The current system of ethical review for medical research in the United Kingdom is changing from the current system involving large committees of 7–18 members reviewing every individual application to a system involving pre-review by small sub-committees of National Research Ethics Officers (NREAs), who have a remit to approve studies if they believe there are no material ethical issues imposed by the research. The reliability of this new system depends on the reliability of the NREAs and in particular the ability of small groups to effectively identify and appropriately assess the seriousness of all the material ethical issues that may be posed by an application. There is anecdotal evidence to suggest that many individual research ethics committee members have had experience of believing that a study presents no material ethical concerns, then on reaching the committee and discussing the application they realise that the committee feels it does present significant ethical concerns. If this is the case then this casts doubt on the reliability of NREAs or small groups to effectively identify ethically problematic research and appropriately respond to this to protect research participants. In this paper we describe a small questionnaire based piece of research carried out to assess how common this and other relevant experiences are.
Statistics from Altmetric.com
Competing interests: DH is the Alternate Vice Chair of HPSS Research Ethics Committee 1 in Northern Ireland. He also sits on the University of Ulster Research Ethics Committee, and the School of Biomedical Sciences Ethics Filter Committee.
Ethics approval: Ethical approval for this research project was granted by the University of Ulster Biomedical Sciences Ethics Filter Committee, in accordance with the University of Ulster Research Governance procedure.
↵i A brief history of these changes can be found in William-Jones B, Holm S. A university wide model for the ethical review of human subjects research and in Department of Health, Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees—The Warner Report.9 10
↵ii It is presently intended that there will be up to 8 NREAs and that they will be able to decide on whether an application contains no significant ethical concerns in subcommittees of at least 2 members.12
↵iii See the supplemental data for a copy of the questionnaire.
↵iv It is only “hopefully” relevantly similar since there is little data available on the experience level of members of HPSS & NHS RECs and more importantly at what level of experience REC members are most effective at identifying ethical issues. It is commonly thought that new members of RECs will be less effective at first, but as with marking essays newcomers may well judge harder than the rest of the committee. Likewise while we would typically think those who have considerable experience will be more effective members of RECs they may well have become jaded, or having seen some truly appalling applications lower their standards because at least this one isn’t as bad as that other one.
↵v We would like to thank an anonymous reviewer for the Journal of Medical Ethics for pointing out these two distinct explanations which we feel has added considerable strength to the overall argument of this paper.
↵vi Unfortunately the data we have does not indicate which explanation is more prevalent. We think it is likely to be the case that both explanations are correct in some cases. However as we will shortly argue both explanations cause concerns for the proposed changes.
↵vii We do not here intend to indicate that research ethics committees are by any means infallible in terms of identifying ethical issues, however we feel that this shows that they are likely to be more reliable than small groups.
↵viii One example includes questionnaires with patients which obviously raises questions of adequate informed consent being taken. Another involves the use of archival tissue without consent.
↵ix The Consultation Document suggests the following types of research would go to full review: “any clinical trial of an investigational medicinal product or clinical investigation of a medical device; any other clinical research; research involving vulnerable groups; studies where participants are to receive payments or incentives exceeding reimbursement of expenses, or investigators are to receive payments or incentives linked to recruitment of participants; and any study in which it is proposed not to obtain informed consent”(p16).11 The Implementation Plan is more circumspect only suggesting that studies requiring physical interventions will definitely automatically go to full committee review.12
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.