that they were receiving treatment when they were not. Congress convened an independent panel that concluded that the Tuskegee Study was highly unethical and should be immediately halted. The panel also declared the protection of human subjects to be a widespread problem and expressed concern that no uniform policy existed for the protection of human subjects of federally funded biomedical research. Among other recommendations, the Tuskegee panel advocated the strengthening of guidelines regarding the review of research protocols by independent committees. These recommendations were reflected in formal policies promulgated in 1971 in the DHEW publication entitled "Institutional Guide to the DHEW Policy on Protection of Human Subjects," mentioned above.

In 1973, the Senate Committee on Labor and Public Welfare held a series of hearings regarding human experimentation that included discussion of such issues as research on human fetuses, sterilization of the mentally retarded, and use of prisoners (Senate Committee on Labor and Public Welfare, 1973). The hearings received extensive television coverage and further increased public awareness of and concern about ethical problems in biomedical research. There was considerable public outrage over reports of fetal research, particularly over a research project that had been conducted in Finland using the perfused heads of aborted fetuses. This study, together with the Tuskegee study, was the stimulus for congressional action on research ethics in the form of the National Research Act of 1974 (P.L. 93-348).

The National Research Act established The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (see Chapter 4 for more information on this commission). The National Commission was charged to identify ethical principles that would guide research on human subjects and to develop relevant guidelines for researchers and institutions. The Act also formally established the requirement that research institutions must have an institutional review board (IRB) as a mechanism for the protection of human research subjects (see Chapter 3 for more information on IRBs).

Thus, during the 1970s and 1980s, serious efforts were made to distinguish biomedical research from medical practice. The inherent possibility of conflict between benefit to the patient and benefit to knowledge and society has been acknowledged, and, groups like IRBs and commissions have been entrusted to help investigators, research subjects, and society decide how best to judge the trade-offs.

Recently, President Clinton appointed a 15-member Advisory Committee on Human Radiation Experiments to provide advice and recommendations on the ethical and scientific standards applicable to human radiation experiments carried out or sponsored by the United States government between 1946 and 1974. The group has been charged with reviewing



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