Universality and its limits: When research ethics can reflect local circumstances

Studies in several developing countries for treatment to prevent HIV-transmission from mother to child generated considerable controversy in 1997. Critics of the studies argued that basic principles of research ethics were violated. According to the critics, researchers subjected women in developing countries to studies that would have been unethical in the United States (and other developed countries) and that the researchers were therefore engaged in unethical exploitation of citizens of the developing countries in which the studies were conducted.

While the critics agreed that unethical exploitation had occurred, they differed on the exact nature of the exploitation. Some observers condemned the researchers for employing a double standard -- because the researchers were applying a standard of care that would have been unacceptable in their own country. In the view of these critics, researchers should have been comparing the experimental treatment to established therapy rather than to placebo, as would have been required in the United States or other developed countries.1 Other critics objected on the ground that once the trials demonstrated the efficacy of the experimental therapy, the therapy would not become available in developing countries because of its high cost. In this view, a study in developing countries need not always conform to the standard of care in developed countries, but studies on residents of developing countries cannot be conducted solely for the benefit of residents of developed countries.2