Institutional Review Boards

Institutional Review Boards (IRBs) are most commonly used for studies in the fields of health and the social sciences. They may be studies of personal or social behavior, opinions or attitudes, or they may be studies of how health care is delivered and might be improved.

IRBs are governed by Title 45 CFR (Code of Federal Regulations) Part 46. This National Research Act of 1974 defines IRBs and applies to all research that is funded, directly or indirectly, by the U.S. Department of Justice.

The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. The chief objectives of every IRB protocol review are to assess the ethics of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.

Originally, IRBs were committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical problems. Today some IRB reviews are conducted by for-profit organizations known as independent or commercial IRBs. The responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed by the same federal regulations.

For more information on IRBs, including a list of federally-recognized IRBs, please visit the Office for Human Research Protection, U.S. Department of Health and Human Services' website.