Document Type

Primary Law

Abstract

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 efficacy of a shorter course of AZT administered during late pregnancy and labor. Significantly, 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 efficacy-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

AZT tests in the developing world, read this new book by Sana Loue, a professor of epidemiology and biostatistics at Case Western Reserve University School of Medicine. Loue's stated and laudable goal is to educate researchers about the historical context of human-subject research, provide a framework for understanding the various theories of ethics from which various guidelines have been derived, and offer a detailed outline of ethical issues within the context of designing, implementing, and reporting on human-subject studies. Although clearly aimed at conscientious researchers, laboratory personnel, research administrators, and others involved in human-subject research, Loue's straightforward and comprehensive book will appeal to anyone interested in the ethical issues raised by such research.

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