A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

Western feminists, physicians, and ethicists condemn the traditional genital surgeries performed on women in some non‐Western cultures. But coming to moral judgment is not the end of the story; we must also decide what to do about our judgments. We must learn to work respectfully with, not independently of, local resources for cultural self‐examination and change.

One of the arguments against conducting human subject trials in the Third World adopts a distributive justice principle found in a commentary of the CIOM'S Eighth Guideline for international research on human subjects. Critics argue that non-participant members of the community in which the trials are conducted are exploited because sponsoring agencies do not ensure that the products developed have been made reasonably available to these individuals. I argue that the distributive principle's wording is too vague and ambiguous to be (...) used to criticize any trial. Furthermore, the mere fact that an experiment does not fulfill this particular distributive justice principle does not entail that it is unethical. (shrink)

This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their supporting (...) rationales, and even to locate the crux of the disagreement in some instances. The goal of the present discussion, therefore, is to disambiguate the concept of a 'standard of care' and to highlight the areas of genuine disagreement among different standards. In the end it is argued that one standard of care argument in particular is more complex than either its proponents or its critics may have recognized and that understanding this possibility opens up a potentially promising avenue of inquiry that remains to be carefully explored. (shrink)

Over the past two years, much has been made by some governments and the media about the possible callous and racist distribution of Quinacrine by two Americans to sterilize women in the Third World. The main criticism of the practice is that though Quinacrine is unapproved by the developed world's health regulatory agencies for this particular use in the developed world due to inadequate testing for long-term side effects, it is used on defenseless women in the developing world.I argue that (...) the distribution of unapproved medical and other products is morally permissible if it satisfies two conditions: agent-centered utilitarianism and Kant's Categorical Imperative. Roughly, I contend that if the situation will probably improve and no one is treated as a mere means, then it is ethical either to give or to sell the products to those who choose to have them, regardless of where in the world they live. (shrink)

It has often been argued that if a clinician cannot decide which of two treatments to offer, a trial may be ethical, but it is unethical if she/he has a preference. Since individual clinicians usually have a preference, most trials could be judged unethical according to this line of argument. A recent important article in the New England Journal of Medicine argued that individual preferences are not as important as the collective uncertainty of informed clinicians. If clinicians are equally divided, (...) there is a state of collective equipoise and a trial is ethical. However, clinicians will seldom be exactly equally divided. We conducted an ethometric study to find out how much collective equipoise can be disturbed before the potential subjects in a trial think that it is unethical. Half of our subjects perceived a trial as unethical when equipoise was disturbed beyond 70:30. In other words, when 70 per cent of experts favour one treatment, 50 per cent of subjects would prefer that treatment to be administered rather than subjected to critical assessment. When equipoise is disturbed beyond 80:20, less than 3 per cent of subjects would consider human trials morally justifiable. (shrink)