IRBs: A Brief History

The modern history of human subjects protections began with the discovery after World War II of numerous atrocities committed by Nazi doctors in war-related research experiments. The Nuremberg Military Tribunal developed 10 principles, known as The Nuremberg Code, to judge the Nazi doctors.

The significance of the Code is that it addressed the necessity to require the voluntary consent of the human subject and that any individual "who initiates, directs, or engages in the experiment" must bear personal responsibility for the quality of consent.

Similar principles have been articulated and expanded in later codes, such as the World Medical Association's Declaration of Helsinki, which calls for prior approval and ongoing monitoring of research by independent ethical review committees.

Revelations about the 40-year-long U.S. Public Health Service Syphilis Study at Tuskegee — and other ethically questionable research — resulted in legislation calling for regulations to protect human subjects, and for a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to examine ethical issues related to human subject research. The Commission's final and most influential report, The Belmont Report, elucidates three basic ethical principles that investigators must balance when conducting research with human subjects: respect for persons, beneficence and justice.

The National Research Act of 1974 established the modern IRB system for regulating research involving human subjects. In 1991, 16 federal agencies formally adopted the core of these regulations in a common Federal Policy for the Protection of Human Subjects (also known as the "Common Rule").

The IRB at Brandeis ensures that all research conducted at Brandeis or by a member of the Brandeis community, regardless of funding source, be reviewed according to these policies before research activities may begin.