Trust in the system

Research Ethics Committees and the regulation of biomedical research

Author: Adam Hedgecoe

This book explores the nature of decision making in one of the most crucial – yet also the most understudied – aspects of the regulatory system around biomedical research: research ethics committees. Every month, all over the UK, groups of people sit down and decide what kind of research should be carried out on patients within the National Health Service (NHS). These groups – Research Ethics Committees (RECs) – made up of doctors, nurses, researchers, and members of the general public, help shape the future of medicine, and play a crucial role in the regulation of a wide range of research from social science to epidemiology, vaccine and drugs trials, and surgery. Despite coming into existence in the late 1960s, and the considerable literature bemoaning the chilling effect such review has on biomedical research, we don’t know very much about how these bodies make decisions. This book provides one of the first empirical examinations of this kind of regulation, drawing on observational, interview, and archival data to give in-depth ethnographic insight into RECs, as they operate in the UK NHS. A key insight of this work is that, despite the trappings of a modern regulatory system – the operating procedures, guidance documents, and websites – NHS REC decision making revolves around very old-fashioned aspects of social life such as interpersonal trust, reputation, and the performance of character, and that an accurate understanding of this kind of regulation requires an acceptance of the inherently social nature of the processes involved.

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