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TEXTBOOK OF RESEARCH ETHICS: THEORY AND PRACTICE

An intense and deeply divided debate is taking place over the testing of a short course of AZT to prevent maternal-fetal transmission of HIV in the developing world. A long course of AZT—administered to HIV-infected pregnant women during their pregnancy and immediately before labor, and then to their newborn children for six weeks—is generally accepted in the United States as providing extensive protection against maternal-fetal transmission of HIV. Given the expense and lengthy administration of the long course, American researchers in the developing world designed studies to test the ef cacy of a shorter course of AZT administered during late pregnancy and labor. Signi cantly, the studies tested the short course of AZT against a placebo, rather than against the long course of AZT. It is undisputed that these studies would not be approved for implementation in the United States because they deny some of the subjects a treatment of known ef cacy—the long course of AZT that is the accepted standard of care in the United States—which could result in the transmission of a fatal disease from the subjects to their children. However, as medical research and study increasingly take place on an international basis, many researchers, ethicists, and others are revisiting the question of whether it is ethical to give subjects a placebo when effective treatment is available in principle, but not in practice, due to the relative standard of care otherwise available to the subjects. If you want to know more about the historical, theoretical, and legal context of ethical issues in human-subject research, such as those raised by the