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105. FDA Regulations: Institutional Review Boards (21 CFR 56)

Part 56 of the FDA regulations address requirements for the composition, operation, and responsibility of an IRB that reviews (a) FDA-regulated clinical investigations and (b) clinical investigations supporting applications for research or marketing permits for products regulated by the FDA.

FDA regulations mirror DHHS regulations for IRB requirements related to membership; functions and operations; review and approval of research; expedited review; institutional review; and review of cooperative research. The University Biomedical IRB complies with these regulations.

FDA exemptions, waivers, and additional requirements are itemized below.

NOTE: The Food and Drug Administration may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subjects.

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