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• RECs as regulators
  Adam M Hedgecoe
  Published on: 18 May 2017

• Published on: 18 May 2017

  RECs as regulators

  • Adam M Hedgecoe, Senior Lecturer

  While I welcome any discussion of the ethics review system in the UK and how it may be developing into a broader regulatory structure, any analysis needs to be based on an accurate understand both of the current academic literature in this area and upon current REC practice. Unfortunately McGuinness’ recent article has problems in both of these departments.

  Given that one of her main conclusions is that provide...

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  While I welcome any discussion of the ethics review system in the UK and how it may be developing into a broader regulatory structure, any analysis needs to be based on an accurate understand both of the current academic literature in this area and upon current REC practice. Unfortunately McGuinness’ recent article has problems in both of these departments.

  Given that one of her main conclusions is that provided processes are standardised, it is possible for different RECs to reach different conclusions over the same application, without this being unfair (the inconsistency claim made against RECs), it is bizarre that she does not discuss Edwards and colleagues’ well known article from 2004 which makes essentially the same point at greater length and detail [1].

  Similarly, a broader reading of the literature would have shed light on her belief that “Surely it will be problematic… for a lawyer [on a REC] to approve a project from which questionable legal issues arise”. The obvious response to this is, ‘tell that to Derek Beyleveld’ who incisively skewered exactly this problem within the UK system, where RECs (even those with lawyers on them) have been explicitly dissuaded from rejecting illegal research, on the grounds that the committee is not a legally competent body [2].

  An awareness of the historical documentation around RECs would have led to an avoidance of the apparent belief that formalised opposition to RECs commenting on scientific issues was introduced by the Ad Hoc Advisory Group (AHAG): it was of course first articulated by the DoH in the 1991 ‘Red Book’. The fact that REC members resist this division of science and ethics, holding fast to their motto of ‘bad science is bad ethics’, and the fact that, rather confusingly, the regulations actually require RECs to think about the science – they are, after all, asked to look at the research design, often with the help of a statistician-member appointed expressly for that purpose – raises complex issues for McGuinness’ rather simplistic belief that ‘technical ethical’ and ‘ethical ethical’ issues can be divided.

  In addition to minor points of error (such as the idea that RECs are “responsible for projects’ being adequately insured” – they are not. Since Northwick Park, NRES has made it clear that the responsibility lies with the research sponsor since RECs are not qualified to judge ‘how much insurance is enough’) a better grounding in what RECs actually do would have prevented an over-overemphasis on risk assessment (RECs also spend a lot of time thinking about informed consent: indeed it is one of the ways in which they resolve debates over the ‘riskiness’ of particular research projects) and allowed a paper which spends so much time talking about the desirability of standardised procedures for RECs to actually acknowledge that since 2004, NHS RECs have operated using a set of centrally generated SOPs, Standard Operating Procedures. These explicitly provide committees with a clear account for their decisions, and to display the correct degree of conformity to process.

  Notes

  [1] Edwards SJL, Ashcroft R, Kirchin S (2004) Research ethics committees: Differences and moral judgement _Bioethics_ 18(5): 408-427.

  [2] Beyleveld, D (2002) Law, ethics and research ethics committees, _Medicine And Law_ 21(1): 57-75

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  Conflict of Interest:
  None declared.

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