Intended for healthcare professionals


Commentary: Failing to seek patients' consent to research is always wrong

BMJ 1997; 314 doi: (Published 12 April 1997) Cite this as: BMJ 1997;314:1081
  1. Rajendra Kale, neurologista
  1. a Laxmi-Kunj 37 Shanwar Pune 411 030 India


    Doing research without the patient's consent is unethical in any part of the world because it violates the fundamental right of the patient to autonomy and self determination. Bhagwanjee et al violated that right because they feared that seeking consent of patients might jeopardise the scientific rigour of their study. They feared that patients at risk of HIV infection would be inclined to refuse the study, so limiting its value.

    On what evidence did they base those fears? A separate study designed to find out the willingness of patients admitted to their unit to consent to HIV testing should have been their first step. Such a study might well have shown that their fears were unfounded and that a significant number of patients would have agreed to give informed consent. This would have allayed their fears and obviated their perceived need to do a study without consent. That such a result was likely is suggested by the findings of the “consent after the event” exercise that the authors carried out. The results of that exercise are difficult to interpret but if true suggest that most patients did not object to being forced into the study. They might well have consented to the study beforehand.

    Were these patients at all aware of their right to informed consent before being included in research? The study was done in a large and busy hospital in South Africa that mainly looks after non-white, poor patients under developing country conditions–a legacy of apartheid. The question of informed consent is not uppermost in the minds of patients and their relatives who attend surgical emergencies in hospitals in third world countries. This places even greater responsibility on the researchers to make sure that their patients know their rights.

    How many of the patients were white? The possibility that different ethical standards might still prevail in South Africa for patients of different races needs to be discussed. I wonder if such a study would have been done or even considered in a hospital serving a predominantly white population in South Africa.

    The arguments that medical resources are limited and that the findings of the study would help to utilise resources better are valid–but only in justifying the need for the study. They are not enough to permit a study without informed consent.

    Such a study would not have been allowed in Britain and other developed countries. But can ethical standards vary from one country to another? Ethical relativism argues that they can and do. But I think that doing research without consent is unethical everywhere. This is possibly more so in a developing county, where patients are likely to be ignorant of their rights.

    The BMJ was wrong to accept this paper, with or without a commentary. Refusing to publish would not have amounted to ethical imperialism, and any fears that one group was imposing its ethical norms on others are unfounded.

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