Informed consent: the intricaciesBMJ 1997; 314 doi: https://doi.org/10.1136/bmj.314.7087.1059 (Published 12 April 1997) Cite this as: BMJ 1997;314:1059
Should the BMJ reject all studies that do not include informed consent?
- Richard Smith, Editora
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% included approval by an ethics committee or institutional review board.3 The JAMA editorial recommends that journals explicitly ask authors to state that their research complies with the World Medical Association's Declaration of Helsinki.2
The Declaration of Helsinki includes four paragraphs specifically on informed consent and does allow physicians sometimes to do without informed consent in the context of “medical research combined with professional care (clinical research).”4 The first paragraph states: “In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely given informed consent, preferably in writing.” The next two paragraphs consider patients in a dependent relationship with physicians or who are not legally competent. The “let out” paragraph says: “If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee.”
Both the studies that we publish comply with the Declaration of Helsinki. Both were approved by ethics committees. Those committees agonised over the studies, and both papers include a detailed account of why the researchers did not obtain fully informed consent. But should the BMJ set a higher–or at least more explicit–standard than the Declaration of Helsinki?
One of the studies, from Edinburgh, is a randomised controlled trial of whether stroke family care workers improve outcomes for patients with stroke and their families (p 1071).5 The authors decided against seeking consent for randomisation primarily on the grounds that a detailed knowledge of the trial and its exact purpose would bias outcomes, which were essentially subjective. In addition, they did not expect the intervention to be harmful, and patients and their families could decline to see the stroke family care worker (p 1077).6 Sheila McLean, a professor of law and ethics in medicine, argues that their reasons are insufficient to justify deviation from the general rule that good research must at all times respect the subject (p 1076).7 “Any failure,” she writes, “to offer this respect is in itself a harm, even if its consequences are not physical.”
The second study, from South Africa, was a prospective double blind study of whether infection with HIV affected the outcome of patients admitted to an intensive care unit (p 1077).8 This is an important question because when resources are tight there is a tendency not to admit patients infected with HIV to intensive care units. Patients did not give consent to be in the study or to have their blood tested for HIV. The authors argue that consent could not be obtained from most cases because they were too sick and that the research was of such importance that the patients' right to informed consent could be waived (p 1082).9 The chairman of the ethics committee explains why the committee supported the research after its immediate reaction that it would not be possible to give ethical approval (p 1083).10 The explanations include the facts that the study entailed no interventions of any sort different from those that are necessary and are carried out in standard intensive care and that the injury done to the patients would be small. Rajendra Kale, an Indian neurologist, argues that the ethics committee was wrong to approve the research and that the BMJ is wrong to publish it (p 1081).11 He thinks that such research would not have been allowed in a fully developed country and worries that it may be too easy to flout fundamental human rights in the developing world.
The editors of the BMJ and our reviewers were divided on whether we should publish these papers. In the end we decided–and I as editor must accept full responsibility–that, rather than restrict the debate to ourselves, we would do better to invite our readers to join in. We are thus publishing the papers together with their commentaries and with an argument from Len Doyal, a professor of medical ethics, that the BMJ should not in future publish papers like these (p 1107).12 He proposes a policy that all medical journals might follow.
Professor Doyal writes that “Our abilities to deliberate, to choose, and to plan for the future are the focus of dignity and respect which we associate with being an autonomous person capable of participation in civic life.” To deny patients participating in research full information on that research is, he argues, a clear breach of their moral rights. Professor Doyal then examines the arguments against fully informed consent: patients may be distressed by detailed information; it may not be necessary when the risks of the research are negligible; and the interests of the public in medical progress will be undermined by too much emphasis on the rights of individual patients. He finds all these arguments unconvincing.
But he does identify three sets of circumstances in which informed consent may not be necessary. So long as a set of conditions are met then research may be allowed without consent on patients not competent to give consent–including children, patients with learning difficulties, and unconscious or semiconscious patients. Otherwise, such patients will be denied the benefits of research. Secondly, epidemiological research on medical records may be acceptable in certain strict circumstances when, for practical reasons, consent cannot be obtained. Thirdly, research without informed consent may sometimes be acceptable on stored tissue from anonymous donors.
Jeffrey Tobias, a radiotherapist argues that the BMJ is right sometimes to publish studies where patients have not given informed consent (p 1111).13 His argument revolves around the facts that patients trust their doctors and that what is clear in “fine and lofty places” like the letters pages of medical journals is much less clear in the “real world,” where “the doctor must somehow juggle the multiple responsibilities of expert, humane, and above all respectful support for the patient … with the wider healthcare concerns and requirements of society as a whole.”
The patient's voice is heard in this debate from an anonymous patient who was included in 1987 in a British trial of a new radiotherapy protocol for cervical cancer without being asked for fully informed consent (p1134).14 She suffered severe consequences from the treatment and later discovered that she was one of many patients who had been included in trials without consent. She feels abused and quotes another patient who wrote: “Somewhere, somehow, I have to expose this abuse of power. The doctors never got my informed consent. This is abuse of society's most vulnerable people. Where is there a platform for my voice to be heard, to make the public aware and the establishment accountable?” Our anonymous patient is against the BMJ publishing any trials that do not include informed consent.
Also in this issue, a news report from India describes how the Indian Council of Medical Research approved research that, without written informed consent, left women with precancerous uterine cervical lesions without treatment to study the natural course of the condition (p 1065).15 And a second news report describes how the Council of Europe is developing a legally binding set of rules on bioethics. These stipulate that research can be carried out only if subjects have given informed consent (p 1066).16 The rules do not have a “let out” clause to waive informed consent in people able to give consent, but they do allow research without consent in some circumstances in those who do not have the capacity to consent.
These are not easy issues, but we cannot avoid them. Researchers are likely to continue to want to do trials that do not include fully informed consent, ethics committees will be asked for their opinion, and medical journals will be offered the results to publish. The Declaration of Helsinki does not provide sufficient guidance, and the BMJ needs your help. Should we adopt the policy proposed by Professor Doyal or a version of it? Or should we continue sometimes to publish papers that do not include consent?