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Institutional Review Board

The Institutional Review Board, or IRB, is a committee that is required by federal law to protect the rights and welfare of human subjects participating in research activities. The committee meets this mandate by reviewing proposed and ongoing research activities, ensuring they meet specific criteria for approval.

The IRB’s function, make-up, and authority are governed by federal law, but meeting the regulations is done on an institution-specific level. The IRB ensures that valid studies meet the ethical mandates of the Belmont Report, and the legal mandates of federal law.

Federal Regulations

The federal law, commonly referred to as 45 CFR 46, formally, the Code of Federal Regulations at Title 45-Public Welfare, Department of Health and Human Services, Part 46-Protection of Human Subjects, is specific to research conducted or supported by a federal department or agency. However, many institutions, including RFUMS, voluntarily apply some or all subparts of 45 CFR 46 (also referred to as the “Common Rule”) to all research conducted by their investigators, regardless of status or source of funding.