The Ethics and Governance of Human Genetic Databases European Perspectives The Medical Biobank of Umea˚ in Sweden, deCODE’s Health Sector Database in Iceland, the Estonian Genome Project and the UK Biobank were planned to contain health data and genetic data from large popula- tions. Some include genealogical or lifestyle information. They are resour- ces for research in human genetics and medicine, exploring interaction between genes, lifestyle, environmental factors and health and diseases. The collection, storage and use of this data raise ethical, legal and social issues. In this book, bioethics scholars examine whether existing ethical frameworks and social policies reflect people’s concerns, and how they may need to change in light of new scientific and technological developments. The ethical issues of social justice, genetic discrimina- tion, informational privacy, trust in science and consent to participation in database research are analysed, whilst an empirical survey, conducted in the four countries, demonstrates public views of privacy and related moral values in the context of human genetic databases. The research presented in this book was conducted within the project ‘Ethical, Legal and Social Aspects of Human Genetic Databases: A European Comparison’, funded by the European Commission’s 5th Framework Programme (QLG6-CT-2001-00062). MATTI HA ¨ YRY is Professor of Bioethics and Philosophy of Law at the University of Manchester. RUTH CHADWICK is Distinguished Research Professor at Cardiff University. VILHJA ´ LMUR A ´ RNASON is a Professor of Philosophy and Chair of the Centre for Ethics at the University of Iceland. GARDAR A ´ RNASON is a Research Fellow at the University of Manchester. Cambridge Law, Medicine and Ethics This series of books was founded by Cambridge University Press with Alexander McCall Smith as its first editor in 2003. It focuses on the law’s complex and troubled relationship with medicine across both the devel- oped and the developing world. In the past twenty years, we have seen in many countries increasing resort to the courts by dissatisfied patients and a growing use of the courts to attempt to resolve intractable ethical dilemmas. At the same time, legislatures across the world have struggled to address the questions posed by both the successes and the failures of modern medicine, while international organizations such as the WHO and UNESCO now regularly address issues of medical law. It follows that we would expect ethical and policy questions to be integral to the analysis of the legal issues discussed in this series. The series responds to the high profile of medical law in universities, in legal and medical practice, as well as in public and political affairs. We seek to reflect the evidence that many major health-related policy debates in the UK, Europe and the international community over the past two decades have involved a strong medical law dimension. Organ retention, embry- onic stem cell research, physician assisted suicide and the allocation of resources to fund healthcare are but a few examples among many. The emphasis of this series is thus on matters of public concern and/or practical significance. We look for books that could make a difference to the development of medical law and enhance the role of medico-legal debate in policy circles. That is not to say that we lack interest in the important theoretical dimensions of the subject, but we aim to ensure that theoretical debate is grounded in the realities of how the law does and should interact with medicine and healthcare. General Editors Professor Margaret Brazier, University of Manchester Professor Graeme Laurie, University of Edinburgh Editorial Advisory Board Professor Richard Ashcroft, Queen Mary, University of London Professor Martin Bobrow, University of Cambridge Dr Alexander Morgan Capron, Director, Ethics and Health, World Health Organization, Geneva Professor Jim Childress, University of Virginia Professor Ruth Chadwick, Cardiff Law School Dame Ruth Deech, University of Oxford Professor John Keown, Georgetown University, Washington, DC Dr Kathy Liddell, University of Cambridge Professor Alexander McCall Smith, University of Edinburgh Professor Dr Mo´nica Navarro-Michel, University of Barcelona Books in the series Marcus Radetzki, Marian Radetzki, Niklas Juth Genes and Insurance: Ethical, Legal and Economic Issues 978 0 521 83090 4 Ruth Macklin Double Standards in Medical Research in Developing Countries 978 0 521 83388 2 hardback 978 0 521 54170 1 paperback Donna Dickenson Property in the Body: Feminist Perspectives 978 0 521 86792 4 Matti Ha¨yry, Ruth Chadwick, Vilhja´lmur A ´ rnason, Gardar A ´ rnason The Ethics and Governance of Human Genetic Databases: European Perspectives 978 0 521 85662 1 The Ethics and Governance of Human Genetic Databases European Perspectives Edited by Matti Ha¨yry Ruth Chadwick Vilhja´lmur A ´ rnason Gardar A ´ rnason CAMBRIDGE UNIVERSITY PRESS Cambridge, New York, Melbourne, Madrid, Cape Town, Singapore, São Paulo Cambridge University Press The Edinburgh Building, Cambridge CB2 8RU, UK First published in print format ISBN-13 978-0-521-85662-1 ISBN-13 978-0-511-28496-0 © Matti Hayry, Ruth Chadwick, Vilhjalmur Arnason, Gardar Arnason 2007 2007 Information on this title: www.cambridge.org/9780521856621 This publication is in copyright. Subject to statutory exception and to the provision of relevant collective licensing agreements, no reproduction of any part may take place without the written p ermission of Cambrid g e University Press. ISBN-10 0-511-28572-8 ISBN-10 0-521-85662-0 Cambridge University Press has no responsibility for the persistence or accuracy of urls for external or third-party internet websites referred to in this publication, and does not g uarantee that any content on such websites is, or will remain, accurate or a pp ro p riate. Published in the United States of America by Cambridge University Press, New York www.cambridge.org hardback eBook (MyiLibrary) eBook (MyiLibrary) hardback Contents List of contribu tors page x 1 Introduction: some lessons of ELSAGEN VILHJA ´ LMUR A ´ RNASON 1 Part I Background 9 2 On human genetic databases GARDAR A ´ RNASON 11 3 American principles, European values and the mezzanine rules of ethical genetic databanking MATTI HA ¨ YRY AND TUIJA TAKALA 14 4 The languages of privacy SALVO ¨ RNORDAL 37 Part II Social concerns 43 5 A sociological perspective: public perceptions of privacy and their trust in institutions managing and regulating genetic databases KJELL E. ERIKSSON, MARGRE ´ TLILJA GUDMUNDSDO ´ TTIR, KU ¨ LLIKI KORTS AND SUE WELDON 45 6 Estonia KU ¨ LLIKI KORTS 47 vii 7 Iceland MARGRE ´ T LILJA GUDMUNDSDO ´ TTIR AND SALVO ¨ R NORDAL 53 8 Sweden KJELL E. ERIKSSON 59 9 United Kingdom SUE WELDON 66 10 Public discourses on human genetic databases PIIA TAMMPUU 73 Part III Legal issues 89 11 Regulating human genetic databases in Europe JANE KAYE 91 12 Consent and population genetic databases: a comparative analysis of the law in Iceland, Sweden, Estonia and the UK HO ¨ RDUR HELGI HELGASON 97 13 Third parties’ interests in population genetic databases: some comparative notes regarding the law in Estonia, Iceland, Sweden and the UK LOTTA WENDEL 108 14 Transforming principles of biolaw into national legislation: comparison of four national laws in three aspects ANTS NO ˜ MPER 120 15 Governance of population genetic databases: a comparative analysis of legal regulation in Estonia, Iceland, Sweden and the UK SUSAN M. C . GIBBONS 132 16 The legal jigsaw governing population genetic databases: concluding remarks on the ELSAGEN legal findings JANE KAYE 141 viii Contents Part IV Ethical questions 147 17 Introduction: ethical questions VILHJA ´ LMUR A ´ RNASON 149 18 Pursuing equality: questions of social justice and population genomics SARAH WILSON AND RUTH CHADWICK 150 19 Benefit-sharing and biobanks KADRI SIMM 159 20 Genetic discrimination LENA HALLDENIUS 170 21 Privacy SALVO ¨ RNORDAL 181 22 Trust MARGIT SUTROP 190 23 Informed consent and human genetic database research SIGURDUR KRISTINSSON AND VILHJA ´ LMUR A ´ RNASON 199 Part V Political considerations 217 24 The impact of biobanks on ethical frameworks RUTH CHADWICK AND MARK CUTTER 219 25 Genetics, rhetoric and policy GARDAR A ´ RNASON 227 26 Genetic databases and governance RAINER KATTEL 236 Part VI Conclusion 247 27 Bioethical analysis of the results: how well do laws and regulations address people’s concerns? MATTI HA ¨ YRY AND TUIJA TAKALA 249 Bibliography 257 Index 276 Contents ix [...]... (i) governance – analysis of the exercise of political, economic and administrative authority in the management of databases; (ii) discourse on databases – analysis of the public discourse on the databases, studying the types of arguments used in the debates; and (iii) social justice – analysis of conceptions and applications of social justice in relation to the databases It is striking that none of the. .. information; (ii) consent – a conceptual analysis of consent and an ethical analysis of issues of consent of participants in population-based human genetic databases; and (iii) genetic discrimination – an ethical and conceptual analysis of the issue of possible genetic discrimination in the context of population-based human genetic databases In the minds of the public, privacy seems to be closely related... concerning human genetic databases, people’s trust in public and commercial organizations with regard to the collection and storage of personal data, and to what extent these views and attitudes vary between the four countries; and (ii) bioethical analysis of the results Some of the most significant results from the empirical survey concern people’s perception of the trustworthiness of professionals and institutions... relation to human genetic databases; (ii) effects on ethical frameworks – an ethical analysis of how ethical frameworks mutate and change in the light of new technologies; and (iii) database sciences in context – a critical analysis of the social, historical and philosophical context of the science and technology on which the human genetic databases are based The upshot of the analysis of fundamental... directly to the Icelandic case, see V Arnason, ‘Coding and Consent Moral Challenges of the Database Project in Iceland’, Bioethics 18 (2004), pp 39– 61 M Hayry, European Values in Bioethics: Why, What, and How to be Used?’, Theoretical ¨ Medicine and Bioethics 24 (2003), pp 19 9– 214 , at p 19 9 Introduction: some lessons of ELSAGEN 7 protecting vulnerable research subjects and in the fair distribution of benefits... scientific and technological developments In order to deal with these theoretical tasks and to reach the objectives of ELSAGEN, five workpackages were formed The following is a brief description of these workpackages and a summary of the main lessons to be learned from them The main results of the research work are described in the individual sections of this book 1 A Workpackage on National and European. .. knowledge of public views of privacy and related moral values in the context of human genetic databases The main theoretical tasks of the project can be divided into five categories: (1) empirical mapping, i.e finding out what are the actual policies and people’s concerns regarding human genetic databases in the four countries; (2) interpretive, comparative analysis of existing laws, policies and views;... ethics and governance The legislation, governance and ethical regulation of these new kinds of databases must reflect their specific and various research uses and purposes and take into account the experience of the scientists who have been involved in database research practice Information technology, for example, has not only enabled the construction of these databases but also provided us with new and. .. population databases of the type discussed in the ELSAGEN research, meets the moral demands of respecting the person of research participants and provides sufficient grounds for voluntary choice and for regulation that respects that choice 5 Finally, a Workpackage on Knowledge, Values and Human Rights was divided into (i) fundamental concepts – analysis of the fundamental concepts of bioethics and their... the Centre for Ethics, University of Iceland S I M M is researcher, lecturer and project manager at the Department of Philosophy, Centre for Ethics, University of Tartu, Estonia KADRI is Professor of Practical Philosophy, Head of the Centre for Ethics, University of Tartu, Estonia MARGIT SUTROP is Lecturer in Bioethics and Moral Philosophy, University of Manchester, UK; and Adjunct Professor in Practical . The Ethics and Governance of Human Genetic Databases European Perspectives The Medical Biobank of Umea˚ in Sweden, deCODE’s Health Sector Database in Iceland, the Estonian Genome Project and. in the Body: Feminist Perspectives 978 0 5 21 86792 4 Matti Ha¨yry, Ruth Chadwick, Vilhja´lmur A ´ rnason, Gardar A ´ rnason The Ethics and Governance of Human Genetic Databases: European Perspectives 978. lessons of ELSAGEN VILHJA ´ LMUR A ´ RNASON 1 Part I Background 9 2 On human genetic databases GARDAR A ´ RNASON 11 3 American principles, European values and the mezzanine rules of ethical genetic