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Institutional Review Board

The charge of an Institutional Review Board (IRB) is to ensure that the rights and welfare of human research participants are protected. IRBs in the USA adhere to the federal human subjects regulations, known as 45CFR46, subpart A, or the Common Rule. These regulations include key definitions, rules and specific requirements regarding committee composition and authority. The Common Rule builds off the Belmont Report, which articulated the three guiding ethical principles of conducting research with human participants: respect for persons, beneficence and justice.

Action-oriented researchers must submit their research materials to an IRB if their project meets the Common Rule's definition of research involving human participants and if anyone on the research team is affiliated with an institution or organization that requires an IRB review (e.g. an university). Additionally, certain funding sources and journal editors require IRB approval. Some action-oriented researchers critique the IRB process for its biomedical orientation and emphasis on individual-level considerations. This entry provides a brief historical overview of the human subjects regulations and the IRB process, an overview of frequently cited critiques of the IRB process and recommendations on how to address these critiques.

Historical Overview of Research Regulations

Due to space limitations, this overview touches upon only the Nuremberg Trials, the Public Health Service (PHS) policy for extramural projects, the Belmont Report and the Common Rule. For a more comprehensive historical review, the reader is directed to the list of further readings at the end of this section.

Nuremberg Trials 1947

The first formalized international code of ethics was written after World War II during the Nuremberg Trials of 23 Nazi investigators. The trials focused on the Nazi ‘research’ atrocities conducted in the concentration camps, such as the infamous hypothermia experiments. The charge of the prosecutors was to distinguish between the Nazi activities and US wartime research. An established code of ethics was not available to guide the prosecutors. In fact, the American Medical Association produced a code of ethics only during the trial, partly in response to the trial proceedings.

The Nuremberg Code was initially drafted by physicians and later revised by the US Counsel for War Crimes. The Nuremberg Code was designed to regulate medical experiments. The code consisted of 10 ‘basic principles', which addressed issues such as informed voluntary consent, risk assessment and the need for scientifically qualified experimenters. Although there was stringency in the language used, the Nuremberg Code did not mention the need for external review boards.

PHS 1966

Prior to the 1960s, the general public had high levels of trust in the efficacy of biomedical research. This trust, however, began to disintegrate, in part as a result of foetal abnormalities caused by thalidomide. In response, Congress passed the US Food and Drug Administration's Kefauver-Harris amendments to the Federal Food, Drug, and Cosmetic Act, which looked at issues such as the safety and efficacy of medical trials and informed consent. At this time the National Institutes of Health (NIH) also commissioned a study that found that few institutions had human participants review the policies in place, while other institutions that had policies were not adhering to them.

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