Editor's Choice | This Week in BMJ | Press releases

BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consent Explicit guidance is required on valid exemptions for need for ethical review Editor, We welcome the recent attention to the ethical conduct of human experimentation.(1, 2) But we believe that an overzealous interpretation of what are intended to be general guidelines can make it difficult to communicate non-experimental case reports, reviews of case notes, and clinical series. We are often asked for advice on whether studies require review by an ethical committee. To advise that a study does not need ethical review is to make an ethical judgment; that is, of course, the function of the committee. Thus it falls to the investigators to decide whether to seek approval of the ethics committee. We believe that when an author submits a manuscript for publication the editor should consider a statement giving valid reasons for exemption from the general need for ethical approval. We find the guidelines issued by the Royal College of Physicians both lucid and helpful.(3) We suggest that editors could adopt these or similar statements making clear what types of report need not be reviewed by a research ethics committee. In essence, the grounds for exemption could include: that the information emerged from clinical practice and so does not constitute research (section 3.1 in the Royal College of Physicians' guidelines) that the information concerns innovative treatment applied with the patients' informed consent and so does not constitute research (section 3.2) that the investigation was considered to be a quality control or medical audit exercise exempt for the need for ethical review (section 4.8). The editor should decide whether the claim for exemption is valid and also ensure that the manuscript respects the confidentiality of the patients. As an example of the difficulties that arise, we are aware of a case in which an editor refused to consider a manuscript because the work had not been reviewed by an ethics committee. The authors were describing five years of clinical experience with a technique generally accepted as a therapeutic option and which they considered to be the method of choice for a life threatening condition. In our opinion, the authors, who were also the patients' medical practitioners, did not need approval of a research ethics committee to provide what they considered to be the best care for their patients or to refer back to the original case notes in order to aggregate the data. In response to an appeal, the editor concerned asked whether the authors could obtain retrospective approval from the local ethics committee. But it is that committee's policy not to consider retrospective applications. More explicit guidance on valid exemptions for the need for ethical review would be invaluable in preventing or resolving this type of impasse. Tom Woodcock Honorary secretary, joint research ethics committee John Norman Professor General Hospital, Southampton SO16 6YD References 1 Rennie D. Disclosure to the reader of institutional board approval and informed consent. JAMA 1997;277:922-3. 2 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.) 3 Royal College of Physicians of London. Guidelines on the practice of ethics committees in medical research involving human subjects. 2nd ed. London: RCP, 1990. Home | Current issue | Past issues | Classified ads | Career Focus | Feedback Collections | About this site | About the BMJ | BMA | Medline