Institutional Review Boards

A Brief History

IRBs grew out of concerns over serious human subject research abuses such as the experiments conducted by Nazi scientists during World War II. The Nuremberg Code issued by the War Crimes Tribunal in response to these atrocities is generally recognized as the first international code of medical research ethics. However, research abuses continued, such as in Tuskegee, Alabama, in the late 1940s when poor, Black men were denied available medical treatment for syphilis so that researchers could study the effects of the disease on them. Although most of the commonly cited research abuses involve medical research, behavioral or social science researchers also committed abuses. Perhaps the most commonly cited example is a set of psychological studies conducted by Stanley Milgram in the early 1960s. These studies would be considered unethical by today's research standards because the participants had been deceived into believing that they were giving excessive electric shocks to other people and were inadequately debriefed about the experiment.

In 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created and the National Research Act was passed by Congress. This law required the establishment of local IRBs to review and approve all human subject research that is federally funded. In 1979, the commission approved a guide for research with human subjects: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.

Enforcement of the human research guidelines has fallen on a number of different federal agencies over the years. Currently, the Office of Human Research Protection (OHRP) in the U.S. Department of Health and Human Services oversees an estimated 3,000–5,000 IRBs across the nation that regulate medical, social, and behavioral science research.

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