The ethics of research ethics committees
BMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7243.1217 (Published 29 April 2000) Cite this as: BMJ 2000;320:1217
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Dear Sir - John Nicholl recently described problems in obtaining
ethical approval for trials. [1] We have experienced worrying
inconsistencies in the decisions of ethics committees concerning the issue
of informed consent.
Currently in the Welsh Ambulance Service, treatment protocols vary
according to geographical area. Two dosing regimens exist for the
intravenous analgesic nalbuphine and we have therefore developed a
randomised controlled trial to compare their effectiveness in patients who
would usually receive such therapy. Routinely collected data will be
analysed to determine efficacy and the incidence of side effects. The only
difference to routine treatment would be the randomised selection of the
dosing regimen, rather than this being determined by the geographical
location of the patient.
In our applications to Local Research Ethics Committees we identified that
obtaining informed consent from subjects recruited to this study would be
difficult, and may be inadvisable in that the explanation of an RCT cannot
but imply doubt. [2] The presence of pain suggests that truly informed
consent may not be obtainable. [3] Furthermore, explaining the trial and
obtaining consent would delay the administration of an analgesic.
The first LREC that received our submission agreed that obtaining informed
consent would be unethical in the circumstances we described.
Unfortunately they consequently ruled that we could not undertake the
trial as obtaining informed consent should be an essential requirement. We
find this judgement extraordinary: if we do not conduct this study we will
be unable to make a rationale choice about which of these standard
regimens to select. Sometimes it is unethical not to conduct trials. [4]
It was suggested that, instead of an RCT, we conduct independent audits in
the areas where each regimen is utilised. But such a design is flawed and
does not represent best research practice. [5] Patients are likely to have
different characteristics in the two areas, and more subjects would be
required to achieve sufficient power to detect differences in efficacy.
Conducting poorly
designed research is itself unethical, as is recruiting more subjects than
are necessary.
An alternative would be to select a dosing regimen on an anecdotal or
arbitrary basis, but such an approach would be totally inconsistent with
the principles of evidence-based health care.
A second LREC was supportive of our study and of our view that informed
consent was not appropriate, but felt the need to obtain a legal opinion
prior to reaching a decision. A third has granted approval and has agreed
that no form of consent (other than that required for treatment) is
necessary.
This confusion does not bode well for the future of research in emergency
pre-hospital care. One can envisage many such
situations where obtaining informed consent is inappropriate. Discussion
is required to ensure that, as far as possible, good quality and highly
desirable research is not blocked in this important area of health care.
Malcolm Woollard
Executive Officer
Pre-hospital Emergency Research Unit,
Lansdowne Hospital,
Sanatorium Road,
Cardiff
CF1 8UL
Peter Elwood
Honorary Professor
University of Wales College of Medicine,
Llandough Hospital,
Penarth
CF37 2XW
Douglas Chamberlain
Honorary Professor, University of Wales College of Medicine
Pre-hospital Emergency Research Unit,
Lansdowne Hospital,
Sanatorium Road,
Cardiff
CF1 8UL
References
[1] Nicholl, J. The ethics of research ethics committees. BMJ
2000;320:1217.
[2] Tobias, J.S. BMJ's present policy (sometimes approving research
in which patients have not given fully informed consent) is wholly
correct. BMJ 1997;314:1111.
[3] Kestin, I.G. "Technical" consent is inevitable in some
circumstances. BMJ 1998;317:947.
[4] Brewin TB. Truth, trust, paternalism. Lancet 1985;ii:490-2.
[5] Sackett, D.L., Haynes, R.B., Guyatt, G.H., Tugwell, P. Clinical
epidemiology. A basic science for clinical medicine. 2nd ed. Boston:
Little, Brown, 1991, p. 192.
Competing interests: No competing interests
It might help readers form an opinion if we could read the submission
sent to the LREC.
Did Dr Pearson tell the LREC the existing procedure was not
scientifically validated?
It raised a further question about how this procedure came to be the
'standard' procedure in the first place, though that applies to many
clinical activities, as I understand it.
Brian Morgan
Competing interests: No competing interests
Sir,
I think Nicholl makes his point well. However whilst sharing his
frustrations I feel that my own would not be resolved by improved focus
within my local ethics committee. I recently had an application to
participate in a randomised controlled trial turned down because “half the
patients who might benefit could be denied the treatment because they have
agreed to take part in a randomised controlled trial”. The treatment under
proposed study (Plasmafiltration in septic shock) is not proven or even
generally presumed to be efficacious. So the response seems either to be
an expression of ignorance about randomised controlled trials or a
statement that they are considered locally to be unethical.
G.A. Pearson
Competing interests: No competing interests
Dear Sir - Jon Nicholl eloquently describes the problems of getting
approval for research studies from local Research Ethics Committees .
But, there is a fundamental flaw in his paper. LREC's give - or not -
approval on the basis that the study is ethical. There is nothing to
suggest that their approval is ethical - indeed, judging by recent
examples their approval is clearly unethical.
Jean Mossman
Chief Executive - CancerBACUP
CancerBACUP, London
CancerBACUP, 3 Bath Place, Rivington Street, London EC2A 3DR
1. Nicholl, J 'The ethics of research ethics committees', BMJ 29
April, Volume 320, p. 1217
Competing interests: No competing interests
Ethics of Research Ethics Committees
EDITOR - Professor Nicholl, in his Personal View, seems to believe
that three issues attributable to MRECs are currently acting as barriers
to NHS research1. These are : (i) delay in getting ethics committee
approval; (ii) inconsistency in decision-making; and (iii) lack of
concentration on the purely ethical dimension. We wish to respond to
each of these issues in turn :
(i) We note that Prof. Nicholl acknowledges that the system of approval
under the old LREC system often led to unacceptable delays in processing
studies. We presume that he would accept that the intent behind the
formation of MRECs is to streamline the system. We also presume that he
accepts that individual experiences, however frustrating, are not good
indicators of the overall benefits or problems with new innovations.
The appropriate measurement should be the overall change in effect from
the old system to the new one.
(ii) Inconsistency in decision-making continues to be a problem within
the new system. To some extent, this reflects the fluidity of notions
of right and wrong, as referred to in Prof. Nicholl's letter. However,
since the formation of the MRECs, dialogue is beginning to take place
between ethics committee members, most notably through the formation of
the Association of Research Ethics Committees. Within Trent, we have
run two regional training days to discuss ethical principles and hands-on
decision-making. We believe that this is progression and that the
benefits
of this dialogue are already beginning to filter through the system.
We would be more than happy to discuss other ways of maximising this
debate.
(iii) One of the specific points raised is the need for ethics committees
to concentrate on 'ethics'. It is
probably based on a misconception that ethics is a discipline separate and
distinct from any other.
In fact a study cannot be ethical if it is not also sound scientifically
and members of research ethics committees are tasked with checking the
scientific integrity of a study. This includes the design and power of
the study, and its capacity to recruit. Ethics committees must satisfy
themselves as far as possible that a study is sound, important enough to
be worth the degree of potential risk to participants, and that it will
yield an answer to the research question being asked. Regarding
confidentiality - it does not need to be stated that this is a
fundamentally ethical question.
The letter infers that the goalposts keep changing. They do, and will
continue to do so, because both the Law and the expectations of society
are changing. Recent controversies in NHS research should illustrate
this point beyond doubt. It is incumbent on all members of the research
community, including those who undertake research and those who serve on
ethics committees, to acknowledge that public expectations are becoming
higher, and that standards which studies will be required to adhere to
will become more rigorous over time. This is not, as the letter
implies, wilful obstruction by ethics committee members. Incidentally,
about one-third of the Trent committee are active researchers, and all of
us are constantly having to readjust our practices as the ethical
dimension of research becomes more focused. We don't claim that this is
easy - we see it as good practice.
It may be that the time has come to undertake a programme of research into
the nature and function of the system of ethics approval. We would
welcome such scrutiny, and, if it happens, we expect that the protocol
will be subject to examination under the ethical principles of the time.
Dr Susan Downe, on behalf of the Trent MREC
1 J.Nichol. Personal View - Ethics of Research Ethics Committees.
BMJ 2000;320;1217
Competing interests: No competing interests