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