Ethical Governance of Biological and Biomedical Research: Chinese – European Co-operation

Final Report March 2010

Designed by LSE Design Unit lse.ac.uk/designunit Contents

Preface and acknowledgments 2

Introduction 4

The new biology and its human implications 7

The new challenge of international governance 12

Ethical deliberation – stewardship and science 16 directions in China and Europe

Ethical regulation 20

Ethical oversight – building ethical review capacity 24

Ethical interaction – grounding research 29 in local contexts

Conclusions – Ethical governance of global life 42 science collaborations

BIONET partners 44

1 Preface and acknowledgments

This is the final report of the BIONET This report has therefore been project, an inter-disciplinary China- produced as a collective effort Europe collaboration on the ethical with input from BIONET’s partners: governance of biological and Nikolas Rose, Herbert Gottweis, Qiu biomedical research consisting of 20 Renzong, Lu Guangxiu, Cong Yali, partners from Europe and China. Over Hans Galjaard, Margaret Sleeboom- the last three years (2006-2009) we Faulkner, Christoph Rehmann-Sutter, have organized a total of 6 events Zhai Xiaomei, Ole Döring, Alicja on key areas of advanced life science Laska-Formejster, Renata Salecl, research – 4 workshops (Beijing, Paul Unschuld, Yang Huanming, Shanghai, Xi’an and Shenzhen and 2 Dominique Memmi, Nick Bunnin, conferences (Changsha and London) John Telford, Jack Price, Genevra covering issues of ethical governance Richardson, Peter Propping and in reproductive medicine, regenerative Wolfgang Hennig. The bulk of the medicine, stem cell research, writing was undertaken by Dr Ayo clinical trials research, biobanking Wahlberg, and the BIONET partners and genomics research. Workshop express their thanks to him for his reports from each of these events are invaluable contributions to this report, available online at (www.bionet- and to the work of the BIONET over china.org/). the past years.

In this report, we summarise some BIONET would also like to express of the key findings from the BIONET its sincere thanks to the over workshops and conferences. The 300 scientists, clinicians, lawyers, report is presented in tandem ethicists, policymakers and others with two other key outputs from who participated in and contributed the BIONET project – a set of to BIONET meetings. It is on the recommendations on best practice in basis of discussions and debates the ethical governance of life sciences at these events that this report has research prepared by the BIONET been prepared. The openness of Expert Group and a BIONET textbook the discussion was impressive, and on issues of ethical governance in the vigour of the debate shows Sino-European research collaborations how seriously these issues are being edited by Ole Döring and with taken, in both Europe and China. This chapters written by workshop promises well for future collaborations. participants as well as BIONET’s exchange students.

2 Ethical governance of international biological and biomedical research collaborations

Epidemiology research in Dai Community, Yunnan province

3 Introduction

Since the beginning of the 21st Biomedical research depends, on century, collaboration between the one hand, on human subjects – and within China and Europe in life either as donors of human biological sciences and biomedical research materials (gametes, embryos, has significantly intensified. blood, bone marrow, tissue) and/ Whether in pursuit of genomic, stem or biographical information, or as cell or clinical research to further recipients of therapies in clinical develop forms of regenerative research – and on the other, medicine, personalised medicine or scientists and medical professionals genetic testing, scientists in China who operate within their particular and Europe are working together in a regulatory, technological, institutional variety of different ways. A and cultural settings. More generally, Ever since WWII, countries Sino-Danish collaboration it depends on efficient ways to throughout the world on the genomics of organise best research practice have been developing cardiovascular disorders in according to the standards of all Shenzhen, Sino-German relevant disciplines and governance governance procedures to cooperation on stem cell bodies. The purpose of such research protect the safety, rights research in Changsha is the improvement of biomedicine and dignity of individuals and clinical trials research (including conditions for research in Beijing for a Swiss and fundamental science), the who participate in pharmaceutical company enhancement of medical technology biomedical research are but a few examples. and the well-being of patients and potential consumers. Through such inter-cultural research collaborations, scientists, biological Accordingly, ever since the Nuremburg materials, biomedical treatments, Code and Helsinki Declaration were scientific equipment and/or drafted in the aftermath of World War information databases are exchanged II, countries throughout the world across continents and countries. have been developing governance Biological samples procured in one procedures to protect the safety, place, are biologically cultured or rights and dignity of individuals who biochemically/ genetically analysed in participate in biological or biomedical another, and the information derived research, and to make the process can be transported instantaneously fair and transparent. These have throughout the world electronically. been very much national efforts to Biomedical treatments developed in introduce legislation and to build one place are transferred to another up statutory systems of ethical country or region for clinical testing, review, especially in human subjects while the chain from donor to bench research. While international scientific to bedside raises technical and ethical communities have long accepted issues at each of its links. general ethical and legal standards beyond such national focus in many

4 How can a national diversity of systems of ethical governance of biological and biomedical research cope with increasingly global life science research collaborations?

areas of research, global conventions sciences and biomedicine, Europe and and declarations have been difficult China. A key question for BIONET has to enforce. been: How can a national diversity of systems of ethical governance and In particular, recent advances in life ethical deliberation about biological sciences research, together with and biomedical research cope with an unprecedented focus on the increasingly global life science implications of such activities for research collaborations? societies, cultures and individuals have raised a number of dilemmas In this report, key findings are regarding, for example, the ‘moral presented from 5 workshops and status of human embryos’ in conferences held in Beijing, Shanghai, life science research, the moral Changsha, Xi’an and Shenzhen acceptability of research cloning, on the topics of reproductive and inter-species embryos and genetic regenerative medicine, stem cell modification, the appropriate use of research, clinical trials, biobanking and genetic information as well as how to genetic testing. Each event examined organise normative procedures such ethical issues arising in these fields as ‘informed consent’ in different of research while also mapping cultural contexts. And again, many of out existing practices of ethical these questions have been addressed governance. During these events, in different ways in countries and discussions were organized with communities across the world. individual scientists and stakeholders who had been invited to speak to This sharing of work between states, selected topics and in view of issues scientific and medical communities, that might arise for international civil society organisations and others collaborations. These inputs form has taken place without much the material basis and limitation of attention to the question of how BIONET’s findings. ethical governance of research can be established for the benefit of all The report begins by providing an in situations where cross-cultural overview of the kinds of biological and and international differences are biomedical research involving human concerned. Over the last three years, subjects that have been the focus BIONET, an interdisciplinary and of BIONET as well as the key ethical multinational China-Europe co- challenges surrounding them. As already operation on the ethical governance noted, such research relies on human of biological and biomedical research subjects as either donors of biological has been examining emerging samples and/or biographical information patterns and consequences of for laboratory-based biological research growing scientific co-operation or as recipients of innovative therapies in between two major regional players clinic-based research. in the field of contemporary life

5 Ethical governance of international biological and biomedical research collaborations

Forms of ethical deliberation, ethical regulation, ethical oversight and ethical interaction are crucial for the ethical governance of life science research in any given country let alone in international collaborations

The report then maps out different interaction are identified as crucial for ‘layers’ or ‘spheres’ of governance the ethical governance of life science when it comes to international research in any given country let alone bioscience cooperation, from global in international research collaborations. to national, institutional and local The report concludes by looking at contexts of life sciences research. how global life science collaborations Forms of ethical deliberation, ethical must increasingly navigate through a regulation, ethical oversight and ethical plurality of ethical governance systems.

BIONET workshop on reproductive technologies, April 2007, Beijing

6 The new biology and its human implications

It was around the mid-20th of synthetic biology – where life is century that a ‘new’ biology molecularly engineered ‘from scratch’ emerged powered by new – will play a role in cleaning up the microscopy technologies and environment and in the production biochemical techniques. Ever since of energy. BIONET has limited itself to the elucidation of the molecular the implications of new life sciences basis of heredity in 1953, impressive research in the biomedical field. developments have taken place both The last three decades have also seen in basic research and in applications often unexpected developments in of gene technology in a variety reproductive technology. In 1978 the of areas. New insights have been first child was born following in vitro gained in the way the DNA code is fertilisation (IVF) involving a couple translated into proteins that determine who could not conceive without the structure and functions of cells assistance. Today, in many countries, and the processes of cell division. thousands of IVF procedures are Consequently, differentiation and performed annually accounting for embryonic development are much 1-2 per cent – in some cases up to 6 better understood. It has become per cent – of total births. The method possible to transfer (parts of) DNA of pre-implantation genetic diagnosis from one organism to another and to made use of the IVF technique by switch off or change a single gene. In allowing for the removal of a single 1990, the first approved gene therapy cell from in vitro fertilised embryos to repair a genetic error was given to a for genetic diagnosis before deciding child suffering from severe combined which embryos should be implanted. immunodeficiency. By the turn of the In 1990, the world’s first child was millennium, the complete human born following preimplantation genome had been sequenced and by selection of an embryo not carrying 2009 the genomes of hundreds of the genetic mutation that causes plants, microorganisms and (higher) Cystic Fibrosis. Six years later the animals had been sequenced. world’s first cloned mammal (Dolly the All of these developments – some sheep) was born using a technique speak of a ‘genetic revolution’ – have known as somatic cell nuclear transfer also led to practical applications: in (SCNT) whereby an egg cell’s nucleus agriculture, the study of evolution, is removed (leaving an ‘empty’ shell) forensic medicine, (prenatal) diagnosis only to have an adult cell injected of human disease, the prediction into it which is then shocked into of individual susceptibilities for dividing using a direct current pulse specific diseases and the prediction thereby creating an embryo which is of response to treatment in the (practically) genetically identical to the design of new medicines. Some donor of the adult cell. Two years later, even expect that the emerging field in 1998, the first successful human

7 Ethical governance of international biological and biomedical research collaborations

Developments in the life sciences have raised concerns and emotional debates about their social, psychological and ethical implications

embryonic stem cell line was derived other parts of the world. Recent by American investigators raising controversies surrounding life hopes that regenerative medicine sciences research have in large (therapeutic use of stem cells) might part concerned fears that scientists be able to cure human diseases like are somehow ‘tampering’ as they diabetes, heart muscle failure or seek to manipulate, reprogram and neurodegenerative disorders. direct human life through genetic and/or reproductive technologies. Each of these developments has raised Commentators have argued that concerns and emotional debates being able to do something (eg, about the social, psychological and genetic manipulation or cloning) does ethical implications of the new life not mean that we should be doing it. sciences. In many countries this has resulted in legislation restricting some As successful and controversial as kinds of research. At the international the new biology has been, neither level, the UN Education, Science and has it escaped scandal. In 1999, Culture Organisation (UNESCO), Jesse Gelsinger was offered an the World Health Organisation experimental gene therapy for (WHO), the Council of Europe and ornithine transcarbamylase deficiency other organisations have published (a relatively mild liver disorder) by declarations and guidelines aiming to clinical investigators at the University ensure respect for human rights and of Pennsylvania. He died four days dignity and to secure the individual later following a rapid deterioration safety of those participating in of his organ functions. The Food and biomedical research. Drug Administration later ruled that the responsible clinical investigators In UNESCO’s Universal Declaration on had not informed Gelsinger Bioethics and Human Rights (Paris, 19 sufficiently about potential serious October 2005), governments from all side effects. A few years later in over the world take note of: 2006, the ‘Hwang scandal’ broke in South Korea which has reverberated the rapid developments in science and since. A whistleblower informed an technology, which increasingly affect investigative television programme our understanding of life and life itself in Korea that acclaimed stem cell [and]… the ever-increasing dilemmas scientist Hwang Woo Suk had in and controversies that science and fact faked data which apparently technology present for humankind. demonstrated the first successful use of SCNT technology using human Moreover, protests against so- eggs and adult cells to create patient- called ‘designer babies’, human- specific embryonic stem cell lines. It animal cybrids/chimeras and also transpired that Hwang had used cloning technologies have been over 2,000 human eggs procured staged throughout Europe and

8 Ethical governance of international biological and biomedical research collaborations

from some 120 female donors some international collaboration, the ways of which were paid and some of in which different countries control which were his junior staff members. and limit the biological manipulation In both cases, principal researchers of human life need to be explained were ruled to have violated principles and synchronised. of informed consent and research Selection – developments in genetic participant protection first laid out research have allowed researchers in the Nuremburg Code (1947) and to ascertain causal relationships Helsinki Declaration (1964) and since between certain rare diseases and made enforceable through national localised genetic mutations on regulations and ethical review different chromosomes. Combining procedures throughout the world. this knowledge with developments As such, one might distinguish in reproductive technology has made between three key areas of concern possible new forms of genetic carrier emerging out of the new biology: testing (to see whether a couple is at risk of transmitting a certain disease Manipulation – advances in genetic to offspring), preimplantation genetic technology have allowed scientists diagnosis (to select desired genetically to manipulate living organisms ‘healthy’ embryos by identifying and at the level of DNA, the so-called discarding undesired embryos) as well ‘building blocks of life’. Genetically as prenatal diagnosis (to determine modified animals and plants are whether a foetus has a certain genetic now commonplace and ongoing condition or disease in order to allow development of gene therapies prospective parents to decide whether suggest that genetic manipulation of they wish to continue or terminate humans may also become possible. a pregnancy in countries where this At the same time, reproductive is a legal option). It has also made technologies allow scientists to it possible to select embryos for manipulate human gametes and implantation which will result in an to initiate human conception in offspring whose umbilical cord blood laboratories. Resulting embryos can can be used to harvest stem cells for also be manipulated and probed in the treatment of a sick sibling (so- order to generate human embryonic called saviour siblings). Concerns have stem cell lines. Human or animal been raised that some parents will use eggs can be enucleated and injected such technologies to ‘design’ their with adult cells to generate ‘clones’ babies and that private companies or to create human-animal cybrids. will exaggerate the feasibility of As a result, questions are raised such aspirations. As such the new about what forms of biological biology has generated questions manipulation of human life (if any) about what forms of selection (if any) should be restricted in controlled should be allowed. In the context laboratory settings. In the context of of international collaboration, the

9 Ethical governance of international biological and biomedical research collaborations

ways in which different countries information or recipients of control and limit the freedom to select experimental therapies, and since human life need to be explained and patients or clients are the targets of synchronised. powerful commercial campaigns, possibilities for exploitation are ever Exploitation – since advanced present. For example, genetic and biological and biomedical research stem cell science have raised hopes relies on human subjects as donors for many persons suffering from of biological samples/biographical currently untreatable conditions and

Ethical Governance of Biological and Biomedical Research

Bench to bedside Manipulation

Therapies Information Human subjects Biological samples Stem cell therapies, gene databases therapies, innovative phar- macogenomic drugs

Pharmacogenomics Genetic testing, Biobank research genetic diagnosis

Some key ethical governance issues • Safety and quality • Informed consent • Storage – biobanks • Data retention • GMP • Genetic counselling • Bio-safety • Privacy • Plausibility • Good Clinical Practice • Quality assurance • Confidentiality • Relevance • Therapeutic misconception • Donor screening • Traceability • Clinical trials • Inducement, vulnerability • Traceability • Re-consent or • Ethical codes of conduct • Donation, benefit-sharing • Cultivation blanket consent • Experimental therapies • Follow-up, feedback • Manipulation (GM, • Discrimination • Trust, exploitation inter-species, IPS) • Status of embryo

10 Ethical governance of international biological and biomedical research collaborations

Most gene and stem cell therapies are at this stage unproven, yet in an age of internet and cheap air travel some patients are travelling long distances to get treatment at often high costs

assisted reproductive technologies to healthcare, can also be particularly provide many infertile couples with vulnerable as they may be misled into the possibility of having genetically- taking research for healthcare. In this related offspring. Such patients can sense, the new biology generates be particularly vulnerable as they may concerns about ‘health tourism’, not have any other treatment options ‘therapeutic misconception’ (that available. Experimental gene and is to say a participant’s belief that stem cell therapies are at this stage the principle purpose of the activity unproven, yet in an age of internet is therapy rather than research or and cheap air travel some patients a clinical trial) and patient/donor are travelling long distances to get vulnerability and therefore about what treatment often at very high costs. forms of safeguards and protections Donors of biological samples can also should be in place for research to be be at risk, especially female donors of carried out responsibly and ethically. gametes who must follow a regime And, in the context of international of pharmaceutical ovarian stimulation collaboration, the ways in which as well as an invasive procedure different countries protect their to collect eggs. Finally, socio- citizens from exploitation need to be economically disadvantaged persons, explained and synchronised, especially especially those with little or no access in view of cross-border activities.

On-site sampling for biobank research, Yunnan province

11 The new challenge of international governance

When the Universal Declaration cultural, socio-economic, regulatory on Bioethics and Human Rights and linguistic context they are was adopted by member states in working in? 2005, UNESCO pointed out that • What factors should the United while ‘the Declaration meets a Kingdom’s Medical Research Council genuine and growing need for take into consideration before international ethical granting funds for Sino-British clinical While the UNESCO standards [and] can help research to develop innovative stem ‘globalize’ ethics in the Declaration meets cell therapies? face of the increasingly growing need for globalized sciences… • What guarantees should the international ethical it is still up to States to Chinese Human Genetic Resources standards it is still up create legal texts and Administration Office require of instruments appropriate European scientists wishing to export to States to create legal to their cultures and biological samples out of China for texts and instruments tradition’ (UNESCO 2005). genetic research? It is exactly this potential appropriate to their • Who are the responsible paradox that has been at the governance bodies that can ensure cultures and tradition heart of BIONET’s work: best practice in Sino-European • What happens when a German research collaborations? How do they scientist approaches stem cell collaborate across borders? scientists in China about possibilities • What role do international scientific to collaborate on research projects journals have in ensuring that data in which human embryonic stem cell emerging out of international science lines are created (illegal in Germany collaborations are not only scientifically yet legal in China)? rigorous but also ethically sound? • Should a randomised controlled These have been some of the many trial carried out in China as part of questions tackled through BIONET’s an international multicentre clinical workshops and conferences which were trial commissioned by a European attended by Chinese and European pharmaceutical company be ethically scientists, clinicians, lawyers, ethicists, reviewed in Europe, in China or both? regulators and social scientists. As a • How should benefits arising from Sino- practice, global science collaboration Danish collaboration on the genomics of raises important issues, on the one metabolic disorders be shared? hand, around harmonisation and standardisation, and on the other • How can European researchers around translation and communication. working in China ensure that Through our workshops and informed consent procedures and conferences, we have identified forms are adapted to the particular

12 Ethical governance of international biological and biomedical research collaborations

numerous ‘layers’ or ‘spheres’ that regulations and ethical frameworks. are relevant when thinking about the This was the starting assumption of ethical governance of global biological the BIONET. and biomedical research collaborations. Second, the question of ethical Each layer or sphere, and the various regulation was often raised. Through ways in which they overlap and interact, the experiences of scientists and forms a part of ethical governance clinicians participating in BIONET systems or regimes. workshops, it became clear that laws First, through debates among BIONET and regulations were a necessary part partners and discussions between of any ethical framework. Distinctions participants at our workshops it were made between ‘soft’ and became clear that the specific terms ‘hard’ regulation. Yet, it was also for national ethical governance abundantly clear that gaps between systems are aided by some form of regulation and implementation ethical deliberation – a kind of were often wide. Moreover, the deliberative space in which science ways in which normative documents directions and national legislative (laws, conventions, guidelines, etc) frameworks for ethical governance are translated into practice and can be debated and fixed. Each into foreign languages can be very country has defined its ethical and different sometimes leading to scientific agenda which have to misunderstandings. At the same be communicated and, in cases of time, it became equally clear that collaborations, sometimes negotiated. regulation was only one part of There are no formulas for ensuring ethical governance systems which the ‘best’ or ‘most inclusive’ forms were better thought of as governance of deliberation, but with a wealth networks consisting of scientists, of experiences in different countries clinicians, regulators, patients, there are plenty of lessons learned publics, civil society organisations, and best practices. Many countries venture capitalists, research councils, have established national Ethics biotechnology companies, scientific Commissions or Councils in order journals, etc. to stimulate and facilitate national Third, ethical oversight mechanisms debate, but there are also other forms such as institutional review boards of public engagement taking place led (IRBs) or ethics review committees by patient organisations or civil society (ERCs) are important parts in organisations in Europe. What matters established models of ethical most for the governance of research governance as it is these institutions collaboration between Europe and that scientists will be in direct contact China and also within these regions, with and who respond to societal is that all research should take place and political concerns. And again, accountably within clear national

13 Ethical governance of international biological and biomedical research collaborations

the way in which such institutions are became very clear that each specific organised can vary widely both within form and site of research raises nations and regionally. The important particular concerns about potentials point is to ensure that effective systems for exploitation. As a result, research are in place to ethically review any could be helped by detailed analyses advanced biomedical or biological of factors that can lead to coercion, research proposals involving human inducement or undue influence subjects before research commences, of potential research participants. and that these systems are adequately Moreover, acquiring genuine capacitated and accountable. With informed consent is a complex countries throughout Europe and Asia act embedded in communicative currently being in the midst of building practice, which depends on special up such systems of ethical oversight, human skills and knowledge about there were plenty of lessons interacting between cultures and Acquiring genuine learned and best practices languages. Empirical social science informed consent is a which should be shared studies can play a central role here, complex act embedded through capacity building and indeed, many presentations by with a particular focus on social scientists at BIONET workshops in communicative international cooperation focused on these questions. It also practice, which depends initiatives. Also, science raises questions about capacity on special human skills journals had a particularly building for researchers specifically to important place in systems of build ethical interaction competences and knowledge about ethical oversight, as published which take into consideration the interacting between research should not only be kind of research taking place (clinical cultures and languages scientifically rigorous but also research, basic science research, etc), ethically sound. the kinds of human subjects to be recruited (patients, socio-economically Fourthly, when it comes to human vulnerable subjects, healthy donors, subjects research, the most visible etc), languages and traditions of internationally-established ethics communication, as well as the forms mechanism is the signed ‘informed of risk to which research participants consent’ form, as a legal requirement would be exposed. preceding any involvement in a research study or clinical intervention. Ethical governance of biological and Notwithstanding numerous biomedical research, then, emerges shortcomings identified around formal as these different spheres – ethical informed consent procedures and deliberation, ethical regulation, forms, these symbols that represent ethical oversight and ethical due procedure nevertheless remain interaction – interact. It is a mix of important tools for organising and top-down and bottom-up since as guiding ethical interaction between a form of governance (rather than researchers and research subjects. It government) it is ‘non-hierarchical’,

14 Ethical governance of international biological and biomedical research collaborations

working through systems of mutual While there may be broad consensus collaboration, coordination and about what the objectives of ethical negotiation among and between governance systems are – protection not just state organizations (such of individuals and societies from as ministries, municipalities or potentially negative consequences of judiciaries), but also a whole range biological and biomedical research of non-governmental institutions, and related medical business – organizations and bodies (science there is no such agreement on just institutions, clinics, lawyers, academic what it is that makes deliberation, journals, patient groups, etc). It regulation, oversight and interaction depends upon co-operation between ethical. This then is the new different agents, and systems of challenge of international ethical sharing of tasks and responsibilities governance: how to cope with a which are flexible and adaptable. As multiplicity of regulatory systems, such, it does not only concern written cultural understandings, socio- regulations and rules, but also informal economic circumstances, research working practices, peer oversight quality assurance standards, forms and the like. Ethical governance of communication and languages? adds a qualitative element as a Where does such ‘ethical difference’ fundamental orientation in governance come from and how is it expressed towards ethical principles, reaching and how can over-reaching beyond technical paradigms such as governance be achieved? functionality and effectiveness. Scientist at work, Beijing Genomics Institute, Shenzhen

15 Ethical deliberation – stewardship and science directions in China and Europe

One of the key discussions in experiment on human zygotes or the BIONET workshops has been whether or not enucleated rabbit around how deliberations about eggs should be filled with human direction in scientific research take adult cells have become public affairs. place in different countries. The On the one hand, national ethics ways in which national ‘consensus’ has commissions and councils have been emerged in each country has been very created throughout Europe to watch different. Moreover, national consensus over developments in the life sciences as can express different views or interests well as to generate public debate. Their on different levels, such as those of members not only consist of ‘expert’ the public, the government, powerful scientists but also ethicists, religious stakeholders, etc, which might not be leaders, lawyers and in some cases directly comparable between countries. also laypersons, etc depending on the In Europe, over the past decades country and kind of institution. Their a new form of ‘participatory terms of reference have similar outlines: governance’ in the life sciences arena has begun taking shape. As argued by the National Ethics Council [is] a members of the European PAGININI national forum for dialogue on project: ‘Areas of administration and ethical issues in the life sciences. It is governance that were previously intended to be the central organ for the exclusive domain of technical interdisciplinary discourse between experts and of meetings behind the natural sciences, medicine, closed doors are being opened up theology and philosophy, and the to public scrutiny and participation. social and legal sciences, and to Increasingly, government agencies are express views on ethical issues arranging for opportunities to interact relating to new developments in with lay persons on what appear to the field of the life sciences and on be highly technical questions vis-à-vis their consequences for the individual regulation’¹. Biology is no longer – and society. The National Ethics if it ever was – an esoteric subject Council has up to 25 members, who restricted to the laboratories, clinics, represent the scientific, medical, university departments, journals theological, philosophical, social, and academic conferences which legal, ecological and economic consume the daily lives of biological worlds and are appointed for a four- and biomedical researchers. Instead, year term by the Federal Chancellor. debates about whether it should As a rule the members hold monthly meetings in Berlin. (Germany) ¹ PAGANINI Project (2007) be permissible to manipulate and Participatory Governance and Institutional Innovation: The New Politics of Life, available at www.univie. ac.at/LSG/paganini/

16 Ethical governance of international biological and biomedical research collaborations

The Nuffield Council on Bioethics What is more, European social was established in 1991 to scientists have in recent years in identify, examine and report on the earnest begun exploring ‘lay person’ ethical questions raised by recent or ‘patient’ views concerning such advances in biological and medical matters as genetic testing, biobanking research. The Council is committed or embryo donation for stem cell to developing explicit ethical research. Such research has involved frameworks, norms, and principles participant observation and in depth that can be applied coherently and interviews with donors and research consistently to the issue in hand. subjects as well as with scientists (United Kingdom) carrying out the research, and has therefore also brought to light the The Irish Council for Bioethics [is] views of research participants. an independent, autonomous body to consider the ethical issues raised In China, the situation has been by recent developments in science different and it does not appear that and medicine. It aims to identify and such a new form of participatory interpret the ethical questions raised governance has emerged around by biological and medical research in life sciences research in the same order to respond to and anticipate way. As in many European countries, questions of substantive concern. a National Ethics Committee has It investigates and reports on such been established in China. It is questions in the interests of promoting under the Ministry of Health and its public understanding, informed mandate is to ‘develop guidelines and discussion and education. (Ireland) regulations on issues like Biomedical Research Involving Human Subjects, On the other hand, public consultations Administration of Genetic Resources and debates have been organised and Ethical Guidelines on Stem Cell on issues such as genetic testing, Research’. At the BIONET workshop on reproductive medicine and stem cell stem cell research held in Shanghai in research. Civil society actors such as October 2007, workshop participants religious groups, patient groups and debated what would constitute ‘public professional organisations have been opinion’ (eg, on the status of the particularly vocal, so much so that some human embryo) on stem cell research have proposed distinctions between in China in the absence of large-scale ‘interested publics’ and ‘disinterested or longitudinal national surveys, focus publics’ (ie, those with no specific stakes group research or qualitative research in a particular issue). The media has also among the public or donors. What played an important role in covering life is more, since China is such a large science issues, often contributing to the nation, some participants questioned controversial tone of some debates by whether it would be possible to emphasising for and against positions. identify a single ‘public view’.

17 Ethical governance of international biological and biomedical research collaborations

Nevertheless, ethical issues concerning Despite the rising urgency of life sciences research have been and media interest in bioethical introduced to China’s public arenas. issues, the media have been poorly A growing bioethics community in equipped to report these issues, China – with many of its members especially in cities outside Beijing participating in BIONET workshops and Shanghai. Journalists should not – has begun engaging not only with be blamed for the insufficiency, as scientists and clinicians through bioethics issues are related to both capacity building workshops but complicated life science research also with the public by calling for and difficult ethical issues, such as more deliberation about biological in the case of how to judge whether research. The Ministry of Health’s certain research could cause harms.² Ethics Committee is planning to publish its findings and opinions to Issues such as therapeutic cloning, encourage discussion among scientists, human-animal hybrids and genetic clinicians as well as the public. Also, testing have entered into national and initial questionnaire and interview- local media reporting. Nevertheless, based research has been carried out one has not seen the kind of concerning lay people’s or medical systematised effort to involve the practitioners’ views on such issues public through public consultations, as participation in clinical trials, the town hall meetings or other forms of moral status of embryos or genetic citizen participation, a fact perhaps databases. BIONET’s own student not so surprising when considering exchange programme also promoted an absence of such vocal civil society qualitative research among donors and actors as Europe’s many churches. participants in biomedical research. Moreover, these particular issues do not necessarily reflect the concerns of In 2008, BIONET supported a satellite all citizens living in different socio- training workshop called ‘Reporting economic and political contexts. Bioethics’ for journalists during its international conference on ethical As concluded by participants at governance of stem cell research BIONET’s Shanghai workshop on which was organised by SciDev.Net stem cell research, it is up to each in Changsha. The context for the country to find the right mix of training workshop was summarised by biology, metaphysics and culture its organisers: to fit their country’s narratives. Finding this mix requires some kind

² SciDev.Net (2008) Reporting of organised deliberation and the Bioethics, Final Report, Institute of Science and Technology Journalism and Communication, Hunan University, Changsha, China, 31 March-1 April 2008

18 Ethical governance of international biological and biomedical research collaborations

Spaces and arenas for ethical deliberation may not result in consensus, but they nevertheless allow for ongoing discussion and debate around which more concrete legislative frameworks are developed in each country

spaces for and ways in which this arenas for ethical deliberation may is carried out will be different from not result in consensus, but they country to country. Global consensus nevertheless allow for ongoing has proved difficult as illustrated discussion and debate around which by the UN declaration on human more concrete legislative frameworks cloning, yet national consensus and administrative procedures can prove equally elusive. More are developed in each country. In practically, dealing with existing codes accordance with BIONET’s agenda, and infrastructures provides a basis such deliberations should be brought to start with in efforts to establish to the level of Sino-European research ethical governance of Sino-European collaboration. research collaborations. Spaces and

Peking University Third Hospital, Beijing

19 Ethical regulation

Throughout the many workshops The most common example cited by and conferences organised by European and Chinese researchers BIONET, regulation was a key topic was the process of informed consent: of discussion. The Declaration of how was one able to ensure that Helsinki remains a landmark and in sufficient time and appropriate care both China and Europe it can be seen was taken in very busy and often to function as a general rule which stressful working environments to ensures that considerations related make sure that patients were given to the well-being of the individual in the time necessary to understand principle should take precedence over risks and benefits, and to avoid a the interests of science and society. situation where informed consent is As already noted, since the Helsinki just a formality? How to ensure that Declaration, a number of international informed consent is organized as guidelines and conventions related to a process and not just a signature? biomedical human subjects research Answers to such questions could have been formulated and adopted. not be found in guidelines and Yet, as became clear through regulations. As a result there was workshop discussions, guidelines often a diversity of practices with and regulations are not sufficient in some best practice institutions in themselves for a number of reasons. China having developed strong systems for ensuring informed Gaps between regulation consent and others still working and implementation to build capacity. Indeed, some In both Europe and China, a number participants suggested that best of regulations concerning biomedical practice institutions play a role in research on human subjects have helping to raise capacity in smaller been promulgated and passed. research institutions and hospitals. However, while there might be broad agreement about the principles laid ‘Hard’ and ‘soft’ regulation out in such documents – eg, informed Most regulations in advanced consent or mandatory ethical review biological and biomedical research of life sciences research projects – fall under the category of ‘soft law’, there is a long way from regulation to ie, they are not legally enforceable. implementation, a pathway that can In Europe, there are often many be filled with obstacles in the form different instruments used to ensure of a lack of capacity or ambiguous or ethical supervision of research. There vague formulations. As put by one are national laws and regulations, the Chinese scientist working in the field regulations of professional associations, of reproductive medicine, regulations recommendations from national ethics and guidelines do not always provide councils or commissions, statements of answers to individual cases on a day- ethical review committees in research to-day basis in the clinic or laboratory. institutions or hospitals, ethical

20 Ethical governance of international biological and biomedical research collaborations

requirements of public or private China over the past few decades funding bodies as well as ethical corresponding to the policy of requirements of scientific journals. opening and transforming China, not In workshop discussions, some least by employing standardisation participants suggested that it was in measures as an instrument to foster particular the funders of research and China’s international role as a global international science journals who player, also in life sciences research. played a key role in ensuring ethical For example, it was noted that almost compliance as researchers would every bioethical aspect regarding always make sure that they lived up biomedical manipulations, including to their requirements, otherwise they those involving human embryonic would risk losing their income or career stem cells, has been covered through opportunities. In particular, funding regulations in order to protect the agency (eg, research councils) ethical rights of human subjects and public guidelines are seen to have ‘teeth’. morality, however most regulations do not enforce legal liabilities (civil or In China, some workshop participants criminal) and damages. spoke of a ‘legislative boom’ in

China’s growing bioethical regulatory framework

In China, over the last ten years or so there has been a ‘legislative boom’ related to biological and biomedical research. The Chinese legal system consists of a range of different regulatory instruments. Laws (fǎ 法) are passed by the People’s Congress or its standing committee and are fully enforceable by the responsible institution specified in the law. Regulations (tiáo lì 条例) are approved by the State Council and are also enforceable. Technical norms or standards (jì shù guī fàn 技术规范) which are intended to ensure safety and effectiveness, and ethical principles (lún lǐ yuán zé 伦 理原则) which are intended to maintain social order, on the other hand are only enforceable if they are specifically authorized in the text of a law or regulation. Finally, there are also administrative measures (guǎn lǐ bàn fǎ 管理辦法) which are directed at the administration and management of certain research and therapeutic practices and which are binding for those institutions, which are licensed to carry out these practices.

As concerns life sciences research these have been some of the key regulatory stipulations concerning biological sample collection, manipulation of human biological materials and testing of biological therapies on humans:

1998: Interim Procedures for Human Genetic Resources Administration (State Council, Ministry of Science and Technology and Ministry of Health)

21 Ethical governance of international biological and biomedical research collaborations

led to the establishment of the Chinese Human Genetic Resources Administration Office. These procedures were strengthened in 2003 and they specify rules for exporting and importing genetic materials.

2003: Regulations on Standards and Norms for Clinical Drug Research Quality Control (State Food and Drug Administration) established Good Clinical Practice guidelines including protection of research participants.

2003: Ethical Guiding Principles for Research on Human Embryonic Stem Cells (Ministry of Science and Technology and the Ministry of Health) set out guidelines for what kinds of research and manipulation would be acceptable.

2004: Administrative Measures on Biosafety in Laboratories with Pathogenic Microorganisms (State Council, Ministry of Science and Technology).

2007: Regulations on Misconduct in Scientific Research (Ministry of Science and Technology), led to the establishment of a science ethics committee and a supervision office to stem academic fraud and plagiarism.

2007: Regulations on Ethical Review of Biomedical Research Involving Human Subjects (Ministry of Health).

2009: Administrative Measures on Clinical Applications of Medical Technologies (Ministry of Health), prohibits clinical use of embryonic stem cells and introduces new approval procedures for autologous stem cell therapies.

Notwithstanding this expanding regulatory framework for biological and biomedical research questions remain as to whether enforceable legal liabilities (civil or criminal) have resulted.

Fast science, slow regulation the areas of different Ministries and also since formulating laws and Another shortcoming of regulation regulations involved consultations relates to the process of formulating with numerous experts from the legal, them. When compared to the fast bioethical, social and medical fields. pace of scientific discovery and For example, even during the duration research, regulation will inevitably of the BIONET project (2006-2009) always be trying to catch up. Chinese developments in induced pluripotent speakers at the BIONET Shanghai stem cell research had raised the workshop noted that it had become question of whether scientific an increasingly laborious and slow progress itself will make current process to prepare legislation related ethical concerns (focused on human to life sciences research involving embryos) redundant while introducing human subjects since it overlapped

22 Ethical governance of international biological and biomedical research collaborations

When compared to the fast pace of scientific discovery and research, regulation will inevitably always be trying to catch up

a new set of concerns – not how 4) allow research only on imported stem cells are derived, but what we hESC colonies should do with them. In genomics 5) allow the creation of human-animal research, thanks to new sequencing cybrids for research purposes. technologies, new findings were being published on a regular basis Moreover, global regulatory uncertainty with possible consequences for has also fuelled ‘stem cell tourism’ biobank projects and research as patients travel to various parts of participant follow-up requirements. the world to receive experimental treatments not available in their own International harmonisation countries. The point being that global Finally, in the context of global science makes it impossible for single science, a number of regulatory gaps nations to prohibit any kind of research appear as different nations adopt on their own. different approaches to regulating This diversity raises numerous areas of life science research. That is questions: To what extent is to say, national regulations cannot moral consensus necessary and in themselves prevent or restrict any achievable? How to find policies kind of research in global context under circumstances of moral diversity of regulatory diversity. For example, in fundamental questions? Does it some countries are considered to make sense to harmonize laws in a have permissive regulation and others globalizing world? restrictive regulation when it comes to stem cell research by classifying them according to whether or not they: Explaining research to a patient, Reproductive 1) prohibit research involving and Genetic Hospital, destruction of human embryos and/ Changsha or production of ‘spare’ embryos

2) allow creation and research on ‘spare’ embryos donated by couples in IVF clinics

3) allow the creation of embryos for research through Somatic Cell Nuclear Transfer (SCNT)

23 Ethical oversight – building ethical review capacity

One of the most important Peer review systems that aim to instrumental aspects of ethical ensure scientific integrity have been governance systems is oversight developed over many decades, and adherence. For it is the principle although they have not prevented objective of all ethical governance all cases of scientific misconduct systems to protect the rights, safety in China or Europe. Nevertheless, and well-being of human subjects there remains plenty of scope for who participate in biological or capacity building when it comes to biomedical research and this implies peer review although the particular some kind of oversight of the research issue of scientific integrity has not process – from recruitment of research been central to BIONET’s work. Ethical subjects, carrying out of research, review, on the other hand, has been. publication of research to follow It is only in relatively recent years that up of research participants; and to ethical review systems have come to be encourage researchers to pro-actively organised at a national level. In Europe, collaborate in this endeavour. ethical review boards were established One key lesson emerging from the locally on an ad hoc basis from around case of Hwang Woo Suk in South the 1960s, often as a result of public Korea, is that a separation of science debates about cases of misconduct, from ethics is no longer (if it ever was) scandals or disputed practice. It was tenable. Once the primary hallmark not until the 1990s that European for ensuring good quality science in governments began taking steps to biological and biomedical research, recognise, consolidate and coordinate peer review has today been joined by their work regionally and nationally. ethical review as an equally relevant The ways in which the work of ethics guarantor of good science. In human review committees is organised varies subjects research, ‘tainted data’ is not greatly from country to country, with only that which has been fraudulently some emphasising institutional levels fabricated or manipulated, it is also and others centralising the task of that which has been unethically ethically reviewing scientific research. procured. Peer review and ethical In China, there has also been an initial review have become inseparable focus on establishing institutional as ‘good science’ is upheld against review boards but the government standards of both rigour and ethical has stipulated that administrative conduct. In particular when it comes departments of health at the to biomedical human subjects provincial level all set up consultation research, good science is not only organizations on ethical review to efficient, rigorous, accurate and ‘guide and supervise the ethical review evidence-based, it is also ethically by institutional review boards (IRBs) responsible and protective of human under their jurisdiction’. The entire IRB rights and dignity. system is currently being developed.

24 Ethical governance of international biological and biomedical research collaborations

Described mandates are very similar Membership of ethics review in both China and Europe, namely to committees is also a key issue as provide public assurance by giving an there has been a move to encourage informed opinion on: broad participation so as to ensure independent opinions. China’s • the scientific research being Regulation on Ethical Review of proposed – scientific merit Biomedical Research Involving Human • the suitability of the investigators Subjects specifies membership (their qualifications and knowledge of as follows: the research topic) Institutions implementing • the adequacy of facilities biomedical research involving • the adequacy of analyses of human subjects and application benefit and harm as well as possible of relevant technologies… shall adverse effects set up Institutional Review Boards. IRBs shall mainly undertake ethical • the methods and documents to review and carry out ethical review be used to inform trial subjects and and supervision over biomedical obtain their informed consent (with research involving human subjects special attention to persons without and application of relevant the capacity to consent / minors) technologies… Members of IRBs shall be elected by those departments • the arrangements for the or institutions setting them up, recruitment of subjects and shall be chosen from among • the amounts and arrangements experts in such fields as biomedicine, for rewarding or compensating management, ethics, law and investigators and trial subjects (with sociology after extensively soliciting special attention to inducement and opinions. The members of each IRB conflicts of interest) shall not be less than 5 and shall include both male and female. IRBs in • the adequacy of insurance ethnic minority regions shall consider arrangements including ethnic minority members.

25 Ethical governance of international biological and biomedical research collaborations

IVF patients, pregnant mothers and stem cell donors

In China’s Hunan province, the Central South University’s Institute of Reproductive and Stem Cell Engineering is housed in the same building as the Reproductive and Genetic Hospital CITIC-Xiangya in China’s Hunan province. Stem cell researchers get their embryos from embryologists at the fertility clinic. And as an unexpected side effect of China’s ‘one-child’ policy, there is no shortage of supply. As a result, the Hospital has over the last years built up a rigorous ethical review system, initially in the clinical context of Assisted Reproductive Technologies and more recently in the context of stem cell research.

The Hospital has therefore established an Ethics Committee Office complete with secretariat and staff which has developed 62 different informed consent forms covering assisted reproductive technologies, genetics technologies and stem cell research. The Ethics Committee consists not just of hospital administrators but also of doctors, nurses and psychologists.

Couples undergoing infertility treatment at the Hospital are asked whether they wish to discard or donate not just so-called ‘bad quality’ or ‘spare’ embryos which will not be implanted but also if they wish to discard or donate to research any ‘leftover’ frozen embryos following a successful birth (some couples choose to freeze any ‘good quality’ embryos which will not be transferred in the first cycle of treatment in case treatment fails). A random analysis of 414 signed informed consent forms in Changsha had shown that in 62 per cent of the cases patients had indicated that they would donate frozen ‘spare embryos’ following successful delivery of a healthy baby.

Stem cell scientists also collaborated with local hospitals which provided cord blood samples for stem cell research. In the past, obstetrics departments had charged an administration fee to provide cord blood samples from the ‘biological waste’ following a birth. Informed consent was not a requirement. However, since the Ministry of Health promulgated new regulations for cord blood banks in 2001 according to which pregnant women must consent to donating cord blood, new informed consent procedures have had to be developed to ensure that pregnant women are in good time informed about what cord blood donations would be used for.

In both cases, doctors and nurses at the Reproductive and Genetic Hospital have underlined that patient trust is the most important factor for consent. The patients must be confident that their biological samples will not be misused.

26 Ethical governance of international biological and biomedical research collaborations

While a requirement to ethically oversee biomedical research has by now been enshrined in national law throughout Europe and China, putting such oversight into practice is a process with numerous hurdles and challenges

Yet, while a requirement to ethically • Researchers tend to give yes/no oversee biological and biomedical answers with insufficient commentary research involving human subjects has on issues of researcher qualifications, by now been enshrined in national risk-benefit analyses, informed law throughout Europe and China, consent and compensation putting such oversight into practice • Lack of qualified members for is a process with numerous hurdles ethical review committees, members and challenges – which are again may have basic training in Good complicated when both regions Clinical Practice but not in ethics are connected through research collaboration. In each of the fields • Lack of resources for ethics covered by BIONET – reproductive committees to train researchers medicine, stem cell research, clinical • There are still large discrepancies trials and biobanking – a consistent in the quality of informed consent, point made by many workshop examples range from half-a-page to participants was that with China 4-5 pages – insufficient explanation of being such a vast country there is a randomisation, placebo, other available variability of institutional practices treatments, risks, adverse effects under the same standards. There are good ethical review practices in top • No attention to insurance questions hospitals and laboratories but more – the most frequent source of dispute problems in less-resourced hospitals comes from disagreement about and laboratories or in differently compensation if adverse or harmful developed regions. Among the effects result from participating in a problems highlighted by scientists and clinical trial clinicians in China were: Two constructive proposals were • Lack of independence – many aired and debated at meetings in ethical review committees were Changsha and Xi’an: firstly, so-called chaired by the heads of hospitals and ‘centres of excellence’ could play external members often did not have an important role in promoting and voting rights sharing their best practices with other less-resourced laboratories and • Conflicts of interest arising hospitals. This would amount to a from researchers’ financial interests provisional two-layer development • Lack of resources to monitor zone model, in which the more and follow up once research has advanced institutions would establish been approved more rigorous regimes of ethical review and the developing zones

27 Ethical governance of international biological and biomedical research collaborations

would gradually be capacitated to so-called ‘biological waste’ (eg, catch up. Secondly, smaller hospitals following births, surgical procedures and laboratories could pool their or diagnostic tests) has become resources and, for example, form joint subject to the informed consent ethical review committees. Building of those from whom it originates, ethical review capacity has become a whether in Europe or China. Some priority for the Ministry of Health and of our workshop participants the bioethics community in China is described resistance on the part of actively supporting such initiatives their colleagues who had perhaps by providing training for ERC and for years been taking an extra vial IRB members. of blood during diagnostic tests for research purposes without necessarily Another key point to make Whereas capacity informing patients. Also discussed concerning ethical review were examples from both a Chinese building in ethical is that, to date, much of and a European biobanking project oversight of clinical the work around ethical in which informed consent forms review committees and research is well stated that ‘There are no known risks institutional review boards underway, an extra involved with this study. The collection has focused on clinical of blood may cause a small amount effort is required trials and clinical research. of pain’ and ‘Your participation in the Yet, with the rising tide of in connection with study does not involve any particular ‘biobanking’, collection of research proposals risk. The blood test corresponds only biological samples (whether to the taking of standard blood test.’ which rely on donations from patients or healthy of biological samples volunteers) has become As a result, whereas capacity building an equally important in ethical oversight of clinical research component of advanced life sciences is well underway, an extra effort is research. This means that any capacity required in connection with research building efforts should also be proposals which rely on donations directed at laboratories and hospitals of biological samples (gametes, which collect biological samples embryos, blood, saliva, urine, etc) as for research purposes. It is only in well as biographical information from recent years that the use of formerly research subjects.

28 Ethical interaction – grounding research in local contexts

Once biological and biomedical results’, conflicts of interest can arise research proposals have been if researchers have financial interests prepared, ethically reviewed and in the research at hand, community funding secured, the mundane, research projects can have unintended everyday work of scientists consequences on community begins. Patients or donors have to be cohesion if certain members of the recruited, informed consent sessions community are excluded while others have to be organised, (if appropriate) are included in research projects, reimbursement arrangements have to patients may feel that saying no to be administratively formalised, (where participation will affect their access applicable) schemes for benefit- to medical treatment, etc. Moreover, sharing have to be developed and the pressures of limited resources and follow-up procedures with research time mean that informed consent participants have to be arranged. processes can quickly become Traditionally, informed consent routinised and bureaucratic, a matter procedures and forms have been of signing a form with minimal seen as the most important tool for interaction around and explanation of ensuring that interaction between intended research. researchers and patients is ethical In workshop discussions concerning and legal. Signed consent forms informed consent procedures and are considered the most important forms, most agreed that these component of ethical audit trails were not sufficient in themselves which, should research subjects suffer to protect and safeguard research from unintended consequences or participants (whether in the context disagreements arise, researchers must of reproductive medicine, clinical be able to produce to document research or biobanking). Yet they that they have acted ethically by were nevertheless described as a communicating due information. necessary sign of respect shown In by far most cases, ethical oversight by researchers towards research of scientific research ends once a subjects – they serve as a point of research proposal has been ethically departure for a relationship between reviewed and approved. There is scientist and a potential participant in little follow up or quality control of a research project. Moreover, widely informed consent processes, not least debated distinctions between so- because of a lack of resources. Yet it called ‘Western’ notions of autonomy is exactly at this stage that research and rational choice which focus on integrity is most under pressure from the individual on the one hand, and multiple directions. A university might ‘Eastern’ notions of harmony and the be pressuring senior researchers who collective (family, village, Nation) on in turn might be putting pressure the other, are difficult to maintain on junior researchers to ‘get some empirically, as both regions appear

29 Ethical governance of international biological and biomedical research collaborations

to be sharing the same basic ethical upon them, they will be able to intuitions in this regard. In both decide whether they would want China and Europe, family and close to take part in a particular research friends are most often consulted project. Yet, there are three important before important decisions are made, ways in which this assumption has especially if these are seen to have been challenged, especially through some kind of financial consequences. empirical social science research And also, in both China and Europe which has focused on how research similar concerns are shared about the subjects experience their participation potential exploitation, for example in biomedical or biological research. of women for procuring oocytes or First, it is very often the case that of desperate patients willing to try potential participants are either anything. The more important point not given the time or do not take to be made is that informed consent the time to read informed consent processes must be embedded into forms. Moreover, scientific research local contexts with due understanding objectives can be complicated and and recognition of cultural norms and risk-benefit information complex. social practices, wherever research Second, it is not often that an takes place. individual will make decisions about participating in medical research on There is an extensive literature on their own. They may ask their doctor informed consent as concerns clinical (who might be recruiting them) ‘what research. With BIONET’s focus on would you do?’, they may seek out advanced life sciences research, we information on the internet or they have identified four particular areas of may discuss matters with friends and concern related to ethical interaction close family. Even if it is an individual between researchers and potential/ who signs an informed consent form, actual research subjects. this does not mean that a decision Concern 1: Vulnerability – has been ‘autonomous’ raising the contexts of inducement question of when influence is ‘undue’. and coercion Thirdly, and perhaps most importantly, there are very often factors other than The assumption behind informed enlightenment which can influence a consent is that most individuals are decision to participate in biomedical capable of and should be responsible or biological research. for making decisions about whether or not to participate in biological or Vulnerability is a concept used biomedical research. By providing to describe situations where individuals with sufficient good certain individuals are in need of quality and appropriate information special protection because of their and without putting undue pressure circumstances.

30 Ethical governance of international biological and biomedical research collaborations

Traditionally, informed consent procedures and forms have been seen as the most important tool for ensuring that interaction between researchers and patients is ethical and legal

Capacity to consent – much often impact health care, individuals of ongoing debate concerning may not be considered to have the vulnerability in human subjects ‘authority to consent’ autonomously. research has been about so-called Poverty and lack of health care ‘capacity to consent’. The less – when research is carried out in individuals are considered to be resource-poor settings, socio-economic capable of autonomously consenting circumstances can be another the more vulnerable they are vulnerability factor. Indeed, for some, considered to be, eg, mentally participation in medical research impaired or minors. Individuals means access to basic healthcare deemed incapable of consenting which might otherwise be difficult should usually not be included in or expensive to obtain. In such clinical research, and if they are cases, it is difficult to avoid some special protections must be afforded form of inducement as there are them and consent must be sought clear advantages from participating from legal guardians. as opposed to not participating. Authority to consent – in some Some argue that the more poor cultural contexts distinctions between and uneducated individuals are the community consent, family consent less possible it is to ensure free and and individual consent suggest that informed consent. In such models, there can be differences in opinion non-coerced informed consent is as to who has ‘authority to consent’. not possible unless an individual’s The assumption that if an individual education and socio-economic status is capable of consenting then it will has reached a certain level. Others always be him or her who has the argue that this builds on outdated, autonomous authority to consent is patronising and ‘Eurocentric’ ideas challenged in certain contexts. Indeed, about civilisation and rationality, research projects which enter into and that free informed consent certain communities can disrupt forms is possible in any socio-economic of social organisation by bypassing circumstances as long as informed established forms of consultation consent procedures and forms are and decision-making and insisting adapted to local circumstances. on individual consent. For example, The debate about whether or not medical care in China has become informed consent is possible in all increasingly commercialised over the socio-economic contexts also runs last two decades meaning that health the risk of reducing informed consent care decisions will often have financial to a legal-technical formality and the consequences and must therefore act of communication itself to a mere be agreed by families. And since response to the form instead of to the participating in medical research will matter at stake.

31 Ethical governance of international biological and biomedical research collaborations

One model of vulnerability according to education and socio-economic status discussed at BIONET³

A Educated and economically sound sections where the conditions for individual informed consent are not socio-economically constrained.

B Educated though economically less well-off sections, living under extended family set-ups where decision-making process is a collective exercise, often with dominant participation of father or husband and the individual’s choice is subordinated to family perspectives or even to extraneous considerations.

C Less educated, economically underdeveloped groups/populations where a community head has a say in matters relating to individual’s private life.

D The very poor whose main concern is to safeguard his/her survival. Conditions for individual informed consent are virtually nonexistent.

Doctor-patient relationships – coercion is an ever present possibility, relationships between healthcare especially if conflicts of interest occur. providers/researchers and patients For example, the links between can lead patients to say yes to reproductive medicine and stem cell participating in research for fear of research have been intimate since damaging their relationship with a embryonic stem cell research has doctor. Insufficient studies among hitherto relied on a steady supply research participants have been of ‘spare’ eggs and embryos and carried out to date in China, but as a result, in many cases, stem cell some initial pilot studies presented at laboratories have been established in BIONET workshops have suggested close proximity to and in partnerships that a major reason that patients with IVF clinics. This proximity can participate in research is to get create conflicts of interest, as there therapeutic benefit or to cure their may be undue pressure on clinicians disease. Some patients also suggest to stimulate ‘extra’ eggs or to create that they agree to participate in ‘extra’ embryos for research rather research in order to ensure a better than reproductive purposes. In relationship with their doctors. The recent years, doctor-patient relations ³ Source: Adapted from inherently unequal relationship are seen to have deteriorated R R Kishore (2008) ‘Clinical Trials: The Indian between doctors and patients considerably in China due to Perspectives’, presented at means that direct or structural increasing commercialisation of health BIONET Xi’an workshop, 9-12 September 2008

32 Ethical governance of international biological and biomedical research collaborations

care combined with high expectations Concern 2: of modern medicine. Experimental therapies Patient desperation – finally, As already noted, advanced life as already noted, with advanced sciences are surrounded by narratives biological research promising stem of hope, promise and even hype. cell and gene therapies for hitherto There are hopes that regenerative untreatable conditions desperately medicine and gene therapies will ill patients might be easily convinced provide solutions to some of the most to participate in medical research. In debilitating conditions in the world, these situations, the less treatment from neurodegenerative diseases to options an individual has, the more cardiovascular disorders and spinal vulnerable they are seen to be. cord traumas. And although most scientists working in these fields will If the point of departure of point out that stem cell therapy is interactions between researchers still a long way off, as any random and research subjects is some kind internet search will show many forms of informed consent procedure of stem cell therapy are currently to which marks a sign of respect shown those who can afford it. Indeed, stem by researcher to research subject, cell tourism has become a growth then ethical interaction between business, even in the absence of them must take into account every mature and approved therapies. factor which might lead to undue influence, coercion or inducement. Many of the most important medical Research subject vulnerability is advances in history have required multi-faceted and directly correlated ‘experimentation’ on human health to risks of coercion, inducement and lives with casualties but also with and exploitation. What BIONET significant benefits for future patients. workshops have shown is that there Arguably, ‘too much’ caution can is no ready-made answer as to which slow down innovation and medical situations will automatically lead to advances. Yet on the other hand, unethical interaction, but a willingness good science is based on thorough, to acknowledge and analyse sceptical and time-consuming scrutiny. potential pitfalls before, during and As put by one stem cell scientist, if after research can help ensure that ‘we don’t understand the biology measures are taken to counteract enough’ at this stage, should patients these. A great deal of collaborative be subject to experimental treatment? social scientific research and How should caution, a ‘pre-clinical’ conceptual reflection will be necessary requirement to know biological in order to work out the multi-faceted modes of action, patient safety and realities to which ethical governance clinical experimentation be balanced? needs to respond on the ground.

33 Ethical governance of international biological and biomedical research collaborations

‘Tomorrow’s medicine today!‘ – global stem cell tourism

Medical tourism is nothing particularly new. It flows in all directions from North to South, West to East and vice versa. Affluent westerners travel to top-class medical facilities in Asia or the Caribbean for routine medical operations at lower cost and shorter waiting times, fertility tourists from all over Europe travel to Spain in search of oocyte donors and so-called ‘National Health Service tourists’ travel to the United Kingdom, France and other countries to benefit from universal healthcare services. In more recent years stem cell tourism has emerged as a new form of medical tourism whereby patients travel to different countries to get access to experimental therapies which might not otherwise be available in their countries of origin.

Private clinics throughout the world are taking advantage of the ambiguous status of experimental therapies in many countries. Extravagant claims are made about the purported curative properties of stem cells in the treatment of Alzheimer’s, spinal cord injury, multiple sclerosis and many other diseases. Patients are recruited through internet sites (eg, www.stemcellschina. com) and personal networks. Patient blogs, testimonials as well as ‘before and after’ video clips feature prominently on these sites. Patients are offered ‘treatment packages’ including accommodation, medical check ups and of course a course of stem cell injections. Patients can pay anywhere between $10,000 and $40,000 for a single treatment which usually consists of 2-3 injections of stem cells. Little or no information is provided about the quality and/or origin of stem cell lines used in treatment.

In Europe, stem cell therapies fall under the recently adopted Regulation on Advanced Therapies and in China, as of 1 May 2009 a new set of Administrative Measures on Clinical Applications of Medical Technologies came into force requiring that stem cell therapies be subject to rigorous safety and efficacy trials. These regulations notwithstanding, stem cell ‘therapies’ continue to be available to those patients willing to pay in both Europe and China.

One of the key ethical challenges for subjects, as a minimum, experimental current clinical testing of stem cell therapies should be subject to strict therapies is how to proceed when not application of existing clinical protocols, much is known about the biological ethical review and informed consent mode of action of stem cells as they procedures and where safety of the are used to treat degenerative diseases patient is the priority; ideally embedded or brain trauma. For interaction in a comprehensive system of ethical between researchers and research and social checks and balances. In

34 Ethical governance of international biological and biomedical research collaborations

Europe, cell and gene therapies, in Category 3 therapies in order to ensure addition to several national codes, fall safety, quality and efficacy. under the Regulation on Advanced This, however, is in stark contrast to Therapies (2007) which sets out a the kinds of stem cell therapy patients system of scientific evaluation (safety, can pay for in different parts of the quality and efficacy of advanced world today including China and therapies), a traceability system for Europe. In many cases, there is no way monitoring starting materials (cell lines), for patients to know whether the stem products and patients and a central cell injections they are receiving are of approach to marketing authorisation clinical grade, or what they can expect of products across the EU. In China, a to get out of the treatments. Legal set of central national Administrative loopholes remain, allowing companies Measures on Clinical Applications of to continue providing experimental Medical Technologies came into force therapies to those patients willing to in 2009 which designate all forms of pay for them. This makes it even more stem cell therapy and gene therapy as important to encourage the scientists Category 3, ie, those that are ethically themselves to pro-actively adhere to problematic, high risk or still in need the highest standards. of clinical verification. The Ministry of Health is now responsible for regulating

Collection of blood samples for genomic research, Kunming

35 Ethical governance of international biological and biomedical research collaborations

Key elements of China’s stem cell ethical governance network

Ministry of Science & Technology 973 & 863 research funding programmes Ministry of Education 211 & 985 projects provide funding for stem cell research Ministry of Health National and Provincial Ethics Committees, Institutional Review Board Ethical principles on stem cell research Administrative Measures on Clinical Applications of Medical Technologies Chinese Academy of Science National Natural Science Foundation

Key stem cell scientists and laboratories Deng Hongkui Peking University College of Life Sciences Li Lingsong Peking University Stem Cell Research Center Pei Xuetao Chinese Academy of Military Medical Sciences Pei Gang Tongji Univeristy, Shanghai Zhang Yu Beijing Capital Medical University, Xuanwu Hospita Zhao Chunhua Center for Tissue Engineering, Chinese Academy of Medical Ouyang Hongwei Science and Peking Union Medical College Zhou Qi Beijing Institute of Zoology, CAS and Tianjin SCRMC Sheng Huizhen Center for Developmental Biology, SJTUSM Tang Qiqun Fudan University Wang Xin CAS KLSCB and IBCB, SIBS/CAS Chen Zhu Institute of Hematology, SJTUSM and CAS Han Wei Stem Cell Center, Shanghai Jiaotong University Jin Ying CAS KLSCB and IHS, SIBS/CAS; SJTUSM Jing Naihe CAS KLSCB and IBCB, SIBS/CAS Zhu Jianhong Huashan Hospital, Fudan University Medical School Cheng Tao Tianjin Institute of Hematology, Chinese Academy of Medical Sciences Feng Gengsheng Stem Cell Program, Biomedical Institute, Xiamen University Han Zhongchao Tianjin Institute of Hematology, Chinese Academy of Medical Sciences Yang Huangtian CAS KLSCB and IHS, SIBS/CAS; SJTUSM, Shanghai Zeng Fanyi Shanghai Institute of Medical Genetics, Shanghai Jiao-Tong University Zhang Suchun Fudan University Shanghai Medical School Zhang Wenjie Center for Tissue Engineering and The 9th Hospital, SJTUSM Ji Weizhi Kunming Institute of Zoology, CAS

36 Ethical governance of international biological and biomedical research collaborations

Lu Guangxiu Institute of Reproduction & Stem Cell Engineering, South China University Pei Duanqing Guangzhou Institutes of Health and BioMedicine, CAS Tse Hung-Fat Department of Medicine, Queen Mary Hospital, University of Hong Kong

University and private hospitals Regenerative medicine, stem cell therapies, eg, www.stemcellschina.com/

Biotechnology companies and venture funds China National Center for Biotechnology Development 20 biotech parks, 500 biotech enterprises Beike technologies

Chinese and international scientific journals Publication of stem cell research findings

Media Reporting on issues such as stem cell therapy IVF and donation of embryos for research.

Concern 3: Donation of gene or genome wide association biological materials and/or studies. In this latter case, donors of biographical information biological samples can also donate biographical, lifestyle and/or family One of the characteristics of advanced medical history information. biological and biomedical research today is its reliance on biological There are in particular two sets of samples. Potentially self-renewing problems related to donation of stem cells can be sourced from biological samples and/or personal six-day old in vitro fertilised human information. The first concerns how blastocysts, aborted human foetal such samples and information are tissues, umbilical cord blood, bone sourced while the second concerns marrow, brain tissues as well as other what will happen with the donated somatic sources. That is to say, stem samples and personal information once cell lines are derived from biological collected and stored – can they be samples, which are taken from human used for research purposes other than embryos, aborted foetuses, newborns those stated in the original research or adults. Genetic research relies on project for which they were collected? blood or saliva samples which can be Who owns these samples once they used to sequence DNA information have been collected and stored? from individuals to be used in single

37 Ethical governance of international biological and biomedical research collaborations

Sourcing – there are different risks regulations expressly forbid any associated with different kinds of coercion or commercial incentives sourcing of biological samples. The to achieve the donation of eggs or procurement of human oocytes for embryos. And finally, the principles of stem cell research involves some patient benefit and minimisation of of the greatest risks for females as harm must always come first, a point collection of eggs can only take place that is all the more important bearing after hormonal stimulation which can the close connections between fertility have severe health consequences. treatment and stem cell research. Donating bone marrow samples is Likewise when biographical, life style Ethical interaction also associated with certain or family medical history is obtained health risks and discomfort. from donors through interviews or between researchers Sourcing can also take place questionnaires, due social and cultural and research subjects in different contexts, for sensitivity is a requisite. Key ethical in situations where example, during medical questions include: Are there any risks procedures, during a birth involved in taking a biological sample? biological samples are or following an abortion. In which contexts are individuals procured requires respect For example, at the BIONET being asked to donate? Shanghai workshop, a and sensitivity, and donor ‘Immortalisation’ – a particular case was discussed where feature of biological sample safety will always be the pregnant women were procurement in advanced life science prime concern asked to donate cord blood research is that of immortalisation. after having gone into A stem cell line derived from an labour. In such contexts, sourcing individual’s biological samples can be of a biological sample can be an immortalised and end up in a stem intrusion. Ethical interaction between cell bank where it may then be sent researchers and research subjects in to other laboratories across the world situations where biological samples or perhaps even used in therapeutic are procured requires respect and treatment of other patients. This sensitivity, and donor safety will raises questions about who ‘owns’ always be the prime concern. For such immortal lines and just what example, when egg and embryo it is that a donor is consenting to – donors are recruited from IVF clinics, especially in light of incalculable future donation must be strictly voluntary developments. Similarly, donors of DNA and must not influence fertility samples and associated biographical treatment in any way. Proper informed data to biobanks will have their consent should be obtained by a third samples and records stored in sample party and not by the treating doctor repositories and databases for the or researching scientist. Also donation remainder of their lives and perhaps should not be commercialised so even beyond. What happens if persons as to ensure that no inducements unrelated to the original research are present. In China, all relevant

38 Ethical governance of international biological and biomedical research collaborations

project get access to this information both Europe and China, BIONET and what guarantees should donors workshop participants stressed have about who can have access that it was necessary to organise a to biobank databases? In BIONET trustful communication culture and in workshops there were numerous particular to take the time to explain debates about the merits and pitfalls sometimes very complex information of blanket consent vs. specific consent about stem cell research. and whether or not donors should be In hospital-based clinical research, re-consented every time a new research therapeutic misconceptions can project using certain biological samples be difficult to set straight as was proposed. many recruited patients consider Concern 4: Benefit- participation in clinical research sharing and trust as medical treatment which can inevitably lead to false expectations Research subjects for advanced life and a breakdown in relationships of sciences research are recruited in very trust between doctors, researchers different situations and contexts. In and patients. In BIONET’s Xi’an BIONET workshops, we in particular workshop on clinical trials, Chinese focused on three contexts: IVF clinics participants suggested that patients, (reproductive and stem cell research), physicians, researchers and health hospitals (clinical research) and care administrators regularly confused communities (biobanking). clinical trials with medical care and On the one hand, it is not in the even that some physicians and specific interest of an individual investigators seem deliberately to to participate in research since treat clinical trials as medical care benefits are aimed at the collective in order to ‘sell’ them to potential as increased knowledge can help participants. Again, the need for improve treatment and lead to new trustful communication between medical breakthroughs. Empirical physicians, researchers and patients is research among IVF patients has a key part of ethical interaction, and shown how some are willing to the distinction between research and donate eggs or embryos for research medical care must be made clear to as a way of ‘giving something back’ research participants. since they feel they have benefited In biobanking it is often a whole from past scientific research community or section of the general themselves. Some might consider public who will be recruited. If a allowing spare embryos to perish genetic research project expects as ‘wasteful’, while others might to recruit research subjects from a see the inevitable destruction of small community steps must actively spare embryos through embryonic be taken to ensure that trust is stem cell research as ‘wasteful’. In

39 Ethical governance of international biological and biomedical research collaborations

established between scientists and be made to ensure that research community members. What might projects undertaken in particular seem like administrative technicalities communities are relevant to those on paper (eg, study inclusion criteria) research subjects being studied (eg, can have unintended consequences in rural populations should not be a community. In BIONET’s Shenzhen approached to recruit for clinical workshop on biobanks a case was drug research destined for affluent discussed whereby the setting up urban populations). Moreover, those of a register for the DNA of some undertaking the research should rural communities with a view to always explicitly consider whether investigating sickle cell disease was research subjects would have access surrounded by fear of information to potential treatments arising from leaks and possible loss of face in the research, especially in the context of community (eg, what if it became clinical research for pharmaceutical known that a family declined to products and give clear ethical participate?). In a genetic project justification for their decisions if this is among ethnic minorities in China, not to be the case. potential participants were explicitly told ‘you will not benefit directly Ethical capacity building from participating in this study. of principal investigators However, your participation will What these four areas of concern benefit the general population by regarding ethical interaction between increasing knowledge related to advanced life science researchers genome diversity and its significance and research subjects – vulnerability, in diseases’. The specific benefits experimentation, donation and that might flow to those ethnic benefit-sharing – show is that communities who contributed their principal investigators have a large samples were not discussed. task in identifying and analysing their target populations for study If human subjects will not necessarily recruitment. Hence, capacity building personally benefit from participating is not only something that should be in biological and biomedical research directed at ethics review committee (indeed the decision to participate members, but it should also be or not may itself cause anxiety and provided for principal investigators apprehension), and benefits to their of scientific research projects, as they specific community are unspecified, should be trained in how to adhere how does it make sense to talk about to the given standards. Ethical review benefit-sharing? First and foremost, of research projects before they if it is the knowledge gained from commence is of course important, research which will ultimately benefit but perhaps more important is the collective, then active steps must

40 Ethical governance of international biological and biomedical research collaborations

to set up mechanisms for ethical empirical research among participants oversight through the duration of a in advanced life science research scientific project (eg, quality control projects. Interdisciplinary collaboration of informed consent procedures, is a key approach to identifying what interviews with research subjects is needed in terms of capacity and and researchers). One of BIONET’s capability building, and how it can strengths as a network has been be achieved under the conditions its interdisciplinary base, and in of international, cross-cultural this particular area social sciences collaboration in the life sciences can contribute through in depth, between Europe and China.

Sequencing at the Beijing Genomics Institute

41 Conclusions – ethical governance of global life science collaborations

The BIONET workshops and (especially those suffering from conferences were attended by incurable diseases). more than 300 Chinese and When Sino-European life science European scientists, clinicians, research collaborations are initiated, lawyers, social scientists, ethicists benefits are gained through the and others. From our presentations, pooling of resources, sharing of debates, case studies and workshop expertise and perhaps also lowering discussions, it was made clear that of costs. Yet, such collaborations ethical governance is not just about also engender their fair share of how guidelines and regulations challenges as outlined in this report. are implemented and followed, When scientists from Europe and rather it involves a complex system China join forces, they are not only wherein research practice is guided bringing together scientific expertise, by respect for the rule of law, they are also bringing together transparency, scientific and ethical distinct forms of ethical deliberation accountability, human rights and and communication, different freedom from corruption. It involves systems of ethical regulation, varied collaboration and coordination not procedures for ethical review as well just between individual scientists, as different traditions of recruitment but increasingly among an entire and interaction between researchers network of scientists (principal and research subjects. Moreover, investigators, junior researchers and the increasing commercialisation postgraduate students), university of science on a global scale further departments, associations of complicates attempts to ethically science or medicine, commercial supervise international collaborations. organisations, clinicians, patients, scientific journals, Ministry officials, For these reasons attention should be local government departments and paid to each of the layers or spheres others. Regulation and regulatory of ethical governance identified in this frameworks are only one element report. Traditions and forms of ethical in much more complex networks deliberation and communication of multi-layered governance. There at national levels are different from can be many pressures to achieve country to country and matters results – international competition of language and translation must (as nations compete to be at the be addressed in order to improve forefront of the biotech revolution), cross-national dialogue on ethical prestige (for scientists, governments, issues raised by life science research. research councils), financial reward (as Countries throughout the world are biotech companies and governments building infrastructures of ethical push to have basic research translated regulation which continues to have into therapy), patient desperation an impact on the possibilities for

42 Ethical governance of international biological and biomedical research collaborations

Regulation and regulatory frameworks are only one element in much more complex networks of multi-layered governance

life science collaboration. Scientists research participants takes place. and ethical review committees must While the BIONET project focused on be aware of national regulatory workshops as a kind of mapping out differences before collaborations exercise, what is now needed is much are initiated. While systems of peer more in depth and empirically rich review have been developed over social scientific research into these many decades (and still do not prevent different layers of ethical governance all scientific misconduct), systems of in China and Europe. Through ethical review are much more recent. such future work, building on the Sino-European research collaborations platform established by BIONET, and will have to be reviewed in both in conjunction with the standing Sino- regions and for this reason scientists European Platform for Biomedical and regulators must be aware of Research Ethics proposed by the differences in systems of ethical BIONET expert group, and together oversight to ensure that they adhere with related initiatives being taken by to relevant procedures. And finally, others, we feel confident about the researchers who travel to an unfamiliar future for ethically sound research country to carry out research involving collaborations between European and human subjects must be aware of Chinese researchers in the life sciences cultural and socio-economic factors and biomedicine that will benefit which will affect the way in which medical knowledge and the health ethical interaction – facilitated and well-being of the populations in by informed consent procedures – both regions. between researchers and potential

43 BIONET partners

• Nikolas Rose, London School of Economics and Political Science, United Kingdom (Coordinator)

• Ole Döring, German Institute for Global and Area studies, Hamburg, Germany

• Herbert Gottweis, University of Vienna, Austria

• Renata Salecl, Institut za kriminologijo pri Pravni fakulteti, Slovenia

• Dominique Memmi, Centre National de la Recherche Scientifique, France

• Alicja Laska-Formejster, Uniwersytet Lodzki, Poland

• Christoph Rehmann-Sutter, Universität Basel, Switzerland

• Cong Yali, Peking University Health Science Centre, China

• Lu Guangxiu, Reproductive and Genetic Hospital CITIC-Xiangya & Central South University, China

• Zhai Xiaomei, Peking Union Medical College, Chinese Academy of Medical Sciences, China

• Qiu Renzong, Institute of Philosophy, Chinese Academy of Social Sciences, China

• Yang Huanming, Beijing Genomics Institute, Chinese Academy of Sciences & BGI Shenzhen, China

• Genevra Richardson, King’s College London, United Kingdom

• Jack Price, King’s College, United Kingdom

• Margaret Sleeboom-Faulkner, University of Sussex, United Kingdom

• Nick Bunnin, University of Oxford, United Kingdom

• Hans Galjaard, Erasmus Universiteit Rotterdam, Netherlands

• Peter Propping, Universitätsklinikum Bonn für den Fachbereich Medizin der Universität Bonn, Germany

• John Telford, Novartis Vaccines and Diagnostics SrL, Italy

• Paul Unschuld, Charité Medical University Berlin, Germany

• Wolfgang Hennig, Johannes Gutenberg Universität Mainz, Germany

44 Ethical governance of international biological and biomedical research collaborations

BIONET Research Fellow: Ayo Wahlberg, BIOS Centre, London School of Economics and Political Science, United Kingdom BIONET Exchange Students: • Li Rong, Reproductive Medical Centre, Peking University Third Hospital, China

• Thomas Streitfellner, Life Science Governance Research Platform, University of Vienna, Austria

• Joy Zhang, BIOS Centre, London School of Economics and Political Science, United Kingdom

• Chen Haidan, Zhejiang University, Hangzhou, China

• Su Yeyang, Beijing Genomics Institute, Chinese Academy of Sciences, China

• Sui Suli, International Institute for Asian Studies, Leiden, The Netherlands

• Anika Mitzkat, Institute for Nursing Science, Department for Medicine, University of Witten/Herdecke, Germany

• Megan Allyse, Institute for Science and Society, University of Nottingham, UK

• Ginny He, Institute of Reproduction and Stem Cell Engineering, Central South University, Changsha, China

• Achim Rosemann, Department of Social Anthropology, University of Sussex, UK

• Wang Chunshui, Centre for Bioethics, Chinese Academy of Social Sciences/ Peking Union Medical College, China

45 © BIONET, London This document is available online at www.bionet-china.org It can also be ordered from: BIOS Centre The London School of Economics and Political Science Houghton Street London WC2A 2AE Designed by LSE Design Unit Copies of all BIONET workshop and lse.ac.uk/designunit conference reports can be downloaded from www.bionet-china.org/ Printed on recycled stock