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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
Given that one of her main conclusions is that provide...
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 .
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 .
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.
 Edwards SJL, Ashcroft R, Kirchin S (2004) Research ethics
committees: Differences and moral judgement _Bioethics_ 18(5): 408-427.
 Beyleveld, D (2002) Law, ethics and research ethics committees,
_Medicine And Law_ 21(1): 57-75