About the Book
Population genomics research drawing on genetic databases has expanded rapidly, with some of this information being combined in 'biobanks'. Managing this information in an appropriate way is a highly complex ethical issue in the health policy arena. This book combines theoretical and empirical research to analyze the areas of conflict and consensus in the regulatory and ethical frameworks that have been developed to govern biobanks.
Ethicists from the Department of Ethics, Trade, Human Rights and Health Law (ETH) of the World Health Organization, the Institute of Biomedical Ethics of Geneva University and the Institute of Biomedical Ethics of the University of Zurich, with the support of the Geneva International Academic Network (GIAN), examine the conditions under which genetic databases can be established, kept, and made use of in an ethically acceptable way. In addition to a comprehensive review of the scientific literature and a comparative analysis of existing normative frameworks, they present the results of in-depth interviews with experts around the world concerning the most unresolved and controversial issues. The results of that study, combined with their normative analysis, leads to recommendations for a better international framework.
Table of Contents:
Contents: Introduction: biobanks, genomics, and research – a nightmare for public policy makers?, Alex Mauron; Part I Research Biobanks: Current Status and Debates: Biobanks in the literature, Bartha Maria Knoppers and Ma'n H. Abdul-Rahman; Guidelines on biobanks: emerging consensus and unresolved controversies, Effy Vayena, Agomoni Ganguli-Mitra and Nikola Biller-Andorno. Part II Consensus and Controversies Among International Experts Concerning Issues Raised by Genetic Databases: Ethical issues regarding research biobanks: aims, methods, and main results of a qualitative study among international and US experts, Nikola Biller-Andorno, Andrea Boggio, Bernice Elger, Agomoni Ganguli-Mitra, Alex Capron and Alex Mauron; Consent and use of samples, Bernice Elger; Consent to research involving human biological samples obtained during medical care, Bernice Elger; Collective consent, Agomoni Ganguli-Mitra; Withdrawal of consent and destruction of samples, Bernice Elger; Anonymization and coding, Bernice Elger; Informing participants about research results, Andrea Boggio; Ownership of samples and data and territorial restrictions concerning data and samples beyond national boundaries, Andrea Boggio; Public domain sharing, patents, and fees resulting from research involving genetic databases, Andrea Boggio; Benefit-sharing and remuneration, Agomoni Ganguli-Mitra; Transfer of samples and sharing of results: requirements imposed on researchers, Andrea Boggio. Part III Shaping the Future Legal and Ethical Development of Genetic Databases: Towards an international framework: results of a meeting of an international group of scholars and scientists involved in legal and practical issues of biobanks, Alex Mauron; Biobanks and genomic research: what shape the future?, Alex Capron; Index.
About the Author :
Bernice Elger is Professor, Institut Universitaire Romand de Medecine Legale Universite de Geneve, and Internist at the University Hospital of Geneva. Nikola Biller-Andorno is Professor of Biomedical Ethics, University of Zurich. She is an advisor to the World Health Organization and Associate Editor of the Journal of Medical Ethics. Alex Mauron is Professor of Bioethics, Faculty of Medicine, University of Geneva. He is a member of the Swiss Academy of Medical Sciences, the Swiss National Advisory Commission on Biomedical Ethics, and the Swiss Science and Technology Council. Alex Capron is a University Professor at the University of Southern California, where he holds the Scott H. Bice Chair in Healthcare Law, Policy and Ethics. A member of the Institute of Medicine (National Academy of Sciences) and the American Law Institute, he was the first Director of Ethics, Trade, Human Rights and Health Law at the World Health Organization. Alex Mauron, Bartha Maria Knoppers,Ma'n H. Abdul-Rahman, ,Effy Vayena, Agomoni Ganguli-Mitra, Nikola Biller-Andorno, Andrea Boggio, Bernice Elger, Alex Capron .
Review :
'This volume is a "must-read" for anyone interested in biobanks, bringing together both theoretical perspectives and empirical data to shed clear light on the sometimes confusing issues of terminology, and identifying where consensus exists regarding ethics and regulation in this important area of scientific development.' Ruth Chadwick, Cardiff University, UK 'Ethical Issues in Governing Biobanks provides valuable evidence of widespread academic concern about ethical issues associated with biobanks.' Journal of the American Medical Association '[This] book provides a comprehensive overview of unresolved ethical disputes in the literature and of conflicting national and international guidelines. Even more useful, much of the book is based on an international qualitative study of the ethical opinions of bioethicists, biobank managers, medical researchers and clinicians.' Monash Bioethics Review 'The strength of the book is the rich and detailed exploration of the moral reasoning concerning a large number of controversial issues surrounding the development of new biobanks and the maintenance of existing biobanks... The authors have managed to present their material in a very lively, compelling fashion... I strongly recommend this book to anyone who is interested in the topic of biobanks and who would like to understand more of the complicated discussions concerning them.' Genomics, Society and Policy
