Research ethics committees (RECs) could serve the interests of the public more
effectively. Faith McLellan, in her Aug 25 news item(1) on the death of a healthy
volunteer in a study in the USA, makes clear that RECs should satisfy themselves
that proposals for new research have been informed by scientifically defensible
reviews of relevant existing research. M Reidenberg (Aug 25, p 664)(2) suggests
that, because biased underreporting of research has harmed patients, a requirement
for ethical approval should be the promise that the study will be published
in full within a reasonable time.
5 years ago, I and others challenged RECs to take steps to implement these principles.(3)
In 1997, the Danish National Research Ethics Committee System concluded that
review of all relevant literature by the research group before submission is
crucial. In the Governance arrangements for NHS Research Ethics Committees(4)
a statement published in another government document is reproduced, which says:
"It is essential that existing sources of evidence, especially systematic
reviews, are considered carefully prior to undertaking research. Research which
duplicates other work unnecessarily or which is not of sufficient quality to
contribute something useful to existing knowledge is in itself unethical."
Although these are encouraging signs that RECs are beginning to acknowledge
the first of the two principles, they do not yet seem to have taken sufficiently
seriously their responsibility to help reduce biased under-reporting of research.
As Reidenberg points out, patients who participate in research believe they
are contributing to the growth of publicly accessible knowledge. Unless the
full results of studies approved by research ethics committees acting on behalf
of the public are made publicly available, the implicit contracts between research
participants and researchers, and RECs and the public, will have been breached.
The new National Health Service governance arrangements state that every REC
should keep a register of all proposals that come before it, and that the register
will be available for public consultation, and that a final report, to be delivered
within 3 months of completion, will be requested. Making these registers and
final reports publicly available, preferably on the worldwide web, would go
a long way towards reassuring people, who are concerned that research ethics
committees have been acquiescing for too long in biased under-reporting of the
research, that they approve.
lain Chalmers
UK Cochrane Centre, Oxford OX2 7LG, UK
1. McLellan F. 1966 and all that-when is a literature search done? Lancet 2001;
358: 646.
2. Reidenberg MM. Releasing the grip of big pharma. Lancet 2001; 358: 664.
3. Savulescu J, Chalmers I, Blunt I. Are research ethics committees behaving
unethically? Some suggestions for improving performance and accountability.
BMJ 1996; 313:1390-93.
4. Department of Health. Governance
arrangements for NHS Research Ethics Committees, July 2001.