Informed consent: the intricacies

Should the BMJ reject all studies that do not include informed consent?

Should the BMJ reject all studies that do not include informed consent? That's a simple question, and surely the answer should be equally simple–“Yes.” Unfortunately, ethical questions rarely allow simple answers, and we want help with answering this one. This issue includes a cluster of material that relates to the question. We publish the material–including two studies in which informed consent was not sought–to encourage debate and to arrive at a deeper understanding if not a simple answer.

Medical journals must consider the ethical aspects of all the material they publish, and medical editors are presented with ethical issues just as often as doctors–that is, every day. Almost everything that doctors and editors do has an ethical aspect. However, a paper published last month in JAMA shows that many journals do not give their authors clear ethical guidance.1 A survey of the published instructions to authors of the 102 major English language biomedical journals showed that a quarter did not give authors any guidance on human research ethics, and only half required approval by an ethics committee or institutional review board before publication.

An accompanying editorial looked at 53 consecutive research papers published in Annals of Internal Medicine, BMJ, Lancet, JAMA, and New England Journal of Medicine.2 The authors found that 47% did not record informed consent and 58% did not record approval by an ethics committee or institutional review board. Importantly, they found six papers in which they judged there was a compelling need for informed consent or approval by an ethics committee or institutional review board and yet where there was no mention of either. These data are supported by a study that found that, of 586 interventional studies published in four geriatrics journals, only 54% included informed consent and 40% …