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Regulatory Stewardship of Health Research

Navigating Participant Protection and Research Promotion

Edward S. Dove

This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides a new perspective on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of ‘regulatory stewardship’.
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Edward S. Dove

This research was conducted with the funding support of the Wellcome Trust, connected with a five-year Wellcome Senior Investigator Award entitled ‘Confronting the Liminal Spaces of Health Research Regulation’ (Award No: WT103360MA). I am grateful to Wellcome for their generosity and enthusiasm in supporting both my research and the research of the Liminal Spaces Project team, including its global dissemination through open access.

This book 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 research ethics committees (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 and Quality Assurance 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.

I would also like to acknowledge the excellent support I received from Edward Elgar Publishing in the preparation and completion of the book, in particular from Iram Satti, Saffron Watts, Stephanie Tytherleigh, Claire Greenwell, and Conor Byrne, and from Roger Brownsword, series editor of Elgar Studies in Law and Regulation. It has been much appreciated.

Heartfelt thanks go to my fellow Liminal Spaces Project team members (Nayha Sethi, Agomoni Ganguli-Mitra, Catriona McMillan, Annie Sorbie, Emily Postan) for their friendship and ongoing academic support. There are many mentors who have guided me before and during the writing of this book. In particular, I am deeply grateful for the mentorship and friendship of Bartha Knoppers, Barbara Prainsack, Mark Taylor, and David Townend. I am also grateful to Emma Cave, Emilie Cloatre, Sharon Cowan, and Shawn Harmon for their comments on an earlier draft of this book.

My principal ‘academic steward’, Graeme Laurie, deserves special thanks. A paragon among mentors, his dedication, guidance, patience, and good cheer sustained me throughout the research and writing of this book. Truly, I cannot ask for a better mentor, nor can I ask for a better friend.

Finally, and most importantly, I thank my sister, Sarah, and my parents, Ed and Jody, for their abiding love and invaluable support. As always, they helped me at every turn. It is to them that this book is dedicated.