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BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consentBritish institutions collaborating in projects overseas may face dilemmaEditor,We agree with the principle that medical research that does not include informed, individual consent should not be published(1) unless it falls into one of the three categories detailed by Len Doyal.(2) We would, however, argue for an additional guiding principle requiring community consultation over difficult ethical issues. Satish Bhagwanjee and colleagues might have sought opinions about HIV testing without consent from former patients of the intensive care unit in South Africa (and their relatives) before putting the study protocol to the ethics committee.(3) It might also have been more appropriate for a local HIV support group to be consulted instead of the subcommittee of the institutional ethics committee comprising a bioethicist, a clinician, and an AIDS expert.(3) We would also argue that a properly constituted ethics committee should remain the final arbiter of the extent to which informed consent should be sought for a given study. This committee must be independent, as suggested by the Declaration of Helsinki, and as close to the community involved in the research as possible. One problem is that, particularly in developing countries, many ethics committees remain to be set up or exist but are not properly constituted to include lay representation. Bhagwanjee and colleagues' study was reviewed by a subcommittee of the postgraduate committee.(3) However carefully that committee agonised over the fact that informed consent was not to be sought, the independence of its judgment must be questioned until its constitution is clarified. As researchers based in a British institution but collaborating in many projects overseas, we are constantly faced with a dilemma. While it is presumptuous to impose an ethical opinion on research that will take place in circumstances very different to our own, it is unethical to be associated with research that does not come under any independent ethical scrutiny at all. All our research is reviewed by our own ethics committee, which includes independent lay representation from a variety of religious and cultural backgrounds. We emphasise that ethical approval from this committee does not absolve researchers from seeking local ethical approval. We recognise that this situation is not ideal and are building up a database of the ethics processes present in those countries with which we have links. We hope that the debate on informed consent in the BMJ will encourage the development of independent ethics review processes in those places where they currently do not exist. Otherwise, medical journals will continue to have difficulty in judging whether, on ethical grounds, to publish some research. S B Squire (chairman)
Liverpool School of Tropical Medicine, References 1 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.) 2 Doyal L. Journals should not publish research to which patients have not given fully informed consent-with three exceptions. BMJ 1997;314:1107-11. (12 April.) 3 Bhagwanjee S, Muckert D J J, Jeena P M, Moodley P. Does HIV status influence the outcome of patients admitted to a surgical intensive care unit? A prospective, double blind study. [With commentaries by R Kale, S Bhagwanjee et al, and Y K Seedat.] BMJ 1997; 314:1077-84. (12 April.)
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