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An Emerging Consensus on Consent

Together these factors worked against implementing the consent requirement of the Nuremberg Code in any formal or consistent fashion in the first decade after it was articulated. But in the early 1960s a wave of medical scandals brought the issue of informed consent to the fore. In 1963, a university team conducted a well-publicized but medically doomed effort to transplant a chimpanzee kidney into a human patient-an experiment conducted partly with federal funds, but without prior animal studies or valid scientific justification. The episode heightened concern about the lack of scientific or government oversight of research using human subjects.

A few years later, Harvard anesthesiology professor Henry Beecher, in an article in the New England Journal of Medicine, claimed to have found 22 obvious abuses of human subjects in the recent medical literature. In one of these cases, researchers injected live cancer cells into debilitated patients at the Brooklyn Jewish Chronic Disease Hospital without the subjects’ knowledge in order to determine whether their immune systems could mount a defense against the cancer. (The subjects were not harmed by the experiment.)

In 1966, the surgeon general announced a policy to govern human-subjects research supported by Public Health Service grants. It required institutions receiving PHS support to create an institutional review board to oversee research involving human subjects and demanded that researchers obtain consent from their subjects.

But if a single event broke the back of medical paternalism in research it was surely the Tuskegee syphilis study. From the early 1930s to the early 1970s, U.S. Public Health Service doctors had studied more than 400 black men with syphilis in Macon County, Ala. The men were not told they had the disease, nor were they offered treatment-even after the discovery of penicillin made treatment much more effective. When a journalist broke the story, a firestorm of outrage swept the country. The requirement for the “voluntary consent of the human subject” had been systematically abused right here in America, in a study that had begun just around the time the Nazis took power in Germany.

The federal government appointed a commission to investigate the scandal in 1972. Recommendations based on its findings, released in 1978, were incorporated into Department of Health and Human Services regulations in 1981 and extended to all federal agencies conducting or sponsoring human-subjects research in 1991. As a result of the Tuskegee scandal, the requirement for voluntary consent in research became deeply etched in the law and in the minds of many who had not seen the need for vigilance before.

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