Research Methods & Ethics
1947
The Nuremberg Code
Written by American judges into the August 1947 verdict against Nazi doctors, its ten points made voluntary consent the first rule of human research and ranked the subject's welfare above scientific interest.

Key people
- Leo Alexander
- Boston psychiatrist who worked with the prosecution and submitted the six-point ethics memorandum in April 1947
- Andrew Ivy
- American physician whose testimony helped define the ethical standards in the verdict
- Harold Sebring
- Florida Supreme Court justice who sat on the three-judge Doctors' Trial tribunal
Source
The trial that produced the Nuremberg Code opened on December 9, 1946, and ended with verdicts in August 1947. Twenty-three German physicians and administrators faced charges before an American military tribunal for experiments on concentration camp prisoners at Dachau, Auschwitz, and other camps. The experiments included deliberate infection with malaria and typhus, high-altitude and freezing experiments, and tests of wound treatments on prisoners who had no choice and no recourse. Sixteen of the defendants were convicted; seven were sentenced to death and hanged on June 2, 1948.
Several defendants argued that their experiments differed little from prewar German and American research and that no law separated legal from illegal experimentation. Two American doctors who worked with the prosecution, Andrew Ivy and the Boston psychiatrist Leo Alexander, took up the problem. On April 17, 1947, Alexander submitted a memorandum to the U.S. Counsel for War Crimes setting out six criteria for legitimate research. The tribunal, presided over by Walter Beals, restated almost all of them in the August 19 verdict under the heading "Permissible Medical Experiments" and expanded them to ten points.
The first point was the longest: "The voluntary consent of the human subject is absolutely essential." The Code further required that experiments have valid scientific justification, that they be preceded by adequate animal studies, that unnecessary suffering be avoided, that no experiment be conducted where there is reason to expect death or disabling injury, and that subjects be free to end their participation at any time. Germany's 1931 guidelines on new therapy and human experimentation had set out similar ideals, and the atrocities followed anyway.
For many years the Code had little practical force; it was a military tribunal's ruling with no standing in civilian international or U.S. law. In the United States, the Tuskegee study of untreated syphilis in 399 Black men, begun in 1932, continued for 25 years after the Code was written, although penicillin had been the treatment of choice for syphilis since 1943. In 1966 Henry Beecher of Massachusetts General Hospital reported in the New England Journal of Medicine on ethically troubling studies published in mainstream journals.
The 1964 Declaration of Helsinki, issued by the World Medical Association, restated the Code's provisions and extended them to allow research with children and others who could not consent for themselves. After an Associated Press story exposed Tuskegee in 1972, Congress passed the National Research Act in July 1974, which created the National Commission for the Protection of Human Subjects. The commission's Belmont Report, completed in 1978, supplies the ethical principles behind federal research regulations and institutional review boards.
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