Internal Review Board

The Nuremberg Code

The formal origin of human subject protections and the initiation of events leading to the formation of IRBs can be traced to the mid-20th century. During the Nuremberg Trials (1946–1949) that followed the end of World War II, it came to light that prisoners of war were required to take part as subjects in experimentation that sought to examine the effects of high altitude, drugs, experimental surgeries, poisons, and different types of explosive ordnance on human subjects. Many prisoners of war and civilians were required to take part in these activities against their will, and without any understanding of the procedures and their long-term effects. Furthermore, an examination of the research itself indicated that much of the experimentation was not scientifically justifiable. In 1947, concurrent with the Nuremberg Trials, 10 rules were set forth as essential principles in the conduct of research with human participants. These rules came to be known as the Nuremberg Code (1947/1996), and form the basis for the governance of human experimentation today. They represented the first codification of the principles of obtaining voluntary and informed consent from participants, the participants' right to withdraw from the research, the necessity of scientific justification and scientifically trained personnel in the conduct of the work, and the moral imperative to seek an experimental design that minimizes risk to participants.

Events Leading to the National Research Act of 1974

Shortly thereafter, the protection of human subjects became an important issue in U.S. research[Page 481] communities. In the 1950s, the NIH established an internal ethics board for the review of intramural clinical research. In 1966, with concerns mounting from reviews of the ethics of clinical medicine, the U.S. Public Health Service (USPHS) issued a policy memo that mandated the formation of “review committees” and the requirement that research be reviewed from a human subjects protections perspective as a prerequisite for the receipt of federal funding for research. Clarifications and additions to this policy followed. In the early 1970s, however, public disclosure of clear ethical violations at the Willowbrook State School for the Retarded in New York and the USPHS Tuskegee studies resulted in the National Research Act of 1974, which established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The charge of the commission was to identify basic ethical principles to govern the conduct of biomedical and behavioral research involving human subjects, and the means by which these principles might be followed and enforced. The Commission produced The Belmont Report, which eventually evolved into the current federal code that governs the operation of IRBs in the United States.

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