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Talk to a SpecialistTalk to a SpecialistArmstrong County Memorial Hospital's Institutional Review Board (IRB) failed to prepare, maintain, and follow written procedures governing IRB functions and operations as required by 21 CFR 56.108(a) and (b), and 21 CFR 56.115(a)(6) during FDA's bioresearch monitoring inspection conducted in November 2023. The violations involved non-compliance with federal regulations under 21 CFR parts 50 and 56 that govern the protection of human subjects in clinical investigations of FDA-regulated products. The IRB's failure to adhere to these statutory requirements under the Federal Food, Drug, and Cosmetic Act raised concerns about whether the rights, safety, and welfare of human research subjects were adequately protected.