1. ESRC Genomics Network (archive)
  2. Gengage
  3. The Human Genre Project

Cesagen · Research

Trust in the System: An ethnographic exploration of Research Ethics Committees

Adam Hedgecoe

Start date



Research ethics review – prior approval of a project by an independent committee or similar body – is commonplace in modern research. Indeed, it is almost unheard of for research involving human beings, whether medical or not, to take place without such review. The requirement for such review is built into national legal systems surrounding clinical trials (such as the US National Research Act of 1974, or the UK’s Clinical Trials Regulations from 2004) and the needs of research funding bodies (for example the ESRC). Yet the bodies that perform such review – IRBs in the US, Research Ethics Committees, or RECs, in the UK – are under examined in terms of their decision making processes, how the constitution of such committees and the micro-sociological aspects of their meetings shape their final conclusions.

While social scientists have spilt considerable ink over the difficulties they face when trying to gain approval from such bodies – and how their work should not be subject to approval by bodies set up to review medical research – they have only very rarely attempted to open the ‘black box’ of ethics review.


This project is an extension of a EU funded comparative ethnography of research ethic review bodies in the EU (ED-REG HAR: Ethical diversity and regulatory harmonisation: an empirical exploration of research ethics committees following the Clinical Trials Directive. 2004-2007) aiming to provide a detailed, historically rooted, ethnographic analysis of REC decision making, focusing on committees approving research based in the UK NHS. A secondary aim is to explore the events surrounding the disastrous phase I clinical trial that took place at Northwick Park in London, in March 2006.


This project uses a variety of methods – ethnographic observation, semi-structured interviews and archive research – to develop a ‘thick description’ of REC decision making. Observations took place at 3 UK RECs over a period of a year; interviews were carried out with members of these (and other) committees, researchers and policy makers; the archive research draws on 21/2 thousand sides of material concerning RECs and clinical trials, drawn from the National Archives, the Wellcome Trust, and the Royal Colleges of Physicians ad GPs.


  • Ethics review bodies are not isomorphic: a key assumption of most international regulation and literature on RECs is that these bodies are isomorphic – i.e. that a REC in the UK does the same kind of thing as an IRB in the US, or a REB in Canada. Yet these bodies differ considerably in a large number of crucial ways, for example in terms of: how they relate to research institutions, how they are constituted and define experts and lay members, what role scientific review plays in their decisions. These differences impact on decision making in such a way that it is hard to claim that bodies in different jurisdictions are necessarily performing the same function.
  • The centrality of trust in REC decision making: the anticipatory nature of REC applications means that such committees place considerable value on making trust decisions about applicants and their research. RECs rely on a wide variety of rational and non-rational factors to help make these decisions, drawing on local knowledge about applicants (from working alongside them) and knowledge gained through personal interactions when applicants appear before committees.
  • RECs are not prejudiced against social science: a common complaint from social scientists is that RECs are unsuited for reviewing their research, especially qualitative proposals. This project undermines this complaint, showing how RECs engage with social scientific applications in reasonable and constructive ways, while at the same time highlighting the importance of factors such as REC institutional affiliation in shaping decisions. 


Hedgecoe, A. (2009) “A form of Practical Machinery”: The origins of Research Ethics Committees in the UK: 1967-1972, Medical History, 53: pp 331-350.

Hedgecoe, A. (2008) ‘Research ethics review and the Sociological research relationship’, Sociology, 42 (5): pp 857-870. [Nominated for the SAGE Prize for Innovation and/or Excellence 2009]

Hedgecoe, A., Carvalho, F., Lobmayer, P. and Rakar, F. (2006) ‘Research Ethics Committees in Europe: Implementing the directive, respecting diversity’, Journal of Medical Ethics, 32: pp 483-486 

Further information

For further information, please contact