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This Thesis Has Been Submitted in Fulfilment of the Requirements for a Postgraduate Degree (E.G This thesis has been submitted in fulfilment of the requirements for a postgraduate degree (e.g. PhD, MPhil, DClinPsychol) at the University of Edinburgh. Please note the following terms and conditions of use: This work is protected by copyright and other intellectual property rights, which are retained by the thesis author, unless otherwise stated. A copy can be downloaded for personal non-commercial research or study, without prior permission or charge. This thesis cannot be reproduced or quoted extensively from without first obtaining permission in writing from the author. The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the author. When referring to this work, full bibliographic details including the author, title, awarding institution and date of the thesis must be given. THE LIMINALITY OF NHS RESEARCH ETHICS COMMITTEES Navigating Participant Protection and Research Promotion Across Regulatory Spaces Edward S. Dove, BA, BCL, LLB, LLM PhD in Law The University of Edinburgh 2017 Declaration As per Regulation 23 of the Postgraduate Assessment Regulations for Research Degrees, I acknowledge that portions of this thesis have appeared, or will appear, in published form in the following peer-reviewed publications. My contribution and those of the other authors to this work have been explicitly indicated below. I confirm that appropriate credit has been given within this thesis where reference has been made to the work of others. Samuel Taylor-Alexander, Edward Dove, Isabel Fletcher, Agomoni Ganguli- Mitra, Catriona McMillan, and Graeme Laurie, ‘Confronting the Liminal Spaces of Health Research Regulation: Beyond Regulatory Compression’ (2016) 8(2) Law, Innovation and Technology 149–176 [equal contribution to article]; Agomoni Ganguli-Mitra, Edward Dove, Graeme Laurie, and Samuel Taylor- Alexander, ‘Reconfiguring Social Value in Health Research Through the Lens of Liminality’ (2017) 31(2) Bioethics 87–96 [equal contribution to article]; Graeme Laurie, Edward Dove, Agomoni Ganguli-Mitra, Isabel Fletcher, Catriona McMillan, Nayha Sethi, and Annie Sorbie, ‘Charting Regulatory Stewardship in Health Research: Making the Invisible Visible?’ Cambridge Quarterly of Healthcare Ethics (in press) [equal contribution to article]; and David Townend and Edward Dove, ‘Approaching Ethics Review Equivalency Through Natural Justice and a “Sounding Board” Model for Research Ethics Committees’ (2017) 36(1) Medicine and Law 61–86 [equal contribution to article]. As per Regulation 25 of the Postgraduate Assessment Regulations for Research Degrees, I confirm that thesis presented for the degree of Doctor of Philosophy (PhD in Law) has: • been composed entirely by myself; • been solely the result of my own work, except where work which has formed part of jointly-authored publications has been included; and • not been submitted for any other degree or professional qualification. Signature: ____________________________________________________________ Edward Stellwagen Dove IV Date: ____________________________________ Acknowledgements This research was conducted with the funding support of the Wellcome Trust. I held a PhD studentship connected with a five-year (2014-19) Wellcome Senior Investigator Award entitled ‘Confronting the Liminal Spaces of Health Research Regulation’ (Award No: WT103360MA): http://www.liminalspaces.ed.ac.uk/. I am grateful to Wellcome for their generosity and enthusiasm in supporting both my research and the research of the Liminal Spaces Project team. This research would not have been possible without the cooperation and gracious hospitality of the people whom I interviewed and observed over the course of a year. I thank each of them for their patience and forthrightness in sharing their insights and experiences with me. Undoubtedly, not all of the participants in my research will share the interpretation I place on my findings. Nonetheless, I trust that they are defensible and contribute to the debate about what RECs do in practice, and how to improve the regulatory framework for health research involving human participants. I owe my gratitude to the authorities and individuals who helped assist in bringing my empirical investigation to fruition. This includes the Health Research Authority; Jo-Anne Robertson at the Research Governance & QA Office of the University of Edinburgh; the staff at the Wellcome Library; the staff at the Archive and Museum Services of the Royal College of Physicians of London; and the transcription team at 1st Class Secretarial Services. Thanks is also given to the organisers of the Postgraduate Bioethics Conference and Socio-Legal Studies Association (SLSA) annual meetings, who permitted me to present initial findings of my research in 2016 and 2017. Heartfelt thanks goes to former Mason Institute colleague Leslie Stevens and to my fellow Liminal Spaces Project team members (Agomoni Ganguli-Mitra, Catriona McMillan, Annie Sorbie, Isabel Fletcher, Emily Postan), and especially Nayha Sethi, for her committed friendship and endless academic support, including a willingness to read several draft chapters. There are many mentors who have guided me before and during this PhD. In particular, I am deeply grateful for the mentorship and friendship of Bartha Knoppers, David Townend, Mark Taylor, and Barbara Prainsack. I would also like to thank Shawn Harmon for supervising me and offering thoughtful advice about the nuances of risk, regulation, and empirical research. My principal supervisor and ‘academic steward’, Graeme Laurie, deserves special thanks. A paragon among supervisors, his dedication, guidance, patience, and good cheer sustained me throughout this journey. Truly, I could not have asked for a better mentor, nor can I ask for a better friend. Finally, and most importantly, I thank my sister, Sarah, and my parents for their abiding love and invaluable support. As always, they helped me at every turn. It is to them that this thesis is dedicated. Table of contents Chapter 1 Introduction ....................................................................................................... 1 1.1 Aims of the thesis ...................................................................................................... 1 1.2 Research questions .................................................................................................... 3 1.3 Anthropology of regulation as methodology ....................................................... 4 1.4 Structure of the thesis ............................................................................................... 5 PART I— CONCEPTUAL FRAMEWORK AND HISTORICAL REGULATORY TRACING .............................................................................................................................. 9 Chapter 2 Conceptual framework—setting the scene for ‘protection’ and ‘promotion’ .......................................................................................................................... 11 2.1 Introduction .............................................................................................................. 11 2.2 An overview of the UK REC system..................................................................... 15 2.2.1 NHS RECs ............................................................................................................ 17 2.3 The roles of RECs ..................................................................................................... 24 2.3.1 Ethics deliberation? .............................................................................................. 25 2.3.2 Primary role: protection ........................................................................................ 30 2.3.4 Ambiguity in the role hierarchy............................................................................ 35 2.4 To protect and (equally) promote? ........................................................................ 37 2.4.1 Ethical, political, and regulatory processes ........................................................... 39 2.4.2 Empirical questions raised by the structure and roles of RECs ............................ 46 2.5 Conclusion................................................................................................................. 48 Chapter 3 The historical development of RECs as health research regulators ..... 53 3.1 Introduction .............................................................................................................. 53 3.2 REC development in the UK .................................................................................. 58 3.2.1 Pragmatic creation in the 1960s and medical profession self-regulation ............. 59 3.2.2 Limited regulation through the 1980s .................................................................. 66 3.2.3 Formal LREC/MREC establishment and further criticism: 1990s ...................... 70 3.3 Centralisation and legislation in the new millennium .................................... 75 3.3.1 2000-2010: A series of fundamental reforms ........................................................ 78 3.3.2 Ongoing criticisms and the critical AMS 2011 report ......................................... 91 3.3.3 Government response: 2011 – present .................................................................. 99 3.4 Conclusion............................................................................................................... 109 PART II— METHODOLOGY
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