends or neighbours rather than a formal professional one. Moreover, it became clear that these close relationships also appeared to allow difficult discussions. For example, at the end of the trials, a community leader met with the PI and freely voiced his concerns, as well as those of other community members, and asked for clarifications (Chapter 10). Examples of events where observation served for data collection include a presentation at a community women meeting organized by the trial social scientists and presented by two entomologists, and interactions between trial personnel and community members in all the interviews.

3.4.4 Field Notes and Memos

Field notes and memos were pivotal for concurrent data generation and analysis. Field notes are defined as written records of observational data produced by fieldwork (Hammersly and Atkinson, 2002). These included my summaries of interviews, notes from informal conversations

74 with team personnel, descriptions of observed social interactions including my own with interview participants, or observed interactions in the field as I have just explained above.

Memos are records of thoughts, insights and ideas in relation to a research project, hence are analytic as well (Birks and Mills, 2011), and are viewed as the most significant factor in ensuring quality in GT. Stern (2007) regards memos as the mortar that holds together the data, or the building blocks that constitute a GT. Birks et al (Birks et al., 2008) outlined memos in a mnemonic: Mapping research activities, Extracting meaning from the data, Maintaining momentum, and Opening communication. I have written memos, in which I have recorded analytic insights and inferences, during interviews, after every interview, while analyzing data, and at times after conversations with team personnel or colleagues. Memos also served to note questions I have identified during interviews or direct observation for future follow up. Fifty Seven memos and field notes were recorded during the field visits, and more than 85 memos were generated during data analysis.

4 Data Management

To facilitate data analysis, all data from interview transcripts and supplementary data sources, were imported to ATLAS.ti (v.6.0), a qualitative research software where each transcript was stored under a corresponding identifier as a ‘primary document’. Open, Axial and Selective coding of the raw data (description below) were also electronically performed through ATLAS.ti.

5 Data Analysis

Data analysis in GT revolves around the generation of different levels of concepts and their integration in different stages of analysis into a set of theoretical propositions that form the theory. A concept is defined as a descriptive or explanatory idea, its meaning embedded in a word, label or symbol (Holloway, 2008), and is generated through coding. Coding means categorizing segments of data, be it a word, a sentence, or an incident, with a short name that summarizes the meaning of each segment (Charmaz, 2006). Different approaches to coding have been developed by different theorists. Nonetheless, regardless of the approach the researcher chooses, the use of essential grounded theory methods requires the development of concepts that

75 are initially low level and subsequently developed to a higher level as analysis progresses (Birks and Mills, 2011). All approaches to GT have three stages for coding and analysis: Initial, intermediate, and advanced. These procedures correlate with low-, medium-, and high-level conceptual development respectively. Constant comparative analysis and concurrent data collection and analysis, core features of GT, necessitate that the researcher alternate between phases of coding throughout the study.

The analysis process is detailed below, and while I describe initial, intermediate and advanced coding in separate sections, these three levels of analysis were concurrent and overlapping. This section applies to all three case studies, as analysis proceeded in an inter-dependent, simultaneous, and iterative fashion between the three cases. Therefore I will make reference to this section in the relevant chapter about the methods used for the Malaysia and the Cayman Islands case studies.

5.1 Initial Analysis (Coding)

Initial coding is the first stage of data analysis, and is used to fracture the data to look for meaning in each segment. I have conducted initial coding in two steps. The first step was performed after the first set of interviews (8 interviews from the second field site visit), during which I coded five interviews line by line, and identified 349 codes. In this step I have followed these strategies proposed by Charmaz (2006). • “Breaking the data up into their component parts… • Defining the actions on which they rest • Looking for tacit assumptions • Explicating implicit actions and meanings • Crystallizing the significance of the points • Comparing data with data • Identifying gaps in the data”

The following quote exemplifies my approach to line-by-line initial coding:

Line Code “We thought that maybe no, that it would not work Doubting but in fact when we saw that it was going to work out, Getting convinced, Foreseeing success there was no turning back” Committing, Moving forward

In the second step, I have coded the data from the remaining 3 interviews (from the first set of interviews/second field site visit) by incident, or by looking at segments that correspond to the same idea rather than line by line. Only 18 additional codes were identified, for a total of 367 codes.

5.2 Intermediate Analysis

Intermediate analysis is a stage that included two phases. The first one involved focused coding. Focused coding refers to “using the most significant and/or frequent earlier codes to sift through large amounts of data… [it] requires decisions about which initial codes make the most analytic sense to categorize your data incisively and completely” (Charmaz, 2006). Categorizing is the analytic step of choosing specific codes that have prime significance and making them categories under which other codes could be grouped, or locating regular patterns in multiple codes and forming an analytical concept that is pertinent to all of them.

I therefore reviewed all the codes that I have generated from initial coding, and grouped them under 63 categories, and used this list of categories to recode the first 8 interviews, as well as the 11 interviews from my final data collection trip to Mexico. If new codes were identified and they didn’t fit under any of the categories, new categories were created and added to the list. To achieve this task and categorize the codes I asked myself the following questions, the first three being proposed by Glaser (1978), while the last proposed by Charmaz (2006): 1. What is the data a study of? 2. What category does this incident indicate? 3. What is actually happening in the data? 4. From whose point of view?

Focused coding is exemplified for the following quote:

Excerpt Initial codes Focused Code/Category “We thought that maybe no, that it would Doubting Agreeing in the hope of not work, but in fact when we saw that it Seeing evidence benefits was going to work out, there was no Getting convinced turning back, I said yes we should, Moving forward because we would be well protected from Foreseeing success malaria, we would be protected from these diseases, dengue hemorrhagic fever, Hoping for benefits and since we don´t have a enough money, Being in need if we get sick we have to rush to the doctor or health center or to a generic pharmacy, but there aren´t any... so we agreed” Agreeing

In the second phase of intermediate coding, I performed what Strauss and Corbin (Corbin and Strauss, 1990, 2008) call ‘axial coding’, to specify the properties and dimensions of categories. Properties are defined as the characteristics that give meaning to the category, while dimensions are the range of variance that the property demonstrates or the conditions under which they operate. Axial coding also starts identifying patterns and relationships between and within categories (Strauss and Corbin, 2008). Axial coding therefore starts reassembling the data that is fractured during initial coding in a coherent analytic construct (Charmaz, 2006). This phase however is fluid and continues with the advanced coding stage as explained below.

I have looked for the following components of statements and incidents, as recommended by Corbin and Strauss (2008): 1. Conditions (why, where, how, and what happens?) 2. Interactions/actions and emotions 3. Consequences (of interactions/actions and emotions)

For example, I studied why and how family heads gave informed consent for the Mark-Release- Recapture trials and consequently admitted the project team to their homes. I examined the interactions that occurred between them and the researchers, and found that consent was given

78 not only after receiving information about the experiments, but also when the community as a whole in Río Florido established relations of neighborship with the project, and hence the personnel were known personally to individuals. These friendly interactions led to a state of support manifested in allowing researchers into homes to conduct experiments, as well as showing them positive attitudes, participating in activities, and actively helping them when needed.

“She invited us to sit on the hammock and got me papaya to eat” (Project Communication Specialist)

5.3 Advanced Analysis

As previously stressed, grounded theory analysis processes are not linear. The interaction between data collection, initial data analysis, and intermediate analysis is cyclical (Birks and Mills, 2011). Advanced analysis also doesn’t follow in a linear fashion, and all analytical phases continue to overlap to ensure that theory remains grounded (Birks and Mills, 2011) Advanced analysis basically is the stage when data becomes theory.

Two strategies were used at this phase. The first strategy led to identifying conceptual patterns and developing connections or relationships between the established categories (Strauss and Corbin, 1998, Corbin and Strauss, 2008) in order to move the story around the central phenomenon in a theoretical direction. The second strategy, using a storyline, deals with the presentation of the theory. A storyline is the “conceptualization of the story” (Strauss and Corbin, 1990: 116), a narrative that explicates the theoretical constructs (categories and their relationships) (Birks and Mills, 2011.) The final theory is presented as a storyline in Chapter 16.

As I mentioned previously, due to the iterative and constant comparative nature of grounded theory, this section on data analysis applies to all three case studies.

6 Summary

In this chapter, I presented the methods I have used for both data collection and analysis in order to answer my research question. These methods were guided by the grounded theory approach considerations. The specific questions I address in this case study relate to the experiences of the

79 different community members with the trials, to uncover the meanings of authorization for research from their perspectives, the considerations that affected their judgments, and the actions they have taken at different stages of the trials. To explore these questions, I followed theoretical sampling, and conducted 19 interviews with 11 key informants. Moreover, I analyzed 6 documents as well as depended on direct observation and field notes as data sources. My data analysis passed through three stages, whereby initial codes led to focused codes and categorically that were finally integrated into a set of relationships that form the theory.

CHAPTER 7 Case Study Research Context

“Qualitative research is context-bound. This means that the researchers have to be sensitive to the context of the research and immerse themselves in the setting and situation” (Holloway, 1997: 5). Knowledge of the context is considered a fundamental aspect of collecting data. Glaser and Strauss (1967) consider that insight, including knowledge of the complex contextual characteristics of the phenomenon being studied, is essential to solidly ground the newly discovered theory (Baptista Nunes et al., 2010).

In this chapter, I describe the socio-political context of my case-study research project. I start by overviewing the scientific and social characteristics of the field site of the GMM trials, and then describe the relevant geo-political context, with the focus on the political agrarian system of ejidos and its implications on community engagement and authorization for the trials. The third part of this chapter addresses the social context of the trials, where I explain the different constituents and levels of the community.

1 The Trials

A genetically-modified strain of A. aegypti, designated OX3604C, was evaluated in large outdoor cages for its potential to suppress local populations of the mosquito. Male OX3604C GMM were introduced weekly into the field cages that contained the target mosquito populations over a period of 17 weeks. When homozygous OX3604C males mate with wild-type females, no reproductive female offspring would be produced, and hence the local population of A. aegypti would be expected to be suppressed. Nonetheless, OX3604C did not have mating competitiveness with wile type males, and therefore the target population was decreased but not eliminated. Accordingly, the researchers concluded that OX3604C may not be effective in large- scale releases (Facchinelli, 2013). Consequently the trials were completed with no scientific success. In Chapters 7 and 8 I show that the local host community was disappointed by these

81 results, as they were anticipating the “sancudos beneficos” (beneficial mosquitoes) to be released in their community.

2 Field Trials Site

This case study was conducted in the city of Tapachula and the neighboring town of Río Florido in the state of Chiapas in Mexico, in the context of the GCGH-funded GMM project entitled: “Genetic Strategies for Control of Dengue Virus Transmission” or GC7#316 (GC7#316, 2006). GC7#316 is a collaboration between a consortium of academic centers, including the Center for Regional Investigation in Public Health (Centro Regional de Investigación en Salud Pública - CRISP), which is a branch of the National Institute of Public Health (INSP) in Mexico (INSP, n.d.), the universities of California (Irvine and Davis), Oxitec, a private UK-based biotechnology company (OXITEC, n.d.), St. Michael’s Hospital, Toronto, and the McLaughlan Rotman Center for Global Health (MRC - currently Sandra Rotman Center for Global Health) at the University of Toronto (MRC, n.d.), among other universities from the United States.

The aim of GC7#316 is to prevent the transmission of Dengue viruses by developing genetic strategies to reduce the population of Aedes egypti, or rendering mosquitoes unable to carry and transmit the Dengue virus, and the trials involved a combination of molecular, entomological, and social science research (GC7#316, 2006). Developing suitable containment cages in which the mosquitoes can be released and compared to wild ones in natural ecological conditions was an essential transition step between successful laboratory studies and environmental releases (Facchinelli et al., 2013). It was crucial to establish the field site for these caged-trials in a location with an appropriate dengue epidemiology and Ae. aegypti ecology, and where researchers would be able to test the relative fitness and the behavior of GM Ae. Aegypti, its interaction with local wild-type mosquitoes, and its ability to spread effector genes designed to block transmission of dengue viruses and reduce or eliminate mosquito populations (Facchinelli et al., 2013).

In October 2006, the GC7#316 team, with input from the Advisory Service of the ESC Program, selected Mexico as the country in which to conduct caged field trials of the genetically modified vectors (Lavery et al., 2008) after surveying three other countries: Thailand, Peru, and Trinidad and Tobago. The decision was based on three relevant broad categories of criteria, which I

82 explain briefly in this section of the chapter: 1) scientific criteria, including favorable dengue epidemiology and mosquito ecology; 2) local capacity for regulatory and administrative authority for conducting the trials; and 3) capacity for community engagement and authorization for the trials, which will be the focus of this case study.

“We were not looking to find a place where it was easy to do it because there weren’t any rules, exactly the opposite” (James from Contenta, 2012)

2.1 Scientific Criteria

Mexico satisfies many scientific criteria to conduct this GMM research. First, Central America and Southern Mexico have been identified by the US Centers for Disease Control as areas with Ae. aegypti and dengue epidemic activity (Brathwaite Dick et al., 2012). Large epidemics of Dengue have been recorded in Mexico since the 1970s (Guzmán et al., 2006) and the incidence has been climbing steadily for a decade (Cuddehe, 2009). Moreover, A aegypti has been detected recently in more Mexican states and at higher altitudes than previously seen, increasing the risk of Dengue transmission geographically (Cuddehe, 2009).

Mexico also satisfies the requirement for scientific and administrative capacity to conduct the trials. The National Institute of Public Health (INSP) is a well-established academic institution that is committed to research and education, and is formed of eight centers, one of which is CRISP, the Regional Center for Public Health Research (INSP, n.d.), which is reputable for its long tradition in research on vector-borne diseases and environmental health. CRISP is located in the city of Tapachula in Chiapas, on the southern border of Mexico with Guatemala, and is considered a research center with regional credibility. For example, Dr. Janine Ramsey, previous director of CRISP and principal investigator of the trials in Mexico, explains that CRISP is a WHO research center that has developed many of the vector control methods that are used nationally and regionally. “[The] center has developed insecticides and methods for application, biological control agents, and other vector control strategies, this is a WHO research center for vector borne diseases … From the entomological vector control viewpoint this center has international [reputation]… We are the regional center for public health and for the

Meso-American project… Some of the methods developed here at the center are used at a national level” (PI)

2.2 Regulatory and Administrative Capacity

Regulatory capacity in Mexico for GMOs is quite developed, with many federal agencies and ministries involved. In this section I list all the institutions, regulations, and biosafety laws that were involved and enacted in issuing a regulatory approval for the trials.

Mexico is a ratifier of international conventions on GMOs such as the Cartagena Protocol on Biosafety (UN Secretariat of the Convention on Biological Diversity, 2000), a supplement to the United Nations Convention on Biological Diversity (UN Convention on Biological Diversity,

1992) Federally, the main institution that is responsible for formulating and coordinating the policies related to the biosafety of GMOs, and for regulatory requirements to grant permits for GMOs research is CIBIOGEM. It is an inter-secretarial commission made up of the heads of the ministries of health (SSA), Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA), Environment and Natural Resources (SEMARNAT), Finance and Public Credit (SHCP), Economy (SE) and Public Education (SEP), representative of the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) and the General Director of the National Council of Science and Technology (CONACYT). INE, the National Institute of Ecology, also supports the Secretary of Environment and Natural Resources in issues related to the environment in general including GMOs. Over the past two decades, several laws have been developed to regulate GMOs in Mexico (Herrera Izaguirre, Hinojosa, Hagelsieb, and Salinas, 2008). The “Biosafety Law on Genetically Modified Organisms” was issued in 2005 to specifically regulate biotechnology and GMOs (Ley de Bioseguridad de Organismos Genéticamente Modificados [Biosafety Law on GMOs], 2005). Other laws include the “General Law of Ecological Equilibrium” (Ley General de Equilibrio Ecológico [L.G.E.E.], n.d.), which deals with environmental protection in Mexico, and contains provisions with respect to the Environmental Impact Assessment (EIA) that needs to be undertaken prior to the import, export, and introduction of genetic material into the environment, and the “Law on Plant Health” (“Ley de Sanidad Vegetal [Law on Plant Health],” 1994) which also regulates the use of transgenic material and its introduction into the environment. In addition to federal legislation, the Official Mexican Standard (Norma Oficial Mexicana) NOM-056-FITO (SAGARPA, NOM-056-FITO-

1995, 1995) is a compulsory standard that is created by the National Standardization Commission and the SAGARPA, and establishes the phytosanitary requirements for transportation, import and experimental trials of GMOs in Mexico. Mexican federal states also have legislative power on issues related to GMOs and the environment (figure 10.1). Regulación Sanitaria enforces COFEPRIS regulations and ratifies the SEMARNAT permit for use of GMM, which eventually gets endorsed by the Municipal Committee of Health (Comité Municipal de Salud) at the county or municipal level (James, 2009).

In addition to meeting all the requirements as stated in the above regulations, the project also had to be approved internally at INSP by the INSP Regulatory Commissions that oversee bioethics, research, and biosecurity, as shown in Figure 7.1 (James, 2009).

Figure 7.1 - Reproduced from (James, 2009): Schematic representation of the Project regulatory structure. The regulatory pathway has two principle domains, one associated with the collaborative institution (left), and the other linking a vertically-integrated system of community agencies (right). Arrows show explicit lines of communications and ratification of approvals.

2.3 Community Engagement and Authorization

The third criterion for the site selection, and the most important for the purposes of this thesis, is related to the capacity for engaging the community with the research project and the possibility of securing authorization from the community for the project to begin and proceed. Concerns about community authorization and participation were actually central to the site selection decision (Lavery et al., 2008).

Public participation in environmental research and decision-making is not a foreign concept to

Mexico, and has been a core provision of the Commission for Environmental Cooperation (CEC) of North America, an international organization created in 1994 through the North American Agreement on Environmental Cooperation (NAAEC), a side agreement of the North American Free Trade Agreement (NAFTA). The provisions for transparency and public involvement in this agreement were seen to have created in Mexico a new space for public participation (Carlsen and Nauman, 2004; CIP Americas, 2005). Moreover, “Increasing Public Participation at the Community Level in Mexico” was a project funded in 1999 by the North American Fund for Environmental Cooperation (NAFEC) and conducted by the Environmental Law Institute (Instituto de Derecho Ambiental - IDEA) from Mexico, The Environmental Law Alliance Worldwide (E-LAW) from the USA, and West Coast Environmental Law (WCELA) from Canada (Commission for Enviromental Cooperation, 2003). Through this project, E-LAW, IDEA, and WCELA produced a 123-page document, “Guide to Public Participation in Environmental Matters in Mexico, the United States, and Canada”, that was aimed to provide communities in Mexico with the information they need to participate more effectively in decisions about the environment (IDEA, E-LAW, and WCELA, 2008). Federally, public participation is promoted in the Mexican biosafety law as a democratic tool for decision-making (Herrera Izaguirre et al., 2008).

Locally at CRISP, the principal investigator has conducted extensive epidemiology and entomology research, both locally and regionally, while fostering the participation of Mexican communities

“I worked for the last 10 years on these types of issues, something I am extremely sensitive to… My mandate was to open up the expertise [in the center] to the epidemiological, clinical, social aspect of a more integrated approach, interdisciplinary approach to vector borne diseases. To complement with social science.” (PI)

Nevertheless, the potential for community engagement and community authorization for research projects ultimately depends on the social and political environment and structure of the community in which the research is taking place. As I will show in subsequent sections, and as Lavery et al. (2008) explain, the political and social structure of the community in Río Florido was promising for a meaningful engagement and the possibility of securing authorization from the community for the trial, even though the meaning of authorization was still not well

86 conceived at the beginning of the trials. In the following sections, I describe the political structure of the community, and in the last section of this chapter I describe the social context of the trials and hence my case study, by defining who is the community in this context.

3 Geographical and Political Context

The selected field site for the caged trials is located on 4.5 acres of land in Río Florido, an agrarian town of around 800 people in the municipality of Tapachula, in the state of Chiapas, 13 kilometers from the Guatemalan border (information retrieved from the town’s records, according to personal communication with the leader and with the anthropologist responsible for community engagement). The field site (14°51′41″N, −92°21′15″W)) is 11.2 km southeast of the center of Tapachula (Facchinelli et al., 2013. Supportive laboratory and insectary facilities were located at CRISP in Tapachula, 15 km from the field site.

Figure 7.2: Geographical Location of Río Florido Figure 7.3: Geographical Location of Río Florido

Figures 7.2 and 7.3, retrieved from Google Maps© show the geographical location of Río Florido. In this section, I present an overview of the relevant geo-political characteristics of the context of the case study, encompassing the province, the city, and the town hosting the trials. I also explain in this section the ejido social system of communal land holding, which is followed in Río Florido, and its implications for the trials.

3.1 Chiapas

The state of Chiapas is located in Southwestern Mexico, but is considered both culturally and geographically isolated and distant from the rest of Mexico. It is the eighth most populous state in Mexico with around 4,796,580 individuals (INEGI, 2012) living in 118 municipalities. It remains the poorest state in Mexico, and ninety-four of its municipalities live on the poverty line (Jimenez Gonzalez, 2009). Around 18% of the inhabitants are illiterate, with rates up to 48% in some areas (Jimenez Gonzalez, 2009). Chiapas is also home to one of the largest indigenous populations in the country with twelve federally recognized ethnicities. Subjugation of these peoples with resultant rebellions was a common theme in the state’s history, with the latest rebellion being the 1994 Zapatista uprising. This historical socio-political context creates an interesting backdrop for the trials. People in the area have been subject to abuse and exploitation, which led to a general apprehensive state about projects coming from the government or abroad as explained to us by one of the project’s anthropology consultants. Nonetheless, opposition and resistance were a common form of collective self-expression, and self-determination is a major demand in all of these rebellions. It was expected therefore that the community, at all levels, would want to have a say with respect to the trials.

Starting from the mid 20th century, Chiapas experienced a significant rise in population that was not commensurate with the economical growth (INAFED and SEGOB, 2010). This economic crisis led to attempts to resettle peasant farmers onto non-cultivated lands, sometimes with land invasions and takeovers of state assets as part of the political crises that started in 1970s and led to the Zapatista movement of the 1990s (Hamnett, 1999). The uprising had many achievements, one of which was favoring ejidos in the agricultural sector, which I will explain in a subsequent section (Harvey, 1998; INAFED and SEGOB, 2011; Mattiace et al., 2002; Reyes Ramos, 1992). It is sufficient to mention at this stage that this system of land ownership was also associated with increased political power and autonomy for local communities, with institutionalized procedures for decision-making and governance (De Aguinaga, 1993; Stavenhagen, 1966).

3.1.1 Agriculture and Genetic Modification in Chiapas

Agriculture, livestock, forestry and fishing employ over 53% of the state’s population (INAFED and SEGOB, 2011).

“It’s rural Mexico, economically, society is totally dependent on Agro [agriculture]” (PI)

Genetically modified crops however were not a common practice in the Southern parts of Mexico as Dr. Ramsey explains, since the area has an abundance of “indigenous groups with traditional perceptions and practices” (PI).

“Transgenics in the Southern third of Mexico was silent…Transgenics is an issue that is peripheral to their immediate needs, there hasn’t been much presence of GMO, companies sometimes coming in with a lot of disinformation… GMO were not brought to the south, except recently, by [biotechnology] companies, and was not considered high priority for CIBIOGEM who was putting laws and regulations, since most transgenic work was being done in the north, that’s where most their programs were done for education, inspection, and where their presence was focused” (PI)

Consequently, most people did not know about nor understand genetic modification.

“The ejido association came to us to respond to certain questions they had a year ago, when Monsanto started coming here [...] it was [the] first time farmers have heard about it, before they only heard about it from us but they really didn’t have a corporate company come after them, this has occurred in the past two years, once our project was off the ground … Agro-business people knew about it [GMOs], one of them was involved, but truly they didn’t understand it… we were their reference and asked us about things related to agriculture” (PI)

Nonetheless, apprehension towards GMOs was present in certain groups, mostly in other states. An example was an international GM research project in which ECOSUR, a scientific research center for sustainable development, was involved, and which was strongly opposed by social and indigenous groups in the state of Oaxaca, north of Chiapas.

“The bomb shell issue of transgenics erupted in Oaxaca due to local farmers and social groups questioning what was being done … ECOSUR was badly [seen] (inaudible) …[there was a] massive backlash [...]. Later there were more issues like this against transgenics, everything gets mixed together in a bag” (PI)

The high rates of illiteracy in the region, and the lack of awareness or understanding of genetic modification even by those using GM crops, create a challenging context for engaging the community around issues related to GMM, especially with respect to authorization and informed decisions or actions.

3.2 Tapachula

Located near the Guatemalan border and the Pacific Ocean, Tapachula is one of the most important economic cities of Chiapas. It is also the capital of the agriculturally rich Soconusco region in Chiapas, and is the port for trade between Mexico and Central America (Figure 7.4).

Figure 7.4: Soconusco Region

The city of Tapachula is home for around 290,000 inhabitants, and is the governmental authority for a number of other neighboring communities (INAFED and SEGOB, 2011). With the 19th century colonization of the Soconusco, and the modernization of the region through capital investment in the coffee plantations, Tapachula received many immigrants from several countries in addition to the local Mexicans who came from different regions. In addition to the local indigenous communities, and the various regional Mexican communities, Tapachula has inhabitants of Guatemalan, German, Japanese, Chinese, North America, English and French origins, making of it thus a cultural melting pot (Garcia de Leon, 1997). Because of its location, Tapachula also is the principal access to many Central American immigrants who are seeking to settle in Mexico or the USA. The presence of many ethnic and cultural groups in the region could have had implications for the meanings of GM, nature, engagement, and authorization. In

90 fact, the main anthropologist on the team explained that they had to include different cultural and religious groups in focus groups, to have “as many different opinions present in the discussion” (Project Anthropologist). Moreover, messages had to be adapted for use with different groups.

Tapachula is considered an education hub in Chiapas. The presence of CRISP makes it an important local as well as regional public health and research center too.

3.3 Ejidos

In this section, I will explain the land ownership system that is followed in Río Florido as well as a big proportion of Mexican agrarian towns. This system is associated with a socio-political structure that confers a certain level of autonomy and governance to communities, as I will explain below, and therefore constitutes a good infrastructure with potential for meaningful engagement and authorization. It is important to explain in detail the land privatization and ownership procedures in this system, as purchasing the land for the field trials site constituted a major milestone for the project with implications for community authorization, as I will explain in Chapter 9.

In Mexico, real estate properties are a mosaic of different types and are classified as public, private, or social properties (Vargas and Ochoa, 2002). Public properties are those that belong to the Mexican nation as a whole, and include domains such as natural resources as well as state and federal properties. Private properties are those whose ownership and domains belong to individuals or groups and are transferable without restrictions. Social properties on the other hand are held communally by a group of people, who share the use but not the ownership of these lands. An ejido is a semi-autonomous social property that is collectively possessed by a community of ejidatarios as a group, or the local association of peasants, and every ejidatario (land owner) is assigned an allotted parcel and acquires the right to use it indefinitely and pass this right to his children (the masculine article is used as ejidatarios are usually men) as long as he does not fail to use the land for more than two years. Traditionally, peasants do not own their shares of the land, and consequently do not have the right to sell, rent, or dispose in any other fashion their lots, except in specific cases that are authorized by the community as I will explain in the next section.

According to data published in 1998 by the National Institute of Statistics, Geography and Informatics (INEGI) and the National Agrarian Registry, 52% of Mexican territory is comprised of ejidos, where more than three million ejidatarios live (Gutiérrez Lacayo et al. 2002). While ejidos were a common practice during the time of Aztec rule in Mexico, they were not re- introduced in modern times until 1934 after the Mexican revolution, as a means of providing land to the poor farmers of Mexico who could not afford to pay for land (De Aguinaga, 1993). The Agrarian Reform Ministry expropriated lands and created communal groupings in the form of communal farms, or ejidos, which consist of members, the ejidatarios, living on and operating the land lots (parcelas) that form the ejido, under the leadership and administrative organization of a defined autonomous governing council, an assembly made up of ejidatarios and headed by a comisariado, or the council leader.

Politically, the ejido in Mexico has three organs: the assemblea (assembly of ejidatarios), the comisariado, and the Supervisory Board. The assemblea is the supreme organ or authority of the ejido, and is an example of modern democracy as it includes all the ejidatarios who collectively make decisions on ejido matters, and who collectively elect the comisariado. Moreover, the ejido system exemplifies community autonomy, whereby the community decides on its local matters. The assembly convenes regularly after requests from the commissioner, 20% of ejidatarios, or the supervisory board, and its role is to approve Ejido Bylaws, accept or authorize new Ejido members, approve business contracts with third parties, and authorize sale or re-allocation of land lots and hence termination of the Ejido status for given ejidatarios. The commissioner is the central figure in the ejido administration, and is in charge for the implementation of the decisions of the Assembly and the representation of the Ejido for legal purposes in the municipality (Bartra, 1993).

Ejidos have been acknowledged as shells that protect social-ecological systems (Alcorn and Toledo, 1998). In fact, some of the ejido system’s intended consequences were to break up the political and economic power of the traditional ruling class and consequently give more social and political leverage to local communities and to increase their participation in finding communal solutions to local, especially agrarian, problems. With a communal property, local elections of officials, and local handling of local matters, ejidos possess the infrastructure for organized democratic political and economic action (Stavenhagen, 1966).

However, it was found that most ejidos do not really function according to the intended models (Nuijten, 2003). In fact, undemocratic elections processes are not infrequent, and often elections are influenced by the balance of power between democratic forces within the community and political and economic elites both inside and outside the ejido (Fox, 1992). Moreover, it is frequent to encounter non-representative or authoritarian comisariados who sometimes almost eliminate the participatory and governance role of the assembly (Nuijten, 2003). Also, even in the presence of democratically elected accountable and representative officials in the assembly, their collective initiative and autonomy are found to be often compromised by governmental control and intervention even in elections. In one research study, it was postulated that assemblies rarely actually make major decisions in mass meetings or through voting, and often such formal procedures ratify decisions that are made previously (Fox, 1992).

This socio-political background presents an opportunity and a challenge for the trials. The opportunity lies in the availability of an infrastructure for engagement, participation, and collective deliberation and collective decision-making necessary for an authentic authorization. The challenge however is to ensure the legitimacy and representativeness of the constituents of this infrastructure, and the authenticity of the followed procedures. In fact, this could be a condition for field trial site selection, where sites are selected only where the collective and participatory procedures of governance are properly followed.

3.3.1 Land Privatization and Ownership in Ejidos

As a result of the North American Free Trade Agreement, reforms to the Agrarian Law were made in 1992, and opened up traditional Mexican ejido territory for privatization and ownership and consequently for sale (Rodriguez, 1999)

Nowadays, ejidatarios can acquire ownership to the land they hold and transfer its title to any third party through the procedures of PROCEDE ("Programa de Certificación de Derechos Ejidales y Titulación de Solares" or Program of Certification of Ejido Rights and Titles over Solares) and Dominio Pleno (full ownership or full domain) (Braña and Martínez, 2005). The Agrarian Act, in article 23, section X, empowers the ejido assembly to autonomously define and allocate lands into three types: common, “Solares” or human settlement lands, and individual parcelas. Once PROCEDE is complete and land plots are defined and assigned according to

93 terms of Article 56 of the Land Law, ejido members are given parcel certificates and can acquire full ownership by converting the parcel into private property through the process of Dominio Pleno (full domain or ownership) and thereof have the right to sell it. However, to gain full ownership over a plot, or Dominio Pleno, the ejidatario must request an authorization from the ejido assembly, which is granted through formal procedures as outlines in the Agrarian Land Act (DOF, 1992; PA, n.d.).

When the project team surveyed Río Florido to select a suitable land for the trial with a favorable landscape, they were shown all the lands whose ejidatarios were willing to sell through the procedures of Dominio Pleno. Once the decision was made and the site was selected, the assembly had to go through the respective procedures, and vote to grant Dominio Pleno to the parcel holder, in order to enable him to sell the land to CRISP for the purposes of the trials.

3.4 Río Florido

Río Florido is a village (Pueblo) of 585 hectares (5.85 Km2), located in the municipality of Tapachula in Chiapas. It has a total population of 831 inhabitants, living in a total of 161 households (Retrieved from Ejido records). The majority of people work as farmers in the village lands producing crops such as mango, soy and corn.

Living in a small village with no infrastructure, inhabitants have to go to Tapachula for financial, administrative, medical, education, and other services. Río Florido however has three schools (a kindergarten, a primary and a middle school) and 86% of the residents have had at least some level of schooling (personal communication with the trials anthropologist – retrieved from ejido records). Water access and sanitation are the most pressing problems in this village, as there is no access to fresh water, which has to be stored in tanks, most often open, leading to increases in mosquito populations and hence vector-borne diseases. Moreover, although a line for drainage has been installed, it hasn’t been finished yet and is therefore not active. Also, since there is no garbage collection available, most people either use wells to bury garbage or burn it. Garbage accumulation also leads to increases in pests including mosquitoes. The underdeveloped infrastructure and consequent hopes for development turned to be important considerations in the assessment of the trials (Chapters 8,9, and 14).

Río Florido is the locality of “Ejido el Zapote”. Today 81 ejidatarios form the ejido. Like other ejidos, Río Florido has a political governing body formed of a representative board (assemblea) and a leader (comisariado ejidal). The assemblea comprises all the ejidatarios, who elect the comisariado. Both the assemblea and the comisariado have legal and moral authority in the community, and vote collectively on issues related to the community in the ejido such as development projects, events, education, and others. Administratively, Río Florido is under the charge of a county agency, which is formed of the county agent (agente), two rural judges (juis rural), and office staff. The agency resolves internal problems when possible, collects certain taxes, and provides administrative civil services such as birth certificates, residence certificates, and identity cards. A municipal health agent also works in the agency.

In the following section, I will present an overview of the social context of the trials and hence the case study, where I define the community and its decision-making mechanisms.

4 Social Context

Learning about the socio-political characteristics of the community was essential to understand the processes that were involved in community engagement endeavors. It also helped me understand ‘authorization’ as applicable locally, in the context-specific core values of the Tapachulan and more widely Mexican community. Moreover, it was essential to understand who constituted the community, and the complexity of the different levels of community as well as the different hierarchies of authority and decision-making, with their correlation with engagement and authorization. Insights into this backdrop were drawn from all the interviews, specially interviews with the social scientists and anthropologists Francisco Javier Camas Reyes and Ana Laura Pacheco Soriano.

Camas Reyes, is an expert anthropologist and author on the meshwork of the Tapachulan society and its socioeconomic and political characteristics. In describing ejido communities in rural Mexico, Camas Reyes alluded to one of the most important challenges that the project has faced, which is to get the community to be “open” to the idea, and eventually gain their confidence. He states that the general “lack of confidence” in others is a common theme in the Soconusco region, as a result to a long history of exploitation.

“People here are product of a history of abuse. It’s a history of taking away from the region but no re-investment, economia de enclave [enclave economy]… People don’t have confidence, their conscience has accumulated all of experiences of exploitation… These are conditions that affect the confidence of the people, the history of exploitation … due to capitalism and the flow of investments from abroad, specially American companies, who take all the benefits … and the difficult process of the consolidation of a cultural and social identity, these filter down and affect the ejidos” (Camas)

As noted before, the Soconusco in general, and Tapachula specifically, are cultural melting pots with many indigenous, regional, and foreign ethnicities. Camas considers that this multiculturalism has also contributed to the general feeling of lack of confidence in others

“Different people from different ethnicities and nationalities also inhabit this area. The process of integration is difficult, to consolidate identity is very difficult”

Finally, as probably in most developing countries, there’s a lack of trust in the government

“The entire Tapachulan region suffers from centralism characteristic in Mexico. Ejidos therefore don’t trust the government, because they are suffering from that centralism” (Camas)

It was therefore expected for the community to assume a cautious or even apprehensive position towards the GMM trials project that is being brought to the community by a governmental agency (CRISP), and with foreign funding. In the coming chapters, I will detail how the project team overcame this challenge and gained the confidence of the community, and how this has consequently impacted authorization.

An important question concerns “who constitutes the community?”. Community is an elusive concept, with no consensus on its definition because of contextual variances and peculiarities. Therefore the best way to answer the question is to build the definition from the data. “The concept of community remains a daunting prospect”, asserts the PI when asked about the relevant stakeholders and the meaning of a community.

“I conceived it as being at multi-level; federal, regional, state, county, the community that calls itself Río Florido, and across all bounds, i.e. academic groups, social

communicators, other interest groups, Agro [businessmen], farmers, public health, and scientific agencies, all across ... As far as I am concerned, community has a broad context and each one of these groups is linked to the other, just like when we go to a community and look for the natural associations that exist so that you can link with them. I just expanded that vision that I had on a community level to something on a national level and over the board. Because we’re 13 km out of Guatemala, the Guatemala and Meso-America was also a region to be dealt with, so my definition included all of this and we should make an attempt at all the levels and throughout as much of these communities as we can to engage” (PI)

While the word community was often if not always used to refer to the local confined community at Río Florido, it was obvious from examining the activities and the milestones of the GC7#316 project that ‘community’ encompassed a wide variety of groups that extended beyond the confines of the local community in Río Florido, as exemplified in the quote above. Social transactions took place at distinct levels of community that can be best demonstrated in figure 7.5. The ‘macro’ community is the broad Mexican context that includes national, regional, state and county entities, with all the respective interest groups, or nested communities, such as

(Meso Community)

Figure 7.5 Community Levels regulatory, academic, business, public health, and other communities. The macro community comprises the micro community, or the ejido, the defined and localized host community in Río Florido. This micro-community is also part of other mid-level or meso communities nested in the macro-community, such as the county. While this micro community is naturally influenced by and linked to the other interest groups or communities that are part of the meso

97 and macro communities, the linkages that exist between its members are of a different nature as there exist a common sense of identity and goals, shared geographical location, and shared political structures, leading to tighter bonds and making out of this community a separate entity than the rest of the communities in the Macro structure. Moreover, as the trials are taking place in a confined geographical location that represents this community, it is natural that this micro community receives special attention and focus in community engagement endeavors. This definition is in line with the community conceptualization I presented in chapter 3 as part of the literature review.

The red lines in Figure 7.5 represent the highest level of political authority for each corresponding community. At the red line representing the intersection between the micro community and the macro community, lies the political structure with both legal and moral legitimacy and representativeness, represented by the assemblea and the comisariado. The micro community, or from now on the ‘community’, includes the subunits of decision-making, and these are the individuals and their households (families).

In what follows in this section, I present the constituents of the macro and micro communities, respectively.

4.1 Macro Community:

As I just explained, the macro community is the all-encompassing context that nests interrelated and even overriding interest groups, or communities. It is the national community that includes all other communities, including the micro one. From the early beginnings of the project, and especially prior to site selection, it was obvious that “different players” (PI) at different levels had to be actively engaged.

“The whole idea is if you try to stimulate a discussion over a topic you need to bring in and engage and stimulate as many of the naturally existing groups that are already existing … [I] would go to all of those who would enter into a group, the public health people, the end users, etcetera, so we can get a better view, a more integrated one of what society thinks about these things” (PI)

It can be inferred from this quote that a community was seen as a “naturally existing group”, or a group with common interests and shared goals. In this section I will list and present the most important communities that were encompassed by the macro community.

CRISP

The first layer that was engaged in this macro community was CRISP as a center. Dr. Ramsey, as the director, was first contacted by Dr. Mario Rodriguez, then director of the Mexican National Institute of Public Health (INSP), and was informed about a visit by the GC7#316 team to consider Tapachula as a site for the future caged-trials. While Rodriguez gave the green light, authorization was required from CRISP. The final decision was that of the center.

“We were informed that we were being considered as a potential site for the project, I openly talked about it, discussed it, with all the center…all scientists share in decision- making” (PI)

Once an internal decision was taken in CRISP to participate in this project, and a collaboration agreement was formalized between CRISP and GC7#316, CRISP personnel, especially Ramsey, turned from being the “engaged” into being the “engager”. The rest of the factions in the macro community were “engaged” concurrently by CRISP from this point on. CRISP in fact appeared to assume full responsibility and full ownership of the project. In the rest of this thesis, I will refer to CRISP and GC7#316 collectively as “the project”.

Federal Level

The first step in preparing for the trials is to apply for and receive an approval or clearance from relevant federal regulatory agencies. Applying for a regulatory approval for the trials wasn’t a simple and straightforward task, but necessitated that many agencies, had to be contacted and engaged. This was due to the lack of regulations in place to deal with GMOs other than plants and seeds. The project team had therefore to engage with different relevant bodies, most importantly CIBIOGEM at SEMARNAT, in a collaboration aimed at developing the needed infrastructure.

“[It was a] collaboration to get their heads around this and bring their people up to speed with [GMM] issues” (PI).

A meeting with the sub-secretary of the environment who is responsible for GMO issues, resulted in a chain reaction in other agencies such as INE and CONABIO that started developing national technical and regulatory guidelines for GMM, and the project team was part of this process. This exemplifies the bilateral relationship that was being formed between the project and the macro community from the start, as I will explain in Chapter 7.

“They took us seriously, on the one hand apart from processing our application, on the other hand they started asking us to join commissions within the ministries and the GMOs regulations committees. We were asked to help them.” (PI)

From these interactions I can deduce that the different agencies constituted different communities that were all nested or enclosed within an encompassing one, under the title of ‘federal community’. An implication of this realization makes it essential for research groups to identify and engage all relevant constituents, or enclosed communities, of each community of interest.

County level, or the Meso Community

At the county level, and before targeting the different ‘communities’, the “first level to talk [to] about this project was the mayor” (PI), stressing the importance of engaging first with official authorities. The mayor in turn referred the project to the different relevant official commissions in the county, and eventually engagement occurred in a chain, with each entity referring to the next link, or entity.

The first commission to engage was the county health commission. This commission had representatives of all the interest groups relevant to the health of the Tapachulan community.

“It had a broad social representation where different discussions of different issues associated with health, garbage, dogs, human health, water system, any health issue that came up in the community, disasters, took place. Decisions were also made within this committee as to how the monies that the county had are to be spent, so it was an advising group with both financial and strategic importance of what the county itself would work on” (PI)

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Other commissions included the ‘county security commission’ and the ‘public protection council’.

“The mayor said we have the county security commission and the public protection council, I called them and I said I want to present this project to you because you are the societal representation to the mayor outside the health commission, and we had a back and forth of questions, there were three directors of universities”

Representatives from these commissions in turn helped the project to identify and meet other relevant stakeholders.

“To each one of them I asked them if they can help me set up meetings with universities, agro, etcetera, so we can go to a different level of discussions, so this information can diffuse out and we can get more feedback from the county level” (PI)

As I argued previously, the different constituents of each community, or the enclosed communities, had to be identified. The examples in this section however suggest that in order to identify these enclosed communities, one ought to identify all relevant interests at stake first.

Other Interest Groups

Other interest groups in the macro community were identified and engaged both at the county level and within the broad macro community. These included academic, research, agribusiness, and civic society groups, among others.

Public

There were no indications from the interviews that interactions occurred with the general public at the macro level. As I will show in Chapters 12 and 13, the publics in the macro communities in both the Cayman Islands and Malaysia demanded to be informed and engaged, in addition to the public in the micro community.

4.2 Micro Community

In this thesis, I used the term micro community to refer to the defined and localized host community in Río Florido where the trials were being conducted, and which is enclosed in the

101 county and hence the meso and macro communities. The assembly, or ejido council, is the body with both official and moral authority at the interface between the micro community and the rest of the macro community. The micro community enclosed other communities, such as the ejidatarios (or land holders), the school teachers, the school kids, and women civil organizations, among others. As discussed before, a community is a group of individuals who share common interests. All of these communities are interrelated, and a person might belong to different communities at the same time. The micro public included all the individuals who live in the community and do not hold any official status, and who might belong to any one or more of the subcommunities. An example would be women who belong to the Opportunidades program. Opportunidades, or Opportunities, is a government anti-poverty social assistance program through which women receive monetary remuneration in exchange for attending education and health classes. Women who benefit from Opportunidades participated in the trials related community engagement activities as Opportunidades participants, as well as household heads and mothers.

Different interest groups in the micro-community were identified and engaged in an inclusive approach, as I will explain in Chapter 8. As explained before, the micro community has a distinct collective political structure, with procedures for decision-making.

In the rest of this thesis, I will use the term ‘community’ to refer to the micro community from Río Florido, unless specified otherwise.

5 Summary

In this chapter, I gave an overview of the context in which the trials were conducted. A close examination of the social context suggested that the community, even the micro community, is not a single homogenous entity, but is a conglomeration of different interrelated communities representing individuals with shared interests and commitments. This conclusion had implications on the way different factions of the community were engaged, as I will explain in the following chapter, as well as on how authorization was conceived and manifested (Chapter 9). Moreover, this community had many characteristics that would facilitate decision-making with respect to the trials. These included the geographical localization, small population, identifiable moral leaders with legal/official status and legitimate representatives (ejidatarios,

102 assembly, and comisariado), and established mechanisms for collective reasoning and collective and binding decision-making. As such, this community was similar in structure and features to Aboriginal communities in developed countries such as Canada.

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CHAPTER 8 Researchers and the Community: A Successful Relationship

In this chapter, I present and analyze the social interactions that occurred between the project team and all levels of the community. I used and categorized the insights from this case study to develop a model of effective community engagement that I present in this chapter, and I argue that this model of community engagement was effective in generating community satisfaction, comfort, and confidence, and hence authorization for the project as I will explain in the next chapter, Chapter 9. In Chapter 9, I will review the community actions towards the trials, and show that community authorization is not a one-step decision or milestone, but is a state manifested in a combination of different decisions, positive attitudes, and actions, that signify permission for the project. This state was the result of the incremental, cumulative, and iterative process that I describe in this chapter. Before embarking on the mission of explaining the elements of the model, it is important to note that these elements, constituting stages of the process, are not limited in time or scope, but are continuous. Therefore they do not constitute distinct phases, but overlap. The process is also iterative, and each phase is revisited when new situations are faced, such as engaging in new activities, or engaging with new stakeholders. Appendix 8 gives an overview of the community engagement process and of the associated milestones.

The five-element model has at its core the development of relationships and the establishment of a general sense of comfort and satisfaction with the trials project and its team. The five elements are 1) Mapping stakeholders, 2) Priming the community, 3) Defining and negotiating roles, risks, and benefits, 4) Developing Relationships, 5) Maintaining comfort and generating satisfaction.

1 Mapping Stakeholders

Before any interactions could take place, identifying the relevant “players” or stakeholders was essential. As explained in the ‘Community’ section in the previous chapter, it was obvious from the beginning that the project team had a broad notion of the community and consequently of the relevant stakeholders that ought to be engaged across all levels. Stakeholders included

104 individuals, groups, or institutions who had interests in the development of the GMM trials, or could be affected by the research. Interests could be those of stewardship (official authorities), public health promotion (agencies), development (local community leadership), or even interests of protection from harms (public).

“I mapped out all the relevant players at a federal, state, and local levels … As far as I am concerned, community has a broad context and each one of these groups is linked to the other, just like when we go to a community and look for the natural associations that exist so that you can link with them. I just expanded that vision that I had on a community level to something on a national level… my definition included all of this and we should make an attempt at all the levels and throughout as much of these communities as we can to engage” (PI)

Mapping relevant stakeholders was a continuous endeavor that proceeded as a chain reaction. As the project team approached political leaders and authorities and started developing relationships with them, these in turn referred the team to other relevant individuals or agencies that needed to be contacted for new connections and new relationships to start. For instance, CIBIOGEM, the main federal agency for regulation of GMOs, referred Dr. Ramsey to other relevant agencies and commissions at the federal level. At the county level, the mayor referred the team to county commissions, who in turn linked the team to the relevant stakeholders at the county level.

The process in the micro community was slightly different. The approach here, or the “conventional process” (Staff Scientist), consisted of approaching political as well as moral, or traditional, leaders at the same time:

“We went to civic authority, the agente (civic agent) and municipality, and to traditional authority, that is comisariado and assemblea, all at the same time” [Phonetic emphasis in interview] (Staff Scientist)

“When I go in to work on a project in a community is to immediately link in to the political authority, the traditional authority, different interest groups, it’s the same thing, but it’s a different scale … We have to go to moral legitimate leaders and political legitimate leaders at the same time” (PI)

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It is important to note that the approach in the micro community was conducted in parallel to the broader approach at the macro community. Leaders in the micro community, political and moral, were approached and engaged at the same time as the mayor, federal agencies, and other leaders at the macro community level, rather than being presented with a done-deal. Moreover, at all levels of the community individuals in leadership roles were the first to be approached and engaged in the project. As I will explain in the next chapter, authorization follows a hierarchical sequence, whereby the authorization by leaders precedes (or should precede) that of the rest of the community, and is a necessary but a non-sufficient step.

The researchers also identified other constituents of the community, such as interest groups in the macro community (agro-business, scientists, research institutes), and in the micro community (Opportunidades women, ejidatarios, etc), as well as the micro public, or residents of the micro community. In the macro community, the researchers identified and connected with the stakeholders through personal relationships or through referral, while in the micro community this task was accomplished in coordination with local leadership, and was less selective. Involving the micro public proved to be a core aspect of the relationship, and crucial for authorization to develop and manifest. As I will show in Chapters 12 and 13, the trials in the Cayman Islands and Malaysia were criticized by groups from the respective communities for disregarding the host communities and their publics.

Mapping stakeholders demonstrated the complexity of the community and its different levels and hierarchies, and the importance of social research for determining these intricacies. It can also reflect an underlying assumption of the project team that people from different levels of the political and social hierarchical ladder have the capability as well as the right to contribute in the discussion around GMM, and hence participate in authorization. Finally, it highlights the importance of working with supportive and cooperative leadership and authorities in local communities, as well as the crucial role research team leaders and principal investigators can play, and the need for them to be known and perceived as credible in the whole community.

In the 5th section of this chapter, “Maintaining Comfort and Generating Satisfaction”, I show that community members were satisfied with this inclusive approach, and one can argue that it might even have contributed to the legitimacy of the trials.

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2 Priming Relationships

In the next section, I describe the relationships that were successfully built with the community as a whole, enabling the state of authorization. In this section I argue that priming these relationship, or preparing them in a good way as I will explain, served two purposes: 1) it facilitated an initial level of comfort that was essential to help prevent antagonism and 2) it generated enough interest and hope in the trials to enable the community to give the project “the benefit of the doubt” (PI).

Priming is the act of making something ready. The concept is applied in mechanics, economics, and even psychology. In mechanics, pump priming is derived from the operation of old pumps, where a suction valve had to be primed with water to enable proper functioning of the pump. It can also refer to the use of a primer, or an igniter, that is used to initiate the burning of a propellant, creating the energy momentum. The term pump priming was also used in the 1930s to refer to government spending in commercial enterprises as a means of stimulating the economy. Priming is also used in learning psychology, where it refers to increased sensitivity to certain stimuli due to prior experience. It is the implicit memory effect in which exposure to a stimulus influences response to subsequent stimuli. Unlike direct retrieval of information that depends on explicit memory, priming is thought to occur outside of conscious awareness, and therefore relies on implicit memory. There is also evidence that priming can affect the decision- making process (Jacoby, 1983, Kolb and Wishaw, 2003).

In this case study, priming seemed to play an important role, by initiating relationships and giving them their initial momentum. The community became ready for the project, and showed openness towards it. At the early beginnings in the lifecycle of the project, and even before deciding on Mexico as the site of the trials and hence finalizing the agreement between CRISP and GC7#316, CRISP personnel who would eventually become the project team started identifying interests at stake and consequently contacting relevant stakeholders as explained in the previous section. This endeavor not only enabled them to test the waters, but also to plant the seeds of prospective relationships. When Río Florido was selected as the trials site, the community seemed to be ready and open to receive the project and to enter the conversation around it. One could also argue that priming has impacted future decisions, but this would need more research to demonstrate a cause-effect or dependency relationship, and is beyond the scope

107 of this thesis. In this section, I try to explore how priming might have contributed to the state of openness.

According to the project anthropologists, communities in rural Mexico are generally apprehensive and suspicious towards projects coming from abroad or from the government, due to a long history of exploitation. However, I found that from the beginning of the project there was a general openness to the GMM trials and to the research team through all the levels of the community I have described before. When asked about an explanation for this phenomenon, confidence in the project team was thought to be the cause.

To overcome [this challenge], to make [the community] open, explaining to them and working closely with them in the community is the solution. Explaining the benefits, for the community and the region, and earning their confidence” (Camas)

However, as can be understood from this quote, confidence comes after “working closely” with the community, and could only be built through a long process of engagement and relationship building, as I will explain in subsequent sections, and was not an immediate or apriori state. A close examination of the events reveals that neither confidence nor trust can explain this openness, but that the community, at all levels, was primed and ready, in the sense that they had enough comfort to preclude antagonism and enough interest to enable them to be receptive and open to knowing more about the project and even participate in it. This openness was manifested in giving the project the “benefit of the doubt” (PI).

“I don’t think they knew me enough to trust me, and people here do not take people on blind faith, it takes a long time for them to open up, could they have given me the benefit of the doubt? I think this is as far as you could get … I guess all of these things together and this showing of effort, is what people bought into originally, so many things there that it can’t be bad, it might not be good, but it can’t be bad, so let’s open the door and let them step in and see how it’s gonna work out along the way, it wasn’t blind faith or trust, I can guarantee it was not, just open the door for me and I will do the rest and I will make sure it is right, just open the door” (PI)

“They made me feel good, and I felt this could be a good project for us, so I said yes, let’s know more about it” (Previous Comisariado)

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It is important to note that priming relationships was not a distinct phase or step that was completed at the start of the project, but was a natural beginning for all new relationships. In other words, ‘openness’ had to be created with all new encounters and before new activities could proceed. One routine incident provided a good illustration:

“We arrived to a lady’s house where Dr. Laura [the entomologist] said that here we can make the release (inaudible)... we gave her the project pamphlet and we explained to her, and she said no (inaudible) … we realized that perhaps the residents population wasn’t really open yet. [Then] we started working more with the people, knowing them and talking to them. How you present yourself is very important… after that the population changed completely.” (Project Anthropologist)

In this section I illustrate this phenomenon of ‘priming’ and explain what it entailed. As mentioned before, priming the relationships with the community and hence enabling a state of openness, involved two phenomena: 1. Establishment of comfort 2. Development of interest and hope

As I will explain for each category, priming could have led to the formation of positive initial interpretations and impressions by the community regarding the risks and benefits of the project, as well as regarding the character and credibility of the project team, leading to the development of interest and hope, and establishment of comfort. It is interesting to note that no decisions, consent, or commitments have been made at this stage. This lies in sharp contrast to the Malaysian experience (Chapter 13), where the community was called in for their consent at the outset for a project they didn’t know much about. Figure 8.1 summarizes the relationship between priming and openness. While at this stage the storyline for the relationships was created, the conduct of the project in the community provided the evidence to maintain that story, as I will explain in Section 5, Maintaining Comfort and Generating Satisfaction.

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Figure 8.1: Priming and Openness

2.1 Establishing Initial Comfort

Data suggest that the community experienced an initial sense of comfort with the team as well as with the project, and that this sense of comfort helped in establishing a premise for the new relationships between the community and the project team.

“There was definitely a sense of comfort” (PI)

“I felt good [that day], you [the project team] made me feel good. We all did. So we wanted to know more” (Previous Comisariado)

2.1.1 Comfort with the Team

Feeling comfortable with the research team presenting the project and executing it had a paramount effect on starting open and amicable relationships with the community. Because of the interactions with the project team, the community formed positive impressions about the researchers’ character as well as their intentions. These in turn led to the assumption that these “nice people” (Current Comisariado), the project team, were honest, and were not there to harm, but to help and benefit the community. “You are nice and high quality people. We knew you didn’t come to do harm” (Current Comisariado)

Comfort with the team might have been the most crucial factor leading to openness. It might actually explain why the community was able to perceive the potential benefits (in contrast to the Malaysia experience, chapter 13). Many factors contributed to these positive assumptions and in turn comfort. First, assumptions were formed around the social status of the researchers, as

110 defined by their relative professional rank and standing in society as a result of their credentials. In a later section of this chapter, I argue that as relationships were developed and the project was established as a neighbor, credentials’ value became insufficient, and the community moved into assessment of the social standing of the researchers in the community as a result of their performance.

“I think they have assumed that if I was the director of the center and leading this project, that I may have certain qualifications and that they may have agreed to give me the benefit of the doubt”(PI) Secondly, it is natural for people to feel comfortable with those they already know (familiarity) or with whom they can identify (closeness). This fact has been manifested at all levels of the community, including internally at CRISP, and helped in turn prime the relationships effectively. The importance of familiarity was mostly evident in the macro community, where the PI Dr. Ramsey, who was known to federal, county, and municipal agencies.

“It was easy to [establish connections] since a lot of government sectors already know Janine” (Project Communication Specialist)

“Since I was thrown here during a national disaster [a hurricane], I had contact with a lot of these people that I used to see every day… Since more than a year before [the project], I have been building a relationship with the county health commissions for various reasons, I actually sat on the health commission, so I had a working relationship with them, it was a healthy forum. So it was a very powerful instrument to start engaging [people] around the issues that might come up by them or by us and that we wanted them to think about regarding the project very early on” (PI)

These quotes also illustrate the importance of a leadership that is locally perceived as credible and prominent. In the micro-community, where none of the research staff was personally known, it was helpful for someone with whom the community leaders could identify to start the conversations with them. Staff Scientist, a male Mexican, went to Río Florido and engaged with its people first. “People identify more with people from the same place, they have more confidence in the same people from the same place … Leobardo just liked me, so he was helpful” (Staff Scientist)

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Thirdly, the respectful and humble attitude of the team members and their approach were of crucial importance in establishing comfort with the team, as I will detail in later sections. In this section I will focus on the way the research team initially approached the community, and explain that entering the community with humility and as neighbors, and inviting its members to collaborate contributed positively to the relationships. “We entered with humility and respect”(Project Communication Specialist)

“Empathy is felt when people come and not ask anything of them… We admitted immediately that there were a lot of things that we still didn’t know about the project, we asked them for their knowledge, for their opinion, we immediately told them that we had certain knowledge they had others and we needed to combine them… I think the openness to the fact that something might happen, because we told them until we do the process obviously with the best we have, we might not know, and we might find out that we have to say stop, I think the openness that something could occur and that they were learning at the same time with us, and that they would engage with us in other issues … all of that [helped]”(PI)

As could be inferred from this quote, there appeared to be a sense of “togetherness” whereby the community became part of the project, or even developed ownership of it. In fact, setting the parameters of the relationship from the beginning had a positive effect on how the community viewed the project and dealt with it, especially that the community in Río Florido had bad experiences in the past with organizations or companies coming in with short-term projects. Inviting the community to collaborate as partners in the project was probably one of the most important factors that led to the positive and cooperative response that the project received. This invitation lay at the core of an integrated and gradual approach, as I explain in later sections.

“We entered the community as a neighbor, we have been trying to establish the relationship with them as a neighbor, and we made that clear from the beginning… We have built a working relationship with them, because the project and the institute want to remain” (PI)

When the project was formally presented to the community before the land purchase, the community was not asked for a holistic and immediate approval “or consent” for the project as a whole, but were explained that the project will be executed in phases, and each phase would

112 require its own deliberations. While it implicitly reflected a certain level of comfort with the project, the decision to sell the land for the project was not a blanket approval for the trials.

“We literally asked them, this is the institute, this is the project, the people funding it, the people working on it, etc., we need to build a field site, so the first question we have of you is can we purchase a site here to go ahead, and I said I still don’t know exactly what we are going to test, because they’re still developing it, but we will let you know once we know, they knew there was going to be a stepwise provision of information… Eventually what we are doing is only one step in the research project and that this early step in the research process is a topic that we wanted the society to discuss so that they later on, should things go forward and there is an intervention in the society, so that the society can voice as to whether they agree or disagree” (PI)

Coming into the community and “not asking anything of them” (PI), in the sense explained above, and emphasizing a multi-step consent for different activities, created a pressure-free ambiance, where people were not pressed into making decisions on issues they did not know about. By listening to the community, and asking them to listen, learn, and collaborate in the project, and by assuring them that it’s going to be a step-wise process, the project fostered a community sense of control and voluntariness, and eliminated reasons for anxiety and suspicion, and hence established a communal feeling of comfort. This lies in contrast to the experience in Malaysia where the community was immediately and only asked for ‘consent’.

“I probably was thinking more in terms of their awareness and not their approval, obviously one step further is evolving to the point of approval, but I don’t think approval is something that is immediate and it’s not finite, it might be ok today, but if we learn something new, it might not be tomorrow, so it’s an evolving process so I thought the first thing is to inform and have everyone aware so that this concept of working towards approval, even though it’s tentative, and tomorrow it’s tentative, and in 5 years they would say no” (PI)

In Chapters 9 and 10, I will get back to this idea and explain that authorization is a continuous state of approval rather than a decision or collection of decisions.

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2.1.2 Comfort with the Research Risks

While research-related risks were rarely mentioned in interviews, comfort with risks could be inferred from the community’s positive assumptions about the project’s safety as well as their interpretations and assumptions about its value and the promise of benefits. “We understood it that way, as a good project, because you [the project team] had come to tell us was that the project wasn´t going to be just for a while, rather for a long time and for us, that called our attention. We knew then that you were not coming to do harm” (Previous Comisariado)

As I will explain in the following section, hopes for benefits and development played a role either by decreasing the community risk perception, or by increasing their risk tolerance, and hence made them open to considering the trials.

Moreover, assumptions of safety and therefore comfort could be associated with expectations of protection from harm by both the organizations and individuals developing and executing the project, as well as those governmental agencies overseeing it and approving it. “It matters that they are coming from the institute, as supposedly they are here to look after the health interests of the community. They won’t do harm, right?” (Community member 1)

Having an approval from federal agencies, such as INSP, SEMARNAT and INE, and knowing that these organizations would be overseeing the trials, constituted a safety umbrella for the community, even for the mayor, as it implicitly provided a reassurance about protection from prospective harms. It meant those with the needed qualifications to assess the scientific merit and safety of the project were comfortable with it. As such, community members might have had a sense of control, knowing that those with the responsibility to assess and protect have control over the situation. “It matters that it was approved by the government, there are scientists there” (Current Comisariado)

“They [community members] know everything, the permits we have to cover them… They know we have been congratulated by the Ministry of Environment ” (Project Communication Specialist)

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“The agro businesses were explained exactly what the regulatory system requested from us, they would be given copies of my documents to SEMARNAT, the mayor was also given copies, they were given copies of the letter of approval, they were informed when we had the inspection, they were informed of the results of the inspection” (PI)

2.2 Development of Interest and Hope: Commitment to Benefits

One of the reasons for the previously described state of openness seemed to lie in the fact that the project immediately appealed to the community at all levels. The project piqued the interest of the community and created hope and promise of benefits. This interest and hope caused the community to be receptive to the idea of the trials, and open to learning more about the project. In other words, the idea of the project was worth pursuing.

“The attitude of everyone, at all levels, was, well, it sounds interesting” (PI)

“I told everyone [ejidatarios] present at that time that an interesting project was coming … and we wanted to know more” (Previous Comisariado)

The project’s attractiveness was largely caused by the perceived prospects of benefits. When asked “what did you want to know about the project when it was presented to you?”, both current and previous comisariados responded by talking about the project’s perceived contributions to the community. The initial intuition of the community was that the project, being a high profile international one, had a high potential for benefits with local relevance. As I will explain in Section 3, most of the benefits that were considered were of a communal nature. In this section I focus on the initial community assumptions about benefits.

“I think everybody, even at a county level, perceived the project as something with a tremendous amount of resource, we had resource of people technically, inside the country at a regulatory level, outside the country at a technical level on an echo of a humungous prestigious financial institution [Gates Foundation] that was funding this… It is clear that they have felt that the institute will maintain this property, remains a presence of a national public health institute and in the future other research will go on which will benefit directly and indirectly the community” (PI)

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“We looked at each other and thought this project would benefit the ejido, but not only the ejido, the whole country too… I repeated to them that for us this is new, it is something that came to benefit us in matters relating to our health” (Previous Comisariado)

At this stage it appeared that the hopes of benefits that the community had were general and broad, such as being healthy as illustrated earlier or becoming an important place. Later on, as the project progressed, the community became more interested in specific activities that had immediate benefits to the community, such as water tanks sanitation programs, awareness and education seminars, and so on. All of these broad hopes could reflect a sense of excitement and interest that was formed at this stage.

“This [project] is for the whole world so it must be good” (Community member 2)

“Well I understood from the outset that the project that you brought to the community would give another meaning to this place” (Current Comisariado)

‘Becoming an important place’ was probably related to hopes of development, as it means that the community would harness indirect benefits, such as other projects getting interested in the town that is now “seen” and that has “pass[ed] into history”, or its members having new opportunities both locally and outside the community.

“Since now you know us and we know you, I would like to ask the professor for the possibility of agricultural projects highly needed here in the community” (Current Comisariado)

3 Defining and Negotiating

The initial perceptions about risks and benefits opened the “door” (PI), or “lock” (Previous Comisariado), to begin the conversation over the trials, and for the community to “learn more, know exactly and in detail what will be done and what we [the community] will get” (Previous Comisariado). In other words, this was the stage for setting the terms of the relationship. Initial conversations at this stage were focused on defining roles, needs, and responsibilities.

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Definitions of roles and responsibilities was evident from the beginning even when CRISP was still considering the agreement

“I pulled all the information required to make a decision, trying to balance what they [GC#316 at the University of California] needed and what is needed here at CRISP… It was unbalanced, because it was clear that the genetic strategy is in the lab development and for the 'testing' of something here...the social concepts of doing that were definitely missing. When I finally got the proposal, I said “what about the social aspects?”, that wasn't in there. I explained to the [U.S. PI] that this was a problem… and we agreed on that” (PI)

From the beginning, the project’s presentations to the assembly and the rest of the community focused on defining the responsibilities of the project and what would be needed from the community. Needs of the community were also communicated to the team at this stage, and sometimes negotiated

“We ask for something, then maybe they will say we can not do that, but we will give support in some other needed way. Same for us, sometimes they say can we do this or that, or they might wants us to do something and we say we will do it this way or that way” (Current Comisariado)

Although risks and responsibilities were also defined at this stage, the community appeared to focus on their needs in these discussions. Hopes for development through direct and indirect collective benefits were a common theme and at the core of deliberations.

“When the discussion started, we wanted to know, what will it bring to the community” (Current Comisariado)

“In our meetings some women asked if there are any risks or dangers, but doubt wasn’t strong. Most asked how it will help us” (Community member 1)

As stated in the previous section, the focus on benefits and the downplaying of risks might reflect that communities in the global south are desperate for development, and are either willing to tolerate high risks for the sake of prospective benefits, or are unable in the face of the big hopes for positive change to consider harms in their deliberations. This insight points to the risk

117 of vulnerability to the implicit promises of research, and raises the need for clarity in describing the goals of trials.

The benefits in consideration by everyone at all levels were mostly those of communal and collective value, benefitting all members of the community equally. Even those who allowed the trial team to enter their houses to perform experiments, such as mosquito collection or mark- release-recapture activities, did it for the common good, for the benefit of the whole community. Exclusively personal benefits that will be collected by some individuals only, such as financial remuneration, or cleaning one’s water tank, were not encountered in any of the interviews.

“I wanted to know what benefits it [the project] would bring to the community, to all” (Community member 2)

Moreover, the focus was primarily on the direct benefits whose impacts are immediately sensed in the community. These benefits included awareness and cleaning campaigns, helping families get rid of mosquitoes from their water tanks, work at schools, and other direct benefits such as access to water and electricity from the field establishments for some of the neighboring houses.

“Most women thought that the other activities like pulling the mosquitoes had direct benefits and that was very important” (community member 1)

4 Developing Relationships

In previous sections of this chapter, I discussed the initial major phases and corresponding thresholds in the lifecycle of the caged trials. The first threshold, marking the openness of the community to the idea, was attained after the relationships with the community were primed and started developing, and the second threshold was attained when these relationships were put in action (Figure 8.2). Figure 8.2 is a hypothetical scheme that caricaturizes the progression of stages with respect to comfort.

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Figure 8.2: Comfortometer

The importance of relationships between the project and the community was stressed by all informants, both from the project team as well as from the community.

“Something in the relationship made people more attuned to messages” (PI), “more receptive” (Project Anthropologist)

“My bias is that you are working as part of the community, so you better be integrated so that we hopefully develop projects together” (PI)

“We have a special relationship with the institute, this helped in everything” (Community member 1)

The notions in the first quote will be explained later. However, it is essential to state at this stage that the established relationships helped in establishing confidence, which in turn enabled effective communication and collaboration. It is obvious from all interviews that the team has strived from the beginning to build a high standard for the relationship as I often explain in this chapter.

“If the facilities are now to be used by someone else, I think it all depends on how they go and work there, there has been a standard of a relationship that will be used as the first

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measure, if it doesn’t move to that standard obviously that will affect the relationship and that’s logical.” (PI)

Achieving this standard however was not a one-step milestone or a one-activity task, but was rather a continuous, iterative, and meticulous process that required commitment and effort, as I will explain in the next section.

“Putting the name in the media is not enough, it’s using some stupid innocuous note in the newspaper but this is not what develops community relationships, it’s informative but doesn’t build relationship… They gave me the benefit of the doubt, which would require a lot of back and forth, constant reinforcement… and had we not had a continuous back and forth it would have just stagnated there, it would have not matured to a different type of a relationship” (PI)

Relationships between the project and all levels of community passed through different phases of intimacy. In the first phase, interactions occurred between institutions; CRISP as representative of the project, and the different governmental institutions as representatives of the nation on one hand, or the assemblea, as representative of the community. At this phase, the relationship was formal, following official rules of convention, and was contingent on the official status of involved parties.

As the project got established as a neighbor in the community, the relationship became an informal amicable one between individuals who have achieved a certain social standing in the community. This relationship was maintained as long as events flowed smoothly without disruption of comfort. Nonetheless, when a situation that would disrupt the equilibrium and cause anxiety arose, such as the failure of an experiment or plans of a national train construction project jeopardizing the cages installations, formal inter-institutional interactions resurfaced, as I will explain below.

4.1 Inter-institutional Relationships

The first interactions occurred between GC#316 and CRISP, two institutions or enterprises planning for a scientific collaboration. Subsequently, CRISP became the representative of the project, or the ‘engager’, and approached the different stakeholders in the macro community.

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Stakeholders at this stage were institutions represented by individuals. These included the different institutions at the federal, county, and municipal levels, as well as the micro community. For instance, when Dr. Ramsey approached the city of Tapachula, meetings took place with the mayor as a representative of the city, and with representatives of the county health committee. Also, when the project team started their interactions with the community in Río Florido, initial engagement and hence relationship-building started with the assemblea, a civil institution representing the community.

As stated, this relationship was a formal one between parties with official statuses, following procedures or rules of convention, and officially sanctioning activities and decisions. Formal decisions that are binding to all parties, were expected in these interactions, as I will elaborate in the following chapter.

“Then we went again to Río Florido, and in an assembly, we told them that Tapachula was selected, we went back over the information formally about what the project was about, we gave them a full explanation of who was in the project what was the consortium of the project what were the objectives … and that we were going to have a discussion with them. There were two meetings, two assembly meeting with them where we discussed formally the topic of the project itself, the people informed, and we formally asked them if they would approve not only public domain for the property but also if they approve going forward with the project… In the assemblea they have attendance and decisions logs, and yes, they are formalized” (PI)

As a result of this relationship between the two institutions, the project and the community council, access and support were given by the community in return for prospective communal benefits provided by the project. The relationship at this stage was therefore a manifestation of commitment and reciprocity from both parties.

As the project got established in the community as a neighbor, inter-personal relationships started to develop, and will be covered next. Nonetheless, interactions of formal inter- institutional nature reappeared whenever events threatening the status quo of comfort and causing anxiety presented themselves, as I show in the following example. As the project was approaching completions, discussions about the future of the project installations in Río Florido were taking place. These discussions were complicated by a governmental construction project, a

121 trans-regional train whose construction plans pass through the land on which the cages are built. The community was anxious about the future of the installations, and consequently the loss of benefits they anticipated from the project. Moreover, the project did not have scientific success as the tested A. aegypti strain failed to compete with wild type mosquitoes in the cages (Facchinelli et al., 2013). This anxiety was reflected in the interactions between the community and the project, when the comisariado representing the assemblea and relating its concerns requested explanations from CRISP in a meeting that I had the chance to attend. In this meeting, the comisariado and his companion both were frequently using terminology of collectivity and institutions such as “we”, “our”, “the institute”, and “the assemblea”, with a formal tone that was different from the one they used in other meetings or interviews I have attended. In Chapter 10, I will refer back to these interactions to illustrate the fragility and revisable nature of authorization. Nonetheless, the interpersonal relationships that were developed and that I will explain in the next section provided the vehicle for reconciling frustrations and for maintaining a healthy collaborative environment.

“We would like the institute to tell us what is going to happen… we want to know where are the benefits that we hoped for. Our assemblea of ejidatarios has many questions for the institute” (Current Comisariado)

“At this stage I think they want the institute, not me per se, because the institute represents opportunity for broad community development, that’s my feeling from what they say, my interpretation, up until now they only knew me and my group, but didn’t have real access or discussion with anyone else and they haven’t come looking for the new director, because all the discussions happened with this group, but they know that the institute is something different, they knew that I am different from the institute, and when there’s a change in hierarchies things change, and you reestablish relationships” (PI)

4.2 Inter-personal relationships

While the relationship started as inter-institutional, between the community as a whole represented by the assemblea and the project represented by the PI and the research team, the

122 constant friendly interactions between the team members and the community members, gave way to inter-personal relationships.

The project anthropologist noted the importance of inter-personal relationships:

“[Some] worked with viable structures, but not necessarily with viable people, it’s important to work with the people” [Phonetic emphasis in interview] (Project Anthropologist)

Examples of the evolution into inter-personal relationships are many. Dr. Ramsey became the friend and the neighbor who was being asked by the comisariado and others about her family and her “personal life” (PI), in whom some ejidatarios could confide, whom they could ask for help, and who acted as an advocate for them and had “attempts to intervene on their behalf” with the county in matters that are not related to the trials (PI). Members of the project team even expressed feeling part of the community

“We’re being responsible as a community” (Project Anthropologist)

Inter-personal relationships mostly developed between community members and staff members who had the most fieldwork, such as the anthropologist who became the liaison between the project and the community.

“I built a relationship with the community, you could say I’m in charge of the social aspect of the project… They get to know you in the community, and so we all get to know each other… I go knock on their doors, if they greet me, that’s because they already know me, they know what I want, they know I’m doing my research… For example, I walk down the street, near a lady’s house, and she says to me: hey, what is a gene? They ask me all sorts of questions, like can you tell us about insulin.” (Project Anthropologist)

As explained before, this relationship was informal and friendly. I have witnessed both current and previous comisariados speak to the anthropologist Ana Laura Pacheco with an informal tone, calling her and referring to her as “Laurita”. Also Dr. Ramsey was addressed by some as “Janine” and not professor or doctor. The team in fact gave many examples in the interviews about the informal and cordial relationship that they have developed with the community

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“We’re always joking with each other and joking with the people, we all know each other” (PI)

“We went to a house to collect mosquitoes, and the woman gave me papaya and mango and invited me to lie in the hammock while the others collected mosquitoes” (Project Communication Specialist)

The progression from formal inter-institutional to informal personal relationships can be taken as an indication of the development of comfort and ease between individuals, and their confidence in each other. Despite the imminent changes to the project and its installations as I mentioned in the previous section, the interpersonal relationships that were developed helped maintain the inter-institutional relationships and enabled the different parties to navigate through the stressful situation. The relationship and the confidence that resulted also made it comfortable for community leadership to talk with the PI freely about their concerns and discuss sensitive matters as implied in previous examples.

“I don’t think that [the train] will affect the relationship with me and my group at all in any circumstance, because the working relationship that they had with anyone in the institute was with me and my group…I feel responsible to try to get on a good track the relationship of the community with the institute… it’s basically us who took care of everything, electricity, water, everything, so now the institute has to take over that role, I kind of feel that I have to help that relationship get started correctly, apart the fact that we will continue to use the installations and whatever relationships we had with them related to what we are going to do there. So yes, I think the loyalty is to the group, which is the project. Janine the project, not Janine the person. And they have to get their head around the institute” (PI)

5 Maintaining Comfort and Generating Satisfaction

In the first two sections of this chapter, I argued that interest and comfort were essential to reach the first threshold in the relationship and create a state of openness whereby the community gave the project the benefit of the doubt. The positive assumptions that the community formed at the beginning created an impression, a storyline, whereby the community and the project became

124 neighbors starting a prosocial and mutually beneficial relationship, and in the next chapter I will argue that authorization was a state that was maintained as long as this storyline was maintained. In this section, I elaborate on the social interactions that maintained the storyline by maintaining comfort and generating satisfaction, and hence maintained the state of authorization. In fact, the project team saw the community’s satisfaction and contentment as a sign of its continuous permission

“We know we have permission, because they are pleased with us and pleased to see us work” (Staff Scientist)

Comfort and satisfaction were the results of the project’s approach, which I detail in this section. I identified five major interdependent features that led to its success: 1) Maintaining a positive and committed attitude, 2) Following an inclusive, incremental and iterative course, 3) demonstrating commitment to promoting community interests, 4) demonstrating respect, and 5) Maintaining a conversation

Community comfort and satisfaction could be inferred from the community’s use of expressions such as ‘feeling good’, ‘happy’ and ‘satisfied’

“We always felt good with you” (community member 2)

“People here are happy with the project because they got information and they were asked for their opinion” (Community member 1)

“The population was satisfied by the presence of the team, satisfied with the work at schools, and the change in the [community]” (Camas)

In the next chapter, I will argue that authorization is a manifestation of maintained and reinforced confidence, which was in turn a manifestation of the maintained comfort and satisfaction that the community has experienced as a result of the approach that I will detail in this section.

“To ask people’s permission is to know the people, to gain their confidence by speaking to them and telling them about the project, speaking to them with truth and transparency, and give them the liberty to stop and question what was said and done, and halt the permission to go ahead” (Staff Scientist)

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“Because we went to them with a very humble attitude and a very open [inaudible], we admitted immediately that there were a lot of things that we still didn’t know about the project … we asked them for their help, we considered them, I think all of these together somehow led them to this trusting, to build up a working relationship that was back and forth, back and forth, and reiteration of building that confidence ” (PI)

5.1 Maintaining a positive and committed attitude

It was obvious from all interviews, and from direct observation in the field, that interactions between the team members and community members were cordial and amicable. In addition to being respectful, as I will explain later, the team members had pleasant attitudes and strived to build friendships in the community, which led to reciprocity:

“You have tried to get along with the ejido… The quality of your people is incomparable for me” (Current Comisariado)

“For me they are excellent and very very kind people who always treat others with quality” (Previous Comisariado)

Trivedi, a “Scientific American” journalist who wrote a report about the trials, also made these observations.

“In a weekly town hall gathering in the Casa de la Cultura on Tapachula's historic main square, Ramsey, the project's field site manager, described the project to an audience of community leaders, 30 men and five women. It was hard to tell she is an American expatriate as she held the room transfixed; she was animated, gesturing and joking…Ramsey answered them all, then smiled and shook hands as she left.” (Trivedi, 2011)

In addition to pleasant and friendly attitudes, both current and previous comisariados expressed that they were satisfied with the “constancy” of the team.

“Throughout your group … have always been constant with us” (Previous Comisariado)

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Constancy could refer to the quality of being faithful and reliable, or the quality of being enduring and unchanging, or consistent. In fact, I have encountered all of these meanings in descriptions of the team’s demeanor by community members, and I will detail each separately in this section, in addition to other traits such as humility and closeness.

These findings highlight the important role of ‘personalities’ of researchers, especially those working in the field, in developing relationships and creating confidence.

5.1.1 Humility

As I explained in section 2.1.2, humility was one of the main aspects that helped in establishing initial comfort with the project and its team. Humility, or being modest and respectful was manifested in treating the community as an equal partner and building a balanced and horizontal relationship with them, a concept that I will explain in detail in a later section. Moreover, in contrast with the experience in Malaysia and the Cayman Islands where researchers claimed absolute safety and efficacy, humility was demonstrated in Mexico by admitting uncertainty. The project admitted that their information was incomplete and asked for the community’s contributions. Consequently, I noted that the community was comfortable with risk, and might have felt prepared and willing to share both successes and failures, emphasizing the ‘togetherness’ in this project.

5.1.2 Faithfulness: Honesty and Transparency

Key informants from the research team stressed in all the interviews on their commitment to honesty and transparency with the community throughout the project.

“We have always been honest and transparent … What is important, is to communicate everything we're doing … go public with this information… What we must do is to tell the truth all the time” (Project Communication Specialist)

This honesty could have helped eliminating reasons for anxiety and suspicion associated with secrecy and lack of disclosure as was witnessed in Malaysia and the Cayman Islands.

“They can feel if people are bullshitting [deceiving] them or not, they can feel this, people had to live with this all their lives”(PI)

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“We know we’re not lied to” (Current Comisariado)

In section 5.5, Communicating, I explore more the concept of information disclosure and transparency.

5.1.3 Consistency

Consistency, or maintaining an unvarying quality of performance, was one of the commended features of the team.

“On your behalf, the people are always looking for us and have been constant with that”

Consistency could be related to both homogeneity of behavior and persistence. I use homogeneity of behavior to refer to the reproducibility of behaviors between different members of the team, as expressed in the following quote:

“I needed the community to understand that they can talk to anybody, and there was going to be a consensus about the best response, we were always in discussions with ourselves and our collaborators in the US, so they knew there was a greater body, we are all [one]”(PI)

5.1.4 Immersion in the Community: Familiarity, Presence, and Closeness

When I visited the field site in Mexico, and went to the ejido to conduct interviews, wherever we went in the community people waved at team members accompanying me, called them by first name or nicknames (such as Laurita), and asked questions about the project or other members of the team.

“They got to know us, and I’m the person in charge of getting information to them… She [Janine] is very familiar with the people… I’m not the only one they know ...They know who Memo is, they know Luca, they also know Laura… I go knock on their doors, if they greet me, that’s because they already know me, they know what I want, they know I’m doing my research” (Project Anthropologist)

This familiarity created closeness as explained previously in the inter-personal relationships section, and was appreciated by the community

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“What is interesting is for Laura, the anthropologist, is to be in touch with us” (Current Comisariado)

Familiarity, and consequently closeness, resulted from the presence of the team members in the community.

“We all go to group talks, generally I’m not the one who gives these, actually I never do, but we are always there…I go to the town three or four times a week sometimes I go on Saturday and Sunday, because that’s when the assemblies are held and the people in charge of cleaning are there on the weekends so I find them and talk to them… Even though they already know you, you have to go the assembly, it doesn’t matter” (Project Anthropologist)

“They [the community] are satisfied by the presence of the team” (Camas)

Apart from the consistent presence in events and activities in the community, different team members who are not typically responsible for community engagement actively engaged with the community in order to establish closeness with them

“We’ve made them [the presentations] like that so we can include everyone, so they [community members] can meet all the researchers… Janine, for example, made the story and read the story for kids, so that she didn’t seem distant from community, so that people can ask her things too” (Project Anthropologist)

Immersion in the community was in fact a strategic decision by the leadership, pointing again to the importance for PIs and sponsors to identify local collaborators who are experienced with working in community-based research.

“Janine had thought that it’s important to stay in touch with the community… It’s important because they remember you and now they’ve put you in a role, besides your reputation is very important to them… I mean it’s to say: well I’m here, I try, I’m still with [you] and you're here, you’ll see me, you already know me” (Project Anthropologist)

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5.1.5 Reliability: Responsibility and Responsiveness

I have mentioned before that reliability is one of the features of the “constancy” that the community was commending. Reliability was manifested in responsibility towards the community and responsiveness to its needs or requests.

To start with, responsibility towards the community was manifested in demonstrating goodwill, effort, and keeping up to promises, and this has been extensively covered in this chapter.

“As an institution you can go and set up a cage and it doesn’t matter, I mean you can say we’re doctors and whatever and do [our work]…but we’re being responsible as researchers and as a community, and this, by itself already implies an effort, and this effort is what counts” (Project Anthropologist)

Responsibility was also reflected in responsiveness, or attending to the community’s needs, questions, requests, and recommendations.

“When I go to the assembly meetings as an observer, they ask me a lot of things, I obviously don’t know all of the answers. Then I go around and talk to some other people and come back and answer, and that’s how it’s always done… The kindergarten teacher said: a story, you should do a story, the high school teacher said: do a contest and give them candy as prizes, the elementary teacher said, do a puppet show and then make the puppets with the kids. We did [all]” (Project Anthropologist)

“They would let us know if anyone had any doubts and they could feed the people back to us and if anyone wanted us to go and give a talk about the project and what has been planned in dengue control then we would be more than willing”(PI)

Responsiveness was also reflected in the way the project dealt with conflicts.

“For example, very early on when the [convenience store] lady was spreading rumors that [the entomologist] Luka was seeding the mosquitoes in the community, we could have just not paid attention, and gone about our business and told Luka just avoid her, which is what usually happens with most projects in the field in communities. Instead we decided to use it as a learning experience, we got everyone together and we said ok let’s

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go look where the breading mosquitoes are, we found the little [container] that was full of garbage and breeding massive quantities of mosquitoes, and Luka and Memo showed them how they could drain it properly so that there wouldn’t be any mosquitoes there, and so we went back to her and asked her is there still the same amount of mosquitoes there or are they less, no they are less she said, she became an active voice, a social actor” (PI)

“Nobody knew about bugs before the talks, so there were rumors about the project spreading the bugs, we mentioned it in the family but discounted it, because they always responded and explained to us all about the bugs” (community member 2)

Responsiveness in this case served two purposes. First it was precautionary and prevented misunderstandings and consequently possible obstruction of project undertakings. Second, it was a manifestation of respect towards the community and their concerns, no matter how ‘unfounded’ these were.

5.2 Following an inclusive, incremental, and iterative course

It was obvious from all interviews that the team did not follow a linear and finite course consisting of consecutive milestones in their interactions with the community as we witnessed in Malaysia (Chapter 7). This course has certainly contributed to the success of the community engagement approach and consequently to the state of authorization for the project. This course was inclusive, parallel, incremental, cumulative, iterative, and continuous, as I will explain in this section.

5.2.1 Inclusive and contiguous

From the early beginnings of the project, and as explained in the “Mapping Stakeholders” section, the project aimed to canvass and include a wide array of individuals and institutions from “all walks of life” (PI), including neighboring communities.

“We need to include them all, I mean everyone, because everyone is going to participate… I was on top of Rio Florido last year, and this year, I have to do more work

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with the other communities nearby that is [inaudible] something important” (Project Anthropologist)

Moreover, the micro community was engaged in parallel to political authorities in the macro community. This could be an indication that the team values the micro community and its right to be a partner equally to other players who are higher on the political hierarchy.

“We talked to the county right at the same time as talking to the ejido… It was a back and forth with him [the mayor] almost in parallel to the community” (PI)

In response, community members expressed contentment that the project aimed to include all members equally in their work, and not only the leadership.

“I was not the comisariado ejidal at that time, and still they continued to participate with me. That made me very happy” (Previous Comisariado)

This approach could be seen to contribute to authenticity and legitimacy; authenticity by striving to ensure everyone understands the information being given, and legitimacy by giving the chance to everyone to participate and express their opinions:

“Everyone will give their opinion, it doesn’t matter who …There are many others that don’t understand, and we also want them to know, to come, to learn” (Project Anthropologist)

5.2.2 Incremental and cumulative

As I mentioned before, explaining to the community from the beginning that the process will follow a step-wise approach helped reduce the anxiety normally associated with pressure to make decisions on issues that were not fully understood.

“I said I still don’t know exactly what we are going to test, because they’re still developing it, but we will let you know once we know, they knew there was going to be a stepwise provision of information… The work was actually very divided in steps… Knowing that even if we cross that threshold, it’s still not done” (PI)

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This incremental approach was followed throughout the project, and was appreciated by the community who felt they were able to understand information better, and take their time to make decisions.

“We knew we will learn little by little because that’s how we understood better, and we felt ok if there was something we didn’t understand, we knew we will later” (Current Comisariado)

5.2.3 Iterative and continuous

As stressed many times before in this chapter, community engagement was not linear and hence proceeding in milestones or stages, but rather all activities, especially information provision, social discussions, and permission requests, were continuous and were never halted. The project followed an iterative approach, going “back and forth” (PI), and repeating different activities, which helped the community interact with and understand the information better.

“You can never inform them enough, it’s a continuous process and I think it’s a back and forth at different levels, you might resolve one doubt and that would make another doubt come up, and so if they feel confident enough they would ask you the next one and you go to the next stage… we are always working to begin, always beginning” (PI)

“Nothing was done just once, it was several times” (Project Communication Specialist)

“If it’s repeated, one or two words stay with us and this way we understand better” (Current Comisariado)

5.3 Demonstrating commitment to promoting community interests

As mentioned before, people in these rural communities were not accustomed to organizations, governmental or not, doing acts that also take into consideration the common benefit for communities. By distinguishing themselves from common practices and demonstrating goodwill against the norm, the project was able to create a relaxed trusting environment, and to generate appreciation from the community.

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“We didn’t want to be Safari scientists, coming in, doing our stuff, and pulling out” (James from Contenta, 2012)

“People didn’t understand the dynamic that we wanted to set up, because there was nothing like this that has ever been done, society is not asked if they agreed, they are always told after the fact and probably they only ever get partial information, so yes this was something totally in left field, and so they were supportive” (PI)

“Other people who bought lands did it for their own benefits, but the institute bought the land for the common benefit” (Community member 1)

“Not like in other projects where they just come to work on a project and go, not knowing what is happening or commenting about anything. You always think of the ejido…You didn´t come to do wrong in this village, that made us feel good” (Current Comisariado)

The community also appreciated the effort that the project was demonstrating and that they are truly doing their best, and perceived it as a manifestation of genuine care and goodwill as well as sense of responsibility for the community’s welfare.

“We’re being responsible as researchers and as a community, and this, by itself already implies an effort, and this effort is what counts, what people sense”(Project Anthropologist)

“They know we are doing everything the best way possible” (Communication specialist)

“We've seen that they are heavily engaged whenever they come, and always trying to do something” (Current Comisariado)

“They are happy the project are doing [their] best” (Camas)

Understandably, people were satisfied when they started witnessing the benefits they anticipated, which provided evidence for and reinforced the positive assumptions they have formed at the outset about the value of the project and the nature of the team.

“They are witnesses of what we've been doing” (Project Communication Specialist)

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“Now we know you, we know what you brought to the community” (Community member 2)

“I'm with you and after seeing the great benefits ” (Current Comisariado)

5.4 Demonstrating Respect

So far I have elucidated three major features of the approach; 1) Having a favorable attitude, 2) Following an inclusive, incremental, and iterative course, and 3) Demonstrating goodwill, and contribution to the community. All of these aspects in fact implicitly reflect respect towards the community. In this section I will address three attitudes that explicitly reflected respect for the community. These attitudes included taking the community and its needs and opinions into account, respecting hierarchies in the community as well as protocols and norms, and valuing regular members of the community and their contributions and not only authority leaders. Although I describe them in different sections, these attitudes are interrelated and interdependent.

The community in turn was well aware of this respectful approach:

“Ana Laura and I together showed respect for the community all [the time]… He [the comisariado] knows that we have acted respectful, he told us”(Project Communication Specialist)

5.4.1 Taking the community into account

Taking the community into account meant in this context treating it as a partner, as well as valuing the opinions of its members. As the community was not accustomed to being taken into account, this attitude was appreciated as it made them feel valued.

“We take them into account, they are entitled to know what we are doing with all the openness of those who are working on this …People are surprised to be taken into account but like it… This is something unique [new] in Mexico” (Project Communication Specialist)

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Treating the community as a partner involved building horizontal relationships with them, or relationships between equals or entities on the same level as opposed to vertical relationships, or top-down relationships that form between entities on different levels of hierarchy. Horizontal relationships also meant involving the community in decision-making as well as collaborations.

“We tried to make them truly understand that we had certain information about dengue control and transmission but we really had little knowledge into how it functions in the community, how actually that mosquito, which one, where, why, how, there was still a lot that we didn’t understand and that we needed their help to understand that, so yes, I think that was a very key message that we tried so that we are not in a vertical dominant hierarchal position above them, rather we were at the same level as them looking for solutions for common problems… [I told the subsecretary of environment]: this is me, this is the project, we are aware of the regulations and procedures, but all of this is new for the country, we would like you to tell us what we need to do ”(PI)

The community was also asked for its decisions, permitting the project and its activities

“She [Ramsey] wanted to give group talks, with the assembly and with the authorities, so that we could ask for their permission”(Project Anthropologist)

“If the community does not want this [project], then we must respect it” (Project Communication Specialist)

Respecting the community as partners also meant accommodating them and their needs.

“I go on weekends, it is easiest for them, they would not be working… I schedule those group talks directly with them … they don’t even have to [change schedules]… at a time that works for them” (Project Anthropologist)

Finally, the horizontal relationship also had implications on communication, but I will dedicate a section at the end of this chapter for this aspect of the approach. As partners, the community would “know about the project before anyone else” and be part of a “bilateral communication” (Project Communication Specialist).

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Additionally, community members have frequently expressed satisfaction with the project for asking them for their questions, soliciting their feedback, and valuing their opinions.

“People are happy with the project because we got information and we were asked for our opinions” (Community member 2)

“[I am] Satisfied because I was able to assist and participate” (Community member 1)

Feedback about the project was constantly asked from the community.

“We asked what they thought about the project, and if they had any doubts” (Project Communication Specialist)

“We were asked if we like what you are doing” (Current Comisariado)

It is interesting to note that the project sought contributions from the community in two areas. First, both the macro and micro communities were asked about their ideas with respect to the scientific and entomologic aspects of the research.

“There was still a lot that we didn’t understand and we needed their help, especially with relation to local epidemiology and behavior of mosquitoes, we asked them that at the assembly… We gave SEMARNAT the guiding document on GM trials that FNIH prepared and asked for their comments and feedback” (PI)

Moreover, the community was asked for active help in the execution of the project and also in community engagement, such as seeking the help of teachers in schools and different organizations in the community among others.

“One thing that was pretty much clear, is that I was trying to promote the fact that we’d like them to help us to discuss the project with their groups, with people they are in contact with, and they would let us know if anyone had any doubts and they could feed the people back to us and if anyone wanted us to go and give a talk about the project and what has been planned in dengue control then we would be more than willing”(PI)

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5.4.2 Respecting hierarchies, protocols, and norms

Respecting the community’s structures, including its authority and leadership, and following the norms and customs in approaching and interacting with the authority as well as other members had a positive effect in setting a good start as well as maintaining a positive response from the community.

“We are always following all of the procedures… If they see that there’s a letter that says “thank you for letting me talk to you” next time, oh, Tom? Anthony? They recognize them as people, I mean, they have a reputation now … We sign documents with a witness, so that people would trust us more” (Project Anthropologist)

“We always told the comisariado, and if there’s one we also told the agente, and informed the community at la casa ejidal and tell them what we’re going to do, like going to households, and we’ll give detailed information in each house. It is the norm in Mexico. You always go to the authority that is directly associated and you also inform the civil authority ” (Staff Scientist)

“Anna Laura and Claudia see the comisariado always once every week or two weeks and go over everything with him, it is to inform him and make him aware all the time” (PI)

5.4.3 Valuing regular members of the community and not only authorities

The first indication of respect for the community in Río Florido according to Dr. Ramsey was that the team engaged the ejido at the same time as contacting the federal and county agencies as previously explained. Their opinion mattered from the beginning, and they were not presented with a “done deal” (PI).

Members of the community have expressed their satisfaction with the project appreciating them and valuing their opinions even though it is expected that only the leadership would be engaged. This is also a manifestation of the horizontal relationship that was described before.

“It is not normally expected that they would look for [me] to help, because usually people look out for the comisariado. It means that my opinion is asked for, it makes me feel as an important person in the community”(Community member 1)

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“I was not the comisariado ejidal, and in office as leader, yet they continued to participate with me”(Current Comisariado)

Another interesting fact was engaging with the children at schools. Theoretically, children have no say when it comes to authorization of a project. So to engage children heavily as active participants and prepare activities for them, could be seen in two lights. First of all, it could be a reflection of an authentic commitment towards development and contribution for the community, and I have encountered in my interviews community members expressing their contentment with the work being undertaken at schools as empowering and beneficial. On the other hand, it could be a manifestation of a holistic respect for the community and all its members, including its children, who can also be participants and not only recipients.

“The story was prepared and was told by Janine… This one [story] in particular was given by Luca, Laura… and another technician …this one was given by Memo. The puppet show was made by 6th. Graders… I instructed them, but the kids participated, they aren’t participating as audience of something they don’t understand… now they are really really participating” (Project Anthropologist)

Valuing community members meant valuing the contribution of every member and their role no matter their vocation or position in the ejido. Every member was considered as a valuable “social actor” (PI).

“From the moment she [the convenience store owner] complained, then we wanted her to become a positive social voice, she expressed a doubt, but her doubt was that the project was acting negatively, so if we didn’t say she’s a social actor and we need to deal with her doubts and her perceptions, and if we did not show her how [mosquitoes] had nothing to do with Luka, to make these experiences extremely demonstrative, take them as learning experiences, and I think had we not done that, possibly we would have come in and go out, we wouldn’t have any impact ” (PI)

5.5 Maintaining a conversation

Communication with the community received a high level of attention from the project team, who appointed a dedicated specialist to deal with this demanding task. His objectives were to

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“communicate, and discuss this project in the best way” (Project Communication Specialist). In the previous sections of the chapter, I have used many quotations that expressed the satisfaction of the community for receiving information and updates about the project

“Now that we understand, even more so do we like the project” (Matute – Scientific American) and also for being asked for their opinions, knowledge, and feedback. In fact, it was obvious from all interviews that information did not flow in one direction in this project. Rather it was a bilateral communication, or even a conversation, whereby the community provided feedback, questions, doubts, opinions, and sometimes knowledge, and received information, education, and updates, all in the context of multi-way conversations.

Marcoschamer refers to this type of communication as “multidirectional” and contrasts it with unidirectional communication often used in research projects. According to him, multidirectional communication is important to ensure a genuine understanding of the information.

“Multidirectional in my opinion makes a receptive communication… a receptive communication makes you know, makes you have information about what’s going to stay. You know what they understood” (Project Communication Specialist)

Effective communication was also seen as an essential element to maintain the authenticity of engagement and authorization as well.

“I mean if we go ahead and ask them can we do that they would look at me and say yes, but that is not truly informing, that is not informed consent, because they don’t know all the information and they are saying yes just because you are asking them to say yes. I wanted them to be informed, for them to be informed about us going ahead with the genetic strategy they had to be informed about how the disease is transmitted how we control and what advantages this strategy can have, and what risks it has. They needed to understand genes, and mosquitoes, and Dengue.” (PI)

Communicating, as a two-way exchange, included five categories of tasks that I describe in this section: Describing, educating, updating, empowering, and receiving. None of these tasks

140 constituted a phase by itself, but they were all interdependent, as well as undertaken concurrently and iteratively.

“It was made clear to them that we were going to be learning things along the way and that we were going to discuss the things that we are learning with them and see how they felt, [an] iterative process of learning something, asking new questions, and going back]” (PI)

5.5.1 Describing

The first task in this project’s communication endeavors was to describe and explain the project, its goals, its activities, and all other related information.

“We went back over the information formally about what the project was about, we gave them a full explanation of who was in the project, what were the objectives, and the purpose that we were going to purchase land, and that we already saw the lands of fulano and fulano [so and so], and which of the properties had advantage over the other, and that we were going to have a discussion with them to make the decision ” (PI)

5.5.2 Explaining

An aspect of the project that was frequently applauded by the community as one of the most impactful direct and immediate benefits, explaining involved providing contextualized information and education about dengue, other vector-borne diseases, mosquitoes and mosquito control. This information was provided in community meetings at the community center (la casa ejidal), in schools, in women’s meetings, and in households where application of the information was done, especially with regards to sanitation and cleaning water tanks.

“They expressed very positively the fact that they had gained a lot of information directly inside each person’s house regarding the mosquitoes in different stages, where they are breading, and information that was given in situ, in each house, of control methods that they can carry out, and they expressed that they were satisfied and were happy, pleased, with the meetings” (Staff Scientist)

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“We started doing that from the very beginning, from the very beginning we had to go back in every talk and talk about dengue how it’s transmitted and what are the basic strategies used for its control, even before we were selected, because you have to contextualize why you are talking to them, and the context was dengue” (PI)

“We have learned a lot in the community on how to protect ourselves from Dengue and mosquito disease. We are grateful for that” (Community member 2)

5.5.3 Updating

Updating is a continuous task whereby the community leadership and consequently the community members received updates on the project’s progress.

“We hear things from Laurita or Janine, about the progress, the importance being given, what is happening. They also present to us everything in the assembly … then I would tell everyone at a town meeting” (Current Comisariado)

Provided information included updates on the project’s findings, challenges, and activities.

“The mayor was informed about the project immediately, after Tony James informed us, I immediately had a meeting with the scientists here and informed them, I had a meeting with the ejido and I had a meeting at the county level I advised now for the first time the mayor I was with the health commissioner we advised him what the project was and that we were going to go ahead, and then we went to Río Florido and in an assembly told them that Tapachula was selected…

“We meet with them, and present the findings, from the epidemiologic studies, or also from the trials” (PI)

“During the assembly we present our progress… Every month, or when needed, I go and tell the assembly: I’m going to create focal groups… interesting interviews, and interview certain people that are authorities of health in the community… and I’m also going to talk to women with and without Opportunities… then I give them my calendar. And I use the opportunity to let them know I’m going to work with the kindergarten kids, I still don’t exactly know what I’m going to do” (Project Anthropologist)

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5.5.4 Empowering

Empowering the community to interact with the information given and use it for their own benefit was one of the project’s communication goals. Analyzing the importance, as well as the societal impact of this aspect, especially on community development is beyond the scope of this chapter, but will be addressed in a separate paper. For the purposes of this thesis, I will stop at reporting the driving philosophy behind this task according to the PI. “It’s providing information and helping them to metabolize it and use it and become independent with it and asking them to take it one step further in whatever way they choose, it’s empowering them in a certain way because hopefully this is information or issues or just thinking together helps them to define what they need and want, we were trying to give them access to whatever information we had or best scenario/technical opinion on any of the issues so that they could then take advantage of our knowledge or what we knew how to do, or how we go about, so this feedback, it was basically opening them up to a group of people who synergize all of our capabilities … I just wanted people to start discuss[ing]transgenics for public health and eventually transgenes, I wanted people to start talking about it and I wanted people to start having an interchange on information, to start moving this is the way that I thought I can get things to start moving both from civil society and civil consultation groups which have all sorts of specialized groups within them and then diffuse out to these specialized groups, also through the healthcare system I tried doing the same thing”

5.5.5 Eliciting

This task involved soliciting and receiving knowledge, opinions, questions, doubts, and feedback from the community, and acknowledging the value of this information, and has been covered extensively in this chapter. ‘Eliciting’, not only helped in demonstrating respect and valuing for the community, but as mentioned before also ensured that the community has understood the information that was presented to them

“It’s not exactly giving information, it’s like when we know that he community has understood something, [through] the information that they give me back” (Project Communication Specialist)

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“We ask people. One of the questions is if they know what the word transgenic means… what do you think transgenic means?and if they know about the project and what it’s about, who has given them information” (Project Anthropologist).

6 Summary

In this chapter, I presented a five-element inclusive, incremental, and iterative model, based on the interactions that occurred between the community and the project researchers. This model had at its core community-centered relationships that are based on mutual respect and reciprocity. The five-elements are summarized in Appendix 9, which could be used as a roadmap for researchers engaging in community-based research. I also argued in this chapter that this approach was effective in generating and maintaining community interest, hope, comfort, and satisfaction. These in turn led to developing and maintaining a state of confidence, which enabled the state of authorization that I will explain the following chapter.

Two key messages could be derived from the results in this chapter: 1) Integration in the micro or host community from the inception of the project is paramount for developing respectful relationships and reciprocity 2) An inclusive approach that encompasses all levels of the community, including the public (lay individuals) promoted respect

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CHAPTER 9 Community Authorization: A Multi-Component Phenomenon

In this chapter I describe and analyze the social transactions that were indicative of community authorization. In order to draw inferences about the elements that constituted community authorization, I examined the different community actions that were reflective of the community’s response toward the trials, including decisions as well as the community’s actions and expressed attitudes.

I argue in this chapter that the project has in fact earned authorization to begin and to proceed by the different levels of the community. Community authorization involved approval for the project, as well as empowerment of the team executing it. Approval was manifested in two ways: formal and informal. Formal authorization included decisions that involved permission granting. Informal approval on the other hand was reflected by the lack of opposition, expression of favor and satisfaction, as well as by community actions that signified their embracing of the project, such as active help and support. Both types of approval were empowering and enabling.

In Appendix 9, I present a diagram of the different actions that formed authorization for the project (on which I elaborate in this chapter). Appendix 10 depicts the underlying social processes of these actions.

1 Formal Approval

Formal approval comprised all the different decisions that explicitly and recognizably expressed permission for the different project activities and hence enabled them, had an official binding status, and were obtained by following, or according to, established forms, conventions, procedures, regulations, laws, or requirements (Table 9.1). These decisions were taken and expressed by community individuals and bodies who have mandates or responsibilities to protect and look after the interest of others (stewardship), such as official authorities at national, regional, or local level, as well as heads of households. Decisions, or declarations that passed and expressed judgments or conclusions on issues under consideration, were divided into two categories, direct and indirect. I use ‘direct’ decisions to refer to those that signified approval for activities that were directly related to the execution of the trials and their experimental milestones,

145 such as the land purchase, development of the cages, or mosquito collection from community houses. Table 8.1 presents all major direct decisions that were enabling for the project. Every direct decision marked overcoming a threshold in the lifecycle of the project, enabling a major step or phase. I use ‘indirect’ decisions on the other hand to refer to those decisions permitting activities that were not directly related to the execution of the scientific aspects of the experiments, but were part of the community engagement aspects of the project, such as presentations in the community about the trials, awareness campaigns, water cleaning and sanitation programs, public health talks, and school activities. While indirect decisions were important, as they were a reflection of the approval for the project, they were not enabling for the actual trials and experiments such as direct decisions.

Threshold Decisions Involved Taken by 1 Project Entry to Community: Memorandum of Understanding CRISP and GC#316 Endorsement by CRISP Regulatory approval CIBIOGEM 2 Clearance Institutional Approval INSP Projection Admission into Permission transfer field site Assemblea 3 micro community: land to project Community Consent 4 Consent for project Assembly consent to build the Assembly milestones cages Assembly consent to approach Assembly the community Assembly consent for Assembly individual experiments Informed consent from families Heads of households for house-based experiments

Table 9.1: Formal Approval (Decisions)

The first direct, or research-related decision for this project by a community institution was actually taken by CRISP to participate in the GMM trials as a partner with GC#316 (Table 9.1). This decision was formalized in an official and binding agreement, a memorandum of understanding, establishing the terms of the relationship and the rights and responsibilities of the two parties. This agreement was reached after following internal procedures at CRISP, such as discussions between scientists and establishing scientific merit of the proposed research, and the final decision was made and communicated by Dr. Ramsey, the highest authority in the institute

146 as the director. Once this agreement was completed, CRISP turned from being the ‘engaged’ by the external partners to being the ‘engager’ of the local community, on behalf of the consortium. This decision marked the first threshold, whereby the project entered the macro community.

The second threshold of authorization involved clearance by regulatory authorities granted to the project by CIBIOGEM, and by an academic and bioethical clearance from INSP. Both clearance decisions established safety of the project, accountability, as well as the responsibility of the project towards the community. Although as I described in a previous chapter there seems to be a culture of participation and engagement in science and research in Mexico, I did not collect data that would inform me whether the public participated in the decision-making processes pertaining to the regulatory approval or had any input into it.

The third major direct decision was taken by the ejido assembly (assemblea ejidal), who consented to privatize and allow the sale of a lot in the community to the project. This action formally declared the community’s endorsement of the project and its admission to the community (third threshold). The micro community’s consent, represented by the assembly’s consent, involved a request or proposal from the project, followed by presentation and explanation of information, deliberation between the assembly’s members. This phase also included the negotiation of the terms of the relationship, establishing the project’s responsibilities towards the community and its expectations from the community. “at the community assembly level, they wanted to know who was involved, who was going to be running it, who was the consortium, what sort of regulatory procedures were being followed, what were we questioning technically. Same questions at the federal level, but not elsewhere.”(PI)

“This was the lock they had to pass to go ahead” (Current Comisariado)

All of these decisions were taken at the beginning of the project, before relationships were fully developed. As I explained in the previous chapter, this was the phase where initial comfort and interest were developed and helped establish a state of openness to the trials. These decisions marked this openness and willingness to take part of the project, but were not indications of authorization for the trials as of yet. As the project got established in the community and as the relationships were maturing, the researchers applied for consent from the relevant individuals or

147 institutions for every ensuing research related activity, as well as for non-research related activities as I will illustrate later in this section. Other direct (research-related) decisions at this stage included consent from the assembly for the project to conduct experiments within the community, and individual informed consent from families for these experiments, such as mosquito and larvae collection in households. “The first agreement was only to buy the land but that did not mean that we could do what we wanted since we had to comply with the ejido conventions and practices and each activity had to have its own information and we had to ask for approval every time, like for example to approach the school, or to do the larval surveys” (Staff Scientist)

This multi-step consent constituted a major component of continued approval, or community authorization, and they were part of a process of relationship building, information sharing, and discussions between researchers and the community. Accordingly, and as I explained in the previous chapter, this stage of decisions was contingent on the development of confidence (Chapter 14). After the third threshold was passed by the assembly’s decision to admit the project to the community, indirect, on non-research related, formal decisions were taken regularly. These included collective decisions by the assembly to permit the project team to address the community and engage them in activities, such as public health talks about Dengue and vector- borne diseases, focus groups about the project, water cleaning programs, school plays and storytelling, among others. Other indirect decisions included permission from school principals and teachers to conduct activities in schools, and permission by civic group leaders to hold presentations for their members (an example is the Opportunidades women group).

As argued in the previous chapter, formal interactions and hence formal approval occurred mostly in the context of inter-institutional relationships, and depended on the official status of the involved parties. Furthermore, unlike informal approval that was developed and reproduced through informal channels such as one-to-one and grapevine communication as I will detail later in this chapter, formal approval was conceived as well as communicated following hierarchies. The project, as a formal institution with levels of management and chains of command, was granted approval to conduct trials from other organizations with analogous formal structures such as the federal government (regulatory approval), the county (county assent and

148 endorsement), and the ejido assemblea (consent). Informed consents from individual householders to conduct trial experiments in their premises have also followed formal procedures, and constituted interactions between representatives of institutions, the project and families. Moreover, formal approval was explicitly requested and solicited by the team from the community, while informal approval was not asked for but worked for, a concept I will elucidate in a later section.

“We would ask are there any objections and can we go ahead? And they say yes. At the level of the assemblea it wasn’t tacit, in the sense that I went and I asked, do you agree that we can go forward with this project” (PI)

“We were asked in the assemblea to decide on this project… They always came to the assemblea and asked us to give them permission to do things like talk to the community. We were asked to approve everything” (Current Comisariado)

All conclusions were reached after due consideration and often after institutional deliberation. Formal approval was hence procedural rather than relational. In addition to being procedural, formal approval is also official, by implying official permission and by being binding, through specifying accountability, rights and responsibilities, in particular the rights of the community and the responsibilities of the project towards it.

“We went to Río Florido and in a formal assembly told them that their ejido, was selected, we went back over the information formally about what the project was about, we gave them a full explanation of who was in the project what was the consortium of the project what were the objectives, and the purpose that we were going to purchase land for… there were two meetings, two assembly meetings with them where we discussed the topic of the project itself, the people involved, and we formally asked them if they would approve not only public domain for the property but also if they approve going forward with the project in Río Florido… We showed them all the official regulatory approval documents [and] the biosafety reports… The assembly’s approval was formal and following votes of ejidatarios, sometimes verbal though always recorded, in some occasions the comisariado communicated it to us, it usually took two forms, either

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immediately, or it was communicated to us, but everyone was there and assenting, and we had to follow all procedures” (PI)

2 Informal Approval

The formal approval described so far in this chapter was not sufficient in Mexico for the project to begin and proceed, as was also encountered through the experience in Malaysia and the Cayman Islands (Chapters 12 and 13). Having regulatory approval, and even approval from the ejido to buy the land and build the cages, were just the beginnings. This case study from Mexico demonstrated that informal types of approval are also essential aspects of authorization.

“Probably we would have been able to do everything just by taking the ok from the ejido assemblea, and probably we would have had issues. But certainly we wouldn’t have had the support that we received, we wouldn’t have any impact on the community. Having the support throughout the community was very important to us” (PI)

Informal approval included all the actions that constituted and reflected the community’s positive attitudes towards the project, but did not have any official or binding implications, procedural structure, or explicit nature. This type of approval is implied, and not plainly expressed as the one discussed in the previous section, and can be inferred through interpretation and analytical reading of actions and incidents. An attitude is "a relatively enduring organization of beliefs, feelings, and behavioral tendencies towards socially significant objects, groups, events or symbols" (Hogg and Vaughan 2005:150). These tendencies are expressed and manifested in actions after “evaluating a particular entity with some degree of favor or disfavor” (Eagly and Chaiken, 1998). The positive attitudes of the community towards the project were very important in reflecting their approval for the project.

“The community will let you know if they agree. They always let us know how we are doing. We feel approval from the way they act” (Project Anthropologist)

This approval was suggested by the absence of antagonism in the community, expressions of satisfaction and solidarity with the project, support that is manifested in responsiveness to the project’s requests and invitations, as well as active voluntary help to enable its activities. I will elaborate on these aspects of informal approval at the end of this section.

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“We know that we had permission because they actually participated in the activities, they questioned, and they also expressed the fact that they were very pleased with what has been done … We know because they received us well, are always available, and do not express negative attitude, when we return results they are pleased to see that we detail and discuss what they actually saw us do (Staff Scientist)

While formal decisions were discrete and finite declarations that were solicited from the community, informal approval was an ongoing, continuous and interdependent phenomenon that required “arduous, time-consuming, [and] careful work” (Trivedi, 2011) as I described in the previous chapter. In other words, this type of approval was not requested but worked for, and hence was dependent on the developing relationships, therefore relational rather than procedural as formal approval was. In the previous chapter I explained that maintaining comfort and satisfaction were essential to create confidence and to maintain the relationships between the project and the community. In this section, I argue that building and maintaining confidence and relationships helped in turn maintain a positive state of authorization for the project. In this sense, informal approval has an affective nature more than formal approval, since it is more directly dependent on the confidence and comfort of the community.

“Once a link of confidence is built, people usually accept and collaborate” (Camas)

“Now we know you, we know Laura and Dr. Janine, we know what you brought to the community … we realized from the talks they have given us that it [the project] won’t bring any negative effects” (Community member 2)

The last two quotations exemplify the importance of interpersonal relationships and getting to know each other in establishing confidence. When community members established confidence in the project and the team, approval for the project ensued, manifested in positive attitudes.

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“We know they feel confidence, because there is an environment of confidence, they permit us to work freely, they are pleased to see us work, and are confident they are not lied to” (Staff Scientist)

“Well, I know it [the project] went very well, that we are doing well and that they are happy with the work, because now they trust us, we can feel it in their actions” (Project Communication Specialist)

“When I saw all of this, all what you are doing in the community and how close we are, I had to support you” (Previous Comisariado)

This last quote also exemplifies another distinction between formal and informal types of approval. Formal decisions of approval always entailed an agreement on the rights of the community, and the responsibilities of the project towards it as explained before. These responsibilities included a commitment to benefit the community and a pledge to reduce the risks and avoid harms. Implicit approval on the other hand reflected a commitment on the part of the community towards the project. This commitment was manifested in the actions taken to support and enable the project, as I will explain at the end of this chapter.

Since this type of approval depends on interpersonal relationships, it was also developed and reproduced through interpersonal and informal channels of social communication such as grapevine communication.

“We are close here, because the project is also talked about, they talk amongst each other all the time” (Project Communication Specialist)

“I spoke to them [ejidatarios] later and they told me that it was good what they [the project] were trying to tell us or say… I know that this is a benefit that they are bringing, I never gave up and I mentioned this, that it’s a good project, to whoever asked. We talk about the project between each other, and we always hear good things” (Current Comisariado)

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Finally, informal approval was contingent on the presence of a priori formal approval, as I explained in the previous chapter, while formal approval is granted independently from informal forms of approval, which were not finite, not quantifiable, and more time and effort dependent.

“It is important that we know that those who have the knowledge, the experts, have already approved it” (Current Comisariado)

2.1 Absence of Antagonism

The first indication that the community was approving the project was in fact the absence of antagonism or any indication of disapproval. “We know that we have permission, because people do not express negative attitudes or comments” (Staff Scientist) “There was no reason or basis to negate the project, there was no argument against the center taking on a project like this, I don’t think there was an argument at a national level that would say don’t try it, don’t explore new strategies” (PI) “Believe me, there were no bad comments about the project in the community” (Current Comisariado) As data revealed and as I explained before, the trials were quite well known in the community at large. Hence, had there been negative or dissenting opinions about the trials, they would be expected to be encountered in the media. When asked about news or media articles, the project team said they were not aware of reports in the local media, despite being interviewed by foreign magazines. A Google search was performed in both Spanish and English, and as expected there was scant coverage in both local and international media, though more was encountered in the international media. Five documents only were found in Spanish. Two of them were from Spain, one being on the Spanish site of the Scientific American Magazine (Trivedi, 2011), and the other a short investigative essay by a Spanish student participating in a students’ essay competition (ES, 2012). The three Mexican reports were slightly different. The first one is a piece in the ECOSUR newsletter, a public research center, announcing that CRISP has engaged ECOSUR in a consultation meeting around the trials (ECOSUR, 2011). The other two articles talk about the dispute between CRISP and the government over the trials site land in Río Florido, through which the aforementioned train project is supposed to pass. Interestingly, the articles discuss the

153 stringent biosecurity measures that CRISP has taken, and criticize the government for not providing CRISP with an alternative site, delaying thus the train project and CRISP’s research “According to residents of the area, CRISP is located there for several years, so I do not understand why this situation was not foreseen by the authorities”1 Internationally, Scientific American, Science Magazine, Pacific Standard Magazine, and the Canadian newspaper and magazine, the Toronto Star and Maclean’s, also featured detailed reports about the trials (Contenta, 2012; Marsa, 2012; Scott, 2011; Trivedi, 2011). GM Watch had only one posting about the trials in Tapachula, in which they featured the Canadian Maclean’s article. All of the aforementioned articles commended the project for its community engagement. “That’s why, when they set the field laboratory in Tapachula, James bought the land and spent more than two years working with local authorities, farmers, nurses, and residents to familiarize them with what the team was doing and why the research would help the area’s residents” (Scott, 2011)

Objections and dissenting opinions were actively asked for at all levels of the community. As objections could arise at any time, this aspect of informal approval was also constantly and continuously worked for. In other words, the project team was persistently following the anticipatory, or diligent approach described in the previous chapter in order to forestall negative attitudes. “I asked the mayor if he has any objections… His approval is tacit because it’s just like the rest of the community just at a different level they want to be informed and today they might not see any reasons why they would want to say no but should something come up they would object and halt the project… We would ask [the community assembly] are

1 These articles were accessed in September 2012 at the portal of the Newspaper Cuarto Poder through the web links below. However these articles seem to be taken off the archive, and can’t be accessed anymore http://www.cuarto- http://www.cuarto- poder.com.mx/%5CPagPrincipal_Noticia.aspx?idNoticia=300590andidNoticiaSeccion=4andidN oticiaSubseccion=15 http://www.cuarto- poder.com.mx/%5CPagPrincipal_Noticia.aspx?idNoticia=309626andidNoticiaSeccion=4andidN oticiaSubseccion=16).

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there any objections and can we go ahead…We always asked community members in the community talks if they had any objections. There was also the commission which was the community participation and security commission, the academic community, agro businesses and farmers… we asked all of them if they had objections or any negative opinions about this” (PI)

Actively encouraging and soliciting dissenting opinions could be an indication of the high importance of this aspect of approval (Lavery et al., 2010). My data cannot however demonstrate whether the absence of opposition in the presence of formal approval is sufficiently indicative of authorization, or whether other forms of informal approval, such as active support for the project are also needed. Also, I cannot make inferences as to how much opposition would be tolerable, and how much would be considerable enough to negate authorization. “At any level they could have said no. The mayor has the right to say, this can or cannot go on independent of what the federal level says. But here you would have a power play between the federal, state, and county level. Should the county level say no, they would have to find a reason why and justify to the state and then to the federal level… If it’s a yes, it’s a safety net just like the regulatory system, if he said no then it would have had much more meaning than saying yes… I think precisely because it’s thought provoking, saying no means there must be some reason, is it political or is it substantive, and they would question that” (PI)

2.2 Expressing Satisfaction and Favor

From the early beginnings, the project team looked at the positive interactions with community members as signs of their approval. “The community will let you know if they are approving the project or no, because they always act happy and satisfied” (Project Anthropologist)

Providing voluntary positive feedback to the project team and commending them for the work and the results also offered a powerful indication to the project team that there was no opposition as well as that the community was satisfied and hence had valid reasons to continue with their approval and support for the project.

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“They expressed that they were satisfied and were happy, pleased, with the meetings and with everything”(Staff Scientist)

“Something that’s really important to us is that everyone is always telling us how good we are doing” (Project Communication Specialist)

“I'm with you till the end after seeing the great benefit this project will give us” (Current Comisariado)

“Believe me that this was something very nice for me… The answer from everyone in the community [regarding the project] was always positive” (Previous Comisariado)

2.3 Embracing the Project

So far I have described two manifestations of informal approval, which are absence of antagonism and expressing satisfaction and favor towards the project. The most important manifestation of informal approval lies however in the community embracing the project, that is not only welcoming the project into the community, but also providing support for its different activities.

2.3.1 Welcoming the Project into the community

Many incidents suggest that the project was well received in the community, and that community members were happy to have the project in their community. These incidents and statements indicate that the state of openness to the project that was encountered at the beginning developed into a state of acceptance. A positive stance towards the project is reflected by simple cordial interactions that show that the project team members were welcome and treated with generosity like neighbors and friends, another indication that this type of approval is dependent on interpersonal relationships.

“When they see us in the community they start talking to us, they wouldn’t want us to go, and would start talking about everything…When we go to collect mosquitoes [at homes], they often make breakfast for us … she [the house owner] gave me papaya and asked me to lie in the hammock” (Project Communication Specialist)

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Moreover, community members expressed that they actually want the project to be in the community and are grateful for it, and that they are worried about losing it, an indication that community members are not simply acquiescing or yielding to the leadership decisions, but are appreciating and embracing the project.

“We had been fortunate here in our community because of the intention to carry out this project that you brought us despite having looked into another… They [community members] are worried that the project would be withdrawn” (Current Comisariado)

“Here in Rio Florido we were lucky to have the experiments”(Previous Comisariado)

2.3.2 Supporting the Project

In this section, I describe the endeavors that community members have taken to support and empower the project and to enable its activities. These endeavors, which I will detail at the end of this section, included responsiveness to the project’s requests and invitations, such as attending meetings and presentations or providing assistance when required, and voluntary active help manifested in taking initiatives to facilitate the work of the project and support its undertakings. Many of the actions that the community took in that direction appear to be motivated by a desire to reciprocate for the research team’s constructive work.

“When we participated in the community, the people participated too … it’s a form of exchanging, continuous reciprocity… The school teachers like others in the community always responded in a nice way, and told us that they want to do their part [in the project]… People gladly attended the meetings, they wanted to.” (Project Anthropologist)

“How can I not do my part when I see this” (Previous Comisariado)

“When I saw all of this, all what you are doing that you are good people, I had to support them, I had to help, it’s like reciprocating, how can I not, I have a duty also towards our children… How can I not help them [the project] and support them when they are doing all of these good things?”” (Current Comisariado)

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“I think if we had gone just to the comisariado and said to him this is what we were going to be doing, without much back and forth, I don’t think we would have had support [and] assistance,” (PI)

The last quote reflects another important insight about the community’s support for the project, where it could be seen as a reflection of the community’s commitment as a partner in this project. As I will show later, many of the community leadership’s actions could be seen to reflect a sense of ownership.

While the leadership’s response to the project was manifested in active and voluntary help to the project team, as I will illustrate later on in this section, the rest of the community showed their support by responding positively to the project’s requests and invitations.

“Most of the people we invited to participate in focus groups usually respond positively. But if let’s say I invite you, and you can’t go, then I will ask you if you know someone who would be available, and you say I can’t but my cousins, my uncles, my relatives (inaudible) can go, I’ll take you to them, and that’s how it’s been” (Project Anthropologist)

Similarly, when the research team was trying to determine how best to reach out to school kids, community members offered their advice about what approaches might be most effective.

“Back at the school they told us how to do some of the things” (Project Communication Specialist)

“The teachers from the [school] have helped me a lot and so have the parents committees of each of the schools…I spoke to the teachers and asked for their advise, and they gave me a lot of ideas on how to do it [the kids’ play]” (Project Anthropologist)

Voluntary and active help on the other hand was mainly offered from individuals in leadership roles, who have the influence and means to provide constructive and practical help to enable the project’s undertakings and activities. Many examples illustrate this kind of support, such as the mayor arranging meetings for Dr. Ramsey with the different relevant county committees, the committees in turn linking the team to different academic and agronomical groups in the macro

158 and meso communities, and the ejido assembly and comisariado helping the team buy the land for the cages and inviting community members to attend meetings, or talking them into allowing the team personnel into their homes to collect larvae. This kind of support could be seen as the leadership’s endorsement of the project, and would provide reassurance for the rest of the community, knowing that those who are entrusted to protect the community and watch over its interests have already cleared the project and are backing it.

“He [the mayor] told me should I need anything to let him know and if there’s anything he can help us with he would do it… When I met with the county health commission and told them about the project, they immediately said do you need a letter from us so that you can go to the rest of the people, and I said obviously if you are informed and you let the rest of society know that you have been informed it will help them accept a meeting with us” (PI)

“The assembly always support[ed] me in everything I wanted to do” (Project Anthropologist)

“I always supported this…When they came to look for a good land to buy and build the cages on, I gladly began to look for one…time is very valuable but we devoted it with all good intention to help this project. I did anything I can do to make it happen.”(Previous Comisariado)

“Now that I'm in charge, I will call assembly meetings as often as necessary and to the best of my ability…When they ask for my help, I am by their side… Our intention in this more than anything else as an authority was to make sure the people understand the importance of this project” (Current Comisariado)

A sense of ownership of the project by the community was reflected in many instances. When community leaders treated the project as an asset that belonged to the community, they acted and supported it out of their responsibility and duty towards their own community and all of its enterprises including the GMM trials. The project hence became part of their domain of duties and responsibilities. Many incidents indicate that leaders in the community were taking the project personally, bridging between the scientists and the community, advocating for the project, and sometimes acting as members of the team.

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I will say that it´s been about twenty people who came so far to ask me about issues or my opinion about the project, and I explain to them… If someone asks me questions I can’t answer I would have told Laurita or you so that you could explain things… I'll ask as a favor others in the community to help… I always do, as authority, what I find suitable for the project, I want people to know, to participate, it is our project” (Current Comisariado)

“In a meeting we had at the assembly before I became comisariado I started to tell them what you have informed me. I was the messenger… I considered what we had to do to present the idea to the community so that they would be aware of it” (Previous Comisariado)

“I am not a member of the project team, but any support that I can give, as a vocal of opportunidades, I will do it, because I have responsibility for the community’s health” (Community member – women leader)

This sense of ownership of the project was translated in solidarity with it when external factors, such as the previously mentioned train project, threatened the existence of the project in the community.

“When some of those things about the train were coming up the ejidatarios in the assembly said, do you want us to write a letter to the governor so they move that train track? What can we do otherwise?” (PI)

3 Summary:

As a summary, community authorization appeared to be more than a formal approval from the relevant authorities giving consent or permission to conduct the trials. In fact, the informal and implicit manifestations of approval had a crucial role in empowering the project. Community authorization had many components, and each is necessary but non-sufficient in its own right, as no single action was by itself sufficiently reflective of authorization. Moreover, the components were co-dependent, as I have explained in many instances of this chapter. Table 9.2 contrasts formal and informal approval.

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Formal Approval Informal Approval

Decisions Actions and Attitudes

Solicited Worked for

From highest levels of hierarchy in macro and micro Everyone

Responsibilities of the project Mutual commitment

Mandatory steps Active voluntary engagement

Procedural Relational

Official status Moral standing

Finite/Discrete Continuous

Deliberative Affective and deliberative

Independent of presence of informal approval Dependent on the presence of formal approval

Table 9.2: Dimensions of Formal and Informal Approval

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CHAPTER 10 Community Authorization: An Experiential State

In the previous two chapters of Part II, I presented the different components of the phenomenon authorization as well as the social processes and conditions that were conducive to it. In this chapter, I examine the characteristics of this phenomenon. I begin by showing that authorization is a state, or a condition, and not an action. I then describe the features of this state based on my data. These are conditionality, revisability and fragility, and non-universality. In the second part of the chapter, I reiterate a previously made conclusion, that authorization is a process, and explain that it’s stepwise, continuous and iterative. Finally, I explain that authorization is responsive and interactive.

1 Authorization is a state

The results presented in the previous chapter demonstrate that community authorization for GMM trials is distinct from consent, and is not a discrete decision or activity that could be identified at any point of time, nor a sum of decisions, and hence not a milestone that could be marked on a checklist. It is not an action, but a state or a condition that is experienced as long as it is maintained and reinforced. In other words, while a project can know and tell when they don’t have community authorization, as in the Malaysian experience, they have to keep on working towards it in a continuous process as if they don’t have it. The state of authorization is therefore maintenance-dependent.

Referring to the community in Río Florido approving the project, the previous comisariado said:

“The proof is that we are here” (Previous Comisariado)

This statement indicates that still being in the collaboration with no objections and still feeling comfortable with the project, which was still active at the time, are indications of authorization. Also it is an indication that authorization is an experienced state, and therefore by default temporal:

“This can change, today we are here, tomorrow we might not [be]”(PI) 162

As I also argued in the previous two chapters, authorization is contingent on the presence and maintenance of confidence, which is in turn dependent on comfort, a temporal and conditional state. As a conditional state, authorization is revisable and fragile, needing continuous maintenance and reinforcement. This state is also non-absolute, in the sense that every activity by the project needed to be assessed separately.

1.1 Conditionality

As discussed in the previous two chapters, every decision involved consideration of a proposal in which risks and benefits are discussed, negotiated, and assessed after due deliberation, and establishment of roles, rights, and responsibilities for both the project and the community. Formal components of authorization were therefore contingent on meeting certain conditions related to minimizing risks and maximizing benefits.

“This is a process with constant inquisition. Many conditions have to be met before we can move on to the next step” (PI)

On the other hand, informal approval was dependent on the maintenance of relationships, which were in turn dependent on the maintenance of comfort and confidence, as I have frequently explained in the previous chapters.

“We know we have their approval because there is an environment of confidence. But we had to work for this, to establish that link, and we have to keep it” (Camas)

In this sense, informal approval was contingent on the community being authentically engaged and being treated like a partner in this project.

Both formal and informal types of approval were conditional on communication, information provision, and achieving understanding of the information being presented, including the goals and objectives of the project, the institutions behind it, the specifics of the experiments, as well as updates on the success or failure of the experiments. This aspect is demonstrated in Malaysia, where lack of information provision and consequently lack of understanding caused the opposition to the trials, as I will explain in Chapter 13.

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1.2 Revisability and Fragility

Being conditional, authorization is then inherently revisable and fragile. Approval is contingent on a comfort level that should stay above some threshold, below which people will no longer feel comfortable to engage in all the actions that make up the authorization state. Consequently, when actions or events that might threaten fundamental interests of the community arise, changes in the community’s comfort and consequently in their confidence in the project could be triggered to the levels below the needed threshold. In this case, objections could be raised, relevant decisions could be withdrawn, and support could be withheld.

“We have the permission for us to work in the community but they can withdraw [this] permission at any time” (Staff Scientist)

“I asked him [the mayor] if he had any objections and I said I think that’s something that may come up at some time and should you have any doubts let me know… it’s just like the community just at a different level they want to be informed and today they might not see any reasons why they would want to say no but should something come up they would object and halt the project…

I don’t think they look or conceive in absolute, nothing is 100% for them, I think that’s why they feel that approval. Maybe something would happen between today and tomorrow and things would change” (PI)

The effect of something “coming up” was actually demonstrated on the ground, when the project was coming close to completion in 2011. When the trials could not be concluded successfully, and having to move establishments because of plans for a transnational train passing through the field site, the project had to be concluded. In the final interview with Don Martimiano Barrio Matute, the ejido comisariado at the time of the data collection (September 2011), I listened to him relaying to Dr. Ramsey the concerns of the community who are now questioning the benefits of the project as well as their honesty in keeping up to their promises as they see the project getting withdrawn from the community. The comisariado whom I have met before, and who used to be friendly and informal with Dr. Ramsey and other team personnel as I have mentioned in chapter 11, was talking in a very formal tone, using formal expressions such as “we request” and

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“we demand”, and was challenging the team’s credibility and intentions. The developments in the trials and the imminent train construction plans threatened the interests of the community, and consequently agitated their comfort and their confidence in the project and its team. Although the community didn’t experience disruption in comfort and confidence to an extent that would make them withdraw their approval, the message that could be drawn is that relationships and hence authorization are fragile and subject to constant revision.

“We are becoming more attentive now... We want to know what are the benefits of the project at this stage and where are they… We are not changing with the project and still see it in a positive light, but we need to always check and make sure everything is as it should be” (Current Comisariado)

“Even if there’s a lot of trust, if we aren’t part of their interests anymore, that’s it” (Project Communication Specialist)

Alignment of interests was probably one of the major drivers of comfort and consequently confidence, as explained in chapter 13. With history of exploitation in the region confidence can be quickly withdrawn, necessitating a high level of constant maintenance. A this point, it was up to the project to demonstrate their commitment to the community, and plans of relocating the field site and establishing a permanent research center in the community reestablished the sense of comfort and thus openness to reestablish new relationships.

“ [the loyalty] is not to Janine, it’s to the project and the group of people, purpose, etcetera, of which Janine happens to take care of responding for … it’s the unit called the group and what we’ve done, I think as you have been saying, the presence of the institute was just the project and now this is coming apart, whereby there is the project and the presence of Janine and her group but now there is going to be other interlocutors who are going to be involved, which teasing this apart and the association of the community with the elements is why I say the need, I feel responsible to try to get on a good track the relationship of the community with the institute, keep it going with whoever takes over” (PI)

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Moreover, the incident just described with the comisariado draws our attention to the importance of setting expectations about interests and benefits in initial agreements, especially with regards to what constitutes successful science, and the relationship between benefits and the scientific success or failure of the trials. Perceptions of benefits seemed to be changeable, being inflated at the beginning with hope and deflated later on with anxiety and uncertainty.

1.3 Non-Universality

Authorization is not absolute and not universal. This means that decisions of approval for specific activities were not extendable to cover other areas of the project. For instance, permission to buy the land to build the cages did not signify approval for the project. Likewise, approving the trials to begin did not mean all related activities are approved by default. Every activity had to be separately assessed.

“No, Selling the land was not an implicit ok to do the work. The 1stagreement was only to buy the land but that did not mean we could do what we wanted since we have to comply by the ejido conventions and practices and each activity had to have its own information and we had to ask for approval for every activity, example to approach the school to do larval survey” (Staff Scientist)

Moreover, the established relationships and openness were not a guarantee that all other endeavors presented by the same group would be automatically approved.

“Then it wouldn´t be automatic or based on our previous relationship or interaction for us to bring a new project [by the institute], but rather we would see what the project is and the benefit for the community” (Current Comisariado)

2 Authorization is a Process

Community authorization in this project was not a discrete and distinct action but was a stepwise, continuous and iterative process, which paralleled the community engagement process that the project has followed and that I described in Chapter 8. Consequently it could not be achieved in a

166 meeting, as it was expected in Malaysia. Similarly, it could not be requested, but worked for to build it up through interaction and effective engagement.

“It’s all in steps, and for this first step you have to speak to the ejido commissioner, so that you can ask him if there is going to be a meeting, if he’s planning on assisting and if he will allow us to go (inaudible). We do this each time we have something.” (Project Anthropologist)

“It was a stepwise process, the first we told them clearly what was being planned, we also made it clear to them that all decisions and go ahead will be stepwise, so that right at the beginning it was do you approve our purchasing the land nominally it was going to be used this way, ok, once we’ve been through that process, we now presented what we are going to do there, we showed them the plans, etcetera, and we were supposed to have gene drive systems and much security, and when we shifted technology we told them and we told them why, and that the new product had much less risk etcetera etcetera… It was said in the sense that at any time they can ask us to stop, and as soon as the project has formulated a plan then we would tell them, then go forward, then move to the next step and ask them about it” (PI)

Nevertheless, authorization was not the sum of the different successful steps, which were often decisions, but was understood and experienced as a continuous process. That means it could not be sought or requested before the trials or at any distinct stage of the project, and could not be a milestone on a checklist that could be crossed and passed. The implications are that engagement with the community should be continuous and coextensive with the technical scientific undertakings of the trials.

“So, then you go, and request for permission and you say, that next time we will continue and we’re going to talk about this and that or next time we will do this and that, but meanwhile we keep on talking regularly to the community and on engaging them with different things, we keep on interacting with them, and they showed us support all along… We keep on doing it, constantly, one long story that doesn’t stop” (Project Anthropologist)

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“I gladly participated with them and have been participating all along” (Current Comisariado)

“In all the work what we have done, at every stage, with every activity we always had a meeting and presented what would be done, and asked them for their consent, at the meeting, collectively. Then we went to the community, and told them… And we’re always repeating the process… Back and forth, all the time”

3 Authorization is Responsive and Interactive

Authorization was manifested in actions that came as responses to or as results of the continuous relational interactions between the researchers and the community. In the absence of previous experiences empowering communities in developing countries to effectively and actively participate in science and research, proactive interaction with the project and self-driven participation in decision-making are not expected. As explained before, the community felt a duty to reciprocate the generosity and kindness of the researchers. Moreover, decisions, support, and even concerns were all reactions to direct and indirect requests or stimuli by the project. Community authorization is therefore a two-way process, an interactive communication that relies on relationships.

“Their [community members’] support was the result of all our work… when people see us participate, they participated too” (Project Anthropologist)

“When I saw all you did, and how you were treating us, I had to do my part, to do whatever I can to support the project in my capacity as authority” (Current Comisariado) “Look we wanna talk to you about this project we want you to think about it, give us your preoccupations your doubts, do you have questions, we’d like to inform, we’d like to hear societal opinion, we would like to stimulate a discussion, that’s what I would tell them, because they would look at me and would say what is it that you want from us and I would say I would like you to give us the opportunity to present what we are doing, we would like to hear from society and different people in different groups, we want you to help us set up meetings with different groups within the county, academic, professional, agro, farmers, whoever. And they usually cooperate and respond well” (PI)

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4 Summary In this and the previous chapters, I showed how community authorization is a continuous and cumulative state of approval, rather than a decision or group of decisions. I also showed how this process is dependent on the partnership between the researchers and the community. The implication of these findings stress the importance of ‘upstream’ work ‘in’ and ‘with’ the community, as I will explain more in Part IV of this thesis.

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Part III The Release of Genetically Modified Mosquitoes in the Cayman Islands and Malaysia: Case Studies

In the first part of this thesis I explained the purpose of the study and provided an overview of the background for the thesis and an account of its significance by reviewing the available literature on the ethical, social, and cultural issues related to the GMM trials, particularly with respect to community authorization. In the second part, I presented an in-depth case study of a prominent GMM caged-field trial from Mexico, where I presented the approach that helped developing successful relationships, which in turn were conducive to the maintenance of community authorization for the trials. I also described how authorization was manifested.

In this part I present the results of two case studies assessing the authorization processes related to the world’s first GMM releases in the Cayman Islands and Malaysia. In the first chapter for this section, Chapter 11, I present the methods that I used for data collection and analysis for both case studies. In Chapters 12 and 13 I present the findings from the Cayman Islands and Malaysia case studies respectively. The purpose of these case studies of two high profile and highly criticized trials is not to pinpoint the shortcomings of the trials with respect to community engagement and consequently community authorization, but to draw insights from the experiences and refine the theoretical account I built from the Mexico case study.

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CHAPTER 11 Methods

In this chapter, I describe the research procedures that I followed to both gather and analyze information. I start by the specific research questions that I have aimed to answer in these two case studies, then describe the units of analysis that I used to collect as well as analyze data and hence answer my research questions. I then detail the procedures that I have followed to gather information, as well as those to analyze the data I have gathered.

1 Research Questions

The overarching purpose of this research study is to answer the research question “what constitutes community authorization for GMM trials”. The specific objectives of these two case studies were to document the community’s experiences with respect to the GMM release trials in each of the Cayman Islands and Malaysia, and to draw from these experiences insights that would elucidate the phenomenon of authorization, and make us understand what does it mean for communities to authorize or oppose research trials, and what are the conditions and factors that contribute to the phenomenon. In particular, the two trials have received high publicity because of public antagonism, and therefore I have aimed to understand the meaning of as well as leading factors for opposition, and its relationship with authorization. I have also tried to determine the assumptions that influenced the judgments of the community with respect to the trials, as well as those that influenced the judgments of the investigators with respect to the approach with the communities in both settings, as could be implied from the data. The specific research questions were therefore:

- What were the reactions of the different levels of the community towards the GMM trials?

- What influenced these reactions?

- What could be the assumptions of the trial researchers and how did these assumptions influence the interactions they had with the community?

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2 Units of Analysis

Like in Mexico, the major units of analysis in the two case studies were judgments, or conclusions formed after consideration, whether in the form of decisions, opinions, statements, actions, or reactions. Judgments were analyzed to look for patterns or differences, and to try to uncover the assumptions and the considerations that impacted them.

The main judgments that were identified and analyzed in these two case studies are the following:

1) Cayman Islands: - Decision by the Mosquito Research Unit (MRU) to conduct the trials release the GMM - Decision by the Cayman Islands government to authorize the trials - Reactions of the community to the news of the GMM release

2) Malaysia: - Decision by the Institute of the Medical Research (IMR) to conduct the GMM trials - Decision by the Malaysian government to authorize the trials - Responses of the community to the call of the government for feedback on the trials proposal - Reponses to the public information forums - Reactions to the plans of the trials - Reactions to the news of GMM release

As in the Mexican case study, the minor unit of analysis in the two settings was ‘interactions with the community’, and was used to assess the relationship between these practices and community authorization, as well as to build the social process aspect of my theory.

3 Data Collection

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3.1 Sampling

Theoretical sampling is the appropriate approach to sampling in Grounded Theory, whereby sources of data are purposefully chosen if they add to the development of the theoretical categories, as I explained in Chapter 6. However, as we were not able to establish research collaboration with the institutions involved in both of these trials to conduct such case studies in situ, I was not able to conduct any interviews or collect any field data. Instead, I resorted to available sources on the Internet, whether through subscriptions (such as newspapers, magazines and peer reviewed journals) or free access (personal websites, newspapers, and blogs). Therefore my research followed convenience rather than theoretical sampling. A convenience sample is when the researcher selects any available relevant data sources because they are convenient, not because the selection would specifically contribute to the development of the theory. For the purposes of the study, this sampling was limiting in four ways. The first limitation is related to the perspectives represented in the sample, as it is expected that mostly dissenting voices or those who feel strongly about the trials would be found in the media and other Internet sources. The second limitation is that many of these people might not necessarily be in the best position to provide insights about the trials. The third limitation is with respect to theory development, as some categories were left undeveloped with unanswered questions since I was not able to get clarifications in follow up interviews, as is usually done with purposive sampling. The last limitation is logistic more than anything, as it involved sifting through a large amount of articles and postings hoping to fish for useful information.

For the Malaysia case study, data were collected between September 2009 and November 2012. A Google search was performed in English, then in Bahasa Melayu (Malay) and Mandarin Chinese languages, the three most commonly used languages in Malaysia. The following keywords were used in Malay and Chinese, and resultant webpages were translated into English for analysis using Google Translate (www.translate.google.com) and Bing Translator (www.bing.com/translator) simultaneously: nyamuk denggi (Dengue mosquitoes), diubahsuai secara genetik nyamuk (GM mosquitoes), nyamuk mutant (modified mosquitoes), nyamuk GM (GM mosquitoes), Oxitec nyamuk (Oxitec mosquitoes), diubahsuai secara genetik nyamuk institut penyelidikan perubatan (GM mosquitoes IMR), institut penyelidikan perubatan (IMR) AND Oxitec, institut penyelidikan perubatan genetik nyamuk (IMR Genetically Engineered

173 mosquitoes), 轉基因蚊子馬來西亞 (genetically modified mosquitoes Malaysia), and 公司 (Oxitec).

A dedicated search was performed also in the specific websites of major Malaysian newspapers in the three aforementioned languages. These included: English language newspapers (New Straits Times, The Star, the Malaysian Insider), Malay Language newspapers (Malaysiakini, Utusan Malay, Harakah Daily, Free Malaysia Today (English language too)) and Chinese language newspapers (Merdeka Review, SinChew).

For the Cayman Islands case study, all data was collected between January 2011 and November 2012. Google search was performed in English, followed by a dedicated search in the specific websites of major printed and online newspapers or news services in the Cayman Islands. These included: The Cayman News Service, The Cayman Compass, Cayman I-News, Cayman Net News, and Cayman 27 Television Channel.

3.2 Sample size

Theoretical saturation constitutes the standard approach to determine the appropriate sample size in Grounded Theory (Chapter 5). Nonetheless, since I followed convenience sampling rather than theoretical sampling, and I had to resort to available online documents where I cannot personally ask specific questions as I would do in interviews, my sample included all the available documents that I could find and that had any reference to the positions, opinions, or responses of community members and groups, investigators, or government in both settings towards the GMM trials.

Two hundred and forty three (243) documents were deemed relevant for analysis. Out of these, 171 were used for the Malaysia case study, and 72 were relevant to the Cayman Islands study.

3.3 Data

All data were drawn as explained before from publicly available sources on the Internet. Data included peer-reviewed journal articles; local newspapers and magazine articles; readers comments on local newspapers and magazine articles; statements by local civic society groups or international non-governmental organizations; government decisions, factsheets, and

174 announcements; personal blogs and webpages; and discussions on local internet-based forums and social networking media such as Facebook.

4 Data Management

4.1 Translation

I have used Google Chrome© (www.google.ca) to conduct the online search, and used the auto- translate to English feature. Therefore I was able to determine from the title of the article whether it was relavant or not to my research study. Once deemed relevant, the articles were translated into English using simultaneously Google Translate© (www.translate.google.com) and Bing Translator© (www.bing.com/translator) and the translations were compared for accuracy and triangulation. Since both translation engines provide literal translations, I had to alter some of the quotations while trying to be faithful to the meaning and context intended.

4.2 Data Storage and Organization:

All data were stored on a personal data cloud (Google Drive©). Since there are no confidential or private information, no special measures were taken to protect the collected data. All the documents were coded using Atlas.ti ™ as delineated in Section 4 in Chapter 5. Atlas.ti is a data management software that facilitates the analysis in qualitative research.

Within Atlas.ti each transcript was stored under its corresponding unique identifier as a "primary text document" from which all quotes were drawn and to which all further steps in the analysis referred.

5 Data Analysis

In the two case studies I conducted the data analysis in two stages. In the first stage I conducted initial and focused intermediate coding (refer to Chapter 6), where I identified the pertinent categories while answering the following questions (Charmaz, 2006; Glaser, 1978): 1. What is the data a study of? 2. What category does this incident indicate? 3. What is actually happening in the data?

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4. From whose point of view?

After this data analysis staged, I started the cross-case comparison. Analyzing and comparing the three cases concurrently helped uncovering many of the underlying social processes involved in the interactions between the communities and researchers. Axial coding to determine the dimensions and properties of categories, as well as advanced analysis through theoretical integration followed. The specific descriptions of these analytical processes have been covered in Chapter 6.

6 Summary

The specific objectives of these two case studies were to document the community’s experiences with respect to the GMM release trials in each of the Cayman Islands and Malaysia. In both case studies, I followed convenience sampling and resorted to available sources on the Internet. For the Malaysia case study, data was collected between September 2009 and November 2012, and yielded 171 relevant documents. For the Cayman Islands case study, all data was collected between January 2011 and November 2012, and 72 were relevant to the Cayman Islands study. Data analysis followed the same procedures as those described in Chapter 6.

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CHAPTER 12 The Surprising Release of Genetically Modified Mosquitoes in the Cayman Islands

In Part II of this thesis, I examined the interactions that occurred between the community and researchers in a caged-field GMM trial in Mexico, and used the insights about the different judgments made by the different constituents of the community to elucidate the phenomenon of authorization.

In this chapter, I examine the world’s first open release of GMM that occurred between November 2010 and September 2011 in the Cayman Islands. This high profile trial had received a lot of international publicity, not only because it was the first open release of GMM, but also because it was conducted “under the radar” (Cayman News Service, 2010b) of the local and international communities, as expressed by many commentators. In this chapter I try to unveil what kind of authorization has the trials received and what did that mean to the different factions of the community.

1 Context and Background

Until recently, the Cayman Islands have been relatively Dengue free but on the look-out for outbreaks, taking into regard sharply rising incidences in the region (Cayman News Service, 2010a). In fact, during the 10 years prior to 2012, the highest number of cases reported in a single year was nine in 2007, and all the cases were believed to have been acquired outside the island while the individuals were visiting endemic countries. The first locally-contracted case of dengue in the Cayman Islands was recorded in 2010, when 4 out of the 7 confirmed cases for that year were found to have been locally contracted. In 2011, one local case was reported (Connolly, 2013). Accordingly, when the trials were conducted in the islands, Dengue was not a real issue. Recently however, between September 2012 and January 2013, government health officials announced that 43 confirmed cases of Dengue occurred in the island, out of which 31 have acquired the infection locally, suggesting that Cayman is no longer free of the disease. While the outbreak is believed to have run its course for 2013 according to health officials, the

177 country, now considered endemic, is on the lookout for new cases (Cayman News Service, 2013).

Dengue has been present in the Caribbean for centuries (Ehrenkranz, Ventura, and Cuadrado, 1971; Gubler, 2005), but the current situation is dynamic, and is expect to worsen (Amarakoon et al., 2008; CAREC, 2012; Wilson and Chen, 2002) with around 41,000 cases reported in the last decade (Amarakoon et al., 2008). In the first 10 months of 2012, 17 of 23 Caribbean countries have reported over 1,500 confirmed dengue fever cases (Caymanian Compass, 2012b). The rise in Dengue cases may be explained by the warming of the Caribbean and increases in mosquito populations, and by immunologic responses of the Caribbean host population to new Dengue serotypes (Amarakoon et al., 2008).

Dengue is an ongoing threat in the Caribbean as long as A. aegypti is present (Harris et al., 2011), which has been detected in the Cayman Islands as early as 1938 (Lewis, 1938; Somers, 1939). The vector had many reintroductions after successful eliminations in the last century. In 2002 it was detected on Grand Cayman after an absence of 5 years (Wheeler et al., 2009), and since then its presence has constituted a public health concern (Harris et al., 2011), especially with high levels of insecticide resistance (Harris et al., 2010).

In 2009, the Mosquito Research and Control Unit in the Cayman Islands, the governmental agency responsible for mosquito research and control, revealed that it was considering the use of genetically modified mosquitoes to prevent dengue fever in the island (Wilson, 2009). In November 2010, at the annual meeting of the American Society for Tropical Medicine and Hygiene (ASTMH), researchers from the British Company Oxitec revealed for the first time that they have conducted in collaboration with MRCU the world’s first open release trial with Oxitec’s genetically modified A. aegypti mosquitoes on the Grand Cayman island in during a period of 4 weeks starting from November 16th, 2009 (Harris et al., 2011), followed by a larger scale study in the summer of 2010, between May and October (Enserink, 2010; Subbaraman, 2011). The first small scale trial involved releasing around 19000 GM A. aegypti males containing the RIDL GM technology, OX315A, in a 10-hectare (ha) area in East End in Grand Cayman, at a rate of 465 males/ha/week over a period of four weeks. This trial aimed to study the fitness of the GM males to mate with wild females (Enserink, 2010; Harris et al., 2011).

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A second larger trial was conducted over a period of 23 weeks, ranging from May to October 2010, to assess the ability of OX315A to substantially suppress the target A. aegypti population within a few weeks or months. Approximately 3.3 million engineered OX513A males were released also in East End in Grand Cayman (Harris et al., 2012). The East End district in Grand Cayman was selected according to a predefined set of biological, sociological and logistical criteria, which included the “cooperation and support of local population and health authorities” as a requirement (McKemey et al., 2008). Grand Cayman is the largest of the Cayman Islands, a British overseas territory, and is the location of the capital, George Town. East End is one of the five districts of Grand Cayman, and is 25 km east of the capital. It has a population of 1371, consisting of a traditional community of Caymanians and immigrant workers living in around 200 houses (Harris et al., 2011). In 2012 Harris et al. released the results in Nature Biotechnology (Harris et al., 2012), where they showed that the releasing approximately 3,500 males per ha per week achieved a mosquito population suppression of 80% relative to control untreated areas. These results constitute the first and only (to date) evidence of successful population suppression, and hence of the potential of GMM.

Figure 13.1: Map of Grand Cayman island

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The announcement shocked opponents of GM mosquitoes and surprised many researchers in the field (Enserink, 2010; Nightingale, 2010; Wallace, 2010).

“The experiment will go down in scientific history as the first release of GM insects that could bite humans. What's scandalous about this field trial is that it was largely conducted in secret. Few people on Grand Cayman knew the mosquitoes were genetically modified. The local population was largely kept in the dark” (von Bredow, 2012)

The news also created a wave of shock and anger in the local media (Canadian Press, 2010; Cayman 27, 2010; Cayman News Service, 2010b; IEye News, 2012; Science/AAAS, 2010; Wallace, 2012; Wilson, 2012). “Do you remember the Frankenstein mosquitoes and the lack of transparency the UK firm Oxitec executed here in the Cayman Islands in 2009 without our full knowledge? It created much publicity and our news story and Editorial was republished and commented upon around the world” (IEye News, 2012c)

When Oxitec announced in November 2010 the Cayman GMM trials at the ASTMH meeting in Atlanta, USA, and in its press release in London, UK (Oxitec, 2010a), the news was taken up by media all over the world. The article by the Science and Development Network (SciDev, n.d.), entitled "GM mosquito wild release takes campaigners by surprise" (Nightingale, 2010) was featured in 70,700 websites as found through a Google search. According to Science magazine, the announcement

“has taken aback opponents of GM mosquitoes and surprised many researchers in the field of genetic control of insect vectors” (Enserink, 2010).

“Oxitec was strongly criticised for failing to seek informed consent for its releases of GM mosquitoes in the Cayman Islands, for choosing a country with no biosafety law to conduct its first experiments, for not publishing a risk assessment for consultation, and for the poor quality of the risk assessment that was ultimately released after the experiments had been completed as a result of a parliamentary question in the UK” (GeneWatch, Testbiotech, Berne Declaration, SwissAid, and Corporate Europe Observatory, 2012)

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In this chapter I will analyze the different decisions taken by the investigators with regards to authorization for the trials, as well as the responses from the community, and examine the assumptions that impacted and engendered these judgments. In turn these insights are used to illuminate the phenomenon of community authorization.

2 Authorization Processes

In this section I examine the different authorization processes for the trials. I start by reviewing the regulatory approval processes, then move to assess whether authorization from the micro community has been granted for the trials.

2.1 Regulatory Approval

The trials researchers reported that MRCU received permission from the Department of Agriculture for the import and release of the mosquitoes, under the Animals Law (Harris et al., 2011), and the trial was reported to be conducted in accordance with the draft National Conservation Law (Beech et al., 2011). In addition to receiving a permit from the Department of Agriculture, the trial researchers reported that they have briefed and consulted several Caymanian government departments, including ministry representatives from District Administration, Works and Gender Affairs (under which the MRCU operates); The Ministry of Health, Environment, Youth, Sports and Culture, Public Health; and the Department of the Environment (Harris et al., 2011). An unsigned import permit from the Cayman government was retrieved in the UK after a Freedom of Information (FOI) request by GeneWatch to the UK Department of Environment and Rural Affairs (Defra), and is dated 28th of August 2009 (GeneWatch, 2012b; “House of Lords Hansard: c264W (November 2),” 2011), that is approximately two months before the first release has taken place. A notification of trans- boundary movement of a GMO was submitted to the (Defra) according to Regulation (EC) 1946/2003 pertaining to the Cartagena Protocol on Biosafety (CPB) to which the UK is party. However, this notification of export was submitted by the end of 2010, after all the trials were completed (“House of Lords Hansard: c264W (November 2),” 2011, “House of Lords Hansard: c450W (January 13),” 2011). It is important to also note that there is a requirement to submit a GMO export notification to Defra under the CPB, regardless if the receiving country is signatory to the CPB or covered under its scope.

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The Cayman Islands does not have a biosafety law and is not covered by either the international Cartagena Protocol on Biosafety (CPB) (Reeves et al., 2012) or the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters, to which the UK is a party (“House of Lords Hansard: cWA261 (November 22),” 2010). These conventions would have required publication of and consultation on an environmental risk assessment prior to release of GMM (GeneWatch, 2012a, 2012b). In fact, no regulatory documents related to the trial such as risk assessments or permits were publicly available through the Cayman Islands official departments, including the website of MRCU, the governmental agency which reportedly conducted the trial. MRCU has a mandate from the Cayman Legislative Assembly to conduct research activities for mosquito control as enshrined in the Mosquito (Research and Control) Law (2007 Revision). The only risk assessment document that I could find was a pest risk analysis (PRA), dated October 2009, while information retrieved from the file document properties in Microsoft Office Word ™ shows that it was created on the 20th of November 2010 by Oxitec’s Regulatory Affairs Manager Camilla Beech (This document was uploaded on January 13, 2011 to the UK parliament website (Risk analysis—OX513A Aedes aegypti mosquito for potential release on the Cayman Islands (Grand Cayman), 2009). It appears therefore that this document was created after the two releases were conducted, and was provided in response to criticisms by NGOs about the risk assessment processes. Moreover, Reeves et al criticize this document for being incomplete, with drafting notes and no experimental details of the releases (Reeves et al., 2012). Many critics have in fact expressed their concerns about the risk assessment and the regulatory appraisal that the trials have received (GeneWatch, 2012a, 2012b; Reeves et al., 2012). These concerns were also published in the Cayman media (Cayman News Service, 2012c; Caymanian Compass, 2012a; IEye News, 2012b; Wallace, 2012b, 2012c; C. Wilson, 2012). It was argued that it is not possible to determine from documents publically available prior to the start of releases if obvious hazards of the particular GM mosquitoes in the Cayman islands (as well as in Malaysia and Brazil) have received expert examination and hence if the trials received a proper assessment (Reeves et al., 2012).

Therefore, although regulatory approval has been granted by the Department of Agriculture in the Cayman Islands, many commentators have deemed this approval inadequate due to the inadequacy of the risk assessment procedures (GeneWatch, 2012a, 2012b; Reeves et al., 2012).

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“Critics say that Oxitec, the British biotechnology company that developed the dengue- fighting mosquito, has rushed into field testing without sufficient review and public consultation, sometimes in countries with weak regulations”(Pollack, 2011)

“An environmental activist group is still raising concerns about numerous errors and omissions in the risk assessment process regarding a UK company’s research into the use of genetically modified (GM) mosquitoes” (Cayman News Service, 2012d)

“Aside from not correctly following the procedure for trans-boundary notification of shipments of GM mosquito eggs overseas the activists criticize the firm and the UK government over the failure to publicize risk assessments prior to open release trials. They say numerous important issues were not properly considered before millions of GM mosquitoes were released in to the environment in the Cayman Islands and Brazil” (Cayman News Service, 2012d)

“A group of independent scientists say that the release of genetically modified mosquitoes in the Cayman Islands, Malaysia and Brazil was not sufficiently transparent or properly regulated which risks undermining the research of what they say is promising technology” (Cayman News Service, 2012c)

In the absence of information about the adequacy of risk assessment for the trials as well as of regulatory approval procedures, it is difficult to conclude that the trials have received valid authorization, even from the official authorities. This deduction raises questions about the importance of appropriate site selection for GMM trials, where clear biosafety regulations and adequate processes are in place. In the following section I turn to the rest of community to examine its attitudes and reactions towards the trials.

2.2 Community Reactions Towards the Trials

It is obvious from the available media reports that no specific form of authorization was sought, or received, from the host community. In fact, although there were some limited attempts at communication, as described above, it is clear from the reports that there was no awareness of the trials or their rationale among the local community at the site of the release, or among other key stakeholders.

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“The release of the genetically modified mosquitoes in the Cayman Islands, where there are no biosafety laws or regulations, caught the international scientific community and most residents by surprise” (Cayman News Service, 2012a)

“With the previous release of the mosquitoes in the Cayman Islands, there was no public consultation taken on potential risks and informed consent was not given from locals”(IEye News, 2012c)

“CNS, this should be Headline! This experimentation was done without the public's consent!” (Reader Comment in Science/AAAS, 2010)

The news of the release caused a negative reaction both locally and internationally (Canadian Press, 2010; Cayman 27, 2010b; Cayman News Service, 2010c). The majority of the reports criticized the trials for both not announcing the trials as well as not receiving approval or consent. For example, the Natural News Network published an article that was taken up by 23,000 websites, including the Cayman News Online network, in which it calls the trials “irresponsible” for not informing the public, prompting “outrage”:

“The company recently released millions of these GM mosquitoes in the Cayman Islands to see what would happen -- and they did so without proper approval or announcement -- prompting outrage by experts and the public over the unknown consequences of conducting such an irresponsible experiment” (Huff, 2010)

The news coverage in the Caymanian media in turn stimulated a mass of negative readers’ comments. Shock and surprise, with resultant anxiety and anger, were the common themes. While supporting the scientific goals of the trial, one editor noted that for the public not to be informed and given a chance to understand and participate, is “criminal” and “careless” (IEye News, 2012a). Readers’ comments were reflective of lack of awareness, as well as discomfort and anger resulting from the news. The immediate community reaction to the news was anger for feeling deceived, abused, and taken advantage of (von Bredow, 2012).

“The Cayman's population has been duped” (Reader Comment in Canadian Press, 2010)

“Have a serious think about what has been done in our community, WITHOUT our input!” (Reader Comment in Cayman News Service, 2012a)

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“This is unbelievable! Who authorized this to happen in Cayman?” ( Reader Comment in Cayman News Service, 2012a)

“L Look at my face, AND TELL ME IF I’M PLEASED (Reader Comment in Cayman News Service, 2010b)

“Luke Alphey…[says] the trial was well-known within the island’s population of 50,000… Like hell it was! So far I can’t find ANYONE who was aware of this prior to it being picked up by the international press. And NO testing should have been taken place without a prior consultation period with the islands population (Reader Comment in Science/AAAS, 2010)

Referrals to being “guinea pigs”, or non-consenting subjects on which experimentation was done, were very common in readers’ comments:

“I wonder what other experiments they are doing without informing the public first! We are not guinea pigs (Reader Comment in Science/AAAS, 2010)

“I believe that we are the guinea pigs here” (Reader Comment in Cayman News Service, 2010c)

Moreover, notions of colonialism and abusive experimentation abound in the Caymanian media.

“The British scientific establishment is acting like the last bastion of colonialism, using an Overseas Territory as a private lab”(Cayman News Service, 2010c; Wallace, 2010).

“Eugenics, Global population control (i.e. decrease), Chemical extermination, Disastrously botched chemical experiments, Notions of 2nd class world citizens…Simple and ignorant / arrogant recklessness? Not sure why, but these are the thoughts running through my mind subsequent to reading the above news story” (Reader Comment in Cayman News Service, 2012a)

Anxiety and increased risk perception were also results of the news.

“Don't we get a say in what biological weapon gets released on the people. I'm outta here! Look on line how many people these same mosquitoes killed in Africa! They are

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not doing this to help us they are trying to reduce us!” (Reader Comment in Canadian Press, 2010)

“We have seen too many horrific movies about mutant bugs being let loose on unsuspecting humans in remote islands by evil biotech firms concerned with making huge profits from the experiment. They don’t care for the humans being exposed to these Frankenstein bugs they just want to see what happens”(IEye News, 2012b)

“I've had two of my relitives after getting bitten by mosiquito's have serious allergic reactions, one ended up in the emergancy room needing a shot to control their situation, I've never seen reactions like that to a misquito bite before, and I'm sure others have as well, I think there is more than been told with this case.” (Reader Comment in Cayman News Service, 2012d)

“This was the worst year since Ivan for mosquitos on North Side. They were bigger, more numerous and out at all times of the day” (Reader Comment in Cayman News Service, 2012a)

“Many of my friends and co-workers have been complaining about unusual mosquito’s bites-the bites would always becomes infected, very painful and upon healing would leave a scar.. Nobody ever had mosquito’s bites like that before” (Reader Comment in Cayman News Service, 2010c)

It is difficult to assess whether these perceptions about harms were a priori mindsets that would have surfaced regardless of the approach with the community or whether they were consequences of increased anxiety from the news of the trials. Nevertheless, these comments reflecting fear of the technology and its risks were limited to the initial phase of reactions towards the trials, and later on as I will explain later, comments became more balanced and more reflective of anger over the approach, and not the mosquitoes themselves, which might suggest that anxiety led to the increased risk perceptions and not the other way.

In an online poll conducted by the Caymanian Compass in December 2010 after the GMM releases made the news (Markoff, 2010), and to which 369 people responded, forty-two people (11.4%) said they were outraged by the release, Sixty-two people (16.8%) thought the potential

186 risks were greater than the potential rewards, while forty-six (12.5%) answered “I don’t know” to the question of whether they support the trials, as they didn’t have enough information to decide. Although the rest of the responders (219 people or 59.3%) were supportive of the releases, the majority of them (116 people) believe the government should have told the public more about the project before releasing the mosquitoes.

In summary, MRCU and Oxitec were criticized for not informing the public or even announcing the trials, for not receiving ‘informed consent’ or ‘public consent’, or other ‘proper approval’ or ‘agreement’ from the community, and for conducting the trials without the input of the locals. These elements added to my understanding of what constitutes community authorization for GMM trials as I will explain in more detail later.

3 On What Basis Were the Trials Conducted?

In the previous section, I argued that neither an adequate regulatory authorization nor any other form of authorization from the rest of the community have been granted to the trials according to both critics as well as community members and media in the Cayman Islands. Nevertheless, MRCU and Oxitec took the decision to conduct the releases based on their judgments that the trials have been sufficiently authorized. In this section I try to uncover the assumptions that could have motivated this decision. At the core of the disagreement on whether the trials were authorized, or not, lie different assumptions about what constitutes authorization, who can and should make such judgments, what constitutes and causes opposition, and the needed scope of community engagement. The categories covered in this section are not mutually exclusive but are interdependent as I will often explain below.

3.1 What is the Needed Scope of Engagement?

As explained previously, the trials researchers made a judgment that only authorities need to be engaged and consulted regarding the GMM trials. Consequently there was no effort to engage the rest of the community, and this was reflected in the amount of information provided before and after the trials, the attitude that the researchers have assumed towards the community, and the way they handled criticisms. As I will comment and explain later, it seems that the researchers aimed from the early beginning not to open any communication channels with the

187 community. In fact, there appeared to be a clear intention from the beginning not to announce the trials, or to disclose information about the use of GMM.

When the trials became news, Luke Alphey, Chief Scientific Officer of Oxitec at the time of the trials and currently Director, responded to criticisms of secrecy and lack of community engagement by saying

"we did lots of engagement work in Cayman, but no special effort either to spread the word internationally or not to" (Alphey from Nightingale, 2010).

On the scope of these engagement activities, Angela Harris, senior researcher at MRCU, told SciDev.net that there had been a newspaper article and public consultation within the Cayman Islands (Nightingale, 2010). In their published results, the trial researchers reported that

“information about the project was provided more broadly through the media and by personal contact and briefing. Project personnel were present on-site ~5 d per week to provide information and conduct operations. All equipment, vehicles and personnel were clearly marked; equipment and written material included MRCU contact information” (Harris et al., 2011).

Unfortunately, the article didn’t contain any details about the media reports and the kind of information disclosed to the community and to individual householders and whether community members were aware of the use of GMM or the rationale of the experiments undertaken in their homes or neighborhoods.

I could identify two activities only to inform the public about the trials. The first and only related announcement was the article in the Caymanian Compass newspaper, published on October 2nd, 2009, approximately 6 weeks prior to the release (Wilson, 2009). In this article, the Director of MRCU Dr. Bill Petrie told the Cay Compass that MRCU is considering the use of GMM, and that the decision has not been taken, which would be subject to budget concerns, logistics and priorities (Wilson, 2009). Dr. Petrie doesn’t mention trials or experiments in this article. The other related activity is the aforementioned video entitled “MRCU sterile mosquitoes” that was produced by the Cayman Islands Government Information Service (GIS) and put on the GIS website and on YouTube on October 4, 2010, one year after the releases had already been

188 conducted (GIS, 2010; MRCU, 2010b). The video does not mention that used mosquitoes were genetically modified as I previously mentioned. Moreover, this video was simply featured on the GIS website, without any effort to disseminate it to the community.

“It is true that the ‘spotlight’ public information video which was also released at the time did not explicitly state that the trial mosquitoes were genetically modified. This was an unintentional omission, as there has never been any attempt to hide this fact” (Oxitec, 2012c)

As it is quite unreasonable to simply ‘unintentionally’ overlook such an important detail as the use of GMM in the first ever open release trial of GMM, the only indication of this last statement is the intentional avoidance of any disclosure about the trials, not to mention that this video was posted on YouTube and the MRCU website after the trials were completed.

Apart from these two undertakings, and prior to the Oxitec Press release in November 2010 (Oxitec, 2010a), three referrals to the trials could be found internationally, all published after the trials were completed, and none directed to the Caymanian community, a notion I will return to later: 1) In a letter by the guest editor, Dr. Seshadri Vasan, who was a director at Oxitec, published in June 2010 in the Asia Pacific Journal of Biotechnology and Molecular Biology (Vasan, 2010) 2) In a note on the Malaria World network by Dr. Mark Benedict on October 11, 2010 congratulating Oxitec and MRCU for finishing the trials (Benedict, 2010) 3) In Oxitec’s newsletter and news updates on October 12, 2010 (Oxitec, 2010b, 2010c)

As mentioned previously and as I will explain shortly, communication avoidance was the theme, and the community was sensitive to this avoidance.

“Although there was some local notification in the district and a GIS TV programme was produced about the release the experiment remained very low profile with very little information about the project in the public domain” (Cayman News Service, 2012c)

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“In the Grand Cayman, public outreach about what was happening involved all of a five-minute spot that described the mosquitoes only as sterile (not GM), with no further opportunity for public discourse or discussion” (IEye News, 2012a)

“I think you have just answered the question of why no-one knew about the trial. No- one reads the Compass or GIS releases” (Reader Comment in Science/AAAS, 2010)

Such comments by community members and media reporters suggest that the undertakings by the project to inform and engage the community were not adequate, and were seen as mere checklists that could be used as alibis for external PR and marketing.

“Publishing some notice (that goes unnoticed) in the newspaper is not engaging, informing or consulting the public!!!” (Reader Comment in Canadian Press, 2010)

“The Cayman's population has been duped and kept in the dark and to the outside they are saying people agreed and offered no resistance. What a big fat lie! They simply published some news, that a tiny percentage of people would read without even understanding much of it, just to be able to say later "Ah, but we warned people!" What is this? Do they think we're stupid?” (Reader Comment in Canadian Press, 2010)

An interesting term in the latter statement is “to the outside”, but I will comment on this notion later on in this section.

Communication avoidance was also manifested in relegating responsibility in two ways. First, and unlike the proactive approach that was encountered in Mexico with regards to information provision and identifying the community’s concern, researchers in the Cayman Islands followed a passive approach where they put the onus on the community to initiative interactions.

“Alphey claimed that he spoke to people on Grand Cayman (he doesn’t say how many and whom) telling them what he was doing and the “Islanders didn’t even ask me about it. It’s not really for us to tell them what their concerns should be.” Wow. What an attitude and a complete lack of openness.” (Reader Comment in IEye News, 2012b)

“The pressure groups could have contacted Oxitec or our collaborators to find out any or all of the above items. One has to wonder why they chose not to do so, preferring

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instead to make up inferences and allegations when simple research and fact checking would have been so easy. We have extended such an offer privately following their previous spurious allegations and now repeat that – if in the future you are interested in portraying the situation accurately rather than issuing scare stories of your own imagination, please contact us with any concerns. Naturally, this offer extends to any member of the public, press or other organisation who has any concern or question regarding any aspect of our technology or its delivery.” (Luke Alphey in Hellen Wallace, 2012a)

It could be inferred from these two statements that there was a ‘natural’ expectation that others, whether “pressure groups” or community members, could and probably should have contacted the researchers for information. Oxitec is probably making a statement here that it was not their responsibility to initiate any communication, but at the same time making themselves accessible and responsive to others, who have this ‘natural’ right to enquire if they wish to know more. While this approach could be explained on the basis of precaution with a highly emotive and charged subject such as GM, it could not be justified in the absence of any communication with the community. In other words, one cannot expect the community to ask for information if they are not even aware of the trials.

On the other hand, these two statements were targeting the international scientific as well as the activist group communities on private forums, and not addressing the Caymanian community. “Naturally”, as Dr. Alphey mentioned, members of the community would have the right and option to also contact Oxitec for information, but the active invitation to communicate was sent “privately” to externals. Oxitec was in fact emphasizing the message that communication with the local community in the Cayman Islands was not in their ambit, as it was not their responsibility, but was MRCU’s responsibility. While I could not get information about the agreement between MRCU and Oxitec and hence on the responsibilities of each party towards the community, my conclusion could be confirmed in the following statements published on Oxitec’s website on April 18, 2012 to describe the trials community engagement endeavors:

“Luke Alphey, the chief scientist at Oxitec, said the company had left the review and community outreach to authorities in the host countries. “They know much better how to communicate with people in those communities than we do coming in from the U.K.” he

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said” (Pollack, 2011) “In the Cayman Islands, the Mosquito Research and Control Unit (MRCU) used its usual practice to communicate with people about the trial” (Oxitec, 2012a).

“The Mosquito Research and Control Unit (MRCU) used its standard practices to inform stakeholders” (Oxitec, 2012c).

“A release of any genetically modified mosquito should be preceded by years of careful groundwork... But little of that has been done in the trial in the Cayman Islands, Alphey says because the government didn't deem it necessary” (Enserink, 2010)

As a summary, Oxitec were changing their justifications gradually. First they started by claiming they have informed the community and conducted public consultation, then they moved into claiming that they made themselves available but no one in the community was interested in asking questions, and finally they defended themselves by stating that they left it up to the government to inform and engage the rest of the community, then ‘edited’ this claim by declaring that the government didn’t deem any engagement necessary. All of these incoherent and conflicting statements point to the fact that Oxitec, together with MRCU, made a strategic decision not to disclose any information, and conduct the trial ‘secretly’

“On the sidelines of a press conference in London today [Luke Alphey, Chief Scientific Officer of Oxitec] said that he had not wanted to publicize the trial until the results were known” (Nightingale, 2010)

When the trials made the news, Science magazine reported that “MRCU could not be reached for comment” (Enserink, 2010). Analysis of media news in the Cayman shows the director of MRCU, Dr. Bill Petrie, commented to the news only twice. The first time was in November 2011 (Cayman 27, 2010a; Cayman News Service, 2010b), and the second was in January 2012 to respond to NGOs accusations and assure the community that the GM mosquitoes did not reproduce (Cayman News Service, 2012b; Caymanian Compass, 2012a; S. Wilson, 2012). In both cases, MRCU did not respond to concerns of secrecy, lack of transparency, or lack of engagement.

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Oxitec’s position with regards to MRCU’s responsibility of communication with the community was actually in sync with the community’s expectations. While community members and media reporters criticized ‘researchers’ or the ‘company’ for not exercising their due diligence with regards to community informing and engaging, when expressing their opinions on who ‘should’ be responsible, and who “should” protect them, all gathered opinions were obviously pointing to the government.

“This is the first time I am hearing this and one would think that the government would have respected the populace of this country enough to at least make an official announcement”(Reader Comment in Canadian Press, 2010)

“The government really should be more forthcoming about such things” (Reader Comment in Markoff, 2010)

“Point blank - the Government should have told the public before doing it” (Reader Comment in Markoff, 2010)

“CAYMANIANS WE HAVE BEEN SOLD?” (Reader Comment in Cayman News Service, 2010c)

“Yes no secret after the event, but somehow I think that’s the point we're all trying to get across… Why are our leaders completely unaware or oblivious to the relevant international regulations” (Reader Comment in Science/AAAS, 2010)

Regardless of what community members think of the government itself, governmental agencies are entrusted and expected to look after the community. Oxitec’s responsibility however was to ensure that their local partners have the capacity to engage with people around issues related to the GMM, an important ESC requirement in GMM trials site selection considerations (Lavery et al., 2008).

I summarize this section in Table 12.1, where I include all the insights from this case study about the needed scope of community engagement in GMM trials.

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Table 12.1: Needed Scope of Engagement from the Community’s Perspectives

3.2 What Constitutes Authorization and Who Should Be Involved?

In responses to condemnations for conducting the trials without proper authorization from the affected community in the Cayman Islands, Oxitec often responded by insisting that they had sufficient authorization from the regulatory bodies in the country.

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“It is the sovereign right of Governments to decide on their own regulatory requirements for any new technology. Our aim is not to avoid regulation, but to take our solution to countries which have a real problem” (Oxitec, 2012b)

“The institutions who determine the acceptability of any new public health technology are that nation’s regulators. By causing unfounded anxiety outside of the regulatory process, inexpert commentators risk consigning more than 50 million people to “breakbone” flu. Oxitec is committed to full transparency in this process. This means sharing all research with these experts who are in a position where they regularly evaluate risk-benefit relationships”(Parry, 2012)

Four judgments are embedded in these statements. First, authorization belongs only to the realm of official institutions. Second, regulators represent the only ‘legitimate’ expertise that is entitled to be informed and engaged. Accordingly, Oxitec had an obligation of transparency only to these regulators. And fourth, by considering that anxiety was “unfounded”, Oxitec delegitimized community concerns and criticisms. In other words, since the researchers considered that decision making is the domain of official leadership only, they established that they have done their due diligence. The implication of this judgment is that members of the community do not need to know about the trials or participate in decisions because it’s not up to them but up to the government. Another implication is looking at the need for the community’s participation in legal terms that are determined by the government.

For instance, in a Freedom of Information request to the MRCU to release information about the trial, the institution justifies its practices by stating that there is no law mandating public consultation, and that obligations of consultation are solely those towards official departments:

“Do the MRCU have to have public consultation before releasing GM mosquitoes into the environment? There is no law in Cayman that mandates MRCU will have to hold public consultation before releasing GM mosquitoes... Given the lack of legislation in Cayman concerning the release of Genetically Modified Organisms MRCU is consulting with Oxitec, the Department of Environment and the Department of Agriculture to ensure that all concerns relating to the release of these mosquitoes are addressed.” (MRCU, 2010a)

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On the other hand, and as shown before in statements by media reporters and readers, the community considered that they also had the right as stakeholders to share and participate in decision-making, and called for ‘public consultation’ and “public consent”.

“This news only highlights the need for all the company’s data on its mosquitoes to be made public so people and local governments can make informed decisions as to whether or not they want GM mosquitoes in their communities” [emphasis added] (Cayman News Service, 2012a)

“Well, this article caught me by surprise. I earned my degree in Genetics from a major research university in the States and am quite familiar with various means of genetic modification as well as the pitfalls each measure has. I would have been very interested in providing some informed input - no fear-mongering but no undue adulation - but never heard a single call for public consultation” (Reader Comment in Science/AAAS, 2010)

Moreover, insights about the judgments of researchers about what “consent” from community members should look like, can be inferred from the following excerpt stated in in their published results about the trials, where they claimed that

“permission was sought from individual householders before project activity on their property, for example, placement and servicing of BG-Sentinel traps. All such requests (100%) received a positive response and no negative comments regarding project operations were received” (Harris et al., 2011).

Accordingly, if any forms of consent were needed from the local population, then it would be the one for conducting research activities in their homes such as placing traps. Hence, if not directly involved as participants in the research activities (Chapter 3), then there is no need to be involved. However, even the validity of this consent is contested by the community, for not being informed and satisfying the conditions of informed consent as agreed upon in scientific and bioethical arenas.

“The impression from the above [article by Harris et al] (and from subsequent statements from Oxitec personnel) is that every individual householder was fully conversant with the reasons for the placement and servicing of BG-Sentinel traps and

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100% of the people contacted said “Yes”. I can inform you that this was not the case. I was one of the householders whose permission was sought to have a BG-Sintinel trap placed on my property and also on another. I said, “Yes,” to both and it was to two different teams of MRCU personnel during the same week. I was never told it was part of an experiment [for] the release of the GM mosquitoes by either team” (Wilson, 2012)

The local community in fact regards ‘consent’ and ‘authorization’ as something different as previously mentioned.

“This is no way of conducting science! This is a total lack of respect for human rights! No matter how safe the researchers think this is, the people who are being the guinea pigs (unwillingly) have the right to say yes or no! This should be taken to the highest international instances so it doesn't happen again and then is presented as a good example instead of a big crime!” (Reader Comment in Canadian Press, 2010)

“These are significant developments with significant implications, and to not have the opportunity to be involved, have influence on, or understand what is going on prior to setting such action in motion is criminal” (Reader Comment in IEye News, 2012a)

The final related conclusion I have made with regards to what constituted authorization in this setting according to different stakeholders is related to the meaning of opposition. In a previously mentioned quote by Harris et al (Harris et al., 2011), and in other instances too, the researchers considered the lack of opposition from the community as an indication for the validity of the authorization they have for the trials. While lack of opposition and resistance is essential for authorization as I argued in Part II of this thesis, the interpretation of this concept is contingent on the conditions surrounding the events, as expressed by community members:

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“From the article... “In the Cayman Islands, officials said they worked closely with the local community and encountered surprisingly little resistance". Perhaps because we did not know about it” (Reader Comment in Canadian Press, 2010)

“Surely we should have been consulted with to determine if there was any resistance” (Reader Comment in Canadian Press, 2010)

“When reading the article in full this part surprised me: "In the Cayman Islands, officials said they worked closely with the local community and encountered surprisingly little resistance". Personally, I've heard surprisingly little about the project, and if the same can be said for everyone else, then I'm not surprised they encountered little resistance! Has anybody else heard about these experiments prior to reading this news report?” (Reader Comment in Canadian Press, 2010)

In summary, it became obvious that there was a mismatch between the community and the researchers’ judgments about what constitutes authorization and who can and should be involved in its processes. While researchers considered that sufficient authorization is having regulatory approval, informed consent for research activities, and lack of opposition, the community contested the validity of these three elements, and considered that conditions of information provision, transparency, and consultation, need to be met before these aspects of authorization could be considered valid. At the same time, they considered that other endeavors should also be part of the authorization formula. Table 12.2 summarizes the judgments of the researchers and the community members regarding what constitutes authorization.

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Table 12.2: The Meanings of Authorization from Different Perspectives

4 What Assumptions Influenced These Judgments?

In order to understand the researchers’ judgments about community authorization and in turn influence them, it is essential to understand the assumptions that influenced these judgments. Although it is difficult to make inferences about researchers’ guiding assumptions without conducting any interviews with them, some statements collected from the media are suggestive.

For instance, data examination suggests that the belief that community members do not need to be engaged and it is up to the authorities alone to decide, could be motivated by an assumption that individuals and groups have agendas, are easily influenced by activist groups, and will oppose GM technology no matter what information is presented to them. This conclusion is suggested by the frequent use of terms such as “skeptics” (Luke Alphey, Oxitec CSO in Hellen

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Wallace, 2012a), “scare the public” (Luke Alphey in Hellen Wallace, 2012a), “Unfounded anxiety” (Parry, 2012; Hadyn Parry, Oxitec CEO in Wallace, 2012a), and “scaremongering” (Luke Alphey and Hadyn Parry in Hellen Wallace, 2012a)

““These are people with an agenda and it’s scare mongering” Bill Petrie said” (Wilson, 2012)

The ‘demonization’ of the interest groups and consequently the public led to blocking all communication channels, as I explained before.

An explanation for these assumptions could be the belief that uneducated and “inexpert” individuals do not have the capability to understand or participate in scientific discourse. This is suggested by the use of terms such as “poorly researched” (Luke Alphey in Hellen Wallace, 2012a) and “inexpert commentators” in referring to the reasons behind “unfounded anxiety” (Parry, 2012). Community members understood it this way, and took the lack of engagement as a message that they are considered “stupid” and “unlearned”

“I have a horrible feeling that this is why we were all kept in the dark. There would have been an instant cry of “No” because we are not educated enough to understand that the risk is zero” (Reader Comment in IEye News, 2012b)

“Are we considered so dim-witted and unlearned that we cannot participate in our own environment? Were we considered to be a calculated risk?” (Reader Comment in Cayman News Service, 2010c)

On the other hand, community members expressed that their opposition to the trials is not against the technology per se, but because of the approach that the trial researchers have followed. As previously mentioned, the exaggerated fear or risks was only encountered at the outset when the trials made the news.

“Oxitec’s careless and unilateral activity endangers not only our ecosystems but also the incredible advances made in this area to mitigate a deadly disease” (IEye News, 2012a)

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“I think you will probably find that most of the opposition to this 'trial' is that Cayman is being used as a petri dish with very little information, and certainly no consultation” (Science/AAAS, 2010)

In fact, it is noteworthy that around 60% of the respondents to the aforementioned online poll by the Cayman Compass (Markoff, 2010) support the government’s announced release of genetically modified mosquitoes on Grand Cayman, but more than 50 percent of those “believe the government should have told the public more about the project before releasing the mosquitoes (Markoff, 2010). These conclusions were mirrored in readers’ comments on different media reports about the trials.

“Even if I had been told everything about the project I would still have given my permission. There is the problem. The lack of transparency” (Reader Comment in Wilson, 2012)

“Yes, I’m mad as hell. I understand [however] the good intentions behind the experiments – people all over the world die in horrific numbers from insect-born disease” (Reader Comment in Cayman News Service, 2012b)

Moreover, many media reporters and editors commented on the scientific and risk assessment aspects of the study, showing that they can in fact engage in scientific and objective discourse about the trials.

“Whilst I have no doubt we were at minimum risk and the experiment will probably result in dengue fever being brought under control, Luke Alphey, a genetic engineer, who dreamed up the idea of the novel insects while he was at Oxford, admits his technique isn’t perfect yet, and GM females may therefore also be released accidentally. And we have to take him at his word that the larva-killing protein definitely can’t be injected into the human blood stream. Unfortunately, like so much else, he can offer not peer- reviewed scientific proof” (IEye News, 2012b)

Finally, these statements suggest that the community’s opposition was not an a priori state but a consequence, and that permission is conditional on being effectively engaged.

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5 Summary

In this chapter, I presented a case study investigating the first open and successful GMM release trial from the Cayman Islands. By overviewing the different judgments on authorization for this trial, I explored the perspectives of the community as well as the researchers on what constitutes community engagement as well as community authorization.

In this chapter I showed that there were concerns both locally and internationally about the adequacy of the risk assessment and the regulatory appraisal, and therefore about the legitimacy of the regulatory approval. Moreover, I showed that it is obvious from the available media that no specific form of authorization was sought or received from the host community. In fact, there was no awareness of the trials among the local community at the site of the release, or any other community in the Cayman Islands. Consequently, the community felt disrespected and taken advantage of.

The key messages that could be derived from this case study are the following:

1) Different constituents of the community and not only official authorities are entitled to be involved in the governance of research that might affect them

2) The adequacy and legitimacy of regulatory approval and even individual informed consent are contingent on the inclusion of different factions of the community in participatory discourses to determine the relevance and acceptability of the research.

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CHAPTER 13 The Release of Genetically Modified Mosquitoes in Malaysia: A Bumpy Journey

“Malaysia does not belong to those in government alone - my home is not your lab. I have title rights to the square feet that I own and is protected by the Constitution of Malaysia. Before anything so major; risks so unknown; the citizens' consent must be sought --otherwise it is trespassing on my property when the government release any foreign element -- living or otherwise into my home ground” (Alor Gajah Residents, 2010)

In this chapter I present the case study I conducted on the GMM trials that were carried out in Malaysia between 2006 and 2011, by Oxitec and the Malaysian Institute of Medical Research. Despite efforts from the government and the research institute to engage the public, the trials were still criticized by local members of the community as well as international organizations. This case study provided rich insights about community engagement as well as community authorization. I start this chapter by providing an overview of the context of the trial, including the regulatory system. Then I present the authorization related judgments that the trials passed through at all levels of the community, to move to portray the public opposition that the trials encountered. In the last part of this chapter, I analyze all of these judgments to draw implications for our understandings of community engagement and community authorization.

1 Context

Southeast Asia has the highest dengue incidence of all regions of the world, and cycles of epidemics have affected the region since the 1950s, with increasing magnitude (Ooi & Gubler, 2009; Poovaneswari, 1993). Dengue illness has been among the most important public health problems in Malaysia (Holmes, Tio, Perera, Muhi, & Cardosa, 2009) ever since its first reported case in 1902 (Skae, 1902). The annual number of Dengue cases has been rising since the 1980s

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(Lam, 1993). According to the 2008 Health Facts by the Malaysian Ministry of Health, the incidence rate of dengue was 167.76 per 100,000 population with a mortality rate of 0.02 per 1,000 (MOH MALAYSIA, 2008). In a recent study, a high dengue IgG seropositivity (91.60%) was found in the population, which was seen as an indication that dengue might be endemic in Malaysia for a long time into the future (Muhammad Azami et al, 2011). Moreover, the economic burden of dengue illness in Malaysia has been estimated at US$56 million per year, approximately US$2.03 per capita, and is thought to be even higher if the costs associated with prevention and with the consequences of dengue were included (Shepard et al., 2012).

1.1 GMM Trials in Malaysia

On the 20th of December 2006, the Government of Malaysia, represented by the Ministry of Natural Resources and Environment (MNRE) and Oxitec signed a Joint Initiative Agreement to undertake an evaluation of Oxitec’s RIDL technology in Malaysia through open field release trials. This agreement constituted the first manifestation of approval for the trials by the government. Oxitec developed a genetically modified Aedes aegypti strain (labeled OX513A) with RIDL technology, that they claimed was sterile. When male OX513A mate with local wild type females, the offspring cannot survive into adulthood, leading to a reduction in the overall A. aegypti population, and supposedly Dengue infection cases. By the end of 2006, OX513A A. aegypti mosquitoes were transferred to Malaysia from Oxitec laboratories in the UK for independent evaluation by the Institute of Medical Research Malaysia (IMR). IMR stated on their website that if the “OX513A is successful in eliminating local populations, then there would be a dramatic reduction in the number of dengue cases and deaths in Malaysia, to the great benefit of not just Malaysia, but other countries that are fighting this same scourge. The technology is not seen as a standalone solution but as part of Integrated Vector Management (IVM), as recommended by the World Health Organisation (WHO)” (IMR, 2013).

The evaluation was planned to be conducted in three phases: laboratory studies, contained field trials, and open field releases (IMR, 2013). In April 2008, the New Straits Times reported that IMR and Oxitec were planning to conduct an open release field trial by the end of 2008 or early 2009, following the success of confined field trials, where “millions of the GM warrior” (Selvarani, 2008) mosquitoes would be released into the fishing village of Pulau Ketam (Selvarani, 2008). The news generated an immediate wave of opposition by environmentalist

204 groups (AFP, 2008; Cyranoski, 2008; MalaysiaKini, 2008; NST, 2008). The ministry of health responded to community concerns by reassuring the public that the GMM release is pending clearance and hence the decision hasn’t been taken.

“Such a release will never be carried out without the proper clearance of the relevant authorities …The ministry would consider the views of residents near Pulau Ketam” (Cyranoski, 2008; Othman, 2008)

In September 2010, the Inter Press Service News Agency reported that IMR had a plan to release the GMM in Pulau Ketam in December 2009, but the plan was aborted because of “strong opposition from the 30,000 islanders, mostly fishers” (Kuppusamy, 2010).

““We strongly oppose this experiment,” said villager Liew Kam in a letter to the Health Ministry in October 2009. “This experiment could expose us and our children to bigger risks.” Liew complained that the islanders were not informed of field trials beforehand, much less consulted about their participation in them”” (Kuppusamy, 2010)

These trials followed successful completion of laboratory studies (Bargielowski, Alphey, & Koella, 2011) and semi-contained field trials (Lee et al., 2013). The releases were planned to involve three experiments: a) Mark-Release-Recapture trials (MRR) in uninhabited area in Bentong (Completed), b) MRR in inhabited area (to be conducted in Alor Gajah, Melaka once all regulatory requirements met), c) Suppression Trial (Currently undergoing institutional review by IMR) (IMR, 2013). At the time of writing this thesis (June 2014), only the MMR in Bentong was conducted, and is the focus of this case study.

The MMR is a field experiment conducted to assess the dispersal and survival of released OX513A males, and to compare these variables to those of an unmodified wild type laboratory comparator strain. Initially, the MRR was scheduled to occur on December 15, 2010, but the ministry announced that the trials were postponed until a later undisclosed time. The actual open release of 6000 male OX513A took place on December 21, 2010, but was announced by the government in January 2011. The release site is located in Hutan Tanah Kerajaan (Bukan Hutan Simpanan or non-reserved government forested land), an uninhabited area on the side of a hill comprising a jungle area (government land), a cleared area and a young rubber plantation on a

205 private land off the highway known as ‘‘Lebuhraya Bentong-Raub’’ (Figures 13.1 and 13.2), in the Bentong district, state of Pahang (IMR, 2013; Lacroix et al., 2012).

The release was conducted in the presence of representatives from an independent monitor (Akademi Sains Malaysia), which is also a governmental agency, and from the Ministry of Natural Resources and Environment (MNRE), to ensure compliance with the terms and conditions associated with the approval from the National Biosafety Board (NBB) at the MNRE. The release experiment was completed on the 5th of January of 2011 and the area treated twice with insecticide (fogged), as stipulated by the NBB (IMR, 2013). The details of the experiment and the chronology of all experimental undertakings are featured on the IMR website (IMR, 2013). Lacroix et al (2012) described the trials, and concluded that the field release was safely and successfully conducted, whereby the engineered strain showed similar field longevity (survival) but reduced dispersal relative to an unmodified counterpart. Nonetheless, they stressed the importance of repeating the trials in urban inhabited environments that are more typical for A. aegypti, where wild females would be present. Effectiveness of the GMM in suppressing local target mosquito population was not assessed in Malaysia.

Bentong is both a town and a district in Pahang. The district covers an area of 1,831 km² and is located 80 km northeast of Kuala Lumpur, while the town of Bentong is 47 km away from the capital. The population of the district is around 104,000, while the town has a population of around 49,000. Bentong is administered by Bentong Municipal Council and is one of the fastest growing towns in Pahang (Municipal Council of Benton, n.d.)

In this chapter I will refer to the city of Bentong as the micro community (host community) and use macro community to refer to the national Malaysian context. The definitions are parallel to the ones I used in Chapter 7.

Figure 13.1: Bentong, Pahang, Malaysia 206

Figure 13.2: Release site in Bentong (Lacroix et al., 2012)

1.2 Regulatory System in Malaysia

Malaysia is signatory and party to the Cartagena Protocol. The Biosafety Act of 2007 (NBB, 2007), put into force on the first of December of 2009, is drafted to be in line with the National Biological Diversity Policy (1998) and the National Biotechnology Policy (2005). The Biosafety (Approval and Notifications) Regulations entered into force in November 2010 (Malaysia Biosafety Clearning House, n.d.) As a requirement for the trials under study, and with technical support by Oxitec, the National Biosafety Board (NBB) and the Genetic Modification Advisory Committee (GMAC) were established in 2010 by the Ministry of Natural Resources and Environment Malaysia (MNRE), under the Biosafety Act. The NBB was formed in March 2010 to function as a regulatory body for making decisions related to the importation, exportation, contained use, and release of any Living Modified Organisms or LMOs (NBB, n.d.). The Chairman of the Board is the Secretary General of the Ministry of the MNRE and its members are representatives from six other relevant ministries and four other persons with knowledge and experience in disciplines or matters relevant to the 2007 Act (Idris, 2013). In May 2010, the Genetic Modification Advisory Committee (GMAC) was formed to provide scientific, technical and other relevant advice to MNRE and NBB. GMAC consists of experts mostly from relevant governmental agencies and research institutes, in addition to experts from universities and the private sector (GMAC, n.d.) Figure 13.3 illustrates the approval process for GMO release applications submitted to the NBB.

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Figure 13.3: Regulatory Approval Process for GMO Release (IBC: Institutional biosafety committee) – Retrieved from the NBB website (NBB, n.d.)

Section 35 of the Biosafety Act 2007 stipulates that decisions by the Minister or the Board on GMO applications may be based on socio-economic considerations, including economic impacts, social and cultural issues and ethical considerations (Letchumanan and Johnny, 2012). However, it is unclear to which extent these considerations are accounted for, as the word “may” in these provisions implies that it is the discretionary power of the Board or the Minister whether or not to take these aspects into consideration in assessing any GM application (Idris, 2013). Idris (2013) argues that the board usually makes decisions based on the recommendations of the GMAC, who normally base their decisions purely on scientific considerations. Moreover, while section 14 of the mandates public participation and consultation in the NBB decisions making processes, in accordance with Article 23 of the CPB, and section 60 calls for public disclosure, section 59 leaves these opportunities to the discretion of the Director-General of Biosafety and gives priority to business confidentiality. The act also does not specify how to conduct public participation and consultation, stating only that it should be done “in such manner as the Board thinks fit” (Idris, 2013; Idris et al. 2013). The act requires applicants to receive prior consent from the relevant state government before NBB approval is granted for undertaking any open field release of LMO.

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The GMM trial under study was opened for public consultation from the 5th of August to the 4th of September 2010. The Boardon GMO applications claimed that in reviewing the application, they received valuable feedback through the public consultation exercise (NRE 2010a, b, c, d). However, until now, many have criticized the information dissemination processes and lack of disclosure, as well as the satisfactory public consultation and lack of engagement, as I will explain in this chapter.

2 Authorization Processes

IMR and Oxitec researchers stated that they had received support and positive feedback for the trials (Lacroix et al., 2012). In this section I will review the different authorization processes that the project had passed through at different levels of the community before the release was conducted, while also describing how community members and groups at these levels were engaged in matters related to the trials. In the first part of this section I provide anoverview of theapproval decisions by official authorities at both macro and micro community levels, which include respectively the regulatory approval and the local authorities consent for the trials. In the second part, I examine how the rest of the sub-communities were engaged in the approval processes at both the macro and micro levels, which included civil society and scientific groups, political groups, and lay members of the public. In the following section, Section 3, I report on the actions and reactions that constituted the public opposition towards the trials.

2.1 Official Authorities

2.1.1 Macro Level: Regulatory Approval

As previously mentioned, the agreement between MNRE, IMR, and Oxitec constituted the first formal approval for the research trials by governmental agencies. However, and as I will explain later, both IMR and Oxitec were publicly involved in the trials, and it wasn’t fully clear who was the entity responsible for engaging the community and seeking their approval. In other words, IMR did not fully become the engager, as CRISP had become in Mexico (Chapter 8).

On October 5, 2010, the National Biosafety Board (NBB) approved the application from the Institute of Medical Research (IMR) to release OX513A mosquitoes in Bentong, state of Pahang,

209 and Alor Gajah, state of Malacca. The NBB made the decision with all associated terms and conditions (NBB REF NO: NRE(S)609-2/1/3) publically available on its website, along with a fact sheet about the project, but not the application itself (NBB, 2010a, 2010b). The permit decision did not specify the factors taken into consideration for the decision, and the risk assessment report by the Malaysian Genetic Advisory Committee (GMAC, 2010) lacked the full risk assessment matrix that they have used to identify the potential hazards they considered. Some commentators considered that this shortcoming weakened the scientific value of the document and undermined its ability to transparently demonstrate what hazards received attention and consideration (Reeves et al., 2012).

“We are concerned that there might be an oversight in the application for the release of GM mosquitoes in Malaysia. However, as the public does not have access to the application dossier, it is impossible to assess whether all issues have been adequately and satisfactorily addressed by the applicant” (Idris, 2010c)

The NBB decision followed a 30 day period of public consultation (NBB, 2010a), as I will elaborate later. The decision stated that “concerns raised by the public were addressed and taken into consideration when making the decision”. However, some commentators found that it is not possible to confirm this statement in the absence of full disclosure about the decision-making process, nor to determine whether public concerns have received adequate expert consideration (Reeves et al., 2012). Idris, president of the Consumers Association of Penang, argued that scientific considerations have been the primary focus of the NBB (Idris, 2013), and Mohana (2013) stated that the Board admitted that in reviewing the application, bioethical issues have never been a priority.

“We failed to receive any response from the department and thus we do not know whether the issues raised by us have been adequately addressed” (Idris, 2010c)

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Figure 13.4. Genetically modified mosquitoes: from laboratory to field. Flowchart showing a summary of the biosafety regulatory process, public engagement and approximate time frame before the deliberate release of sterile male genetically modified Aedes aegypti mosquitoes in a limited MRR field experiment. (Subramaniam et al., 2012)

The NBB decision was conditional, as it stipulated that a consent letter should be received from the local council where the trials are and that the local community had to be engaged and informed about the project and consequently their approval had to be secured before the trials could be conducted (NBB, 2010a;,NBB, 2010b). I will analyze these requirements in a later section. Also, since some mosquito traps were to be placed aon private land adjacent to the trial location, IMR was also required to provide the written consent from the landowner (IMR, 2013). The field trial was also reviewed by the National Medical Research Ethics Committee.

2.1.2 Micro Level: Bentong Council

IMR and Oxitec researchers reported that permission for the trials was obtained from Pahang state, as well as from local councils and community leaders (Lacroix et al., 2012), but details

211 given about these decisions were scant (Subramaniam et al, 2012). On its website (IMR, 2013), IMR mentioned that they have conducted a briefing session for the Bentong Municipal council on November 1st, 2010, with information presented by both IMR and Oxitec representatives and in the presence of MNRE representatives, again suggesting that IMR was not taking full ownership of the project.

“Representatives from Bentong Municipal Council stressed that they supported the project. However, they proposed that all of the stakeholders in Bentong (Bentong Health Office, Bentong District and Land Office and Bentong Police Department) should be invited to meet and discuss the implementation of the project” (IMR, 2013)

A second briefing session was conducted at the Bentong Municipal Council office on November 10th, 2010 in the presence of other government departments including Bentong Health Office and Bentong Land and District Office. The Star newspaper reported that, according to an officer in the Bentong Municipal Council, the council had given the approval for the trial with a consent letter (Chin, 2010).

“All stakeholders and chairman agreed to give their cooperation to IMR by giving all the necessary support letters in order to fulfill the terms and conditions required by NBB …. The Chairman agreed and the support letter was faxed to IMR” (IMR, 2013)

IMR also reported that they have “briefed” the representative of the claimed “independent monitor” Akademi Sains Malaysia, which is in reality another governmental agency, on November 16th, 2010, and the Pahang State executive council on December 1st 2010.

As was the case in Mexico, formal approval was granted by those who have stewardship dutiesthree decision making levels: The highest authorities in the macro community, or the relevant federal regulatory agencies, the highest authorities in the micro communities, or the Bentong Municipal Council, and the owner of the land where experiments were conducted. “Support and cooperation” (IMR, 2013) were needed from the rest of stakeholders, including those at the state (meso) level, who were just “briefed” (IMR, 2013). Moreover, formal approval by the local council was not dependent on approval by the rest of the community.

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2.2 The Public

In what I have presented so far, decision-making and approval for the trials were limited to institutions with official status. In this part, I examine how the rest of the community, those without any official authority, or the public, were engaged in the trials and whether their approval was sought for the trials. Here, I use the term ‘public’ to refer to the sub-communities of the general population, which include civil society and non-governmental organizations, political groups, scientific groups, and other individuals who do not have any official authority. Macro public refers to the general population at the macro community level, while micro public would refer to those groups and individuals in the local micro community level.

Before publicly announcing the trials in August 2010, engagement was limited to local scientists from IMR and regulatory agencies, and was centered around risk assessment and risk communication. Between 2007 and 2008, Oxitec and the WHO Collaborating Centre for Vectors based at the Institute for Medical Research (IMR) in Malaysia conducted three workshops on risk assessment of GM mosquitoes attended by delegates from Oxitec and the IMR and international experts. The third workshop was also attended by participants from local universities, research institutes and government agencies (Oxitec, 2007, 2008, Pillai, 2009). A fourth workshop on Risk Communication for Transgenic Insects was held in March 2010, led by Oxitec’s Chief Executive Officer in Malaysia Seshadri Vasan (Beech, 2010; Tropika, 2010).

While these activities could be seen to have “helped build the capacity of scientists and regulators in risk assessment and management to facilitate decision making process under the Biosafety Act” (Beech, 2010), international NGOs criticized Oxitec for unduly influencing the discussions around risk assessment and the design of the regulatory approval process through its role in leading those workshops (GeneWatch, 2010; GeneWatch et al., 2012). Moreover, as mentioned chapter above, Oxitec seemed to have been the main player on the ground in these trials, and IMR did not appear to have fully taken charge as the leading institution.

The first allusion to public participation in authorization for the trials was encountered in the MNRE regulatory approval processes. On the 5th of August 2010, the NBB posted the project fact sheet on its website (NBB, 2010a) and called in this announcement on members of the public to submit their comments within a period of 30 days (until September 4, 2010)

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“Any member of the public may submit their comments or queries on a publicly notified information about the application… The submission of the comments or queries should be prepared carefully as it will be given the same scrutiny as the application by the NBB… Even if the submission is not science-based, and focuses on cultural or other values, it should still be developed in the form of a well-founded argument” (NBB, 2010a).

On the 15th and 19th of August of 2010, MNRE issued public announcements about the trials in two newspapers, Berita Harian (In Bahasa Malay) and The New Strait Times (in English). The public announcement message was also simultaneously uploaded onto the Biosafety Department's website (IMR, 2013). In this announcement, the ministry called for feedback and “submissions of opinions/comments from the public regarding the application”.

On August 23, 2010, due to low response to the online call for comments, the Biosafety Department invited nine Non-Governmental Organizations to provide their comments on the proposed GMM trials, and gave them only 30 days to provide their feedback, without providing any information about it other than the announcement itself.

In the absence of prior publicity and prior engagement of the community, and consequently opportunities for communal discourse, it could be argued that it is not expected to receive meaningful feedback about the application process, especially that which takes into consideration collective opinions, including those related to the social and cultural implications of the trials. Questions arise at this stage as to whether it was the responsibility of the NBB as a regulating body to inform and engage the public in the trials project or if it was the responsibility of IMR as the research institution executing the project to inform, educate, and prepare the community at an earlier stage to make informed arguments and decisions about the trials.

The NBB’s efforts to include even nominally the opinions of the public were commended as progressive by many organizations as I will illustrate later in this chapter, even though these efforts were seen by many to be unauthentic, and as deceiving “window-dressing”. After the thirty-day period, the biosafety department reported that they have had analyzed the issues raised, but did not explain how this feedback had been used in the decision-making process. Some commentators even doubted that this feedback had been used at all (Reeves et al., 2012; Idris, 2013) as I mentioned previously. In IMR and Oxitec researchers’ letter about the trials’

214 public engagement activities, Subramaniam et al. reported that thirty two responses were received by NBB during the one-month consultation period, and that these responses were divided into four categories: information seeking, neutral, rejection of the trials, and support and positive response (Subramaniam et al., 2012). They did not however report how many responses fell in each of the categories and how these responses affected the approval decision. On October 29th, 2010, MNRE organized a Question and Answer session with the media about the NBB decision and the proposed trials, and 21 members of the media registered at this event (NBB, 2010c). Again, MNRE targeted a specific community group whose positions can impact the public opinion. Moreover, there wasn’t a clear separation of responsibilities with the regards to the community between MNRE (NBB), IMR, and Oxitec.

The NBB decision mandated that IMR had to engage the micro public, or local residents, in awareness activities and to obtain their approval before conducting the GMM release. This requirement implies that the micro public’s approval is distinct from the feedback that the NBB had received from the macro public in response to the trials application. An extension of this finding implies that community authorization is distinct from but could include community consultation. It also emphasizes that the community has different levels, and that feedback and approval is needed from all of these levels.

“Residents from the field trial site will be engaged in Public awareness activities and information about the field trial will be made available… A consent letter should be provided from the Local Council for the district/s where the release sites are located for the proposed MRR field trial… It is mandatory that the applicant through a public forum obtains prior consensus and approval from the inhabitants in the release sites regarding the proposed MRR field trial” (NBB, 2010a, 2010b) As such, MNRE’s regulatory approval stipulated what should constitute community authorization from the government’s perspective. This account of community authorization included two aspects that were both limited to the micro community. The first aspect is specific and concrete as it refers to formal approval manifested in a decision, a consent letter obtained from official authorities in the micro community, outlining the permission for researchers to conduct their trials in the location under the authority’s jurisdiction. This notion was also encountered in Mexico, where the ejido assembly granted CRISP its permission to conduct the GMM trials in Río Florido (Chapter 9). The second aspect refers to “consensus and approval”

215 from local inhabitants in the trial site. Although this requirement treated approval as a procedural and formal endeavor that could be accomplished in a meeting or a forum, it is less specific on the definitions of consensus and the mechanisms of consensus building, and leaves it as a general undefined concept.

However, what the decision clearly states is that approval from the local residents is needed in addition to the consent of local councils, and by creating a distinction in terminology between consent on one hand and approval and consensus on the other hand, the statement implies that approval is not equivalent or limited to consent, as I have previously argued. The decision also mandates that seeking local residents’ approval should be preceded by information provision as well as community engagement in awareness activities. The distinction between these two endeavors could also suggest that community engagement is not limited to information provision, as experienced in Mexico (Chapter 9).

Figure 13.5: Community Authorization from the Regulators’ Perspectives

On the other hand, in their scientific report about the release, Lacroix et al. stated in the section about community engagement and approval that MNRE asked IMR to

“obtain permission from local government authorities, and to display large multi-lingual posters in the uninhabited trial site for at least two weeks prior to the date of release. These conditions were met by IMR to the satisfaction of NRE inspectors at the trial site located in an uninhabited area in Bentong district” (Lacroix et al., 2012)

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In other words, the trial researchers seemed to reduce and equate local residents’ approval to permission from official authorities in the local council, despite the NBB’s differentiation between “consent letter… from local council” and “consensus and approval from the inhabitants”. They also equated local residents engagement to displaying large posters in the trial site. In this sense, community authorization and community authorities’ consent were seen as equivalent, and community engagement was equivalent to announcements. This explains why the researchers judged that they have gained approval and support of the community as they expressed in the previous quote. Moreover, the mere fact that the trials were conducted, means that the conditions set by the NBB, including the “approval and consensus” of the local residents, were deemed as met. In Section 4, I will analyze in more detail the assumptions that could have influenced this judgment. As can be inferred from the available reports, all activities aimed at engaging the community and gaining their approval were basically centered on “briefing” the micro community about the trials, while the macro public was just informed through the public announcement. Locally in Bentong, IMR did the following: 1) Displaying posters announcing the trial in the uninhabited trial sites 22 days before the beginning of the trial (November 30th, 2010), 2) Participated in two public briefing sessions on the Limited Mark-Release-Recapture Experiment on the 9th of December of 2010 (less than two weeks before the release), one arranged by the Bentong Municipal Council in its own hall and conducted in Bahasa Malaysia and English languages and another arranged by the Bentong Malaysian Chinese Association in Dewan Perhimpunan Cina (Chinese Town Hall, Bentong) and conducted in Mandarin (IMR, 2013, Lacroix et al., 2012; Subramaniam et al, 2012).

IMR officials reported to the Star newspaper that about 150 people attended the Malay briefing session and about 100 residents attended the Mandarin session (Fong, 2011), which was contested by community members. Community members criticized the two sessions for targeting different groups that were mostly from governmental and municipal agencies with only one NGO present, and “constantly hushing questions” (Lim, 2012).

“What was most amazing about the whole scenario was the fact that the local communities in Bentong and Alor Gajah were not part of the mandatory consultations

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before the approval was made by the Board. Local communities in the release sites should have been consulted with the highest standards of prior informed consent when it comes to obtaining their consensus and approval. Such lack of information suggests the lack of transparency, which has attracted considerable criticisms from the consumer association, the environmentalists and the public” (Idris et al., 2013)

Although the public meetings were seen as “window-dressing” activities by community members (Chui-ni, 2010), Lacroix et al. claimed that the public meetings that MNRE and IMR conducted

“reinforced the ground-level support for the trials and positive feedback from the local community was reported by The Star (“GM mosquito plan gets the thumbs-up”, 1 November 2010) following its independent survey of Bentong residents”(Lacroix et al., 2012).

The article in the Star newspaper (The Star, 2010) claimed that the project has received good response from the locals, citing interviews with a few residents who expressed their support for governmental action against Dengue.

Beside the articles by the trials researchers cited above, no other documents reporting community approval for the trials could be publically found. Only three letters to the editor of Malaysiakini were written in support of the trials by two individuals (Param, 2010a, 2010b; Rehman, 2010). The trials have actually faced a considerable amount of opposition, both locally and internationally, and IMR researchers admitted that despite their efforts, there was still “some dissatisfaction from some community groups” (Subramaniam et al., 2012). However the report doesn’t mention what this opposition meant to the researchers and to their conceptualization of community authorization. This opposition is described in more detail in Section 3.

“The report [(Lacroix et al., 2012)] also spells out steps taken by the researchers to obtain regulatory and community approval, including newspaper advertisements, notices, writing to NGOs, and public meetings, the latter of which was reportedly positive. However, no mention was made in the report of objections from civil society, including an open letter endorsed by 22 NGOs” (Lin, 2012)

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Although the researchers didn’t seem to attach great importance to the opposition they faced, this opposition was considerable enough to force IMR to postponing the trials from their initial scheduled day, and then conduct the release secretly and announce it a month later (AFP, 2011; Anti-GM Mosquitoes Coalition, 2010; MalaysiaKini, 2011b).

"There are a lot of protests. We are now aiming to carry out the trial in the first half of 2011," said Mohamed Mohamad Salleh, the department's director of research and evaluation” (AFP, 2011)

As I will explain below in Section 3, opposition towards the trials was encountered across different groups in the community, and was frequently expressed in online as well as print media. Nevertheless, apart from the two forums that the government held in Bentong to inform residents about the project, the government, IMR or Oxitec did not put a lot of effort to responding to the community’s concerns, leaving the discussion in the media single-sided. Only 5 articles were published in response to community concerns despite repeated requests by community members to hold public discussion forums and national debates: 3 articles posted by Madame Yamuna Perimalu from the corporate communications unit of MNRE in Malaysia Kini newspaper in response to other letters to the editor another posted by her on the website EnvDevMalaysia, or Environmental Development Malaysia (Perimalu, 2010a, 2010b, 2010c, 2010d) and an article posted by Dr Lee Han Lim, head of the Medical Entomology Unit at IMR, in the The Sun Daily newspaper (Perimalu, 2010a; Lim, 2012). The responses to these postings were generic and seemed like general PR statements reiterating the same information, which is also included on the MNRE website, without addressing the specific concerns raised. Here again there wasn’t a clear distinction of responsibility towards the community between MNRE and IMR, another indication that IMR might have failed at developing channels of communication as well as relationships with the community.

3 Public Opposition

In this section I detail the reactions of different community groups towards the trials at both the macro and micro levels, and I use these findings to describe what constituted considerable opposition for GMM trials in this setting. I show that the opposition, which was expressed in

219 both formal and informal ways, was encountered in the micro, meso, and macro communities, with opposition groups belonging to different ethnic, age, socio-economic, educational, and political sub-communities. This opposition was also impactful as it forced the researchers to first change the release date and then conduct the release without announcing it. In turn, analysis of the underlying assumptions and factors that led to this opposition, helped me determine what would constitutes community approval in this setting, from the perspective of community members as I explain at the end of this chapter in Section 4.

Opposition was encountered as early as 2009 when news of the proposed trials reached the media. Residents in Pulau Ketam, which was one of the proposed sites, organized protests together with local politicians and activists, and wrote to the health ministry, asking it to refrain from using the island as a laboratory (Kuppusamy, 2010).

Since then, strong sentiments against the field release “abound in online chatrooms and other social media, where discussions have been uninhibited compared to the government-controlled mainstream media in the country” (Kuppusamy, 2010). Newspapers also often contained articles and letters written by opponents of the trials, who included individuals and organization from different social groups, including scientists and environmentalists (Chye, 2010; Rengam, 2010; Seng, 2010; Sinchew Daily, 2010b; Yi, 2010), merchants and consumers’ associations (Idris, 2010a, 2010b, 2010c, 2010e, 2011a, 2011b; MalaysiaKini, 2008), students’ groups, and residents from “all walks of life” (Anti-GM Mosquitoes Coalition, 2010). Negative comments about the trials were also frequently encountered in readers’ comments on the aforementioned articles. These reactions were encountered at the macro as well as micro levels.

The civil society and non-governmental organizations in Malaysia were very assertive and organized in their campaign against the trials. For instance, the Centre for Environment, Technology and Development (CETDEM), has been one of the most active organizations and its chief director has been quoted in many media articles. CETDEM is an independent, non-profit, training, research, consultancy, and development organization that is committed to improving environmental quality through the appropriate use of technology and sustainable development (Yi, 2010). Also, a group of 23 of the most active and influential groups in Malaysia, including environmental, religious, political, and students’ groups, prepared on the 17th of December 2010 an open letter to the government in which they expressed their dissent and outlined their

220 concerns and demands (Malaysian NGOs, 2010). At the same time, the Consumers’ Association of Penang (CAP) and the environmental group Sahabat Alam Malaysia (SAM - Friends of the Earth Malaysia) produced a 59-page memorandum that “outlines some of the serious ethical issues which need to be addressed before any field releases of the GM mosquitoes are allowed to take place” (CAP and SAM, 2010).

The memorandum was sent to the government, and was distributed to other NGOs and civil society groups. The two organizations also publicized their opinions, speciallye their calls for more engagement, information, transparency, and community consensus and consent, through commentaries and articles in leading newspapers (Idris, 2010a, 2010b, 2010c, 2010d, 2010e, 2011a, 2011b). The Third World Network was also a very active national NGO lobbying against the project (Vinod, 2010a). An online petition in Penang, entitled “No to the Release of GM Mosquitoes in Bentong and Alor Gajah” collected 372 signatures, demanding the government to assume full responsibility and make itself liable for any problems that may arise from the GMM release (Giam, 2010a, 2010b, 2010c; “No to Release of GM Mosquitoes in Bentong & Alor Gajah,” 2010; Saunders, 2009).

Locally in Bentong, one of the most active community groups was the Jaringan Anti Nyamuk Transgenik (Anti-Genetically Modified Mosquitoes Coalition, referred to henceforth as the coalition), which was jointly established on December 1, 2010, by the Students’ Democratic Movement (commonly referred to as the Students’ Movement), the Socialist Youth League, and Malaysia Youth. The coalition was not exclusive to these groups, and called on other organizations and individuals “from all walks of life” to join (Anti-GM Mosquitoes Coalition, 2010). Their goals were to “put pressure on the government to suspend the planned field trials of GMM, collect the views of the public, enhance the public's awareness on this topic, and promote the process of local democracy and popular participation in decision-making” (Anti-GM Mosquitoes Coalition, 2010). The coalition organized a series of events and activities to achieve its goals including collecting signatures from households in Bentong on a petition against the trials (Anti-GM Mosquitoes Coalition, 2010; SinChew, 2010), distributing flyers, conducting local seminars about the trials where local residents were invited to attend (Anti-GM Mosquitoes Coalition, 2010), and submitting a memorandum to the government (“[World’s second case of genetically modified mosquitoes in Bentong, Pahang - Organizations denounce the release

221 without informing the public] (Chinese),” 2010). The coalition was also announcing the government’s and other NGOs’ activities on their Facebook page, which has 202 subscribers, as well as featuring articles from local newspapers, international forums, journals, websites, and other relevant media outlets. Information was announced in both Bahasa Malay and Mandarin Chinese (Anti-GM Mosquitoes Coalition, 2010) “The Anti-GMM Coalition called on people to respond through a petition that expresses grass-roots concerns about the plans of the government to use GMM” (Editorial- SinChew, 2010).

It appears therefore that since local residents were uninformed about the project and unengaged in it, community groups such as the coalition took up the responsibility to inform as well as to educate “grass-roots” and individuals from “all walks of life” about the trials and empower them to participate and express their opinions but from an opposition perspective.

Dissent wasn’t limited to the civil society or the scientific community, and political parties also picked up on the topic as early as 2009, when local politicians were reported to have participated in protests in Pulau Ketam with residents, threatening to vote for the opposition if the administration persisted with the experiments (Kuppusamy, 2010). In 2010 and 2011 the situation escalated, especially after the sudden announcement in January of releases that took place earlier in December. Members of the parliament also expressed their dissent in the House of Representatives and in the media (Chye, 2010; Malaysian Parliament, 2011).

“The opposition party (PAS) joins green groups in condemning the secrecy of the field test. PAS today became the first political party to condemn the field test, saying the news was “shocking” ... Pahang PAS commissioner Tuan Ibrahim Tuan Man, in a statement carried on Harakah Daily, said his office had received “many complaints” since the release was reported” (Pragalath and Vinod, 2011)

The trials have also attracted international concern and 87 international organizations signed a petition urging Malaysian authorities to reconsider their decision (International NGOs, 2010; The Star, 2011). Local opponents used this petition as evidence against the trials. However, the content of this petition is beyond the scope of this thesis.

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As can be inferred from this section, while the hypothetical approval seeking was limited to the micro community, opposition was an all-encompassing phenomenon that included groups and individuals from different sub-communities belonging to the macro and micro publics.

4 Decoding Judgments: Implications for Community Engagement and Community Authorization

The previous sections suggest a mismatch between the judgments of the community and those of the researchers with respect to community authorization. While the researchers considered that they have received “ground-level support for the trials and positive feedback from the local community” (Lacroix et al., 2012), following “a well planned transparent public engagement process” (Subramaniam et al., 2012), community members heavily criticized the trials and the researchers’ approach towards the community, for not exerting the needed effort to meaningfully and effectively engage the community in issues related to the GM technology and the trials, and for not seeking or securing community authorization

“Calls were made for the submission of comments, but no effort was made to debate this important issue with civil society” (Idris, 2010b)

“The proclamation through the media that they tried to listen to public opinion is to create an illusion, in fact only a handful of local residents attended the briefing. (“[World’s second case of genetically modified mosquitoes in Bentong, Pahang - Organizations denounce the release without informing the public] (Chinese),” 2010)

“Most residents [in Bentong] had a “jump” on people in authorities for the ‘window- dressing’ attitude” (Chui-ni, 2010)

“Please don’t try to pull wool over our eyes” – Comment by reader (Perimalu, 2010c)

As I will show in the rest of this chapter, IMR and Oxitec appear to have deliberately chosen to avoid communication with the public, as was found in the Cayman Islands case study. In addition to not announcing the date of the GMM release, IMR did not explain why the intended public forum was shelved, nor responded to the public’s concerns and requests for information, even after the release was conducted.

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“The two groups [IMR and Oxitec], through their media firm, declined to comment on the trial or respond to the environmental concerns, saying it was inappropriate as their “application is now going through the final stages of regulatory scrutiny”. (“Anti- Dengue mosquitoes set for release, environmentalists worry,” 2010)

IMR and Oxitec might have taken a shortcut, the easy way of doing the minimum as stipulated by the Biosafety Act of 2007, and in line with the Cartagena Protocol to which Malaysia is signatory. As a result, community members considered that IMR, Oxitec, as well as MNRE, chose to interpret the NBB’s approval conditions in a way that would give them an escape clause to avoid engaging the community.

“While the institute has adhered to the word of the terms and conditions laid out to them by the NBB, it is arguable whether they have followed the spirit of the guidelines” (Chin, 2011)

In their letter about the trials’ public engagement exercise, IMR researchers admitted that learning about the relationships between science and the community and developing community engagement plans was an ‘evolving process’, and that

“due to the complexity of this [community engagement] process, we [they] do not have a clear mechanism or guideline for effective communication and outreach especially for health-related projects… The IMR learned valuable lessons in the public engagement process from our personal experience as well as the successes and failures of open field releases conducted in Cayman Islands and Brazil” (Subramaniam et al., 2012)

In this section, I analyze and contrast the assumptions that led to the difference in judgments, in order to draw inferences on what constitutes effective interactions with the community as well as sufficient community authorization in this setting from multiple perspectives. In fact, I argue that the difference in judgments with respect to the quality of community engagement as well as the presence of sufficient community authorization stems from the difference in assumptions about and understandings of community engagement, community authorization, and the relationship between the two. This difference could be due to the lack of guidelines and hence consensus on what constitutes effective and meaningful community engagement and sufficient community authorization.

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4.1 Community Authorization

In the previous sections, I explained that the trials’ researchers considered that the formal approval they have received from official authorities for the trials was sufficient to conduct the trial and was equivalent to community approval, and hence they decided to forego the public forum.

An important assumption that might have led to this judgment was the belief that community engagement and community authorization were different and non-dependent tasks, and that the community just needs to be informed, as I will show later. Accordingly, to engage the public in decision-making was not seen to be appropriate. Moreover, this assumption was affected by views on expertise and hence the relevant community to be consulted in these trials as I will also explain later. Another reason for considering the formal approval to be sufficient was related to the meaning of community authorization, and assuming that community approval is equivalent to the sum of informed consent collected from all individuals living in the vicinity of the trial site areas.

“The terms “public engagement” and “public consultation” have often been used interchangeably, but they refer to different processes… Consultation, that is consulting the public on issues, contributes to, and feeds into some decision making process. … There were some concerns that applicants did not get individual informed consent from communities at the trial site. Individual informed consent is a process aptly used in research when individuals partake actively on a one-to-one basis for example in clinical drug or vaccine trials. The field trial was also reviewed by the National Medical Research Ethics Committee. It was widely acknowledged that it is impossible and impractical to get approval from every individual when the research was not intrusive and involved a field release in an uninhabited area.” (Subramaniam, 2012)

In other words, community authorization (CA) was reduced to a mathematical formula:

CA = Σ Individual IC

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And since collecting informed consent from every individual is impractical in inhabited areas (CAà∞ (infinity)), or inapplicable in uninhabited areas (CA=0), then sufficient approval would be limited to formal approval from regulatory and local official authorities.

Approval = CA + Regulatory Approval + Approval from Local Authorities

In this case, the community was considered to be limited to the immediate vicinity of the trial site, and since they chose an inhabited forest, then the formula becomes

CA=0 è Approval = Regulatory Approval + Approval from Local Authorities

For community members, community engagement and community authorization were closely associated, as I will explain in the rest of this chapter, which suggest that effective community engagement is compulsory to develop community authorization. This finding is also encountered while exploring the meaning and causes for opposition. Moreover, for community members, community authorization would include both permission, or consent from the micro public, even those beyond the localized field site, and consensus of the macro public.

“The general public are integral to effective dengue control and there must be consensus on this issue”(Malaysian NGOs, 2010)

“Has the government obtained the permission of the locals in Bentong and Alor Gajah before releasing the mosquitoes?” (Vinod, 2010b)

“Consent should be obtained from the communities involved” (Ex Vector Control staff, 2010)

“The prior informed consent of the communities living in and around the proposed field release sites must be obtained”(Malaysian NGOs, 2010)

Although I had limited data to suggest what obtaining the “informed consent” of local inhabitants might entail, it was obvious that it was not perceived as equivalent to the consent of the local authorities. There were references however to the need for a public forum in which consent of the micro community could be sought. On the other hand, ‘Consensus’ and ‘agreement’ of the general public have been frequently stressed as ethical requirements for the trials (Malaysian NGOs, 2010; Ex Vector Control staff, 2010; SinChew Editorial, 2010), and

226 consensus conferences such as those conducted in Denmark or Taiwan were recommended (Chui-ni, 2010). Unfortunately, I did not have enough data to explore the meanings of these two concepts, although there was enough evidence that the presence of opposition towards the trials negated the presence of either consensus or agreement. In the following part, I explore the meaning of opposition and its causes.

Figure 13.6: Community Authorization from the Community’s Perspectives

4.1.1 Opposition

Many examples demonstrate that the researchers avoided disclosure out of fear of creating or stimulating opposition groups. At the core of this fear lies the commonly held assumption that individuals hold a priori negative perceptions and automatic apprehension and hostility towards science and technology, in particular genetic modification, and that individuals will oppose the trials no matter what information is presented to them. For example, IMR researchers asserted that in addition to not having guidelines, their communication and outreach efforts were

“further complicated by negative perceptions in some quarters over the use of GM technology” (Subramaniam, 2012)

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Data suggest that to engage the public in the trials and provide them with information about the GMM technology and release, could have been seen by IMR and Oxitec as opening the door for debates and for opponents to come in with their preset agendas.

“He [Director of MNRE Department of Research and Evaluation] added that at that time, he could not reveal that the release had already taken place as the Biosafety Department had been instructed not to release that information to anyone for fear that people might “disturb” the release site” (Chin, 2011)

“The authorities never revealed the release date and place. The Ministry of Health still followed a ‘fait-accompli’ practice, when it announced the release a month after the trials, because apparently they are afraid of the opposition and the pressure from the public” (Anti-GMM Coalition, 2011)

Nonetheless, opposition appears to have been a consequence of experiences and of the approach that IMR has followed, rather than a position against the technology. In particular, opposition appears to have been a result of secrecy and lack of disclosure, and consequently of not seeking the community’s approval for the trials. In other words, secrecy and not seeking community approval out of fear of opposition and dissent are what actually precluded approval and caused opposition. In fact, community members have frequently expressed that they are not against the technology per se, but against the approach that researchers have followed in developing that technology.

“Proper due process was not followed prior to GM mosquito release” (CAP and SAM, 2010)

“The coalition criticized the authorities for ambiguous consultation with local views, it is an irresponsible and inhumane practice” (Anti-GMM Coalition, 2011)

“The development of a GM mosquito is certainly a scientific and technological tour-de- force and the accomplishment needs to be appropriately recognized as such. However, what is most disturbing about the present planned release of GM Aedes aegypti mosquitoes is the lack of information and further approvals associated with the proposed release as outlined below” (Ex Vector Control staff, 2010)

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“We are convinced that science and technology are for the benefit of mankind, but at least one must be allowed to decide whether to accept or not that technology. It is absolutely necessary to provide more comprehensive information by third-party experts to the people, so they can decide. Democratic process no doubt states that public opinion should not be ignored, and only with transparent multi-party discussions rather than unilateral information that we can get more mature to be able to decide whether to accept genetically modified mosquitoes’ technology. But you cannot force people to accept” (Yang, 2010)

“The government and scientific experts with their top-down education approach did not resolve the controversy for the civil society. Although many of the attendees who listened to the Malaysia insect agency director Dr. Li Hanlin last Thursday in the Bentong briefing explanation will accept the implementation of this program, the project has been denying the participation of the public from the moment it was established four years ago”(Chui-ni, 2010)

“Having been in contact with many people in Bentong, I can attest to the fact that up till now, the majority of the population there has scant information on the issue of GM mosquitos! This is obviously not in the spirit of 'Public Consultation' within the context of our Biosafety Act” (Giam, 2010c)

Opposition, despite the presence of formal approval, also demonstrates the fragility of community approval. “It was heartening to note the efforts made by the National Biosafety Board (NBB) to

elicit public feedback during the approval process for the Institute for Medical

Research’s (IMR) application to release genetically-modified (GM) maleAedes

aegypti mosquitoes in Bentong, Pahang, and Alor Gajah, Malacca … However, all that

effort was negated by the rather clandestine way IMR carried out the actual release last

month” (Chin, 2011)

“We are most appreciative of the National Biosafety Board (NBB) and Genetic

Modification Advisory Committee (GMAC) within the Ministry of Natural Resources

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and Environment (NRE) for their efforts to evaluate the safety and efficacy of the

genetically modified (GM) Mosquito. However, this evaluation was apparently

conducted with little or no input from the public at large as evidenced by the numerous

questions that have been raised. This is a major oversight that can only lead to rejection

of the GM mosquito programme” (Ex Vector Control Staff, 2010)

Lack of disclosure and keeping the project low profile with the community, in addition to conducting the release “secretly” without any announcements, led to suspicion and consequently anxiety. Consequently, community members interpreted secrecy as an indication that something dangerous is being undertaken.

“We deplore the lack of transparency on the issue, in particular the way in which the Institute for Medical Research (IMR) released its press statement more than one month after the trials began” (Idris, 2011a) "If these mosquitoes are completely safe, then why the hush-hush?" says Gurmit Singh, chair of the Centre for Environment, Technology and Development in Malaysia, where Oxitec hopes to start a field trial soon” (Enserink, 2010)

“The absence of effective public participation and the shroud of secrecy surrounding the project, and the undue haste in implementing the field trials have caused unease and anxiety among Malaysians”(CAP and SAM, 2010)

Anxiety was reflected by the abundance of posts with notions of exploitation and abuse such as using the non-consenting poor as guinea pigs and lab rats in research, as well as conspiracy theory perceptions.

“Giam told Xinhua [News Agency] by e-mail he is concerned his country is being taken advantage of by groups in the west looking to make a profit” (Saunders, 2009)

“Don’t let Malaysia be the world’s guinea pig for a British firm – which provides the GM mosquitoes – hoping for a commercial success” (Omar, 2010)

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“We can not comprehend why the government wants to put the Malaysian public and environment at risk and subject us as guinea pigs in this study” (Idris, 2010c)

“Are Malaysians “lab rats” of Oxitech? [sic]” – Comment by reader (Ex Vector Control Staff, 2010)

By extension, anxiety seemed to be the driver for opposition in Malaysia, while maintained comfort seemed to be the driver for authorization in Mexico (Chapters 7-10). However, like comfort, this anxiety and hence opposition seemed to be revisable. For example, many scientists and commentators who expressed their opinions about the trials, insisted that they would need more convincing, compelling, and satisfactorily assuring evidence before trials could be conducted, which implies that approval for the trials is conditional on the presence of those provisions, as exemplified in the following quotes (stress added for demonstration).

“If there is no convincing explanation how this technology can be used in a cost- effective manner, then there is no point at all in exposing the people in Bentong and Alor Gajah to genetically modified aedes mosquitoes. The government should call off all field trials until all the economic and bio-safety issues have been resolved - Aliran member Dr Jeyakumar Devaraj, a respiratory physician who once won a gold medal from the Malaysian Medical Association for community service, is the Member of Parliament for Sungai Siput” (Devaraj, 2011) [emphasis added for illustration of idea]

“Malaysia Nature Society (MNS) president Associate Professor Dr Maketab Mohamed said it was not satisfactorily assured despite the Biosafety Department saying that the risks are minimal” (New Straits Times, 2010) [emphasis added for illustration of idea]

“Most signatories [on the online petition’ echoed concerns that no compelling evidence had been provided to the public on the plan’s effectiveness and its long term effects to the environment. “Show us more convincing studies that tell us there is no impact on the environment” says [one signatory]” (Vinod, 2010b) [emphasis added for illustration of idea]

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Figure 13.7: Considerable Community Opposition

4.2 Community Engagement

In this part, I explore the different assumptions about community engagement from the perspectives of the researchers as well as the community. The analysis also focuses on important elements of community engagement, such as who constitutes the relevant community and therefore who needs to be engaged, and what constitutes effective community engagement, and therefore how should the community be engaged.

IMR and Oxitec’s researchers considered that engagement consists of and is limited to information dissemination in order to raise ‘awareness of science’, which would lead to increased trust in their work. In Part IV of this dissertation, I discuss that this assumption is in line with the ‘Deficit Model’, which stems from the ‘Public Understanding of Science’ thought paradigm, and is no longer considered appropriate to explain the complex relationships between science and society.

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Engagement is generally raising awareness of science and the issues it raises among the public… An international guidance on public engagement would definitely assist researchers and regulators of future releases with a comprehensive communication plan that ensures transparency and a mechanism to respond to feedback following public consultation… IMR has postponed the project, until an improved, effective communication plan can be implemented… For the applicants, public engagement was important to gain public trust through dissemination of information” (Subaramaniam, 2012)

This view explains why IMR and Oxitec reduced community engagement to announcing the trials in a newspaper, displaying “large multi-lingual posters in the uninhabited trial site for at least two weeks prior to the date of release” (Lacroix, 2012), and participating in two briefing sessions arranged by the local council in Bentong and the Malaysian Chinese Association.

“The communication plan proposed would adopt a proactive approach before any trial begins with advertorials, engagement of journalists, media interview and distribution of flyers from door to door at the trial site” (Subramaniam, 2012)

However, and as I mentioned before, the trial researchers admitted that they lack the full knowledge to effectively engage the community. Their call “to create a more democratic and deliberative approach to communicating science and medicine and build stronger links between professional scientists, the lay public and other communities through greater openness and engagement” (Subramaniam, 2012) despite previous descriptions of community engagement as information dissemination in the same paper, has two interpretations. First it could demonstrate once again that community engagement is an ambiguous concept and that the researchers simply did not know what to do, or it suggests that they might have revisited their views in light of the community response. Building ‘links’ or relationships with the public was mentioned again in the same paper, although in the context of developing effective communication plans:

“The relationship and trust would also be established through meetings with residents allowing specific concerns on GM vector control to be addressed and for direct feedback” (Subramaniam, 2012)

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Horizontal, democratic, and deliberative approaches that consider the public as an active and equal partner, were at the core of the community’s understandings of community engagement. “The government and scientific experts with their top-down education approach did not resolve the controversy for the civil society… Based on the scientific and democratic thought, the government has to move from a one-way communication (risk communication) into a two-way public participation trends, such as citizens conference (consensus conference) public participation mechanisms like the ones in Denmark and other European counties, so that the public informed and involved in the discussion. Taiwan has also held GMO citizens’ conference” (Chui-ni, 2010)

“[Malaysian Kedah Board Deputy Secretary] said that from a democratic and humane point of view, the Ministry of health has the obligation to engage and let the people of the regions concerned to understand that the male mosquito does not bring any harm, the Ministry of health may not have done enough in this regard, some people do not understand, and let people take advantage” (MalaysiaKini, 2011a)

Transparency and full disclosure were seen as indispensable requirements for community engagement, as was also encountered in the other two case studies.

“Information should be openly exchanged as broadly as possible to relevant community leaders, members of the community, and mass media” (Ex Vector Control staff, 2010)

“They [anti-GMM coalition] pointed out that the public needs transparency and the absence of interest-linked pertinent comments given by experts, so that we can better judge the quality of this product, and whether it is necessary. (Sinchew Daily, 2010a)

“We urge the government to be transparent on the issue and to immediately disclose the details and specific sites of the releases” (Idris, 2010e; Malaysian NGOs, 2010)

“This means that they [local inhabitants] must also have the potential risks of the study adequately explained to them, and information about the sources of funding and any possible conflicts of interest provided” (Idris, 2010e)

“The many worrying concerns raised regarding the GM mosquito make it imperative that the Risk Assessment (RA), in line with the Precautionary Principle, be made public.

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Similar to the Environmental Impact Assessment (EIA), which is required by law, the detailed RA should be in the public domain. This is crucial as the people especially those in the release sites must know the details to make an informed decision”

“If the National Biosafety Board and the Biosafety Department does not set the bar high for meaningful public feedback; detailed study of socio-economic and environmental impact; solid science; risk assessment; risk management; transparency; liability and redress, it will mean a lack of scrutiny for other GM crops, food, feed and processing in the future” (Idris, 2010c)

As community members were suspicious of IMR and Oxitec’s intentions, calls were also made for the independence of community engagement activities such as the intended public forum, and for third party experts to be involved. This requirement was not encountered in Mexico where the community had more trust in the trial team.

“Any public forum conducted for the purpose of obtaining the consent and approval of the local population must be free, open and balanced, representing the benefits and risks of GM mosquitoes. We think, the public forum should not be carried out by IMR, although they may be asked to provide scientific or technical input or to answer any specific questions on the test. Relation to IMR, public forums conducted by IMR clearly be seen as a conflict of interest as the IMR is to test the applicant's field. ” (Idris, 2010d)

“Without inviting third party experts, there is no credibility at all… (Anti-GM Mosquitoes Coalition, 2010)

This lack of confidence could have stemmed from confusion over who is actually the leading and hence accountable entity, as I alluded to before.

“Who will be accountable?”(Ex Vector Control staff, 2010)

“All the agencies involved should be responsible” (Harakah Daily, n.d.)

“Presumably Oxitec will collect rewards for their invention, but will they bear responsibility should anything go wrong? they [Malaysia NGOs] asked.” (Vinod, 2010c)

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“What commercial entity is undertaking this endeavour and who are the individuals involved? There has been no disclosure of what and who is supporting the GM mosquito and its release (other than the Institute for Medical Research, IMR)” (Ex Vector Control staff, 2010)

Finally, community members called for inclusivity, or the inclusion of a wide array of groups and members at all levels of the community, as a requirement for democratic approaches to participation. This call contrasted with the views of the researchers on whom might be considered the relevant community to engage, and which members can participate. I will address these points in the following and last part of this chapter. Figure 13.8 contrasts the perspectives of the community with those of the researchers with regard to the needed scope of community engagement.

Figure 13.8: Perspectives on Community Engagement

4.2.1 Who is the Relevant Community, and What Constitutes Expertise to Participate

When community groups and commentators questioned IMR on reasons for conducting the trials without announcing them and without informing the public, researchers responded by stating that MNRE and IMR deemed the requirement to hold a public forum to gain community approval, as mandated in MNRE’s regulatory approval, unnecessary. “An IMR scientist with the project said that as the release was only being conducted at an uninhabited site, the public forum to gain approval from the local community was not required… GMAC head Dr Ahmad Parveez Ghulam Kadir said that the [NBB] committee and IMR had agreed during discussions that for an uninhabited site, the

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institute had to obtain clearance from the local municipal council, and put up notices informing the public about the field trial around the release site at least two weeks before the planned release… Non-profit Third World Network’s senior researcher (biosafety) Lim Li Ching said “we think that, even if it is in an uninhabited area, the local community who live around the area have a right to know (about the release)” (Chin, 2011)

“[IMR director stated]: "We released the mosquitoes in an uninhabited forest, no one living nearby, so I can not solicit opinions, unless we asked the monkeys in the forest." (Sinchew, 2010)

In this interpretation, IMR and MNRE’s decision implies a narrow conception of the relevant community to engage, limited to immediate inhabitants of a release site, or those who might be directly affected in the micro community, explaining why the informed consent of the landowner was still sought.

The reason behind this understanding of the relevant community, and the consequent avoidance of communication, could have been the commonly held assumption in scientific arenas that the lay public does not have the needed expertise and hence cannot or even should not participate in scientific decision-making, which should be left to experts. This assumption was implied by Oxitec’s communication regarding the trials in the Cayman Islands, and was also implied in MNRE’s response to Datuk Norah Abdul Rahman, a parliament member, where MNRE claimed that the government didn’t need to announce the trials since the NBB has already approved the application based on the GMAC scientific recommendations (Malaysia Parliament, 2011). This view was reiterated in IMR’s letter about the community engagement processes for the trials

“For the consultation process, it would be more appropriate to engage focus groups and relevant administrative authorities who have the necessary capacity and are able to act in the best interests of the populations they serve” (Subramaniam, 2012)

This view could also be demonstrated by the fact that NBB invited environmental NGOs only for the public consultation session as explained previously in this chapter. On the other hand, to keep the approval decision limited to the realm of scientific expertise from the ministry was seen by community groups to be driven by the assumption that non-scientific perspectives are not

237 considered as sufficient expertise and hence are non-valid and non-relevant. Moreover, many in the community felt disrespected, as they felt that the government or IMR’s researchers did not consider them capable of understanding and judging scientific knowledge.

“We say that Dr. Lee [from the Ministry of Health] is really underestimating people's ability to judge”(Yang, 2010)

Consequently, community members and groups refuted this conceptualization of the community and considered that the nature of the research mandates more inclusivity in the realm of expertise, and that the relevant and affected community spreads even beyond the city or the district of Bentong to encompass individuals and groups even at the macro or national level. Some even considered that the debate should include neighboring countries.

“IMR is at present developing gene technology industry as a whole from a “sciences” thought, while experts from different fields are absent, with a lack of mechanisms for dialogue to reconcile”(Editorial-SinChew, 2010)

“The social impact of genetic technology can not be ignored, the government should expedite the establishment of the National Genomics Research Center, and the establishment of the National Bioethics Advisory Committee and other organizations to follow the United States and Europe, in addition scholars and experts should be joined by others in the medical, legal, education and other disciplines, who will expand the range of academic research for discussion and consensus, and gradually form a consensus in the community” (Editorial-SinChew, 2010)

“The fact that GM is involved, implicitly expands the controversy beyond science, as it has impacts on health, natural, ecological, social, and ethical aspects of life, therefore it is imperative that all of these aspects are taken into consideration, and hence the voice of the non-scientific community have to be included and heard.” (Chui-ni, 2010)

“Mosquitoes do not recognize town, state, national or international boundaries. Therefore, the release of man-made organisms like GM mosquitoes should not just concern the people of Bentong but all Malaysians. The release of GM mosquitoes in the

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town of Bentong is in fact a national release of GM mosquitoes in Malaysia.” (Giam, 2010b)

“ Selangor Voter: I am a genetics researcher. I am so so so sad to read this… We should seek out the opinions of our neighbours like Singapore, Thailand, Brunei and Indonesia”(Ex Vector Control staff, 2010)

The implication of this definition of the relevant community to engage is that regulatory approval was not sufficient to conduct the trials, and different forms of community approval were also necessary.

This conceptualization of the relevant community is similar to what was encountered in Mexico, where researchers engaged interest groups and individuals, or sub-communities, at the macro or national level, meso or state level, and micro or the trials site level. This conceptualization is also aligned with Etzioni’s definition (1998) that I detailed in chapter 1. A broad notion of the relevant community implies that community approval cannot be limited to an isolated event such as a public forum or a finite decision such as a consent letter. In the final section I will elaborate more on this concept.

5 Summary

In this comprehensive chapter, I presented a rich case study documenting the experiences with GMM trials in Malaysia. The results are aligned with the findings from Mexico, showing that community authorization is a complex, multi-faceted and multi-level phenomenon, that is not limited to a decision or a group of individuals. The case study has emphasized that the notion of community encompasses a wide range of constituents and stakeholders, belonging to subcommunities across the national context. It also highlights the importance as well as the

239 intricacy of the interactions and the relationships between researchers and community, and the association of these interactions with community authorization.

Two key messages could be derived from this case study: 1) While all community commentators stressed the importance of horizontal, democratic, and participatory engagement of all community levels, there was an agreement that “consent”, or approval, is needed from the host community, while consensus only, or lack of opposition after deliberation, is needed from the rest of the community. In other words, commentators emphasized the need to involve the public in the micro community in decision-making. 2) This case suggests that opposition would be considered considerable when it’s encountered at different and unrelated sub-communities including the publics, with the potential of adversely affecting the progression of the trials. The weight of opposition could be best assessed however in discussions with legitimate representatives of the community, especially at the micro level. The case also confirms that opposition does not reflect an a priori position towards the technology, but develops as a reaction to the conduct of the researchers towards the community.

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PART IV Discussion and Conclusions

In the previous two parts of the thesis (Chapters 6 to 13), I have presented the results from three case studies: Mexico, the Cayman Islands, and Malaysia. In Part 2 (Mexico), I presented a successful example of a relationship between the researchers and the community as well as community authorization for GMM trials, while in Part 3 (the Cayman Islands and Malaysia), I showed that in both settings we could not infer that the communities have granted their authorization for the trials. Whereas in Mexico there were no indications of any resistance or apprehension towards the trials, opposition was encountered at multiple levels of the communities in both Malaysia and the Cayman Islands.

This part of the thesis includes three chapters. In the first two chapters (14 and 15), I compare the three case studies and present an interpretive analytical account of the results. Adhering to the grounded theory approach, I developed my theory (presented in Chapter 16) after I completed the cross-case comparison, where I selected the emerging categories from each case, then compared them looking for similarities and differences between the cases. This task helped me to identify patterns, test the relationships between the variables, and sharpen my theoretical constructs by refining definitions as well as build evidence for them (Eisenhardt, 1989). In the first chapter, Chapter 14, I explore the factors that led to different responses from the three communities towards the GMM trials, while discussing the findings in light of available literature. In the second chapter, Chapter 15, I compare the perspectives on authorization from the three settings, and discuss the procedural and substantive aspects of community authorization. In the final chapter, I present the resulting theory of community authorization for GMM trials, and discuss its implications for global health research ethics. I also present the limitations of the study, comment on its generalizability to other fields, and propose points for future research.

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Chapter 14 The Social Process of Community Authorization

In this chapter, I compare the three case studies to analyze the underlying social processes of community authorization. After analyzing the documents related to the trials in the Cayman Islands and Malaysia, I noticed a common theme, or a narrative, recurring in most if not all of the postings by community members, including newspapers’ editors, NGOs, scientists, local students’ associations, and residents of the area. This narrative, or the story of the trials as “constructed” by the community, was full of notions of conspiracy, supernatural mosquitoes, and abuse. The following excerpt by von Bredow perfectly summarizes the narrative that was developed after the Cayman Islands’ release hit the news, which was encountered in most postings, and which is similar to the one in Malaysia:

“Yet something of a scientific thriller has developed around these designer animals. Were anyone to turn it into a horror movie, the story would go something like this: At the heart of the tale there are the managers and scientists at a British biotech firm. These are the bad guys. Their crime: Secretly exposing the unsuspecting inhabitants of a faraway Caribbean island to mutant mosquitoes; a flying army of horrific creatures hungry for people to prey upon. The company -- of course -- is only interested in the huge profits it hopes to make. And then there are the good guys; upstanding researchers and idealistic activists determined to ruin the bad guys' evil plans”(von Bredow, 2012).

1.1.1.1.1.1.1.1 The discussion in this chapter refers to the publics (or members of the community other than official authorities) in both the Cayman Islands and Malaysia, as the available data do not include the perspectives of official authorities in the local communities.

In Mexico, on the other hand, the recurring theme, or narrative, in all of the interviews with the community members (including leaders) was the opposite. Researchers were the ‘good guys’, who were backed by trusted university professors from the USA, they came in with their

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“beneficial mosquitoes” (community member), to promote the interests of the community by saving them from diseases and bringing in “good projects” (Current Comisariado).

As no interactions occurred between the researchers and the community in the Cayman Islands, I will limit the discussion in the rest of this chapter to the case studies from Mexico and Malaysia only. Narratives constituted the medium through which community members understood the trials and articulated their concerns about them. At different stages, the narratives prevalent in community members’ statements reflected the judgments that they had formed about the trials. Cross-case comparison also reveals that these judgments passed through two main stages in both communities, as I will explain the coming sections. Affect, or the way community members felt about the trials, was central in these processes.

In the first part of this chapter, I will analyze the process through which judgments seem to have developed, while in the second part I discuss these findings in light of the literature.

1 Process of Judgments-Development

As I showed in the previous two parts of this thesis, the community in Mexico embraced and supported the GMM trials, while the Malaysian community exhibited antagonism to the GMM trials conducted there. By examining how the judgments seem to have developed, as suggested by the data, I was able to identify a pattern that would be the basis for my explanatory theory. This process had two main stages.

1.1 Stage 1: Comfort, Anxiety, and Openness to Risk

When the researchers in both settings had their first interactions with the communities, whether through announcements, proposals, information provision, or even discussions or negotiations with the community, individuals and groups interpreted these interactions and the information received, by forming assumptions about the safety of the GMM trials, the ensuing benefits, whether direct from the technology or indirect from having the trials in their communities, and finally about the intentions and the moral character of the institutions and researchers conducting the trials. If the interpretations resonated with the community values, and were aligned with their interests, such as what happened in Mexico, the community developed a state of comfort with

243 both the researchers and the trials, which in turn led to openness to risk. On the other hand, if the community interpreted the interactions with the researchers through forming negative assumptions about risks, benefits, or the intentions of the researchers and their perceived values, individuals and groups sensed that their interests were being threatened, and hence developed anxiety. Anxiety in turn led to a state of resistance. This scenario was witnessed with the publics in Malaysia, as I will explain below.

In Chapter 8, I showed that a main advantage of the approach followed with the community in Río Florido, was related to the entry into the micro community and the initial interactions with its members. First, the long-term commitment, and the prospect of a reputable institution that was planning to get established locally, signified investment in the community, and hence positive assumptions were formed about all the indirect benefits that might result. These included among others, local development of infrastructure, employment opportunities for local inhabitants, national and international reputation for the town, and scientific education and public health awareness activities for community members. The community also did see hope in the GMM to eradicate local mosquitoes, and hence perceived favorably the direct benefits of the technology itself. Moreover, when the researchers admitted uncertainty from the beginning, and committed to a transparent and step-wise approach, as well as delineated accountability, protection measures, and oversight mechanisms, they succeeded in establishing an initial sense of communal comfort with the trials risks. Finally, the community interpreted the humble and respectful attitude as well as the approachability of the local researchers as an indication of their “goodness” and benign intentions. All of these factors led to the development of openness to the trials. This openness implied mainly openness to risk but not yet risk tolerance. In other words, the community was open to the idea of risk, but wanted to learn more, more before making any decisions and to assess whether they are willing or not to tolerate the research risks. This is the stage where the “plot” of the narrative was being formed as explained before.

“Yes, there was definitely comfort from the beginning, and that made them want to try, they thought it’s worth it” (Local PI).

As I will discuss later in this chapter, trust in institutions was implicated as an important factor associated with risk tolerance. However, in this case the community seemed to be open to the

244 project and its risks from the beginning even before they developed trust in the researchers (Chapter 8).

A similar process occurred at the macro level with official authorities (in both Mexico and Malaysia). The trials resonated with authorities interests related to protection as well as promotion of public health and research programs, inter alia, and therefore were authorized to enter the community. The openness at all levels to risks marked the first formal stage of approval, admission of the trials to the community (Chapter 15).

In Malaysia on the other hand, when the news about possible GMM release reached the non- official community through the media in 2009, fear and anxiety were experienced both in the local community in Pulau Ketam and in the general public. Because they were not aware of previous research on GMM in Malaysia, the community considered the release to be “hasty” and “sudden”. The fact that a private British biotechnology company is responsible for the seemingly secret trials, immediately evoked memories of colonialism, as well as narratives of big biotechnology corporations taking advantage of vulnerable poor populations for their own benefit.

“Giam told Xinhua by e-mail he is concerned his country is being taken advantage of by groups in the west looking to make a profit. “Why should a developing country bear the brunt of being the site of a field trial for releasing genetically modified mosquitoes?” (Saunders, 2009)

Moreover, news of the secret release in the Cayman Islands provided momentum in Malaysia for this exploitation narrative and for the community’s judgments about the intentions of the researchers and their moral characters. Thereafter, the first formal interaction between researchers and community occurred when NMRE made the call for public feedback on the trials proposal. As discussed in Chapter 13, that call was perceived as perfunctory and tokenistic due to minimum provision of information that was simplistic and overly confident, without convincing reassurances or meaningful opportunities for deliberation about the trials’ value, benefit sharing, accountability, oversight, governance, or future use. Consequently, the community’s interpretations of all of these interactions were aligned with the narrative in which risks are high and benefits are only reaped by ill-meaning researchers with ulterior motives.

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“Don’t let Malaysia be the world’s guinea pig for a British firm – which provides the GM mosquitoes – hoping for a commercial success”(Omar, 2010)

These interpretations meant that the community’s interests of self-protection would be jeopardized if the trials were to proceed.

“The interests of the Oxitec project scientists are more important than public health

“In the public or private interest? While Oxitec has received grants for its research, it is clear that the company expects to gain income from continual releases of GM mosquitoes in large numbers in several countries” (Malaysian NGOs, 2010)

A state of uncertainty and anxiety followed, creating the frame in which future interactions would be received and interpreted. Here the community became resistant to the trials, or more specifically unwilling to tolerate risk. Nonetheless, although anxiety and resistance had formed, the community was not totally opposed to the trials, and so when the government announced the trials and called for public feedback, the community commended the government’s actions and asked for more information and more engagement. This finding suggests that opposition was reactive and not pre-formed.

In the rest of this chapter, ‘community’ will be used to refer to all the non-official constituents. After the initial interactions with the trials and the ensuing interpretations, both the Mexican and Malaysian communities seemed to develop expectations from the trials and the researchers. These expectations were either expressed before the trials were conducted, or can be inferred from post-trial statements in which community members expressed satisfaction or disappointment. When I examined all of these expectations, I found that they revolve around three central themes: 1) Maintenance of a communal sense of control, 2) Promotion of community interests, and 3) Demonstration of respect. Maintenance of the community’s sense of control relates to all the conditions that researchers have to meet in order to provide the community with a sense of control over the circumstances. I use the definition of Merchant (1984:10) where “good control means that an informed person can be reasonably confident that no major, unpleasant surprises will occur” (emphasis in original reference). The purpose of control mechanisms is therefore to shape activities in accordance with expectations, so that the ultimate goals can be attained (Das & Teng, 1998). These are activities or attitudes that would

246 reduce volatility, uncertainty, and ambiguity, and hence are directly related to development of comfort or prevention of anxiety.

Promotion of interests was an important concept especially in Mexico, and is related to both short-term and long-term interests. Benefits to the community, whether directly related to the GMM technology, such as control of mosquito numbers or eradication of vector-borne diseases, or indirect trickle-down effects such as development of local social capital and infrastructure (Chapter 8), were the most prominent aspect of interests in Mexico. In Malaysia on the other hand, interests of protection from harm, as well as having access to the technology and sharing in its profits if successful, were more salient. Finally, demonstration of respect included all the actions and attitudes that would extend respect not only to individuals, but also to the community as a whole (Chapter 4). It was interesting to note that initially, the two communities stressed different elements, based on what they thought of the trials. In other words, the communities articulated what formed the main theme of their own narratives, or what they perceived was at stake. For instance, in addition to focusing on protection from harm, the Malaysian community also stressed the need for involvement and information provision, and hence the expectation of control was the most salient. In Mexico on the other hand, although the community expressed satisfaction for being afforded the ability to decide whether they wanted to be involved in the trials or not, and for being taken into account and given opportunities for input, their focus at the beginning was centered on the promotion of development interests. In both cases, openness or resistance were not related to the GMM technology itself, but to the approach that was followed in both settings.

In table 14.1 I provide a list of the conditions that needed to be fulfilled to satisfy each of these expectations, along with the different dimensions for each condition. The conditions and their dimensions featured in this table are not exhaustive, nor mutually exclusive, but are grounded in the data and limited to the results derived from the three case studies. All of these elements were already covered in Part II and III of the thesis though in different contexts, and hence I will limit the discussion here to their relationship to expectations and hence to the process of narrative and judgment development. The rating I followed in this table is not based on any standardized evaluative tools, but is based on my interpretation of the data. It is also not meant to provide any score, but to give a general comparative idea about the approaches in the three countries.

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Maintenance of communal sense of control

Table 14.1: Community Expectations

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1.2 Stage 2: Constant Assessment, Judgment Formation, and Action

As the trials proceeded, the actions of the researchers were judged in as much as they met the expectations of the community, and were taken as evidence in support of or against the storyline that was being developed. Consequently, the community developed feelings ranging on a spectrum from disappointment to satisfaction according to the extent to which the community felt in control, respected, and that their interests were being promoted. In Mexico, as the trials progressed, an approach that aimed to develop a partnership with the community, based on commitment, respect, communication, reliability, and amicability, succeeded in maintaining the state of comfort and in generating satisfaction. In Chapters 8 and 9, I discussed how satisfaction with the project and its team led the community to develop confidence in researchers and in the potential of the trials to promote the community. The interpersonal relationships and the perceived values and morality of the researchers also led to development of trust. In the next section, I will discuss the difference between confidence and trust, and discuss how the two were important in developing authorization. Satisfaction with the partnership, and commitment to promote it, led in turn to reciprocity, whereby the community not only maintained its approval for the project but also provided support for it.

“After I saw all of this, all what they’ve done, how can I not do my part and help them? They are quality people and did quality work in my community” (Community Leader)

In Malaysia on the other hand, the community kept on collecting evidence, from the behavior of the researchers, to support their initial story, or hunch, that the trials must have been dubious and the researchers were evil. The community became suspicious and distrustful of the researchers as well as the government. Consequently, the state of animosity led to growing opposition at all levels of the community as I explained in Chapter 12.

"If these mosquitoes are completely safe, then why the hush-hush?" says Gurmit Singh, chair of the Centre for Environment, Technology and Development in Malaysia, where Oxitec hopes to start a field trial soon” (Enserink, 2010)

“The absence of effective public participation and the shroud of secrecy surrounding the project, and the undue haste in implementing the field trials have caused unease and

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anxiety among Malaysians. Conflicts of interests of Oxitec have further fuelled distrust [emphasis added]” (CAP & SAM, 2010)

“Most residents [in Bentong] had a “jump” on people in authorities for the “window- dressing” attitude” (Chui-ni, 2010)

“Please don’t try to pull wool over our eyes” – Comment by reader (Perimalu, 2010c)

“The Consumers Association of Penang (CAP) and Sahabat Alam Malaysia (SAM) are very shocked to learn from press reports today that GM Aedes mosquitoes were released on 21 Dec 2010 in Bentong, Pahang. This despite statements in the press in January 2011 by senior Biosafety Department officials saying that the trials had been postponed” (Idris, 2011a)

Figure 14.2 schematizes the process through which the narratives and associated judgments were formed, and summarizes the discussion in this section.

The two case studies from Mexico and Malaysia provide evidence that the narratives, and thus the judgments, were reactive and not inherent or pre-formed. In Mexico for instance, we learned that the default position towards initiatives brought into communities by the government or foreign institutions is one of suspicion, due to a long history of exploitation by multinational corporations and centralized governments. Yet, as a local sociologist explained, the community constantly reassesses situations, and their opinions and judgments are constantly reshaped according to evidence.

In the previous section, I argued that comfort and anxiety were correlated with the extent to which the perceived risks and benefits about the trials were aligned with the communities’ interests, and consequently their openness or resistance to the trials. In the second stage, promotion and protection of community interests were central themes in the assessment of the trials and of the researchers’ performance, and consequently in the development of judgments. Both communities therefore acted in a manner that would protect and promote their interests.

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Figure 14.1: Judgments and narratives development.

What was interesting was the fact that these actions ultimately affected the interests of the projects. In the Mexican case, the viability of the partnership, meant that development would be achieved in the community, and success of the project meant that the “beneficial mosquitoes” would be released to help with vector-borne diseases. The community therefore perceived their interests to be aligned with those of the project, and hence, to promote their own interests, they had to promote the project’s, by providing support to it. In Malaysia on the other hand, possible interference in and obstruction of the trials could have happened had they been announced ahead

251 of time. In other words, to protect their interests of safety, the community would have obstructed certain interests of the project.

2 The Role of Narratives, Affect, and Confidence in the Assessment of Research: discussion from the literature

In this section, I will discuss the findings from this chapter in light of the literature, which is drawn from different disciplines such as sociology, social psychology, organizational psychology, studies of science and technology, among others, pointing to the interdisciplinary nature of the topic.

2.1 Narratives

Risk is nowadays understood as embedded within the social experiences and interactions of persons, groups, communities, and institutions (Dake, 1992; Douglas & Wildavsky, 1982; Gadamer, 1976; Invernizzi & Foladori, 2006; Masuda and Garvin, 2006; Rosa, 1998; Schutz, 1970; Sherer and Cho, 2003; Short, 1984; Slovic, 1987, 2000; Wilkinson, 2001; Wynne, 1992). The experience of risk is seen as not only a personal experience of physical harm, but the result of processes by which people, both as individuals and groups, learn to co-shape interpretations and meanings of risk (Kasperson et al., 2003). Fitchen et al. (1987) recognized the vital role of community settings as arenas in which risks are perceived and acted upon. Here, empirical studies have demonstrated the existence of multiple publics within a setting, and the social generation of multiple meanings for any given risk (Horlick-Jones et al, 2002; Howel et al. 2002; Irwin et al., 1996; Macgill 1987; Walker et al. 1998; Zonabend 1993)

Meanings about risks and innovations of science and technology are incorporated in the everyday lives and knowledge base of non-scientists, principally within stories and narratives (Tulloch and Lupton, 2003; Wynne, 1996, 2002; Satterfield, 2004). Narratives become the medium through which these individuals and groups understand and articulate science as well as scientific innovations or research associated risks. Moreover, narrative theory and interpretive research were also used to analyze sense-making in relation to science and risk (Currie et al, 2009), and to elucidate the social construction of risk and risk management (Mairal, 2003; Kewell and Beck, 2008 ; Keady et al , 2009; Leontini, 2010). Toumey (2006) found that people order values and make sense of new things, such as scientific innovation, through creating

252 narratives, or stories that incorporate context, history, and meaning, and linking these narratives with stories from the past. Finucane and Satterfield (2005) explained the development of risk narratives by noting that individuals are situated in rich contexts, where they express their memories and stories of the past, the observed and lived present, as well as the possible future, in the narrative form of sequence and consequence. Ideas of risk develop in these contexts, and narratives get constructed during “cyclical conversations” between different stakeholders, including scientists and experts, authorities and regulators, interest groups, and the publics (Finucane and Satterfield 2005).

Moreover, Swiestra and Rip (2007) found that even scientists and regulators use narratives that contain recurring patterns of argument or story-lines and that frame the ethical debate. In fact, contemporary risk research recognizes widely the scientific value of narratives (Corvellec, 2011; Gregory and Satterfield, 2002; Lindbladh and Lyttkens, 2003; Weaver et al., 2006), which are found to be efficient and effective ways of communicating risks, either alone or together with scientific information (Dieckmann et al., 2009, 2010; Drew et al., 2004; Eriksson et al., 2007; Golding et al., 1992; Johnson, 2004; Palenchar and Heath, 2007; Sanne, 2008). Moreover, the publics not only form their own narratives, but do so after being confronted and influenced by a host of competing risk-narratives, each one defined by differing value judgments. Corporate narratives for example may favour and exaggerate the positives, omitting uncertainties, and “sanitizing”, or over simplifying the complexities raised (Dawson and Buchanan 2005). Special interest groups, such an environmental NGOs might instead do exactly the opposite, highlighting uncertainty, exaggerating the negatives, and amplifying the complexities. This is in line with what happened in Malaysia. In Mexico on the other hand, the researchers’ initial narrative, or story about the trials, was subtle and humble, recognized uncertainty, and acknowledged the role of the community. In turn the community responded with a balanced narrative that acknowledged the experimental nature of the trials, while looking forward for the benefits.

Moreover, in Malaysia the community seemed to be vulnerable to exaggerated and amplified narratives by environmental groups. Although I did not encounter or find signs of opposition in Mexico (from interviews and from media search), one can argue that comfort infers some sort of immunity against amplified narratives, while anxiety creates vulnerability. The Social Amplification of Risk Framework (SARF) is an important theoretical approach that could explain this finding. The framework captures the complex and multi-layered processes of

253 responses to risk and uncertainty (Stebbing, 2009) by explaining how social context might influence interactions and communication, and hence narratives about risk events (Freweret et al., 2002; Kasperson et al., 1998; Pidgeon et al. 2003). SARF explains for example why certain risk events can be perceived as dangerous and become the focus of attention and concern and consequently sociopolitical activity within a society even though experts assess risks as relatively low (social amplification), such as the experience in Malaysia, while other hazards, assessed more serious by experts, are dismissed or receive comparatively less attention in the same or a different society (risk attenuation) (Kasperson et al., 2003).

The SARF posits that “risk experience can be properly assessed only through the interaction among the physical harms attached to a risk event and the social and cultural processes that shape interpretations of that event, secondary and tertiary consequences that emerge, and the actions taken by managers and publics” (Kasperson et al., 2003). Accordingly, risk events are first observed and interpreted by individuals and groups, and become portrayed as stories through various risk signals (images, signs, and symbols). These stories and signals in turn interact with a wide range of psychological, social, institutional, or cultural processes, as they filer through a network of socially mediated communication channels. These communication channels can be formal, such as scientists, politicians, government agencies, community meetings, media, and interest groups, or informal, such word-of-mouth interaction within social networks. The various communication channels act as crucial ampliﬁcation or attenuation stations that receive, transform, and send re-interpreted risk signals, influencing in turn the risk perceptions of others. Transformation of signals happens in these stations through increasing or decreasing the volume of information about an event, emphasizing certain aspects of a message, or reinterpreting the available symbols, images, and narratives. Some transformed events, or signals, can get expressed in "ripples" of secondary and tertiary consequences that may extend far beyond the scope of the original event. Such secondary impacts include reactions such as community opposition, loss of credibility and trust, and demands for regulatory constraints (Kasperson et al., 1988, 2003). Analysis of the three case studies within the SARF is beyond the scope of this thesis. However, the framework provides important insights that could explain why risk features were attenuated in Mexico whereas notions of “Frankenstein” mosquitoes developed in Malaysia. Moreover, it points to the importance of affect (comfort, anxiety,

254 satisfaction, disappointment, among others) in the way people receive and react to notions of risk. “Do you remember the Frankenstein mosquitoes?” (IEye News, 2012c) “Eugenics, Global population control (i.e. decrease), Chemical extermination, Disastrously botched chemical experiments, Notions of 2nd class world citizens…Simple and ignorant / arrogant recklessness? Not sure why, but these are the thoughts running through my mind subsequent to reading the above news story” (Reader Comment - Cayman News Service, 2012a) “I've had two of my relitives after getting bitten by mosiquito's have serious allergic reactions, one ended up in the emergancy room needing a shot to control their situation, I've never seen reactions like that to a misquito bite before, and I'm sure others have as well, I think there is more than been told with this case. [sic]” (Reader Comment - Cayman News Service, 2012d) “This was the worst year since ivan for mosquitos on North Side. They were bigger, more numerous and out at all times of the day” (Reader Comment - Cayman News Service, 2012a) “Many of my friends and co-workers have been complaining about unusual mosquito’s bites-the bites would always becomes infected, very painful and upon healing would leave a scar… Nobody ever had mosquito’s bites like that [sic]” (Reader Comment - Cayman News Service, 2010c)

Recognizing the value of narratives, and understanding their development can be crucial for harmonious interactions between researchers and communities. Building relationships with the community, and becoming integrated in it, means that researchers become part of the narrative development processes, and participate in the meaning exchange and co-creation. Narratives can hence form the basis for a constructive dialogue, through which the values embedded in the stories of the community can be understood (Finucane and Satterfield 2005).

2.2 The Role of Affect in Judgments

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As I previously explained, the community in Mexico seemed to tolerate the research associated risks, whereas in both Malaysia and the Cayman Islands risk amplification was witnessed. Although increased risk perception has been thought to result from decreased trust, in both the

Table 14.2: Affective states in the three settings Malaysia and the Caymanian cases it appears that risk amplification was a result of the anxiety stemming from perceptions about the approach that the researchers followed with the communities, and hence a factor for decreased trust. In other words, affect appeared to be the main driver for reactions and actions in the three countries. Table 14.2 summarizes the affective states that the communities in the three countries have experienced, as drawn from the data (Chapters 7-13).

The risk research literature points in the same direction, and stresses the importance of affect in risk perception and risk judgments. In fact, contemporary definitions of risk go beyond technical assessments of hazards and their probabilities (Invernizzi and Foladori 2006), and recognize perceptions of risk as subjective, socially constructed, and context and culture-dependent (Epstein, 1994; Slovic et al., 2004, 2005; Stebbing, 2009). According to Epstein (1994, p:710), a view echoed by many:

“There is no dearth of evidence in every day life that people apprehend reality in two fundamentally different ways, one variously labeled intuitive, automatic, natural, nonverbal, narrative, and experiential, and the other analytical, deliberative, verbal, and rational”

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Slovic et al. (2004, 2005) characterized this duality in the ways risk is perceived, in what is known as the dual-process theories of information processing (Cameron & Leventhal, 2003; Chaiken & Trope, 1999; Sloman, 1996), by separating between “risk as feelings” and “risk as analysis”. Risk as feelings, or the experiential affective system, refers to individuals’ fast, instinctive, and intuitive reactions to danger, based on affect, associations, images, metaphors, and narratives, while risk as analysis, the analytical system, deals with the technical and brings logic, reason, abstract symbols, evidence, and scientific deliberation to deal with risk management (Connor and Siegrist, 2010; Slovic et al., 2004, 2005). The reliance on feelings as information in the decision process, or “the affect heuristic” (Slovic et al., 2004, 2005), is increasingly being acknowledged as an important component of the subjective ways in which lay perceptions of risk issues are constructed (Alhakami and Slovic, 1994; Finucane et al., 2000; Macoubrie, 2006; Slovic et al., 2002, 2004, 2005), especially when knowledge is lacking and uncertainty is high (Loewenstein et al. 2001). For example, Connor and Siegrist (2010) found that the experiential system, and not the analytical system, determines lay people’s perception of gene technology. Experiments actually suggest that when it is necessary to make rapidly an appraisal of a risky situation, affect heuristics are employed (Finucane et al., 2000), Slovic et al., 2005), because affective responses are considered to be more automatic and readily accessible than cognitive responses (Zajonc, 1980). Affect is also seen to influence other judgments as well as subsequent information processing (Zajonc, 1980).

Affect here is defined as the specific quality of goodness or badness that is experienced as a feeling state and demarcating a positive or negative quality of a stimulus (Slovic et al., 2004, 2005). A risk will be perceived or assessed as high: when it can induce fear or anxiety; appears uncontrolled; exposure is involuntary; is unfamiliar; has the potential to cause large-scale damage or deaths; affects vulnerable populations (including future generations) (Sandman, 1989, Siegrist et al. 2005). These risk qualities were incorporated into Sandman’s “outrage model”, which was thought to be the main explanation for the difference between public and expert evaluations of risk (Sandman, 1989). Most of these qualities were actually encountered in the discourse of the Malaysia community with respect to the GMM trials, which might partially explain why the associated risks were deemed to be very high, and consequently rejected. In Mexico on the other hand, the GMM were contained, exposure was voluntary, the community had a sense of control, and therefore risks were more tolerated.

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In addition to risk perception, data support the theory that risk and benefit judgments are inversely related, and are also impacted by affect (Fischhoff et al., 1978). The inverse relationship between perceived risks and benefits was greatly accentuated when opportunity for analytic deliberation was reduced (Finucane et al., 2000). Furthermore, Alhakami and Slovic (1994) found that the inverse relation between perceived risk and perceived benefit of a technological activity was linked to the strength of positive or negative affect associated with that activity. In other words, in this experiment, people were found to judge risks as low and benefits as high if their feelings toward an activity are favorable, and to judge the opposite, high risk and low benefit, if their feelings toward it are unfavorable. This finding could explain the situation in Malaysia, where due to lack of opportunities for deliberation and input, anxiety developed, and discourses focused on high risks with no reference to benefits. Moreover, an increased benefit perception for a technology was found to lead to more positive overall affect about it, which in turn decreased perceived risk (Finucane et al., 2000). For example, in many studies, because medical applications were perceived to be more beneficial and less risky than food applications, they often evoked more positive attitudes and were generally better accepted (Bonfadelli et al., 1998; Connor and Siegrist, 2010; Frewer et al., 1995; Frewer & Shepherd, 1995; 1997; Hoban, 1998; Magnusson & Hursti Koivisto, 2002). In fact, as the Malaysian GMM trials were conducted primarily by Oxitec, a commercial biotechnology firm, the community frequently referred to the commercial gains that the company would make as evidence for their claims that the trials were unethical. On the other hand, the Mexican trials were perceived to be in the public health interest.

Many studies have found that perceived benefits are the most important factor determining gene technology acceptance (Connor and Siegrist, 2010; Hossain et al., 2003; Siegrist, 2000). In Mexico, community members in Río Florido often referred to the GMM as “Sancudos Beneficos”, or beneficial mosquitoes, a term that was coined by a community member, and picked up be the rest. Moreover, as I previously explained in Chapter 8, when discussing the trials and the factors that were considered in decision-making, community members, especially leadership, often talked about short term and long term benefits. When asked about risks, and how they perceived them, the responses were similar across many interviewees

“Some women asked about the risks, but these concerns weren’t high… We wanted to know how this project can benefit our community” [Community women leader]

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This phenomenon could be explained by the results of the above mentioned experiments by Finucane et al. (2000) and Alhakami and Slovic (1994), although it is not possible to determine whether the increased benefit perception preceded or resulted from the favorable affective state towards the GMM, or whether it was a combination of the two. Moreover, the control and voluntariness that the community has experienced due to the researchers’ approach, might have decreased their risk perception according to the outrage model, and in turn led to a favorable benefit perception and affect about the GMM.

A critical limitation to the affect heuristic lies in the vulnerability it creates. Deliberate manipulation of affective responses to technologies by providing more benefits to the community or by cunning but successful marketing strategies risk exposing poor communities to the dangers of abuse. However, as I will argue in chapter 15, a relational upstream approach that shifts power and control to the community, and gives them enough time to assess the trials and the performance of the researchers without the need to make hasty decisions, can mitigate these risks. Moreover, impoverished communities could be also vulnerable to the implicit promise of research, that is the impression that is created within a host community when high profile scientific projects are introduced. Although effective communication of the science is crucial, clarifying the precise scientific goals and procedures for a GMM trial does not, in itself, ensure that the scientists and host communities will have a shared understanding of the significance or meaning of the trials. Incorporating these issues in formal and informal dialogues between the researchers and the community, both early on and periodically as the process moves forward.

2.3 Confidence, Trust, and Action

There is ample empirical evidence that trust in institutions is closely related to the perception and acceptability of various risks (Bonfadelli et al., 2002; Bord & O’Connor, 1992; Flynn et al., 1992; Freudenburg, 1993; Ganiere et al., 2006; Jungermann et al., 1996; Pijawka & Mushkatel, 1991,1992; Poortinga and Pidgeon, 2005; Siegrist, 1999, 2000; Siegrist et al., 2000). Trust is especially considered important under conditions of uncertainty, when people have limited knowledge about a certain technology, and tasks are too big or complex (Earle and Cvetkovich, 1995; Siegrist and Cvetkovitch, 2000; Slovic, 1999). Using Durkheim’s theory on the societal division of labor (1893, 1984), Freudenburg (1993) explains that as societies become more

259 complex with more differentiation and specialization, members become more dependent on each other, and have the expectation that people who have specific skills and a specific task will perform their duty in a way that others can count on. Studies in fact showed that fewer risks and greater benefits were attributed to a new technology, when the relevant institutions were trusted (Siegrist, 1999, 2000; Tanaka 2004). Eiser et al (2002) termed this the causal chain account of trust. An alternative approach, the associationist view of trust, sees that the acceptability of a risk as well as trust in institutions are the result of a positive general attitude toward the technology (Eiser et al. 2002; Poortinga and Pidgeon 2005). Trust has also been implicated as an important component of the dynamics of social amplification of risk. Distrust in particular was found to heighten risk perceptions, intensify public responses, and stimulate political activism to reduce risk (English 1992; Jenkins-Smith 1991; Kasperson et al., 1992; Lofstedt and Horlick-Jones 1999).

There is no consensus, even within disciplines, on how trust should be defined and studied (Earle & Siegrist, 2006; McKnight and Chervany, 1996), and many of these definitions confound confidence with trust and use the two terms interchangeably. Moreover, studies on trust have dealt with various “levels” of social trust (Greenberg and Williams, 1999; Kasperson et al, 1992; Renn and Levine, 1991) such as “interpersonal” (Holmes & Rempel, 1989; Rempel et al., 1985) versus “institutional/social” (Aryee et al., 2002; Fryxell et al., 2002) or “local” vs “global” (Brehm & Rahn, 1997). Different models of trust have been proposed. The dimensional models identify the dimensions of trust and these include: Competence (Frewer et al, 1996a, 1996b; Hunt et al., 1999; Kasperson et al., 1992; Metlay, 1999; Renn and Levine, 1991) objectivity, fairness, faith and truthfulness (Hunt et al., 1999; Renn and Levine, 1991,), consistency and predictability (Kasperson et al., 1992; Renn and Levine, 1991), communication (Anderson and Narus, 1990; Etgar, 1979; Moorman et al, 1993), commitment and caring (Frewer et al, 1996; Kasperson et al, 1992), general trustworthiness (Frewer et al, 1996; Metlay, 1999), and vested interest (Frewer et al, 1996). These dimensions were also confirmed in organizational psychology research (Altman and Taylor 1973; Dwyer and LaGace 1986; Larzelere and Huston 1980; Rotter 1971). Earle and Cvetkovich (1995; also Siegrist and Cvetkovich 2000; Siegrist et al, 2000) provide a different view of social trust based on similarity of basic values.

In this study, trust and distrust were certainly two important factors. In Malaysia, notions of distrust were frequently encountered in the media, while community members in Mexico

260 expressed that they trusted the principal investigator and her team. However, although most if not all of the above mentioned dimensions were encountered in my data (Chapters 7-10, 12-13), “trust” in researchers or in institutions did not seem to be a sufficient concept to explain the complex process, especially in relationship to authorization. Close examination of the data showed that “trust” (or distrust), is only one aspect of the affective dynamics that characterize the relationships between the community and the researchers, and that confidence is a more appropriate and more encompassing conceptualization in this case. Based on my data, I found three forms of confidence that were incurred: 1) Confidence in the researchers’ intentions and values, or trust, 2) Confidence in the researchers’ abilities and performance, and 3) Confidence in the potential of the project to benefit the community, 4) Confidence in the potential of the trials to succeed and provide the intended benefits as well as in their safety. The latter can be an extension of a positive risk perception as explained in the first part of this section. The dissection of the concept of confidence as well as the distinction between confidence and trust can make it easier for practice as well as for evaluation, as researchers can have concrete dimensions to target, rather than dealing with ‘trust’ as an abstract and intangible ideal.

The TCC (Trust-Confidence-Cooperation) model by Earle and Siegrist (2006), and the consensus model by Earle (2010b), which integrates all the previous empirical evidence on the matter, both support my claims, by offering a simplified two-dimensional view of trust. Social psychological literature also supports this view. According to these models, trust and confidence are separate, though interrelated and though both support cooperation. Trust is but one specific form of confidence, and is a relational emotion that is a construction of belief in others’ “benign” intentions (Dunn, 1990) as well as values (Barbalet, 1996, Earle, 2010a, Earle, 2010b; Earle and Siegrist, 2006). It therefore relates to morality judgments about others, and therefore is experienced in interpersonal relationships. The antecedents of trust, as identified in a wide variety of empirical studies, include social relations, benevolence, integrity, fairness, and caring (Earle and Seigrist, 2006). However, these are “placed in the freedom of others” as Earle and Siegrist put it (2006), and at the same time they are limited to internalized feelings or judgments, and hence dissociated from action. Trust is therefore passive.

In this study, trust was encountered in Mexico, and was probably formed early in the project timeline. However, while trust developed from comfort with the researchers, and was important to maintain the interpersonal relationships, it was obviously not sufficient to create satisfaction.

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Satisfaction was related to constant assessments of the researchers’ performance. As I frequently explained in this chapter as well as in Chapters 8, confidence was contingent on satisfaction, which was a function of the extent that the community felt respected, in control, and that their interests were being promoted. In other words, confidence was a function of met expectations. This claim is support by the literature, where confidence is defined as the belief, based on experience or evidence, that another's actions will correspond with one's expectations and that certain future events will occur as expected (Barbalet 1996, 1998; Earle and Siegrist, 2006, Earle 2010a). This definition is based on Rotter's (1967, p. 651) classic view that confidence is "a generalized expectancy held by an individual that the word of another ... can be relied on". For instance, parties in alliances were found to be more confident about partner cooperation when they feel they have an adequate level of control over their partners (Beamish, 1988; Sohn, 1994).

Moreover, confidence and satisfaction have been shown to be promoters of cooperation and partnership development (Earle and Siegrist, 2006; Earle, 2010a, 2010b; Das and Teng, 2009). Yaqub et al (2010) found that the successive realization of mutually beneficial outcomes engenders satisfaction between the participants in a relationship, which in turn fosters process- based confidence, which will ultimately result in increased inter-organizational commitment. Mutual commitment is in fact seen as the foundation of successful relationships (Berry and Parasuraman, 1991). Drawing on the conceptualization of commitment in social exchange (Cook and Emrson, 1978), marriage (Thompson and Spanier), relationships marketing (Berry and Prasuraman, 1991), and organizations (Meyer and Allen, 1984), Morgan and Hunt (1994) define relationship commitment as “an exchange partner believing that an ongoing relationship with another is so important as to warrant maximum efforts at maintaining it; that is, the committed party believes the relationship is worth working on to ensure that it endures indefinitely”. They also note that parties in successful relationships often identify commitment as key to achieving valuable outcomes for themselves (Morgan and Hunt, 1994).

This body of scholarship supports my findings, where I showed that in Mexico satisfaction derived from met expectations (Table 14.1), engendered community confidence in the researchers and in the trials, which nurtured the emerging partnership between the community and the researchers. Commitment to support the relationship meant to the community that their own interests would be promoted. Finally, there was also evidence that the community’s commitment to support the project was a reflection of an underlying reciprocity. Reciprocity and

262 its role in promoting cooperation also finds support in a large body of literature, especially from research on social exchange theory (Das and Teng, 1998; Gulati, 1995, 1999; Johnson et al, 1997; McDonald, 1981; Morgan and Hunt, 1994; Ring and Van de Van, 1994; Yaqub et al, 2010).

3 Summary

In this chapter I presented an explanatory account of community judgment and response formation in relation to the GMM trials. I showed that judgments form in the context of narratives, and that these narratives reflect the affect of the community. I also showed that openness to the trials, marked by approvals to admit the trials to the community (Chapter 15) is contingent on an adequate level of comfort, while authorization, entailing commitment is a function of maintained comfort and of developed satisfaction and confidence. These in turn are contingent on the extent to which the community’s expectations are met, whereby the community feels respected, in control, and that their interests are being promoted.

Authorization= f(Action) = f(Commitment)= f(Confidence + Satisfaction) = f(Expectations) =f(control)+f(respect)+f(interests promotion) (f:function)

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Chapter 15 Procedural and Substantive Aspects of Community Authorization

In Part II, I showed that community authorization consisted of two types of approval, formal and informal. In Part III, I showed that only formal approval was sought and granted for the trials in both Malaysia and the Cayman Islands. I also showed that communities in both countries considered that this approval was not reflective of or equivalent to community approval. The cross-case comparison reveals that the different actions denoting formal or informal approval can be divided into two chronological stages of approval: 1) Admission, and 2) Reinforcement and Maintenance. The admission stage comprised all the decisions that authorized the trials to be admitted into the community at different levels, while the stage of reinforcement and maintenance included all the actions that denoted ongoing approval for the research. In this chapter, I discuss these two stages of approval, which together constitute authorization. The framework embedded in this discussion can be used as the foundation for a roadmap for GMM trials and researchers.

1 Admission

‘Admission’ stage comprised all the formal decisions that were taken at different levels of the community to open the door for the project to be admitted into the community. These included the research collaboration agreement between the local research institutions and the GMM technology developers, institutional scientific and ethics clearance, regulatory approval, regional or state approval, and the local authorities consent in the micro community. Most of these decisions were taken by authorities who have ‘stewardship’ interests, i.e. responsibility to protect the community and look after their interests (e.g., promoting the public/common good such as public health, research capacity, and knowledge economy). As can be inferred from the case

264 studies from Mexico and Malaysia (Chapters 7-9, 13), these decisions were not preceded by major interactions or relationship building with the community, and were only contingent on the relevant authorities having a certain level of comfort, based on the ‘relevance’ of the research, its satisfaction of safety criteria, and its ‘resonance’ with the community interests. Consequently, and as I explained in the previous chapter, these decisions reflected ‘openness’ to the trials, which led to admitting them into the communities in both settings. In Malaysia however, the approval processes were limited to this stage. In other words, the project was admitted to the micro community, but was not ‘authorized’ to proceed by those who have the highest stakes in the conduct and outcomes of the research, i.e., the residents of the micro community.

In the following section, I will present each of the admission decisions, and discuss their conditions, as well as some implications for practice, as grounded in the data. Table 15.1 summarizes these decisions.

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Table 15.1: Admission Stage of Approval

1.1 Research collaboration agreement

In the three countries, the first manifestation of endorsement was in establishing scientific collaboration between researchers from developed countries and local public health or research governmental agencies. These agencies have the responsibility of public health promotion and hence had interests in promoting initiatives aimed at finding solutions for vector borne-diseases. The role of these agencies was to first establish the relevance as well as the scientific value of the trials, and then act as local partners for implementation. As I have discussed in the previous chapter and will reiterate in this and the next chapter, sharing control with the community turned to be crucial to establish respect, engender satisfaction and confidence. In Chapter 8, I explained

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that CRISP assumed fully the research related responsibilities, and turned from being engaged by the foreign researchers, to engaging the local community. Members of the community, whether at the macro or the micro levels, felt comfortable with the researchers who were familiar and close (Chapter 8), and had a sense of control knowing who exactly was responsible and accountable for the research, and that these researchers are “neighbors” (Current Comisariado) (Chapter 8). The project was therefore perceived as being owned by the community, indicating the first sign of an authentic partnership. In Malaysia on the other hand, many examples (Chapter 13) showed that IMR did not assume full responsibility for the trials and Oxitec was perceived as having the control, and therefore the project remained foreign to the community, who consequently felt powerless and exposed.

These results denote the importance of partnering with local research institutions that independently have the capacity to develop and implement research studies and have experience in community-based research, and who are perceived as credible in the communities in which they work. Sharing control with local partners appeared to be the first step towards local governance of the research (Lavery et al., 2010).

1.2 Regulatory approval

Approval by regulatory agencies at the national governmental level is now recognized to be a necessary step before any GMM trial, and was obtained in the three countries. The experiences from the three trials show however that this type of approval is necessary but not sufficient (Chapters 9, 12, 13). The purpose of this approval is to establish biosafety and biosecurity, but the community was cognizant of the fact that it was not a sanction to proceed with the trials. A regulatory approval basically meant to these communities that the trials could be conducted once other safeguards and approvals (such as community approval) were established, and is therefore conditional. Moreover, the experience from Malaysia and the Cayman Islands in particular indicate that from the community’s perspectives, the legitimacy and validity of a regulatory approval is contingent on the satisfaction of certain conditions. These included the implementation of a transparent, thorough, and multi-agency risk assessment process that is designed to take into consideration all types of risks beyond the technical and the scientific, as well as to create meaningful opportunities for interest groups and interested individuals to provide input (Chapters 12 and 13). Finally, for the purposes of site selection for future research

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trials, it seems crucial to identify a setting where a robust biosafety and regulatory system is already in place, and where the Cartagena protocol on Biosafety is ratified (Lavery et al., 2008). Established regulatory protocols can minimize the likelihood of inappropriate manipulation of the regulatory processes. For instance in Malaysia, many community groups, international organizations, as well as scholars criticized the regulatory system and the new biosafety act for being unduly influenced by Oxitec (who conducted training workshops for regulators), and thus for being designed to fit the purposes of the trials. The regulatory system was consequently accused of overlooking some risks (Chapter 13).

1.3 Approval from authorities at meso-community level when prescribed by jurisdiction

The data I had about this level in the three settings were limited. In Malaysia it was legally required to secure an approval from the host province’s authorities. In Mexico on the other hand, just informing the county relevant agencies as well as the mayor was sufficient (Chapter 9). Although there was no requirement for a formal approval at this level, authorities had the power, as stewards of the community’s interests, to prohibit the trials had they suspected it would jeopardize the interests of the community. This insight points to the value of negative opinions, especially at an official level, even when no decisions are required. Moreover, it emphasizes the need to reach out to different official constituents of the community at all levels of hierarchy.

1.4 Consent from local community authorities to admit the trials into their communities

In both Malaysia and Mexico, the research institutes received consent from local official authorities to host the trials in their communities. In Malaysia however, although the local council in Bentong authorized the trials, the community both at the macro and micro levels protested and claimed that the community in Bentong did not provide its consent, and demand public forums where community members could receive information and voice their opinions. This finding implies that the approval of official authorities is not equivalent to community approval (as was claimed by researchers in Malaysia), a common misunderstanding that is often encountered in the literature (Macer, 2005; Resnik, 2014; Subaramian, 2012), but is only one aspect of it (Chapter 16). At the same time it points to the need for transparent information

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provision and opportunities for public deliberations. Although the available reports in the media did not indicate who would be invited to these public forums, and how the “consent” of the community would be operationalized, one could conclude from the available data that local traditional leaders, opinion leaders, and interested individuals would have been concerned and interested in participating. In Mexico, the traditional leadership in Río Florido, represented by the assembly of ejidatarios (land owners), also has official status. Still, the first decision to admit the project into the host community was preceded by many sessions of information provision, explanation, discussions, and hence opportunities within and between sessions for intra- community deliberations.

2 Reinforcement and Maintenance

One of the main differences between the approach in Mexico and the one in the Malaysia, was the way ‘community consent’ for the trials was viewed and operationalized. In Malaysia, community consent was limited to the official authorities’ consent described in the previous section, because the releases were conducted in an uninhabited forest. Had the area been inhabited, the original plan was to hold a public forum where residents could “give their approval” (NBB, 2010a). In other words, the approval of the community was seen as a one-time decision that could be achieved in an administrative meeting. In Mexico on the other hand, the community in Río Florido was not asked for a blanket or holistic approval for the project, but were asked to just “open the door” (PI, Previous Comisariado), and then assess each research activity independently. This multi-step permission was based on incremental and gradual (step- by-step) information provision, discussions, and hence understanding (Current Comisariado, Chapter 8). Consequently, the researchers organized periodical sessions for community members to hear about the trials, learn about updates, ask their questions, voice their concerns, and have discussions about the trials.

“I can not ask them for permission to release GM mosquitoes in the cages and they still don’t understand what GM is, or even why they would be in cages. We started with explaining basic things, we went there to the ejido and talked to them both in formal sessions with the assemblea or informally with other people in the casa ejidal [community center], we explained and discussed and asked them questions and they asked us questions, mosquitoes, then dengue, bit by bit, and asked for permission to do

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basic things, baseline epi [epidemiological] work, then we built up… we told them everything will be step-wise, and we will be updating them and explaining to them, and will go back to them and ask for permission, can we do this, can we do that?” (Ramsey)

Accordingly, the multi-step permission meant that all research-related activities for the contained trials, no matter how mundane they were, involved the community from start to finish. In Malaysia on the other hand, although the research started in 2006 and passed through different stages from laboratory to semi-contained conditions (Lee et al, 2013) before proceeding into open release, the community wasn’t brought into the picture until few weeks before the open release.

The incremental or ‘multi-step’ approach created therefore a structure or a system for ‘upstream’ engagement (Rodgers-Hayden and Pidgeon, 2007) fostering partnership between the researchers and the community to develop and enable authorization to evolve and manifest.

First, by engaging in multiple encounters with the community, interactions and consequently inter-personal relationships were promoted. It became then easier for the researchers to conduct activities in the community, and for the community members to interact with these activities and offer support in different capacities. Multiple encounters also created opportunities for community members to first digest the information, and then come back with their questions either to the researchers or to their leaders, leading to development of ‘conversations’ between the researchers and the community rather than one-way communication (such as briefing sessions). These conversations led in turn to better understanding of information as expressed by community members (Chapter 8).

Some of the limitations of consultative or informational exercises, such as the ones conducted in Malaysia, lie in their focus on information provision without opportunities for understanding, as well as missing on the kind of learning that forms over time by interaction and deliberation between members of the community. These exercises often lead to counterproductive knee-jerk reactions that certain groups with agendas can capitalize on. By allowing time between different encounters, the multi-step approach allows community members to have enough time for deliberating amongst each other, without the anxiety usually associated with time-pressed decision-making, and hence forming collective judgments that reflect the values and interests of the community as a whole rather than the values or agendas of certain groups (Chapter 4).

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Increased understanding can also enhance the legitimacy of individual informed consent granted by heads of families in households where experiments were being conducted.

Furthermore, the multi-step approach serves a political function as it allows members of the community opportunities for a sort of ‘civic engagement’ in ‘democratic’ interactions around the project. First, members have time to constantly assess the merit of the project as well as the performance of the researchers. Consequently, they have the chance to voice their concerns and procedures could be negotiated or even adjusted accordingly when possible. Finally, community members could question their own leaders if authoritarian decisions have been taken. In this sense, breaking up the authorities’ consent into different steps would prevent a “fait-accompli” (Anti-GMM Coalition, 2011). As a summary, the multi-step consent approach has the potential to enhance understanding and therefore increase the chances of informed decisions as well as to promote voluntariness and control.

In chapter 9, I showed that in Mexico informal approval, consisting of ‘embracing’ the project coupled with lack of opposition, constituted a major aspect of community authorization. Through frequent interactions, interpersonal relationships develop, and hence opportunities for regular members of the community to be involved in the project and its activities arise. In the previous chapters I explained how reciprocity develops when satisfaction and confidence are established following positive assessments of performance. By providing their support, community members show their approval for the trials, constituting the final link in the authorization chain, and filling the gap between formal government approval, authorities consent, and individual informed consent from those who are considered research subjects.

Finally, in Mexico the absence of opposition was indicative of the continuous state of approval, while in Malaysia the presence of opposition negated and precluded community authorization. At first sight it might appear that the presence of opposition would negate authorization, and it would be counter-intuitive to talk about both at the same time. However, as I explained in Chapter 13, opposition is like authorization, multi-dimensional and multi-leveled, and therefore, it would be possible, and even likely, to encounter some opposition from certain groups and yet have authentic community authorization. The question then is, how much opposition can be tolerated, and how much opposition is significant to preclude a state of authorization? First of all, the findings from the Cayman Islands indicate that lack of opposition could be considered

271 meaningful only if information was provided to the community and opportunities for involvement have been afforded (Chapter 12). On the other hand, I presented in Chapter 13 the features of the opposition in Malaysia, and theorized that opposition that is encountered at different levels of the community, and that is expressed by different groups (and not only by special interest groups such as environmental organizations) would be considerable. However, every situation needs to be assessed in situ. For example, if concerns come up, researchers can address them and negotiate them through their interactions with the community, and if opposition arises, whether at the macro or micro, researchers can discuss the value of dissenting opinions with the partners and gauge their significance.

Table 15.2: Reinforcement and Maintenance Stage of Approval

3 Summary

The findings from this study support a view of authorization as a continuous state of ongoing approval for research to have access to the host community and conduct activities in it. Accordingly, community authorization does not consist of a single discrete decision or a sum of decisions. This state, which is manifested at different levels of the community, including the macro (national) and micro (host) levels, consists of two stages. The first stage marks the admission of the research into the community, or opening the door for it, while the second stage involves all the decisions and actions that are taken by community members, authorities and publics, to permit the activities of the research to be conducted and to show to show their support and endorsement.

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Chapter 16 Implications and Conclusion

In the previous two chapters, I presented an interpretive account of the findings, where I compared the three case studies and analyzed and discussed the social processes, as well as the procedural and substantive components of community authorization. In this chapter, I discuss the implications of these findings for practice and for future scholarship and research. I start by summarizing the theory of community authorization, and then show how this theory can be generalized to apply to other fields of research as well as other disciplines. I then discuss the implications of these findings for the field of bioethics, and for practical guidance for funders, scientists and research programs, as well as regulatory agencies or research ethics boards (policy). I end this chapter by suggesting points for future research, and showing the limitations of my study.

GMM technology is still relatively in ‘upstream’ stages, and more empirical research is certainly needed for the development of evidence-based guidelines and policies. However, as the GMM field is moving quite fast towards application and commercialization, and as the end of practical knowledge is “to do,” not simply “to know” (Aristotle, 2009), we need to start putting any knowledge we have into practice. This thesis provides the first empirical evidence for community authorization, its meanings, and its contributing factors.

In Chapter 5 I stated that I followed a constructivist approach to qualitative research, and hence I view empirical data as partial accounts of research participants’ experiences, that are contextually unique. The question then is, to what extent can these data guide the development of ethical norms (Dunn and Ives, 2009)? I stress that my theory of community authorization is explanatory and not normative. However, I believe that the findings are generalizable to other contexts as well as research fields. Moreover, by taking into account actual experiences and meanings, I can propose recommendations that are connected to real life situations (Musschenga, 2005), and which can be explored in future research, or even considered as departure points for

273 normative conversations. I uphold Lindblom’s view that moral decision-making has more to do with “muddling through problems” rather than with rational problem-solving (Hoffmaster, 1992;

Lindblom, 1959)

1 Community Authorization Theory

The purpose of this thesis was to build an explanatory grounded theory of community authorization for GMM trials, answering the question “What constitutes community authorization to begin and proceed with caged-field or open release GMM trials?”. The development of this theory focused on three main aspects of the authorization phenomenon: 1) the meaning of authorization for such trials from different perspectives, 2) the kinds of formal and informal actions that were taken by different groups of the community to signify authorization, and 3) the factors that affected these actions.

In this section I crystallize the findings into a grounded theory of community authorization. The grounded theory is an “explanatory scheme comprising a set of concepts related to each other through logical patterns of connectivity” (Birks and Mills, 2011: 112-113).

The findings of this study support a relational notion of community authorization. Community authorization does not consist of a single discrete decision or a sum of decisions, but is rather an experiential state of ongoing approval for the research to have access to the host community and conduct activities in it. This state, which is manifested at different levels of the community, including the macro (national) and micro (host) levels, consists of two stages.

The first stage of approval is ‘Admission’, and includes all the formal decisions that are taken at an institutional, regulatory, national, regional, and local levels to admit the research into the community. At the macro level, these decision are mostly taken by official authorities, while at the micro level (host community), decisions include those taken by both official authorities as well as traditional and moral leaders, stressing the importance of mapping stakeholders from the inception of the research to identify representatives who can legitimately speak for the different sub-communities. At both macro and micro levels, the participation of the publics (which include interest groups) in this approval stage is essential. This means disseminating wide scale

274 information about the research (for example through seminars, public forums, and involvement of opinion leaders), and actively seeking feedback (for example through focus groups and consultation sessions). At this stage, authorization reflects initial comfort with the research, as well as interest in its outcomes, based on the ‘relevance’ of the research, its satisfaction of safety criteria, and its ‘resonance’ with the community interests. It therefore implies openness to risk.

The ‘Admission’ stage of approval is necessary, but non-sufficient, and needs continuous maintenance and reinforcement by the community, particularly the host community. The second stage of approval, ‘Maintenance and Reinforcement’, includes all the formal decisions and informal actions taken by community members at all levels to permit activities or to show their support and endorsement for the research, and hence maintain and reinforce the initial approval. Decisions include those taken by authorities and leaders to authorize individual activities directly related to the execution of the research and its milestones (such as permission to build cages for contained-field trials, placement of traps for mosquito collection, or approaching homeowners for home-based experiments), or non-related to the experimental execution of the trials (such as informational activities or public forums and focus groups). Decisions also include informed consent by homeowners to allow experiments such as mosquito collection or release to be conducted in their homes.

On the other hand, approval at this stage can be mostly suggested by all the informal actions that reflect the community’s positive attitudes towards the project on a continuous basis. These include expression of satisfaction or other positive emotions about the research project and its conduct, favorably responding to researchers’ requests, and actively offering help to enable the research activities. By providing their support, community members show their approval for the trials, constituting the final link in the authorization chain, and filling the gap between formal government approval, authorities consent, and individual informed consent from those who are considered research subjects. Absence of antagonism in the community is also reflective of approval, given the community is fully informed about the trials. Approval in this stage reflects developed confidence in both researchers and in the potential of the research, as well as satisfaction with the conduct of research.

Community authorization therefore includes but is not limited to “community consent”, and takes into consideration the interactions that occur between individuals, groups, and researchers,

275 and the ways these non-linear nodal interactions shape as well as enact judgments related to the research. Consequently, a relational approach to interactions with the community, aiming at building equitable relationships and reciprocity, has the potential to enable community authorization. These relationships are maintained as long as the community feels respected, in control, and that their interests are not jeopardized. In this sense, community authorization is conditional and temporal, and is not a mere permission for research, but is a permission that entails mutual responsibility and commitment to cooperate and collaborate. Finally, community authorization is not absolute, and is not an all-or-none state, in the sense that situations and activities need to be assessed on a case-basis, and relationships need to be constantly maintained and reinforced.

2 Lessons and Recommendations

Based on the findings, I can suggest four key lessons that have implications for policy and for practice. For each lesson, I suggest points of action or recommendations targeted at bioethics scholars, funders, regulators/policymakers, and/or researchers.

2.1 Community Authorization includes but is not limited to ‘consent’

The main finding of this thesis is that community authorization for research does not consist of a single discrete decision or a sum of decisions, but is rather an experiential state of ongoing approval for the research to have access to the host community and conduct activities in it. It therefore includes but is not limited to consent.

2.1.1 Implications for Bioethicists

Community “consent” has become a regular feature in the research ethics vernacular related to community-based research (Resnik, 2014, Macer, 2003, 2005, Touré et al, 2003; Touré and Knols, 2005, Touré and Manga, 2006; Weijer et al, 1999). However, whenever “consent” is invoked, community approval is immediately correlated in the minds of users as well as readers with the prevalent, widely recognized “individual informed consent”. Consequently the discourse seems to get stuck in the procedural aspects of traditional informed consent. The problem with using “consent” in this context lies in it bringing people back to notions inspired by liberal democratic models designed to protect the individual, and hence perceiving community ‘consent’

276 as a sum and collection of informed consent from all its individuals, or to representative democratic notions, substituting community approval by explicit permission of its representative leaders (for a more detailed discussion refer to Chapters 3 and 4). For example the researchers in Malaysia justified ‘waiving’ community approval by stating: “There were some concerns that applicants did not get individual informed consent from communities at the trial site. Individual informed consent is a process aptly used in research when individuals partake actively on a one-to-one basis for example in clinical drug or vaccine trials... It was widely acknowledged that it is impossible and impractical to get approval from every individual when the research was not intrusive and involved a field release in an uninhabited area” (Subramaniam, 2012)

The use of “consent” in referral to community approval or authorization constantly forces us to fall in a language trap (Hacker, 1972) that Wittgenstein (1991) describes as “[a] picture [that] has held us captive. And we could not get outside it, for it lay in our language and language seemed to repeat it to us inexorably”. In their recent published paper on the regulatory structure, the researchers in Mexico were cognizant of this conceptualization error, and used the term ‘pragmatic “informed consent”’ (Ramsey et al, 2014) to refer to community approval processes (reporting “informed consent” between quotations in the original article illustrates the awkwardness associated with using it in this context).

To be able to envisage new possibilities for community approval for GMM trials or other types of research (as suggested by the findings of this thesis), and to preclude falling again into the same trap, a solution is then not to repurpose “consent” but to limit it to its initial intended meaning. In other words, we have to limit the use of “informed consent” only to refer to informed consent sought from individuals who are considered subjects of research. And we need to start using ‘community authorization’, in the sense developed in this thesis, to refer to all the formal and informal processes that are needed to begin and proceed with GMM trials, or any trials of similar nature and impact on communities, as I detail in a later section.

Moreover, the definition of Research Human Subjects seems to be awkward in these types of trials, forcing researchers into viewing authorization in purely technical terms. As mosquitoes disperse quickly throughout areas of radiuses reaching 320 m (Liew & Curtis, 2004), everyone in the vicinity of the experiment or release site would be automatically and directly affected, even if the environmental manipulation is not specifically “designed to produce a direct effect on that

277 individual” (McRae et al., 2011a, 2011b), that is if the individual is “subjected to an action by the investigator” (National Bioethics Advisory Commission, 2001). On the other hand, if we follow these definitions, then no one in the community, including those who allow experiments in their homes, would be considered a research subject, as the trials are not designed to obtain any data about those individuals, but about their environment, which is ‘shared’ by others. The concept of informed consent from these homeowners (as suggested by King et al. (in press) and Resnik (2014), seems to be artificial in this type of research. For example, why wouldn’t the neighbor, who is sharing the exact same risks provide consent too? And why would researchers get consent from one member of the household and not the others?

Moreover, it was obvious that all those who allowed experiments to be conducted in their “backyards”, did it for the communal benefit, and were also influenced by the general communal sentiments about the trials. Therefore we might need a new conceptualization of research participants.

2.1.2 Implications for Policy Makers/Regulators/Research Ethics Committees

One way to enforce a system of approval for trials is by creating a multi-stage regulatory or institutional ethical approval. The findings point to a multi-stage notion of community authorization, where even consent from authorities and leadership is step-wise (Chapter 15). Accordingly, regulatory and institutional approval should parallel the process in the community. Every stage of approval would be activity or group of activities-specific and would be contingent on the approval from the host community for these activities, and on the presence of proof of efforts by researchers to engage the rest of the community (publics), which could be communicated through appointment of a community representative on the boards (practiced in aboriginal research overview).

Moreover, in order to operationalize new conceptions of research subjects, I suggest the creation of a system of cluster approval (described below). The multi-stage approval would also be contingent on evidence of cluster approval.

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2.1.3 Implications for Researchers

In this system, the community would be divided into clusters, or units of neighbors (including homeowners where experiments or research activities are assigned). Researchers would invite these units to meetings where information about the research would be given, in presence of authorities, traditional leaders, and opinion leaders from civil society. These meetings would not be limited to information provision, but would aim to create a discussion between community members themselves, in the sense of moral dialogues to reach a consensus of values to elicit ‘assent upon reflection’, as suggested by Kuczewski (2002, 2009) (For a detailed discussion please refer to Chapter 4). There are many mechanisms for consensus decision-making that also could be used, but these are beyond the scope of this thesis, and are probably dependent on the context itself.

In this system, homeowners’ decision whether to allow researchers in their homes or not, would be a direct reflection of the communal position toward the research, as it affects them and the whole community. In other words, individual decisions would be reflective of the communal life and its relationship with the trials. Their consent would be an agreement to allow researchers into their homes, and not consent to be research subjects (in other words, more related to civil matters than to bioethics). On the other hand, investigators are also challenged by questions about the meaning of informed consent in communities that are largely unfamiliar with vector biology, genetic modification and often the role of mosquitoes in transmitting disease (Marshall and Taylor, 2009). In fact, many raised concerns that homeowners, not knowing what genetic modification is, did not understand the goals of the trials in both Malaysia and the Cayman Islands, even when informed consent was obtained. In these instances, the spirit of informed was completely lost. Cluster meetings that take into account the kind of learning that forms over time by interaction and deliberation between members of the community, could enhance individual understanding, and hence informed decisions.

2.2 Community Authorization is a multilevel phenomenon

Most literature pertaining to the ethical and social issues related to GMM trials, recommend building relationship with authorities (Lavery et al., 2010), and securing permission or authorization from community leaders or ‘gatekeepers’ (Diallo et al, 2005; Macer, 2003, 2005;

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Resnik, 2014). Findings of this study however point to the role of publics, as integral constituents of the community, in authorization for research, i.e. those who do not have any official status and who might concurrently belong to different sub-communities (including civil society organizations, academia, peasant organizations, homemakers, students, and so on). Nonetheless, results from the three cases suggest that while researchers have to inform and consult the macro public, relationships need to be developed and maintained with the micro public (in the host community). For example, in Malaysia, all commentators called for information sessions and general “consensus” in the macro setting, and for public forums to build “consent” in the local community. In Mexico for example, schoolteachers, school children, and women organizations among others in the local community, were the focus of the researchers’ activities and relationships.

2.2.1 Implications for Researchers:

This lesson calls for researchers to be inclusive in their interactions with the community at all levels, macro and micro, yet be focused on the micro community and its different constituents. That also means selecting or developing procedures and activities for engaging with the different publics that are most appropriate for every setting and in collaboration with community members. For example, in Malaysia, with a more urban setting and higher levels of scientific literacy in Bentong than in Río Florido in Mexico, community members asked for mechanisms for public participation in decision-making like the ones used in Denmark (e.g. citizens conferences). Also, while researchers can engage with the macro publics in initial consultations and in periodical encounters for updates and information, interactions with the micro community need to progress in a continuous manner and in form of relationships.

Nonetheless, legitimate and proper representation is often problematic in participatory efforts (Israel et al., 1998; Zakus and Lysack, 1998). Community Advisory Boards were suggested as effective mechanisms to represent community perspectives regarding health priorities and concerns (Conway et al, 1997), and to serve as a liaison between participants and researchers. Nevertheless, ensuring that CAB representatives are “actively connected to diverse people in their local communities and empowered to function in ways that are meaningful to their community base” (MacQueen et al, 2001) is essential to prevent conflicts, improve validity and maximize efficiency. Moreover, a common error in scientific arenas is equating non-

280 governmental organizations (NGOs) with the public, leading to foregoing interactions with community groups to prevent clashes (experience in Malaysia and the Cayman Islands). Although many NGOs often claim to speak in the public interest, ‘public opinion’ will not always support them (Hagendijk and Irwin, 2006).

2.2.2 Implications for regulators/research ethics committees

First, committees need to develop and apply informed definitions of ‘community’, and include these definitions in their assessment of the ethical, social, and cultural aspects of research trials. Second, these committees should work with researchers to select or develop the most appropriate procedures to engage with lay members of the public, and adopt these procedures as part of their research assessment criteria.

Third, as I will elaborate in a following section, regulatory and research ethics committee need to open up their constituency to include members of the community in which the research operates, as is practiced in many settings where research is conducted in aboriginal communities. In case community advisory committees or boards were established in the host community, regulators and research ethics committee should include input from these boards in their regular assessments, especially if a multi-stage approval system is adopted.

2.3 CA is a relational process not a procedural milestone

In each of the three case-studies settings, ‘engagement’ was understood and enacted differently. For instance, in Malaysia, the researchers stated that “engagement is generally raising awareness of science and the issues it raises among the public” (Subramaniam, 2012).

This view of engagement is obviously informed by the ‘deficit model’ of public engagement (Irwin and Michael 2003, Sundqvist and Elam, 2010). This model, “tested to destruction in a series of science policy disasters, such as BSE and genetically modified food” (Jones, 2014), views that the problem that needs to be solved is “the deficient scientific knowledge of a reluctant public, so that they can be persuaded to accept a controversial technology that ‘science’ has determined to be an appropriate and safe response to some problem” (Jones, 2014). This model sees that opposition to research and technology is caused by lack of information, which

281 explains why researchers in Malaysia and the Cayman avoided interactions with the ‘inexpert’ community, in order to prevent any public opposition to the trials (Chapters 12 and 13). In Mexico on the other hand, researchers adopted a participatory relational approach to engagement that aimed at building a partnership with the community (Chapter 8).

In international biomedical research, collaborative partnerships with communities are now widely recognized as a fundamental ethical requirement (Coe et al., 2006, Emanuel et al, 2004). Tindana et al (2007) consider that community engagement is the “process of working collaboratively with relevant partners who share common goals and interests”. This process involves “building authentic partnerships, including mutual respect and active, inclusive participation; power sharing and equity; mutual benefit or finding the ‘win-win’ possibility” (Zakus and Lysack 1998).

Most of this scholarship though, derived its information and recommendations from research in or with localized and confined communities, and which was not subject to multi-level regulatory considerations in which multiple stakeholders had interests in decision-making. In this regard, drawing on scholarship from public engagement in scientific and technological policy decision- making is relevant to GMM trials. Contemporary understandings of ‘engagement’ from this field stress early (upstream) deliberation between all stakeholders who may be affected by the results of the research (London, 1999; Royal Society and Royal Academy of Engineering, 2004) with the aim of participating in the governance of the science and technology. These views draw on theories of deliberative and participatory democracy (Habermas, 1989; Rawls, 1971), “in which direct deliberation is seen as a solution both to the inadequacies of representative democracy and to the vagaries of social choice” (Arrow, 1951).

However, in practice there is great variation in how engagement is understood and enacted (Marris and Rose, 2010). Barney (2006) found that engagement is often used “to apply the veneer of democratic legitimacy to policy development and decision-making undertaken through elite consultation and accommodation; to ‘educate’ the public and significant stakeholders, increasing their ‘awareness’ surrounding contentious policy issues in the hope of mitigating ‘uninformed’ opposition; to gather strategic information about how various constituencies might be expected to react to specific policy outcomes; and, to test and optimize public communication strategies surrounding particular initiatives, programs and policies”.

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In other words, engagement can serve strategic purposes as part of an agenda with ends that are usually in the interests of the scientific establishment, and often the community interests get lost in the process. In such cases, engagement becomes perfunctory, stripped of its spirit, and often gets counterproductive.

The problematic in my opinion lies in the focus on engaging the community rather than engaging with the community. Engagement inherently implies an engager and an engaged and hence power imbalance that challenges the very foundations of engagement. A change of discourse is probably the first needed step to get us back on the right track. We need to appeal to a clearer concept that is less prone to multiple and contradictory interpretations. We probably need to revive the concept of community partnerships, but develop its dimensions to be applicable and concretely useful for the field of GMM trials.

2.3.1 Implications for Researchers

The most important message of my study is that community authorization is contingent on developing mutually respectful and mutually committed relationships between the researchers and the community. In other words, community authorization, as well as collaborative interactions with the community, should be a ‘lifestyle’ for the research rather than an exercise.

To adopt this ‘lifestyle’ successfully, upstream integration in the community, or “insertion” as expressed by Dr. Janine Ramsey the PI in Mexico, from day one is of paramount importance. This means that the research should start priming the relationships and developing them with different stakeholders even at Phase I of research (laboratory). It also means that Phase III releases shouldn’t be attempted, before the researchers have established themselves as “neighbors” (Chapter 8) or “insiders” in the community (Cocker, 1991), preferably during phase II research (contained-field trials).

David Crocker (1991) proposed a dynamic approach to the ethical relationship between researchers and the community, in which the relationship is in constant flux and undergoes constant scrutiny and fine-tuning. He views that part of the dynamic work required of researchers in developing and improving on a constant basis their relationship with a community may lie in gaining ground as insiders.

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My recommendation to achieve ‘insiderness’ is based on the Mexican experience. There, humility, transparency, presence, and demonstration of care about the community’s interests, were the key ingredients. Framing the relationships as “invitations to collaborate” (Mexico) rather than “engagement exercises” (Malaysia) is also crucial to create a comfortable and equitable environment. Marketing approaches, such as using advertisements through the media, can in my opinion have the opposite effect. In other words, simple rather than complex approaches are the key.

2.3.2 Recommendations for Regulators/Research Ethics Committees

In Section 2.2 I proposed a multi-stage approval system for continuous assessment of the conduct of research. The implication of the above discussion is that regulators or overseeing research ethics committees need to incorporate assessment of the relationships between the researchers and the community in their appraisal stages. Having community members on the boards might help in providing real time information about these relationships and about researchers’ efforts to engage with all constituents of the community.

An example can be drawn from scholarship for research in aboriginal communities. Freeman (2003) gives an example from the United States, where community relationships are stressed in the process of application to Native American Research Centers for Health (NARCH): “In science review, each grant proposal is judged on both the scientific merits of the research projects and also the quality of the relationship of the tribe and the researcher. For instance, the Request for Application for NARCH gave the following criteria for judgment: ‘ the quality of the partnership of the institutional and community partners, and the quality of the involvement of the Community and Scientific Advisory Council, as demonstrated by documentation of, for instance: the intellectual and tangible contributions and activities of the partners, and of the Council, in developing the application and the proposed NARCH; the interactions of the partners, and the members of the Council, in meetings such as those to develop the application and proposed NARCH; the past activities and future plans to increase the capacity of the partners and of the Council; the plans for future contributions and activities by the partners; and by the Council, in development of the partnership itself (Freeman, 2003b: 42).

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2.4 ESC aspects should be given the same consideration in appraisal as the technical aspects of research

All the recommendations from the previous section indicate that the ethical, social, and cultural aspects of research should be given the same attention as the technical ones. In fact, although the science was successful in both Malaysia and the Cayman Islands, lack of attention to the ESC aspects of research undermined its impact. When the results from the Cayman Islands were announced at the meeting of the American Society of Tropical Medicine and Hygiene, they created a mixed reaction from researchers and commentators alike, instead of generating hope and excitement (Chapter 3). Many have even questioned the validity of these results (Reeves et al, 2012). In Malaysia, despite the fast spread of Dengue in the country, the release of GMM seems to remain a contentious issue (No plan yet to release GM mosquitoes to fight dengue, 2013, July 13). In Mexico on the other hand, the community was disappointed when they learned of the unsuccessful results of the trials.

The first recommendation is for funders to mandate detailed plans in research proposals, on how relationships with the community will be approached, developed, and maintained, and how community authorization would be gauged. This means that funders need experts on their assessment committees, with experience in participatory research modalities. It also means that grants should include budget and time provisions dedicated for the ethical, social, and cultural aspects of the research. Budgets for example should allow for dedicated staff. I recommend a minimum of one staff member at a national level and two members in the host community. The exact number of staff members ultimately depends on the size and complexity of the communities. For example, in Río Florido having two dedicated specialists (anthropologist and communication specialist) was sufficient, while in a larger setting like Bentong, more staff might have been needed. Budgets should also include provisions for training of local capacity, such as ethics committees, in participatory mechanisms, as well as for operational costs (such as having members of the community on ethics committees, and conducting different meetings, seminars, focus groups, etc.)

Regulatory and ethics boards and committees need to familiarize themselves with participatory research mechanisms as well as participatory decision-making processes. One of the practical ways to achieve this goal, is to open up committee constituency to include 50% non-technical

285 experts, including but not limited to the following: Public health specialist with experience in participatory research, social sciences specialist with experience in community work, and two representatives of the host community. This might also be a practical way of engaging academics in the research.

Having said this, funders, regulators, and oversight ethics committees need new standardized appraisal criteria for assessing and overseeing research proposals, and researchers need standardized and effective guidelines to help them conduct their research in an ethical and collaborative way in the community. These new tools should take into consideration new conceptualizations of research subject and consent (section 2.1). Journals also need criteria to assess these ethical dimensions of research. For example, despite all the international controversy about the Cayman Islands trials (Enserink, 2010, Reeves et al, 2012), Nature journal published the research from the Cayman Islands in two papers (Harris et al, 2011, 2012), without giving any attention to the appropriateness of the ethical consideration sections in these papers. The only framework available today for GMM researchers is the one developed by Lavery et al. (2010) for community engagement in GMM trials. However, the framework provides general principles or points to consider for researchers. My findings support and supplement this framework by elucidating these points and elaborating on them, taking the “science of community engagement” (Newman, 2006) a step further toward developing detailed and evidence based guidelines.

Multi-disciplinary streamlined efforts are needed to tackle this task. Long-established traditions of non-participatory styles of decision-making are not going to be changed overnight (Holmes and Scoones 2001). We critically need to open up GMM ‘research ethics’ beyond ‘bioethics’ and anthropology, often the two disciplines dominating the conversation, and build on the experiences of colleagues from other disciplines such as the ‘Sociology of Scientific Knowledge’, ‘Science and Technology Studies’, and ‘Social Psychology’. We even need to move beyond focusing on GMM trials to develop guidelines that would be useful for all types of research that can affect whole communities.

Science-society relationships as well as science communication underwent many transitions over the past few decades. Approaches to enhance social exchange between science and society were influenced by learned lessons from successive technologies (nuclear technology, biotechnology,

286 nanotechnology). “What happened in science communication in one technology field fed forward to and contributed to shaping what happened in a different field later. We observed that science and technology communication was initiated at a progressively earlier stage of technology development in each field” (Kurath and Gisler, 2009). Yet the experiences from the GMM trials from the Cayman Islands and Malaysia, as well as most of the literature related to GMM trials research ethics (Chapter 3), makes us feel that we are reinventing the wheel, as we seem to miss on all the advances in thinking that were attained in other disciplines and with previous technologies. Our challenge as bioethicists lies in the limits of our existing tools. As we sift through our over-used and exhausted principles, which seem to lose their edge and relevance when we deal with communities rather than with mere individuals (Chapter 3), we tend to get stuck within the confines of what we know and what we are used to. Perhaps the next step would be an international conference inviting colleagues from different disciplines to join their experiences and their efforts through working groups.

3 Implications for Communities

Although most of the actionable implications of the thesis are directed at funders, research ethics review committees, GMM researchers, regulators, and policy makers, this thesis has also implications for communities. By understanding the complex social processes involved in the authorization of GMM trials, those communities that serve as hosts for GMM trials can be better prepared to negotiate with investigators and sponsors, especially where their interests intersect with the trials, and how these interests could be most effectively represented and attended to. Moreover, communities in developing countries are often pressed into making decisions, either because of institutional and political pressures, power imbalances between them and researchers, or because of the fear of missing out on promises of development that research endeavors bring with them. By becoming aware of the authorization processes that could be followed, and by becoming cognizant of the possibilities of equitable relationships between the community and the researchers, there is a possibility of some real community empowerment as they see how their actions can have an impact in the ethical conduct of research and as they can have the time and the freedom to think about their own interests with respect to research.

Ethicists, and other scholars interested in the social processes involved in the interactions between researchers and communities can start working on guidelines in collaboration with

287 different communities in the world who either have experience with research, or who are potential hosts for new trials. They can draw on experiences from aboriginal communities around the world, who have developed their own guidelines for research (Code of Research Ethics, 1997; Freeman, 2003b; Inuit Tapirisat of Canada, 1993; Kaufert et al., 2004; Masuzumi et al., 1993; NHMRC, 1998, Snarch, 2004). These guidelines provide some standardization of processes and procedures and can provide guidance for researchers about the kind of expectations and interests at play in the communities with whom they would like to develop research relationships.

4 Generalizability of My Findings

The initial considerations that the community had at all levels for assessment of the research were related to its safety, relevance, and resonance with the community interests. Subsequently, the community moved into assessment of the research conduct and outcomes, in a constant process of judgment-development and shaping. All of these considerations are not specific to GMM trials. In fact, community authorization for research is expected to be an ethical requirement for any research with the potential of affecting the whole community in nonexcludable and unavoidable way. This can include environmental trials, large-scale epidemiology or genetic research, and even non-health related research such as anthropological and archaeological studies. Furthermore, I believe that the results can be even applicable in non- research settings, such as construction of nuclear and hydroelectric power plants or wind turbines, metallurgy and mining, clearing mine zones, reintegration of child soldiers into their communities, and so on. In all of these cases, the programs have the potential to affect the whole community, and all members of the community will share the risks and the potential benefits in a non-exludable and non-rivalrous way. Moreover, in all of these cases, program executives (including researchers) will need to develop respectful relationships with the community that will host their programs, foster confidence in their work, protect the interests of the community, and depend on the community’s support, including but not limited to non-obstructing program activities.

Moreover, the generalizability of the theory is enhanced by the fact that the findings are derived from three different settings, with different socio-political community structures, and that they confirm previous scholarship from aboriginal communities. Ultimately, the generalizability of

288 the thesis remains an empirical question that needs to be addressed in future research.

5 Areas for future research

This thesis provides the first empirical evidence for the meaning of community authorization for community-based wide scale health research. I suggest four points for future research.

First, this theory needs to be tested in multiple settings of health research and other disciplines, and refined to enhance both its internal and external validity.

Second, I believe that testing the relationship between community-researchers’ relationships and community authorization in prospective research is warranted to enhance our understanding of community authorization, and to further the “science of community engagement” (Newman, 2006).

Third, although the cases from Malaysia and the Cayman islands provide a rich understanding about community opposition for research, two questions need to be answered through empirical research: 1) what constitutes considerable opposition, and 2) what kind and how much opposition can be tolerated?

Fourth, researchers will ultimately need evidence-based and effective tools that will help them develop and gauge the success of their relationships with the communities in which they operate. Moreover, regulatory and overseeing institutions will require standardized rating tools as bases of an evidence-based appraisal framework. In Chapter 14, I presented a list of practical dimensions that could be checked to assess if the community’s expectations of respect, control, and interests protection are being met (Table 14.1). This table has the potential to be transformed into an appraisal framework through testing, refining, and standardization in empirical research.

6 Limitations of this study

Many limitations challenged this research. With respect to the Mexico case study, I can identify four main limitations. The first lies in the fact that this study was retrospective, and hence involved some speculation and personal reading of events. For example, although I developed the social process of community authorization while grounding all findings and conclusions in the data, I could not observe how judgments actually developed in real time, and how the

289 feelings of the community at different stages affected their actions. Moreover, I had to depend on people’s memories and their own constructions of experiences, Ex post facto. Two other challenges were related to data collection in an international site. Due to time and budget constraints, I was not able to conduct more interviews, especially with lay community members, nor to go back to the field to follow up on certain questions I had or to test the emerging theoretical relationships through more research. As I anticipated these three challenges from the beginning of my research, i.e. the retrospective nature of data collection and the inability to conduct more interviews, I aimed in every interview to fish for maximum information and to ask about minute details that seemed irrelevant at the time but turned extremely helpful as I was building my theory. The fourth challenge lay in the presence of the GMM research team, including the PI, in interviews with community members. The PI was actually sensitive to this issue, and asked interviewees if they preferred her to leave in every interview. Although every one of them insisted that they don’t mind her being present, I anticipate that her presence might have affected certain answers. Nonetheless, in one of the interviews, the current Comisariado did in fact criticize the non-successful experiments and was free to voice his concerns and question the PI, which might imply that his answers were always sincere and not biased by the presence of the research team. To deal with this challenge, I aimed to ask open-ended neutral questions and to focus the interviews on fact-based recounting of experiences, such as chronological sequence of events and so on, and then I tried to dig in between the lines for the meanings that gave depth to my theory, especially with relation to the social processes of authorization.

Two main challenges were associated with the Malaysia and Cayman case-studies, both related to the data collection sources. First of all, since all of the data was drawn from openly-available sources on the Internet with no interviews, there is a risk that dissenting voices could be disproportionally represented, as it is expected that mostly dissenting voices or those who feel strongly about the trials would be found in the media and other Internet sources. Moreover, many of these people might not necessarily be in the best position to provide insights about the trials.. The second limitation is with respect to theory development, as some categories were left undeveloped with unanswered questions since I was not able to get clarifications in follow up interviews, as is usually done with purposive sampling. To address these two challenges, I tried to look for all available documents online, leading to the huge amount of articles used for analysis (243), trying to be as thorough as possible. At the same time, I tried to focus my analysis

290 on facts and events, rather than on the emotions that were so prevalent in the retrieved documents. In fact, I have rewritten both Malaysia and Cayman Islands results chapters twice, to ensure that my analysis is fact-based rather than emotions-influences.

The interdisciplinary nature of this thesis is both a strength and a vulnerability. The limitation is related to the breadth of literature that is used in this thesis. First, in order not to lose the focus on the research question, I tried to concentrate my literature review chapters on that which might directly illuminate the concept of authorization and research-related decision-making in the context of communities. Moreover, as this is an empirical grounded theory study, the aim was to find empirical answers to my research as grounded in the data, or as grounded in the real experiences of communities. The nature of literature review in this type of research is such that the most relevant literature isn’t clear at the outset, as the dimensions of the theory itself aren’t clear at that stage. The relevance of some literature was not apparent until the later stages of the thesis and as a result, some of this relevant literature was not covered in the thesis. For example, relationships appeared to be central in the authorization of GMM trials. Drawing from public health ethics for instance, such as concepts of relational autonomy (Baylis et al., 2008) might have been then warranted in the discussion, and is certainly an area to dedicate a deeper look into in the future.

7 Conclusion

This thesis provides the first empirical explanatory theory for community authorization for research. Although this theory was developed in the context of GMM trials, it can apply to other endeavors, research or not, where whole communities might be affected.

The thesis supports a relational notion of community authorization as a process and as an experiential state of ongoing and maintained approval for research. Enabled by successful relationships between researchers and community groups and individuals, this state manifests at all levels of the community; institutional, regional, official, local, and even individual.

The findings dictate that funders have to allow budget and time provisions in research proposals, and to have the needed capacity to assess how researchers will attend to ethical, social, and

291 cultural issues related to research. Regulators and research ethics boards have to develop new ways of conceptualizing consent and community approval, and new ways of approving and overseeing projects, such as issuing approval in different stages based on evidence of community ongoing approval. One way is to adopt a multi-stage approval system that takes into consideration regularly the quality of the relationships between the researchers and the community as well as the community’s perspectives about the research. Finally, researchers have to integrate themselves from day one as neighbors and as partners in the communities that will host their research, and work hard towards developing respectful and equitable relationships with authorities, leaders, and publics alike. Future research is needed to provide researchers as well as research ethics boards and regulatory agencies with standardized tools to gauge the conduct of research in relationship to the community. The reliability, applicability and generalizability of this theory need to be tested and refined in future empirical work in multiple contexts and different fields.

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Appendices

Appendix 1: Definitions

Cage or caged-field refers the state and conditions were organism, in this case mosquitoes, are physically contained and separated from the environment. Contained field research is an intermediate stage of experimentation between controlled laboratory testing and field trials involving open-air release of mosquitoes into the environment. This is usually undertaken in fully-caged conditions that closely simulate natural habitats (Core Working Group on Guidance for Contained Field Trials, 2008).

Containment refers to conditions and practices undertaken to prevent unplanned or uncontrolled escape or release of mosquitoes into the environment. In cages or caged-fields, containment is physical, but might be augmented by biological containment (the use of mosquitoes that have reduced ability to survive or reproduce in the environment) or ecological containment (geographic, climatic or spatial isolation) (Core Working Group on Guidance for Contained Field Trials, 2008).

Dengue is an infectious tropical disease caused by the Dengue virus, which is transmitted by mosquitoes of the Aedes genus. Dengue’s symptoms include fever, headache, muscle and joint pains, and a characteristic skin rash. In severe but small proportion of cases, the illness can develop into a potentially lethal condition called Dengue hemorrhagic fever (DHF) with decreased levels of platelets, bleeding, and blood plasma leakage. Dengue shock syndrome is another life-threatening potential consequence with dangerously low blood pressure.

Genetically engineered (GE), genetically modified (GM), or transgenic, are terms used interchangeably in this document, and refer to mosquitoes whose genetic material has been altered using modern recombinant DNA technology. The engineered or modified genome would have novel DNA of endogenous, exogenous, or mixed origin.

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Appendix 2: University of Toronto Research Ethics Approval

UNIVERSITY OF TORONTO Office of the Vice-President, Research and Associate Provost Ethics Review Office

PROTOCOL REFERENCE #18578

October 25, 2006

Prof. Peter Singer Joint Centre for Bioethics 88 College St. Toronto, ON M5G 1L4

Dear Prof. Singer:

Re: Your research protocol entitled “Community Engagement in Global Health Research: Case Studies from the Developing World”

ETHICS APPROVAL Original Approval Date: October 25, 2006 Expiry Date: October 24, 2007

We are writing to advise you that a member of the Health Sciences II Research Ethics Board has granted approval to the above-named research study, for a period of one year, under the REB’s expedited review process. Ongoing projects must be renewed prior to the expiry date.

The following consent documents have been approved for use in this study: Consent Form, Invitation Letter (received September 18, 2006), and Study Information Sheet (received October 16, 2006). Participants should receive a copy of their consent form.

During the course of the research, any significant deviations from the approved protocol (that is, any deviation which would lead to an increase in risk or a decrease in benefit to participants) and/or any unanticipated developments within the research should be brought to the attention of the Ethics Review Office.

Best wishes for the successful completion of your project.

Yours sincerely,

Jenny Peto Ethics Review Coordinator

xc: Mr. W. Maurice (Grants Officer, Health Sciences)

Simcoe Hall, 27 King’s College Circle, Room 10A, Toronto Ontario M5S 1A1 TEL: 416/ 946-3273 FAX: 416/ 946-5763 EMAIL: [email protected]

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Appendix 3: Ethics Approval National Institute of Public Health (Comisión de Investigación, Instituto Nacional de Salud Pública)

Instituto Nacional de Salud Pública Comisión de Investigación

No. de Ref. 581.

Cuernavaca, Mor., a 26 de enero del 2011.

Dra. Janine Madeleine Ramsey Willoquet Responsable de Proyecto CRISP-INSP Presente

Por medio del presente informo a usted que se registró la aprobación de la comisión de ética, del proyecto secundario titulado: “Qué autorización es requerido de la comunidad para iniciar ensayos sobre mosquitos vectores modificados? Estudios de caso de México y Australia”; cumpliendo así los requisitos para su aprobación definitiva.

Aprovecho la ocasión para enviarle un saludo cordial.

Atentamente,

Dr. Eduardo C. Lazcano Ponce Presidente de la Comisión de Investigación-INSP

Ccp.- Dr. Américo David Rodríguez Ramírez.- Director CRISP.-Presente. Mtra. Martha Edith González Bravo.- Jefe del Departamento Administrativo del CRISP.- Presente. M.E. Víctor Hugo Minor López.- Subdirector de Proyectos.- Presente.

Av. Universidad No. 655 Cerrada de los Pinos y Caminera Tels. 01 (777) 3293003 Col. Santa María Ahuacatitlán Tels. 01 (777) 3293078 62100 Cuernavaca, Morelos Tels. 01 (777) 3111148 México [email protected]

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Appendix 4: Invitation Letter

Carta de Invitación

Entrevistas y Grupos de Discusión

Fecha:

Nombre:

Puesto:

Instituto:

Tel:

Fax:

Correo electrónico:

Estimado ,

Participación de la Comunidad en la Investigación de la Salud Mundial: Casos de Estudio del Mundo en Desarrollo.

La Universidad de Toronto esta conduciendo un estudio con la colaboración del Centro Regional de Investigación en Salud Pública (CRISP) para identificar estrategias efectivas de participación comunitaria en el mundo en desarrollo.

El propósito de este proyecto es mejorar el conocimiento actual base acerca de lo que constituye el compromiso efectivo de la comunidad por medio de identificar “buenas prácticas” en la conducta de participación comunitario en el mundo en desarrollo. Específicamente, nuestro objetivo es estudiar lo que constituye una autorización adecuada por parte de la comunidad para comenzar pruebas de mosquitos modificados para combatir la fiebre del Dengue. Su participación en este estudio, si esta de acuerdo, es participar en entrevistas individuales o grupos de interés, para discutir sus puntos de vista y experiencias con la participación comunitario.

La entrevista o grupo de discusión, la cual o el cual se haría cuando fuera mas conveniente para usted, tardaría aproximadamente 60 minutos. Su participación en este estudio es voluntario. Mas aún, si usted decide

358 participar, usted estaría completamente libre de retirar su consentimiento y de descontinuar su participación en cualquier momento sin tener que explicar la razón.

Le agradezco de antemano su consideración a esta invitación. Su participación es crítica ya que podría ayudarnos a evaluar la importancia de los factores que afectan la adopción de nuevas tecnologías en la lucha por el mejoramiento de la salud mundial.

Por favor déjeme saber su disponibilidad al teléfono XXXXXXXXXXXXXX o xxx, o por medio del correo electrónico [email protected] tan pronto como le sea conveniente.

Muy atentamente,

Investigador Principal/miembros del equipo de investigación

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Appendix 5: Study Information Sheet

Hoja de información

Titulo del proyecto

La Investigación en salud global y la participación las comunidades: Casos de estudio para en vías de desarrollo.—GCGH7 #316: Estrategias genéticas para el control de la trasmisión del virus del dengue

Titulo del estudio

¿Qué permiso es requerido por parte de la comunidad para dar inicio a los ensayos con mosquitos vectores modificados?

Investigadores

Dra. Janine Ramsey Willoquet

Instituto Nacional de Salud Pública. Centro Regional de Investigación en Salud Pública. 4 ª Avenida Norte Esq., 19 oriente centro. Tapachula, Chiapas. Tel: (962) 625-0800 de 9:00 AM a 5:00 PM de lunes a viernes.

Dra. Lara El-Zahabi Universidad de Toronto. Centro McLaughlin Rotman para la Salud Global. 101 street College, Toronto, ON, Tel: (416) 673-6546, E-mail: [email protected]

Dr. James V. Lavery

McLaughlin Rotman Centro para la Salud Global

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Email: [email protected]

Tel: 1 416-673-6567 (solo para larga distancia)

Agencia financiadora

Fundación Bill y Melinda Gates

Antecedentes y objetivo de la investigación

El objetivo de este estudio, es determinar qué permisos se requieren por parte de la comunidad, para iniciar y proceder con las instalación de jaulas de campo o liberación abierta de mosquitos vectores modificados.

Los objetivos específicos para este estudio e investigación son:

1. Examinar las perspectivas de las distintas partes involucradas, para saber qué permisos se requieren de la comunidad.

2. Describir las actividades en donde la comunidad participe en temas relacionados con los permisos requeridos por la comunidad para la ejecución de proyectos.

3. Evaluar los resultados con el fin de generar una posición crítica, sobre los permisos requeridos para los ensayos de campo (jaula de campo o liberación abierta) con los mosquitos vectores modificados.

Invitación a participar

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Se hará una invitación a las personas para participar de una entrevista individual o grupal (ver la carta de invitación). En ésta se preguntará acerca de los puntos de vista y perspectivas con respecto a sus experiencias en la participación de la comunidad en Tapachula, sobre los permisos para las pruebas de campo de mosquitos vectores modificados.

Si usted acepta participar, puede negarse a responder cualquiera de las preguntas, sin tener consecuencia alguna. Asimismo, en cualquier momento puede optar por retirarse.

Procedimiento

La entrevista individual o el grupo focal se realizará en el lugar y el momento que la persona crea conveniente. La entrevista tendrá una duración aproximada de 60 minutos, mientras para el grupo focal será de dos horas. La información recogida tanto en la entrevista como en el grupo focal será almacenada en un medio digital y posteriormente transcrita.

Como herramienta de difusión se filmaran las entrevistas individuales y los grupos focales, este material se usará para editar un video sobre " La Investigación en salud global y la participación las comunidades". La grabación y la producción del video estarán sujetas al criterio de las personas entrevistadas.

El objetivo de las entrevistas será identificar los puntos de vista y perspectivas sobre la experiencia y la participación bidireccional, sobre el permiso de la comunidad de Tapachula para la prueba en campo con mosquitos.

Se contará con la participación de un traductor de ingles - español y viceversa para facilitar la comunicación entre la investigadora Dra. Lara El Zahabi y los y las participantes de las entrevistas.

Privacidad y confidencialidad

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Los datos recopilados en campo (Grabaciones en audio digital y en vídeo, transcripciones de las entrevistas, notas de campo, entre otros.) serán almacenados por un período de cinco años a partir de la fecha de finalización del estudio. Los datos y los materiales serán encerrados en un gabinete de seguridad en las oficinas de investigación en Toronto, a las que sólo los miembros del equipo de investigación tendrán acceso. Del mismo modo, todos los archivos electrónicos correspondientes a este estudio se almacenaran en computadores protegidos con contraseña y con acceso restringido.

Tanto en las publicaciones, como en la presentación de resultados y el video se citaran las opiniones de las personas, así como el nombre de quien ha hecho la aportación, si es que la persona lo permite. De lo contrario el nombre de los y las participantes quedara en el anonimato, lo cual debe ser manifestado en el formulario de consentimiento.

Riesgos y beneficios

Los riesgos para la participación en este estudio, son mínimas. Los nombres de las personas serán codificados durante la transcripción y sólo estarán disponibles para las y los investigadores de este estudio. Como se señaló anteriormente, el nombre y el cargo pueden aparecer en los informes derivados de este estudio, sin embargo, si la persona indica que no desea ser identificado, la determinación será respetada. Para el caso del grupo focal, la confidencialidad sólo se puede mantener en la medida en que todos los y las participantes lleguen a un acuerdo en común.

Para el caso de las entrevistas grabadas en vídeo, los y las participantes pueden permanecer en el anonimato. Si usted elige participar en el vídeo, tiene la oportunidad de quitar cualquier material que usted considere necesario. Algunos de los riesgos involucrados en la grabación de vídeo y la difusión son los siguientes:

1. Riesgo de estigmatización individual; 2. Riesgo de estigmatización por la comunidad;

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3. Riesgo de inferir o cuestionar las prácticas cotidianas de la comunidad 4. Riesgo de sentir vergüenza por los usos del audio y / o grabaciones de vídeo; 5. Riesgo de la representación injusta de las personas o la comunidad a través de la edición las declaraciones u opiniones fuera de contexto o alteración de su significado. 6. Riesgo de incumplimiento de anonimato y confidencialidad.

Para mitigar estos riesgos, nos aseguraremos que las personas tengan la oportunidad de ver la película ya editada. El cortometraje será en inglés, y tendrá subtítulos en español. Nosotros les proporcionaremos un plan detallado sobre la difusión en cine y con tiempo suficiente concederemos el espacio para hacer preguntas y expresar sus preocupaciones antes de la filmación. También se tendrá especial cuidado para incorporar las peticiones surgidas en el proceso de grabación y edición de la película.

El principal beneficio de la participación de los y las participantes será la oportunidad de contribuir en la generación de nuevos conocimientos y la comprensión de las estrategias efectivas de participación comunitaria para la adopción de nuevas tecnologías derivadas de los Grandes Desafíos en Salud Global en los países en vías de desarrollo.

Compensación / Remuneración

Este estudio no dará ningún tipo de remuneración o compensación económica a los y las participantes.

Difusión de los resultados

Los participantes de este estudio pueden solicitar una copia del informe final.

Sus derechos como participante

Usted no renuncia a ningún derecho legal por participar en este estudio.

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Si usted tiene alguna pregunta o desea información, por favor contactarse con:

Dra. Janine Ramsey Willoquet

Dra. Lara El-Zahabi

Universidad de Toronto. Centro McLaughlin Rotman para la Salud Global. 101 street College, Toronto, ON, Tel: (416) 673-6546, E-mail: [email protected]

Si se tienen preguntas sobre los derechos como participante dentro de este estudio de investigación, puede comunicarse con la Presidenta del Comité de Ética del Instituto Nacional de Salud Pública, Dra. Ivone Castro Romero, teléfono (777) 329-3000, extensión 7424, de lunes a viernes 9:30-5:30. O si lo prefiere, puede escribirle a la dirección de correo electrónico: [email protected]

Si usted acepta participar, se le proporcionará una copia de este documento. Gracias.

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Appendix 6: Consent Form

Carta de Consentimiento Entrevistas y Grupos Focos

Título del Proyecto: Participación de la Comunidad en la Investigación de Salud Mundial: Estudios de casos en el mundo en desarrollo Título del Estudio: ¿Qué autorización se requiere de la comunidad para comenzar los ensayos con los mosquitos vectores modificados?

La Universidad de Toronto (Canadá) está realizando un estudio de investigación en colaboración con el Centro Regional de Investigación en Salud Pública (CRISP). El estudio tiene un período de un año y tiene como objetivo generar conocimientos que ayudarán a los científicos en los países en desarrollo a participar a las comunidades para sus investigaciones de manera más eficaz, ética y en una manera respetuosa.

Procedimientos Nos gustaría extenderle a usted una cordial invitación a participar en este proyecto, que se llevará a cabo en el municipio de Tapachula, Chiapas. Si usted acepta participar en el estudio, le pedimos lo siguiente.

1. Responder durante una entrevista o un grupo de enfoque, que durará aproximadamente 60 minutos y estará dirigido por el investigador del estudio, que previamente fueron entrenados en este tema y tiene experiencia para realizar entrevistas y grupos focales. La entrevista / grupo de trabajo se centrará en un lugar y horario que sea más conveniente para usted. 2. Le pediremos su consentimiento para grabar audio-digital de la entrevista, transcribir y traducirlo al Inglés, y con su consentimiento, utilizar sus respuestas para nuestra investigación. 3. Podemos grabar vídeo de la entrevista que se utilizarán con su consentimiento, parcial o totalmente, en una película de vídeo editado sobre el tema de la “participación de la comunidad de investigación en salud global”, como una de las herramientas para la difusión de los resultados de esta iniciativa de investigación.

Privacidad y Confidencialidad Todos los datos recogidos y los materiales asociados (por ejemplo, grabaciones de audio digital, grabación en vídeo, transcripciones de entrevistas, notas de campo, etc.) serán almacenados durante un período de cinco años desde el cierre del estudio. Los datos y materiales serán encerrados en un gabinete seguro en nuestras oficinas de investigación en Tapachula y Toronto en la cual sólo los miembros del equipo de investigación tendrá acceso. Asimismo, todos los archivos

366 electrónicos correspondientes a este estudio serán almacenados en los ordenadores protegidos con contraseña, con acceso restringido al equipo de investigación. En las publicaciones o presentaciones de informes de los resultados de este estudio, se podrá identificar por su nombre en asociación con sus opiniones o citas específicas. Usted también puede ser identificable a través de su aparición en las grabaciones de vídeo, si estos se utilizan en las presentaciones de vídeo final. Si desea indicar una preferencia a la participación anónima en los casos previstos en el formulario de consentimiento, su nombre no aparecerá en las publicaciones, presentaciones, o en el listado de participantes en el estudio.

Riesgos y molestias

Los riesgos previsibles a la participación en este estudio son mínimas. Como se señaló anteriormente, su nombre serán enumerado en los informes resultantes de este estudio, sin embargo, si usted indica que usted no desea ser identificado en relación con sus visitas o citas, entonces no será identificado. En el caso de un grupo de enfoque, la confidencialidad sólo se puede mantener en la medida en que todos los participantes cooperen con la petición de mantener el proceso confidencial. En el caso de grabaciones en vídeo de entrevistas con los participantes individuales de investigación, debates en grupo, y la participación de otras actividades relacionadas con el anonimato no puede garantizarse. Por esta razón, los participantes que deseen permanecer en el anonimato no será filmada. Si usted elige a ser grabado en vídeo, le daremos una oportunidad de quitar cualquier material de vídeo desde el final antes de finalizar la presentación de vídeo. Nos aseguraremos de que haya una oportunidad para ver el piloto de la película editada por sus comentarios y observaciones. Nosotros le proporcionaremos con un plan detallado de difusión de cine, y se le concederá el tiempo suficiente para hacer preguntas y expresar sus inquietudes antes de la filmación. También se tendrá un cuidado especial para incorporar sus necesidades en el proceso de grabación y edición de películas. Por ejemplo, usted puede solicitar espacio independiente y el tiempo para registrar sus puntos de vista.

Beneficios El beneficio principal de la participación es que los participantes se les dará la oportunidad de contribuir a la generación de nuevos conocimientos y la comprensión de las estrategias de participación efectiva de la comunidad, lo que ayudará a los científicos participación de las comunidades (incluyendo la suya) en la investigación de una forma más ética, eficaz y en una forma respetuosa.

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Participación Voluntaria / Retiro

Usted es libre de elegir si desea participar o no participar en este estudio. Si usted acepta participar, puede negarse a responder a cualquier pregunta específica, sin ninguna consecuencia adversa. Del mismo modo, más tarde podrá optar por retirar su participación en cualquier momento.

Números de contacto:

Si usted tiene cualquier pregunta, comentarios o sugerencias sobre el proyecto, por favor, póngase en contacto con los investigadores principales del proyecto:

Dra. Lara El-Zahabi

Universidad de Toronto. Centro McLaughlin Rotman para la Salud Global. 101 Calle College, Toronto, ON, Tel: (416) 673-6546, E-mail: [email protected]

Dra. Janine Ramsey Willoquet Instituto Nacional de Salud Pública. Centro Regional de Investigación en Salud Pública. 4 ª Avenida Norte Esq., West 19th Street, Downtown. Tapachula, Chiapas. Tel: (962) 625-0800 de 9:00 AM a 5:00 PM de lunes a viernes.

Si tiene preguntas en general sobre sus derechos como participante en un estudio de investigación, puede comunicarse con el Presidente del Comité de Ética del Instituto Nacional de Salud Pública, Dra. Ivone Castro Romero, teléfono (777) 329-3000, extensión 7424, de lunes a viernes 9:30-5:30. O si lo prefiere, puede escribirle a la dirección de correo electrónico siguiente: [email protected]

Si usted acepta participar, se le proporcionará una copia de este documento y le pedimos de favor firmar a continuación.

Si usted NO desea que su nombre sea vinculado a las cotizaciones u opiniones concretas que usted ha expresado, por favor inicial a continuación. Seguiremos lista tu nombre entre los participantes del estudio.

Iniciales: ______

Si usted NO desea ser incluido entre los participantes del estudio y deseo de participar en este estudio de forma anónima, por favor inicial a continuación.

Iniciales: ______

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Si usted NO desea ser filmado durante la entrevista o la participación en un grupo de enfoque, por favor inicial a continuación.

Iniciales: ______

Nombre del Participante: ______Firma del participante: ______Fecha:

Nombre del Testigo : Testigo Firma: Fecha: ______

¡GRACIAS POR SU COLABORACIÓN!

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Appendix 7: List of Interviewees – Mexico Case Study

Name of the Interviewee Title Quotation code

Dr. Janine Ramsey Principle Investigator (CRISP). PI Willoquet Director of CRISP at the time

Ana Laura Pacheco Soriano Project Anthropologist Project Anthropologist

Abraham Marcoschamer Project Communications specialist Communication Specialist

Leobardo Àlvarez Previous Comisariado ejidal Previous Comisariado

Francisco Javier Camas Project anthropology and social Camas Reyes science consultant

Martimiano Matute Current Comisariado ejidal (at the Current time of interviews) Comisariado

Guillermo Bond Martinez Staff Scientist Staff Scientist

Community Member Community Member 1

Community Member Community Member 2

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Appendix 8: Mexico Community Engagement Processes

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Appendix 9: Relational Model/Roadmap

1. Mapping Stakeholders and their Interests a. Multiple levels: Macro and micro b. Official authorities, publics, interest groups

2. Priming Relationships: Commitment to promote different community interests a. Upstream: Since inception of the project b. Development of interest in prospects of benefits c. Development of initial comfort Establishing Openness i. With the project risks 1. Assurances 2. Accountability and redress 3. Acknowledging uncertainty 4. Long term commitment 5. Oversight ii. With project team 1. Credibility 2. Familiarity 3. Humility

3. Defining and Negotiating terms of the relationship a. Risks and benefits b. Procedures for engagement/partnership Establishing Governance c. Mutual needs, expectations and responsibilities

4. Maintaining comfort and generating satisfaction a. Demonstrating commitment to promoting community interests Establishing reciprocity b. Demonstrating respect i. Taking the community and its needs into account ii. Respecting hierarchies and norms iii. Valuing regular members of the publics c. Maintaining the conversation i. Procedures tailored to different community groups/levels d. Maintaining a positive and committed attitude i. Humility ii. Faithfulness (honesty and transparency) iii. Consistency iv. Reliability: responsiveness and responsibility v. Immersion in the community: Presence, familiarity, and closeness e. Following an upstream, inclusive, incremental, and iterative approach f. Maintaining that the community constantly feels in control

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Appendix 10: Authorization Procedural Milestones (Mexico)

Responsibility of protection and non-maleficience (Project and Community) responsibilities and rights of Establishment (Neighbors/Friends/Health Reference) relationsip of nature the of Specification (Project) Responsibilities and Roles of Establishment Establishment of Scientific Integrity Scientific of Establishment Establishment of Relationships of Establishment Establishment of accountability of Establishment Threshold 1 Threshold 3: Threshold 2 leadership Acceptance by trusted/morally legitimate Ongoing acceptance by the community Agreement among scientists authority Acceptance by trusted scientific and official Procedural Milestones: Decisions and Actions Decisionsand ProceduralMilestones: Local academic clearance (CRISP) Formal and public Assent from community authority - Assemblea Ejidal Formal Endorsement by INSP/CRISP Institutional Motivation and Interest Admission into the community Regulatory Clearance macro community Lack of antagonism from constituents in the CIBIOGEM - Federal INSP - Institutional and ethics and INSPInstitutional - Informed Consent for house-based experiments house-based for Consent Informed Ownership, Solidarity, and Loyalty Participation in activities and events and activities in Participation Cooperation, Collaboration, and Active Help Lack of Opposition INSP (Director - Mario Rodriguez) Mario - (Director INSP MOU/Agreement Permission for land purchase land for Permission Permission to approach community members community approach to Permission Permission to build the cages and start the trials the start and cages the build to Permission community the in experiments carry to Permission/consent Ejido assembly Ejido Mayor County commissions

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Appendix 11: Procedural and Substantive Aspects of Authorization (Mexico) Responsibility of protection and non-maleficience (Project and Community) responsibilities and rights of Establishment (Neighbors/Friends/Health Reference) relationsip of nature the of Specification (Project) Responsibilities and Roles of Establishment

Integrity Scientific of Establishment Establishment of Relationships of Establishment Establishment of accountability of Establishment

Threshold 1 Threshold 3: Threshold 2 leadership Acceptance by trusted/morally legitimate

Ongoing acceptance by the community Agreement among scientists authority Acceptance by trusted scientific and official

Local academic clearance (CRISP)

Formal and public Assent from community authority - Assemblea Ejidal Transactions (Procedural) Transactions Formal Endorsement by INSP/CRISP Institutional Motivation and Interest Admission into the community Regulatory Clearance macro community Lack of antagonism from constituents in the CIBIOGEM - Federal INSP - Institutional and ethics and INSPInstitutional - Informed Consent for house-based experiments house-based for Consent Informed Ownership, Solidarity, and Loyalty Participation in activities and events and activities in Participation Cooperation, Collaboration, and Active Help Lack of Opposition INSP (Director - Mario Rodriguez) Mario - (Director INSP MOU/Agreement Ejido assembly Ejido Mayor County commissions Permission for land purchase land for Permission Permission to approach community members community approach to Permission Permission to build the cages and start the trials the start and cages the build to Permission community the in experiments carry to Permission/consent Authorization Intra and Inter-Institutional and Intra Inter-personal Processes(Substantive) Informal Formal Implicit Explicit Deliberative Decisions Deliberative Affective Moves Declarations Moves Moral legitimacy Influence of Social Status (Standing) - Official legitimacy - (Positions) Status Official of Influence