Institutional Review Boards

An institutional review board (IRB) is a committee of people with diverse backgrounds, training, and experience who are responsible for reviewing, approving, and periodically monitoring research involving human subjects. IRB members are normally appointed by the organization that is overseeing the research, such as research institutions, but there are commercial IRBs as well. The impetus for establishing IRBs lies in the history of human experimentation, some of which is sordid and ugly.

Some notable atrocities committed on human subjects in the name of research in the 20th century are familiar. Nazi doctors (such as Josef Mengele) conducted inhumane experiments on concentration camp victims during World War II (1). From the 1930s through the 1970s, the U.S. Public Health Service conducted the "Tuskegee study," which involved withholding treatment from Black men with syphilis in Alabama long after penicillin was shown to be an effective treatment (2). These events show what can happen when clinical investigators are unconstrained by ethical and regulatory structures, and public revulsion over these atrocities eventually led to the establishment of IRBs to provide ethical oversight.

In the wake of the atrocities committed in the Nazi concentration camps and the trial of some of the Nazi doctors who were responsible, the Nuremberg Code was developed in 1947. The Code's essence is captured in the first section, which states regarding research on human subjects: "The voluntary consent of the human subject is absolutely essential." The Code laid the foundation for the field of biomedical ethics that then developed (3).

Following the revelations of the Tuskegee study, the National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which issued the Belmont Report (Ethical principles and guidelines for the protection of human subjects of research) in 1979. The Commission was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral...