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Regulatory Stewardship of Health Research

Navigating Participant Protection and Research Promotion Edward S. Dove, School of Law, The University of Edinburgh, UK
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’.
Extent: c 224 pp
Hardback Price: $120.00 Web: $108.00
Publication Date: February 2020
ISBN: 978 1 78897 534 6
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  • eISBN: 978 1 78897 535 3

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  • Development Studies
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  • Regulation and Governance
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 new perspectives 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’. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application.

This book is a key resource for academics and students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action.
‘This excellent book presents an original and intriguing insight into the “black box” of decisions made by Research Ethics Committees (RECs). Put simply, if you want to understand the changes that ethics review and research governance has undergone over the past ten to fifteen years, then this book is required reading. In its intense empirical approach to a topic normally addressed in rather more theoretical terms Regulatory Stewardship of Health Research lays down a challenge to socio-legal studies of regulation, pushing debates towards what he calls an “anthropology of regulation”, drawing explicit attention to processes, passages, and change inherent in the regulation of modern medical research.’
– Adam Hedgecoe, Cardiff University, UK

‘Dove’s careful and detailed analysis of the regulatory system for health research is a refreshing and valuable contribution to theory and practice of ethics review committees – and not just for the UK, but for any jurisdiction thinking seriously about the twin goals of protecting research participants while promoting research. Researchers, research ethics committees, regulators and the public will each find insights about the ways society can make research better for all.’
– Eric M. Meslin, Council of Canadian Academies, Canada
Contents: 1. Introduction 2. Conceptual framework—setting the scene for ‘protection’ and ‘promotion’ 3. The making of RECs as health research regulators 4. Anthropology of regulation 5. Operationalising ‘next-generation’ health research regulation—what is happening in practice? 6. Charting a framework for regulatory stewardship 7. Conclusion