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The Experiences of Human Research Participants of Health Studies

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The Experiences of Human Research Participants of Health Studies BODIES OF SCIENCE BODIES OF SCIENCE: THE EXPERIENCES OF HUMAN RESEARCH PARTICIPANTS OF HEALTH STUDIES By LEIGH HAYDEN, B.Sc., M.A. A Thesis Submitted to the School of Graduate Studies in Partial Fulfilment of the Requirements for the Degree Doctorate of Philosophy McMaster University © Copyright by Leigh Hayden, November 2009 DOCTORATE OF PHILOSOPHY (2009) McMaster University (Anthropology) Hamilton, Ontario TITLE: Bodies of Science: The Experiences of Human Research Participants of Health Studies AUTHOR: Leigh Hayden, B.Sc., M.A. (McMaster University} SUPERVISOR: Professor W. Warry NUMBER OF PAGES: v, 392 ii ABSTRACT This dissertation examines my investigation of the experiences of participants of university-based health research. My primary research questions were: (1) Why do people participate in health research, despite its risks? (2) Why are people asked to participate in health research? (3) What factors influence local research environments? I employed a critical-interpretive medical anthropology framework to investigate and describe three studies: a Phase 2a asthma drug study, a Phase 1 oncology drug study, and a muscle regeneration study. I followed each of these studies, conducting hundreds of hours of participant observation and interviewing 31 participants multiple times during the course of their enrolment. To learn about the organization and governance of university­ based health research I also interviewed researchers, research coordinators, and ethics experts. In addition, I conducted participant observation at three different research ethics boards (REBs) and two industry conferences. Participant enrolment was significantly influenced by: belief in the "good" of medical research, the enjoyment they experienced as former participants, and desire to receive benefit, including remuneration and possible health benefits. Participation often entails long hours, and much of this time is spent socializing with the research team. Participants often develop trusting relationships with the research team, and learn to adopt its scientific language, in addition to its interests and perspectives. Thus, participants rarely question how research is funded and who ultimately benefits from research. They also do not identify as participants, but rather as volunteers or guests. This is a significant obstacle for participant organization. Since they are not organized to voice their interests collectively, REBs are responsible for protecting their interests. Research ethics board focus almost exclusively on reducing risk and rarely address increasing the potential benefit of researcher to the participants. I conclude my analysis with recommendations for REBs, policy makers, and researchers. iii ACKNOWLEDGEMENTS My sincere thanks to my informants for their cooperation, insight, and willingness to interrogate their own experiences. Many thanks to my supervisor, Dr. Wayne Warry, for his pragmatic, perceptive, blunt, and extremely helpful advice and guidance. I also extend my gratitude to my committee members, Dr. Andrea Frolic and Dr. Gordon Guyatt, for their challenging perspectives and their dogged attempts to help me think sophisticatedly and write clearly. I also was blessed by the support and academic mentors hip of: Sharon Bruce, Catherine MacDonald, Tara Goetze, Lana Mamisashvili, Tom O'Neil, Lisa Schwartz, Jean Michel Montison, Sean Kidd, Mona Gupta, Donna Goldstein, Michal Coughlin, Michael McDonald, Dorothy Pawluch, Susan Cox, Rhue Hayden and Worth Hayden. I thank the Social Science and Humanities Research Council, the Ontario Ministry of Research and Education, and McMaster University for their financial support. Finally, I thank Shane Dzioba for his guidance, encouragement, wisdom, and critical but irreverent thinking. This project would not have been possible without the participation, guidance, involvement, support, and encouragement of all of these exceptional people. Any errors are my own. iv TABLE OF CONTENTS Chapter 1: Introduction Page 1 Chapter 2: Methodology Page 36 Chapter 3: Political Economy of University-Based Health Research Page 88 Chapter 4: Rhythms of Research Page 142 Chapter 5: Laughter and Humour in Research Page 208 Chapter 6: Medical Research Ethics Page 242 Chapter 7: Autoethnography of a Research Participant Page 297 Chapter 8: Summary Page 332 References Page 353 Appendix A Page 389 Appendix B Page 391 v PhD Thesis - L. Hayden McMaster - Department of Anthropology CHAPTER 1: INTRODUCTION A) Purpose of Research In this study, my main objective is to understand, primarily from the perspectives of research participants, the world of university-based health research. My research questions are: 1. Why do people participate in health research, despite its risks? 2. Why are people asked to participate in health research? 3. What is the research environment like? What factors influence this environment? I am interested in health research because I find it fascinating that people put their health at risk and undergo sometimes inconvenient, painful, or difficult procedures for strangers. Moreover, these participants are often paid by multi- national pharmaceutical companies, which have been known to value shareholder interests over human life and safety (Angell 2004). I am also genuinely interested in research activities. As a Master's student, one of my part-time jobs was to interview National Science and Engineering Research Council (NSERC) recipients about their research and write articles about them for the faculty newspaper. I enjoyed this work immensely because it enabled me to speak with researchers about their dreams and passions. Participants of health research, in many ways, also have opportunities to inhabit the worlds of medical researchers, and to help them actualize these dreams. At the very least, they 1 PhD Thesis- L. Hayden McMaster - Department of Anthropology become exposed to the worlds of researchers; their strange language, obsession with measurement, and plodding logic. B) Health Research in Canada Health research in Canada is conducted in a variety of contexts. Much of it is conducted in universities and colleges. Such research is funded by both private and public sources. Other "public" research is conducted in government- based laboratories. Finally, private industry, such as biotechnology firms and pharmaceutical companies, often fund their own research. This research is either conducted "in house" or is contracted to contract research organizations (CROs) who are responsible for conducting the research on their behalf. CROs are important and under-researched actors in the current health research milieu and will have significant impact on how the industry evolves (Mirowski and Van Horn 2005). However, my research concerns university-based health research only. Private industry is growing and challenges both the academy's domain over research and modern research ethics. Academics now compete with CROs for research funding from private industry. Industry does not necessarily rely on the academy to develop and test drugs and medical devices; it can pursue its research and development goals through partnering with CROs instead of academics (Petryna 2009). In addition, industry-sponsored studies are often multi-sited, increasing the complexity of research governance (McDonald 2005). By focusing on "public", rather than "private" research, I am documenting the 2 PhD Thesis - L. Hayden McMaster - Department of Anthropology experiences of research participants and researchers within the public context, no doubt a very different world than research conducted by CROs. CROs are a growing industry, the economy and practices of research are becoming more privatized. However, research participation in public institutions continues to be intellectually and technically important. Publicly-funded health research may be a shrinking field, so this is an important documentation of the practices and discourses of the sector. There are numerous types of health research involving humans, ranging from health behavioural research to clinical trials. When people are invited to participate in health studies, they are typically invited to complete a survey, or participate in an epidemiological study, kinesiology study, a psychological study, or a clinical trial. Investigators survey people for a number of reasons, but primarily to explore participants' knowledge, attitudes and behaviours. Epidemiological studies typically follow populations over time and attempt to link health outcomes with exposures to substances or events. Kinesiology studies explore bodily movement and function. Psychological studies investigate numerous cognitive, emotional, and behavioural responses in humans. Clinical trials are studies which determine the effectiveness and safety of drugs and medical devices (Cancer Research UK 2006). After bench testing and safety testing on animals, drugs are typically tested on humans in four phases. Testing can stop at any phase if evidence suggests the drug is unsafe or ineffective. Phase 1 tests the safety, toxicity, and side effects of a new 3 PhD Thesis - L. Hayden McMaster - Department of Anthropology intervention. Most Phase 1 studies use a dosing cohort design to determine the maximum tolerable dose. Participants are put into dosing cohorts, where each cohort receives a different dose to learn the maximum safe dosage. Phase 2 tests preliminary effectiveness and further evaluates safety. Phase 3 tests the effectiveness and side effects of the intervention compared to placebo and/or
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