Lessons for research ethics committees

Iain Chalmers: Lancet 2002; 359:174

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.