Human Subjects Research in the United States after World War

Despite the Nuremberg Code and the Declaration of Helsinki, medical research after World War Two con tinued to be tainted by revelations of widespread abuse of human subjects. Henry K. Beecher described some of these revelations in an article published in the New England Journal of Medicine in 1966 (Beecher, H., 1966). In this article, Beecher described 22 studies conducted at prestigious institutions and published in leading medical journals in which human research subjects were subjected to excessive risks (i.e., risk to benefit ratio) often without their knowledge or consent. Beecher concluded that (a) it is ''absolutely essential'' to obtain informed consent from research subjects; (b) consent is not valid if the patient doesn't understand ''what is to be undertaken'' in the study; (c) ''the gain anticipated from an experiment must be commensurate with the risk involved''; (d) research reports should explicitly state that ethical ''proprieties have been observed''; and (e) data obtained unethically should not be published. Notably, Beecher hypothesized that these ethical breaches were due partly to the growth of public funding for research coupled with the need for investigators to publish to obtain such funding and advance professionally.

A number of studies cited by Beecher became notorious on their own. In a study of immunity to cancer at the Jewish Chronic Disease Hospital (New York), investigators injected live cancer cells into human subjects without obtaining informed consent. Another study involved the deliberate induction of infectious hepatitis (to understand better the natural history of the disease) in mentally impaired children who were residents at the Willowbrook State School for the Retarded (New York). The ethical concerns raised by this study were the deliberate exposure of the children to harm, and the deception and coercion that occurred during the parental informed consent process (Weyers, W., 2003).

Another study that achieved notoriety was the Tuskegee (Alabama) syphilis study. The purpose of this study, which was funded by the U.S. government and conducted by the U.S. Public Health Service from 1932 to 1972, was to determine the natural history of untreated late-stage syphilis in poor African-American men. The men were not told that they had syphilis, did not receive effective treatment for the disease, and were not informed that they were participating in an experiment. Instead, subjects were told they had ''bad blood'' and that the examinations they underwent were treatments. In fact, the study continued after effective treatment for syphilis became available. A widely publicized media report of the study resulted in public outrage, a class-action lawsuit, a congressional investigation, and the study's termination (Weyers, W., 2003).

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