FDA 483 - UCLA Medical IRB 1 (OHRPP) - June 26, 2019

An FDA inspection of UCLA Medical IRB 1 (OHRPP) conducted from June 24 to June 26, 2019, revealed a significant observation regarding the composition of its Institutional Review Board. The primary issue noted was that the IRB did not include at least one member whose primary concerns were in nonscientific areas during a meeting on January 11, 2017. During this specific meeting, the IRB proceeded with critical actions, including approving initial research, approving pending modifications, and deferring other research items, despite the absence of the required non-scientific representation. This observation, documented on a Form FDA 483, highlights a deviation from regulatory requirements governing IRB structure and is issued pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While the FDA 483 does not explicitly mandate specific actions, UCLA Medical IRB 1 is expected to address this finding by reviewing its internal procedures and implementing corrective measures to ensure all future IRB meetings consistently meet the stipulated composition requirements for ethical oversight of human subject research.