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BIONET Textbook 2 ______ _____________________________________ Ethical Governance of Biological and Biomedical Research: Chinese- European Co-operation TEXTBOOK Life Sciences in Translation – A Sino-European Dialogue on Ethical Governance of the Life Sciences Edited by Ole Döring Second Edition December 2009 BIONET Textbook 2 _______________________________________ Contents PREFACE Ole Döring 5 PART 1: MAIN TOPICS Ole Döring: Introduction 8 Biobanks Jan Reinert Karlsen, Jan Helge Solbakk and Roger Strand: Should Biobank 14 Regulations be Harmonized? Chu Jiayou: “Informed consent” and the Establishment of an Immortalized Cell 22 Line Bank of China’s Different Ethnic Groups Margaret Sleeboom-Faulkner: Biobanking in Transnational Perspective 28 Genomics Wolfgang Hennig: General Implications of Genomic Research for Society and 33 Governance in Sino-EU Co-Operation Wang Xiaofeng and Jin Li: Cohort Profile: Taizhou Longitudinal Study – a 39 Prospective Study of Non-Communicable Diseases Zhang Xiaoyong: Benefit-Sharing in Human Genetic Research: International 49 Experiences and Chinese Legal Choices Translational Research Tu Ling, He Jing, Lu Guangxiu: Practice and Evaluation of Ethical Governance in 55 Assisted Reproductive Technologies (ART) Erica Haimes: Acquiring Eggs and Embryos for hESC Research: Socio-Ethical 64 Considerations Pei Xuetao: Human Stem Cell Research and Ethical Regulations in China 77 International Dynamics Ayo Wahlberg and Thomas Streitfellner: Stem Cell Tourism, Desperation and the 81 Governing of New Therapies Detlef Niese: Research in Humans in China: The Role of Industry in Governance 98 and Protection of Research Participants R. Kishore: Clinical Trials: The Indian Perspectives 113 Conceptual reflections Zhu Wei: Does Chinese Culture Constitute Challenges to Informed Consent? 126 Christoph Rehmann-Sutter: Concerns and Principles. Bioethics and the Challenge 132 BIONET Textbook 3 _______________________________________ of Cross-Cultural Biopolitics PART 2: STUDENTS’ FINDINGS Ole Döring: Introduction 150 Chen Haidan: Stem Cell Governance in China: From Bench to Bedside? 153 Achim Rosemann. The IVF-Stem Cell Interface in China: Ontologies, Value- 168 Conceptions and Donation Practices of Embryonic Forms of Life Anika Mitzkat: Donation of Spare Embryos for Stem Cell Research: Experiences and Views of Couples Undergoing IVF at CITIC-Xiangya Hospital of 179 Reproduction and Genetics, Changsha, China Megan Allyse: The Political Stabilization of Technology: The Case of Oocyte 197 Contribution to Stem Cell Research in California, China and the UK Joy Yueyue Zhang: The Regulation of China’s Stem Cell Research in the Context 206 of Cosmopolitanization Wang Chunshui: Ethical and Social Aspects in Neuroscience: Focus on Medical 217 Interventions of the Brain Li Rong: Informed Consent in the Clinical Work of ART and the Research of 224 Stem Cells Sui Suli: Comparing the Practice of Genetic Counselling in the UK and China 230 Su Yeyang: Engaging the Interactions Between Scientist and the Public: Understanding the New Partnerships in Today’s Biological and Biomedical 238 Research CONTRIBUTORS’ DETAILS 250 PART 3: KEY DOCUMENTS AND RESOURCES 1. Chinese Institutions: Who is Who? 253 2. Ethical Guiding Principles for Research on Human Embryonic Stem Cells 259 3. Ethical Guidelines for Human Embryonic Stem Cell Research 261 4. Regulation on Assisted Reproductive Technologies 266 5. Ethical Principles for Human Assisted Reproductive Technology & Sperm 274 Banks 6. Global Regulation of Human Embryonic Stem Cell Research and Oocyte 278 Donation BIONET Textbook 4 _______________________________________ 7. Regulations in EU Member States Regarding hES Cell Research 286 8. PRC Regulations on Informed Consent and Protection of Human Subjects in 287 Biomedical Studies 9. Revised Guidelines on Ethical Review of Biomedical Research Involving 289 Human Subjects 10. Law on Practicing Doctors 292 11. Management Methods on Clinical Applications of Medical Technologies 295 12. Ministry of Health Procedures for Ethical Review of Human Biomedical Research 297 (Provisional) 13. Regulations for Implementation of the Drug Administration Law of the 308 People's Republic of China 14. Drug Clinical Trial Guidelines (China) 309 15. SFDA Drug Application and Approval Procedures for Clinical Trials 312 16. Regulation on Research with Human Subjects 313 17. MRC China UK Research Ethics Report: Recommendations 318 18. The Chinese Alternative to the Stem Cell Research Debate 322 BIONET Textbook 5 _______________________________________ Preface Ole Döring The 23 chapters in this collection are the outcome of three years of dialogue and research between scholars from Europe, China and other regions about the ethical governance of biological and biomedical research in Sino-European collaborations. This textbook provides insights into multifaced and fruitful discussions on this emerging, broad and difficult area of study. The BIONET project, (Ethical Governance of Biological and Biomedical Research: Chinese-European Co-operation), was funded between 2006 and 2009 under the European Commission’s 6th Framework program, as a Coordination Action, and received additional support from the United Kingdom's Medical Research Council and the Wellcome Trust. The focus was on advanced biological and biomedical research, in particular upon reproductive and regenerative medicine, clinical trials and the genomics of disease susceptibility. This area is a key national, commercial and scientific priority in both China and Europe. Such research raises many challenges and new opportunities for ethical governance of scientific and medical practice, many of which have particular relevance to ensuring best practice in EU-China scientific collaborations. BIONET is a Consortium of 21 EU-based and Chinese partners examining the challenges facing the ethical governance of research in the life sciences and biomedicine in China and the EU (www.bionet-china.org). With the intention to build a sustainable network within and between China and Europe, BIONET has focused on three key areas: (1) reproductive and regenerative medicine, (2) clinical trials and (3) biobanks and the genomics of disease susceptibility and treatability. We made collaborative efforts to (1) map the rationales for and practices of ethical governance of advanced biological and biomedical research in and between China and Europe; (2) provide a platform for the development of comparative research on ethical governance in China and the EU; (3) advance social scientific understanding of key bioethical issues, challenges and approaches generated in contemporary biomedical research through dialogue between researchers and practitioners in China and Europe; (4) undertake training of researchers and practitioners in key issues; and (5) inform policy and practice in the ethics of biomedical research in China and the EU with particular emphasis on issues relevant for scientific collaboration. This textbook offers some of the findings that were generated during this collaborative project. It is meant as a reference for students, researchers, practitioners and administrators, in the scientific, public, economic and political arenas. All authors and BIONET partners hope that our project will inform and inspire readers towards a refreshed understanding of the approaches to China-European collaboration in ethics and governance. This collection of chapters and materials will contribute to the BIONET’s objectives of dissemination and science capacity building; and it is intended to motivate researchers to continue empirical and theoretical work in and between both regions. BIONET Textbook 6 _______________________________________ This textbook draws from the BIONET’s series of workshops and conferences. It is organised in three parts in order to express the pattern of material concerns addressed over the course of our interactions: First, the topical chapters explore a number of core aspects in the areas of biobanks, genomics, and translational research, followed by investigations into the international dynamics of the field as relevant for Europe-Chinese ethical governance, and finally, by related cultural reflections. Second, arguably the most remarkable product of the BIONET, the reports of the findings of the BIONET exchange students represent first steps into the future of cross-cultural collaborative research between our regions. BIONET was able to subsidize 7 Chinese and 4 European students with funding and personal support from the BIONET’s network, to conduct fieldwork in various places and benefit from cultural encounters (http://www.bionet-china.org/student_exchange.htm). Some of these works are exemplary for the broad interdisciplinary design of embedded governance studies and illustrate both the need and feasibility of these research activities as they lay grounds for an enhanced scientific understanding of what makes ethical governance and best practice in the globalised life sciences. Third, the final part includes a collection of key documents and resources that provide more context-relevant factual information and should encourage continued research. First of all, this editor would like to thank all authors who contributed to this collection. Of course, I should like to thank the EC, the UK’s MRC and the Wellcome Trust for providing us with financial support for different aspects of the work of the BIONET. To all colleagues who supported this project from the outside, including the participants of our workshops and conferences, who informed
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