Regulatory Stewardship of Health Research

Edward S. Dove, School of Law and Criminology, Maynooth University, Ireland

• 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 Index

'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