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Ethical Issues

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Ethical Issues The collection, linking and use of data in biomedical research and health care: ethical issues Nuffield Council on Bioethics Professor Jonathan Montgomery (Chair) Professor Simon Caney Professor Bobbie Farsides* Professor Peter Furness Professor Ann Gallagher Professor Robin Gill Dr Andy Greenfield Professor Erica Haimes Professor Julian Hughes Sir Roland Jackson Professor Graeme Laurie David K Lawrence Professor Tim Lewens Professor Ottoline Leyser (Deputy Chair) Professor Anneke Lucassen Professor Martin Richards** Dr Tom Shakespeare Dr Geoff Watts Professor Robin A Weiss Professor Heather Widdows Adam Wishart Dr Paquita de Zulueta * co-opted member of the Council while chairing the Working Party on Children and Clinical Research ** co-opted member of the Council while chairing the Working Party on Health and Biological Data: Ethical Issues iii Secretariat Hugh Whittall (Director) Ranveig Svenning Berg Peter Mills Tom Finnegan (until January 2014) Katharine Wright Kate Harvey Catherine Joynson Laura Medhurst Sarah Walker-Robson Carol Perkins Seil Collins Bettina Schmietow (from March 2014) Anna Wilkinson The terms of reference of the Council are: 1. to identify and define ethical questions raised by recent advances in biological and medical research in order to respond to, and to anticipate, public concern; 2. to make arrangements for examining and reporting on such questions with a view to promoting public understanding and discussion; this may lead, where needed, to the formulation of new guidelines by the appropriate regulatory or other body; 3. in the light of the outcome of its work, to publish reports; and to make representations, as the Council may judge appropriate. The Nuffield Council on Bioethics is funded jointly by the Medical Research Council, the Nuffield Foundation, and the Wellcome Trust iv Acknowledgments The Council would like to thank the Working Party for the generous contribution of their time, knowledge and expertise to this project. We should also like to express our thanks to the large number of people, individually and from within institutions and other organisations, who responded to the open consultation that informed the development of the Working Party’s understanding of and approach to the issues addressed in this report. As well as these, we are grateful to the knowledgeable contributors who attended our four ‘fact-finding’ meetings. A list of these people may be found at Appendix 2. The Working Party commissioned two independent reports to assist their deliberations, which are published on the Council’s website alongside this report. The first, commissioned jointly with the Expert Advisory Group on Data Access (EAGDA), explored evidence of the harms associated with misuse of data and the second the relationship between public and private sectors in the use of data in biomedical innovation. We would like to thank the authors of these reports, Professor Graeme Laurie, Ms Leslie Stevens, Dr Kerina H Jones and Dr Christine Dobbs (for the first report) and Professor Paul Martin and Dr Gregory Hollin (for the second). We should also like to thank the members and secretariat of EAGDA for their assistance in commissioning the first independent report and for giving us the opportunity to present and discuss with them the direction of our research at a very early stage. We are also greatly appreciative of the value added to the report by the dozen external reviewers, representing a range of professional backgrounds and academic disciplines, who are listed in Appendix 2. In addition to these, members of the Council, Secretariat and Working Party also benefitted from discussions and correspondence with a number of other individuals at different stages of the project, including Professor Dame Fiona Caldicott, Dr Alan Hassey, Dr William Lowrance, Katherine Littler, Dr Natalie Banner, Dr Alfred Z Spector, Dr John Parkinson, Dr Mark J Taylor, Tim Kelsey, Kingsley Manning, Dr Stephen Pavis, Laura Riley and Adrienne Hunt. We also extend our thanks to Dr Anna Wilkinson of the Nuffield Council Secretariat for her careful proofreading and to Clare Wenham and Tom Burton for additional research and assistance. Finally, we should like to acknowledge the contribution of two members of the original Working Party who, for supervening reasons, were unable to see the report through to completion: Lynn Molloy and Peter Singleton. While the Members of the Working Party listed below take responsibility for the final form of the report, we are very grateful for the valuable contribution of those colleagues to the deliberations. v Foreword The germ of this report might, perhaps, be found in discussions leading to the Council's annual 'forward look' meeting in May 2011. Some time in 2010, with typical foresight and perspicacity, the Council identified a bundle of emerging issues to do with the application of information technology and data science to health records and biological information that had the potential to generate substantial public hopes and concerns. The discussion in May 2011 persuaded the Council that significant and under-explored ethical questions were at stake and that a Council report could offer a useful and timely contribution to debate. I doubt that many of those who, like me, attended the Council's initial scoping workshop in February 2012 would have predicted the shape this report would take or could have imagined just how wide-ranging, complex and passionate the debate would be. Recalling that the project began life under the rubric 'Genomics, Health Records, Database Linkage and Privacy' may shed light on the some of the preoccupations underlying the report that resurfaced repeatedly as it emerged. But when the Working Party set to work in March 2013, with the tide of enthusiasm for 'big data' reaching a high water mark, it seemed that the issues we had to consider were much more general than the use of particular 'kinds' of data or the linking of particular 'kinds' of records. This was confirmed when we began to gather evidence at a number of fact-finding meetings. It was further confirmed by the extraordinary richness of responses to our open consultation. Our task was complicated by the fact that we built on shifting sands. The negotiations around the new European Data Protection Regulation, the well-publicised vicissitudes of the 'care.data' programme and the expectations built around the '100,000 Genomes' project: all these unfolded during our deliberations and remain largely unresolved as we go to press. Although the report addresses these and other examples explicitly, and will no doubt be read differently in the light of further developments, the reader should remember that our principal concerns are moral questions, not contingent questions of law and practice. We have tried to produce a report that adds insight to these but is not diminished by the fact that they may unfold in one way rather than another. We intend and expect, in other words, that readers will continue to find value in our report as initiatives, methodologies, and indeed laws, come and go. Some of the matters that we have had to address – the challenging complexity of health service and research practices, the technical sophistication of data science, for example – were new to many of us and we relied heavily on our colleagues' expertise to bring these unfamiliar concepts into our common grasp. Nevertheless, we could not have reached our objective without the contribution of every member of the Working Party to our deliberations, since each brought a perspective that at times enriched, at others challenged, and often enriched through challenging, the understanding that developed among us. I should here express my gratitude to those colleagues for their hard work and commitment to our objective, and, though we have had some robust debates, for demonstrating a belief in the centripetal potential to produce something of value over the centrifugal force of our differences. Although, for purely contingent reasons, not all of the original Working Party were able to see the project to completion, the imprint of earlier contributions remains on the final document. As a group we are deeply indebted to the Nuffield Council and especially to the subgroup of Council members who reviewed and commented on our output at various stages of the project for their intellectual engagement, wise counsel and moral support throughout. Beyond these we have benefitted considerably from the contributions of numerous others, among them those who responded to our open consultation. Though we vii have not engaged with specific responses explicitly in the report, these have been immensely valuable in informing our thinking, providing a common wealth of knowledge and questions for a diverse working party such as ours to draw on, to discuss and to pursue. We benefitted greatly from the contributions of those who attended our early fact finding meetings, who gave generously of their considerable knowledge and patiently addressed our questions, and of the authors of two independent commissioned reports. Our initial drafts were improved immeasurably thanks to our external reviewers who saw an early draft of this document and commented more in the spirit of collaborators than critics. Though we have not been able to reflect the totality of their advice in a single document, it has enriched and informed the report beyond anything that we might otherwise have achieved; any shortcomings that remain are, of course, our responsibility rather than theirs. Finally, I should thank the members of the Nuffield Council Secretariat who supported our work. Peter Mills, not only organised the whole project, but also undertook the lengthy and arduous task of drafting and editing the report. Without his expertise, patience, and his dedication beyond the call of duty, our work would not have reached a successful conclusion. Peter was ably supported by our research officers, Tom Finnegan (to the end of 2013) and Bettina Schmietow (from March 2014) who also deserve our gratitude.
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