Institutional Review Board

Brief History

In 1947, 26 Nazi physicians were tried in Nuremburg, Germany, for conducting experiments on prisoners of war. The outcome of the Nazi War Crime Tribunal was a document known as the Nuremberg Code, the first internationally recognized standards for research ethics. The Nuremberg Code established that any participation in experimental research must give consent to participate in the research. This code also established the standard that benefits of the research must outweigh the risks. The Nuremberg Code did not carry the force of the law in any country; rather, it is the first document to advocate for voluntary participation and informed consent.

Other experiments that took place between 1930 and 1970 reinforced the need for a standard code of ethics for research with human subjects in the United States. A series of experiments in Tuskegee, Alabama, that spanned 40 years prevented poor Black men with syphilis from treatment and information about treatment options even after a cure had been established. These men were given free medical examinations, but not given information about their condition. A cure for syphilis (penicillin) became available in the 1950s. Some subjects were informed about their disease by doctors from outside of the research study and offered treatment, but in some cases the researchers intervened to prevent the treatment. The experiment was not stopped until 1973 when public knowledge of the study led to political embarrassment for the U.S. government.

The use of thalidomide is another example of the need for research oversight. In the late 1950s, thalidomide had been approved in Europe but not by the U.S. Food and Drug Administration (FDA) for use as a sedative and for controlling nausea. Physicians in the United States prescribed thalidomide to pregnant women. It was discovered that taking the drug during pregnancy led to severe deformities in the fetus. Some 12,000 babies were born with severe deformities. The women who were prescribed thalidomide did not know the drug was not approved by the FDA, nor did they give consent to be part of an experimental study. As a result of thalidomide, in 1962 the Kefauver-Harris Bill was passed in the United States to ensure greater drug safety.

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