FDA 483 - University Medical Center IRB - November 18, 2022

During an inspection conducted from November 14 to November 18, 2022, the FDA issued a Form 483 to University Medical Center IRB. The inspection highlighted a significant observation regarding the Institutional Review Board's record-keeping practices. Specifically, the minutes of IRB meetings were found to lack sufficient detail concerning attendance, actions taken, and the complete voting record, including the number of members voting for, against, and abstaining on reviewed protocols.

Several instances of these deficiencies were cited. From September 2017 to October 2022, meeting minutes frequently failed to identify all voting members for each study protocol. For example, some minutes only noted the total number of voting members present rather than specific individuals. Furthermore, a meeting minute from February 2021 regarding an Unanticipated Problem submission did not specify the protocol under review, and instances were noted where the number of voting members recorded as present did not match the number who actually voted on a protocol. Additionally, conflicts of interest where members recused themselves were noted.

These observations indicate a need for the University Medical Center IRB to enhance its documentation procedures to ensure comprehensive and accurate records of its decision-making processes, aligning with regulatory expectations for clinical research oversight. The firm is expected to respond with corrective actions to address these findings.