Which federal regulations govern IRB review in the United States?

The federal regulations that govern IRB review in the United States are primarily found in 45 CFR 46. This regulation outlines the protection of human subjects in research, detailing the requirements for IRB review, informed consent, and the ethical considerations necessary to safeguard participants.

45 CFR 46 is crucial because it establishes the framework for how institutions and researchers must operate to uphold ethical standards and ensure the rights and welfare of human subjects are protected during research activities. This includes the stipulations for what needs to be included in informed consent documents, how risks must be assessed and communicated, and the roles and responsibilities of IRB members in reviewing research proposals.

The other options relate to specific areas of regulation but do not govern IRB review in the same way. For instance, 21 CFR 50 pertains to the protection of human subjects in research under the jurisdiction of the Food and Drug Administration (FDA), while 42 CFR 73 relates to select agents and toxins. Lastly, 49 CFR 100 deals with transportation regulations. None of these focus specifically on the broad scope of human subject protection as outlined in 45 CFR 46, making it the primary regulation governing IRB review processes.