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Proportional ethical review and the identification of ethical issues
  1. D Hunter
  1. Correspondence to:
 D Hunter
 School of Biomedical Sciences, University of Ulster, Cromore Road, Coleraine, Co. Londonderry BT52 1SA, UK; d.hunter3{at}ulster.ac.uk

Abstract

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted.

  • NHS, National Health Service
  • REC, research ethics committee

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Footnotes

  • i I should note here that I do not intend to imply that ethics committees will necessarily identify all of the risks or ethical issues with an application; simply that generally they will do a better job than an individual or a small group.

  • ii I do not intend to imply here that, typically, NHS RECs contain ethicists; indeed they do not, and the standard operating procedures do not currently contain any requirement in this regard, in contrast with the requirements of the Economics and Social Research Council as regards university-based social science research ethics review. Nonetheless, members of RECs have often received some training as regards research ethics and, in combination, have considerable expertise on research ethics.

  • iii I am assuming it is plausible that the decisions whether there are ethical issues or risks entailed by a research project can be answered as a yes or no question so that there are only two values. That said, it has been argued that Condorcet’s jury theorem is also applicable in cases where there are more than just two possible outcomes as long as the participants’ chance of a right answer is better than average.19 I have also been assuming that there is just one best answer, not often the case in research ethics review, as it frequently includes trade-offs. Nonetheless, as long as there are better answers, the theorem still holds.

  • iv Formally, this may be expressed as “Let (X1…Xn) be n independent identically distributed binary random variables, such that Pr(Xi = 1) = p>½ and Pn = Pr(ΣXi> n/2). Then, (a) Pn>p and (b) Pn is monotonically increasing in n and Pn→1 as n→∞. If p<½ then Pn<p and Pn→0 as n→∞. Finally, when p = ½ then Pn = ½ for all n.”20

  • v I am presuming here that research ethics advisers in general will not be considerably better decision makers than individual members of RECs.

  • Competing interests: DH presently sits on one of the ORECNI (Office for Research Ethics Committees, Northern Ireland) research ethics committees. He also sits on the University of Ulster research ethics committee.

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