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.
Rajendra Kale
37 Shanwar,
Pune 411 030,
India
