Article Text
Abstract
The history of the National Health Service research ethics system in the UK and some of the key drivers for its change into the present system are described. It is suggested that the key drivers were the unnecessary delay of research, the complexity of the array of processes and contradictions between research ethics committee (REC) decisions. It is then argued that the primary drivers for this change are and will be replicated by the systems of research ethics review being put in place at UK universities in response to the Economic and Social Research Council research ethics framework. It is argued that this is particularly problematic for multi-centre review and for researchers who switch institutions. Finally, some potential solutions to this problem and their feasibility are discussed.
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Footnotes
Competing interests: The author is presently alternate vice-chair of one of the ORECNI (Office for Research Ethics Committees, Northern Ireland) research ethics committees. He sits on the University of Ulster research ethics committee and the School of Biomedical Sciences ethics filter committee. He is an external member of the Liverpool Hope University research ethics sub-committee. He is a member of the Association for Research Ethics Council (AREC) and its universities research ethics subcommittee.
↵i I am well aware of the debates about which word should be used to refer to those who are researched on, whether they should be referred to as subjects, participants, researchees, etc. I am ambivalent between these terms, so feel free to read subjects as participants if you wish. I use subject simply because it is traditional, and it seems to me to accurately reflect the typical, though perhaps regrettable, relationship between researcher and researchee. See, for example, Corrigan and Tutton.2
↵ii However, I believe that this position does require defence and that we ought not automatically presume that all research ought to be reviewed by a research ethics committee.
↵iii I would like to thank an anonymous reviewer for the Journal of Medical Ethics both for pointing out the shortcomings of this section as it was originally conceived and for pointing towards appropriate sources for strengthening it. A fuller history can be found in Hazelgrove.3
↵iv COREC is now called the National Research Ethics Service (NRES).
↵v Future efficiency gains are planned. At present, NRES is piloting an integrated research application system (IRAS), which aims to provide one central form that researchers enter information into and that then populates other forms such as the NHS ethics form and the research and development form used by research governance within hospitals automatically. Details of IRAS and the pilot can be found at https://www.myresearchproject.org.uk/.
↵vi I raise this sort of consideration myself with regard to the supposed efficiency projected for the new system of research ethics regulation that may be introduced by NRES.20 21
↵vii For reference, at the University of Ulster, we estimate that, including student research, about 1200 pieces of research with human subjects are carried out per year, the majority of which are non-medical in nature.
↵viii Despite its not being dictatorial, I suspect that many present systems of review in place in UK universities don’t meet the REF’s requirements, since either the committees doing the review are not properly constituted according to the REC or the model adopted by some universities don’t require most research projects with human subjects to receive ethics review.
↵ix More information about the different models of research ethics review in UK universities can be found in Hunter (2006).25
↵x I don’t intend to imply that different RECs should always come to the same conclusion. There may be good grounds for RECs to disagree. See, for example, Edwards et al (2004).26
↵xi AREC represents the members, mainly of NHS RECs but also including university RECs, of research ethics committees. Details of AREC can be found at http://www.arec.org.uk/.
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