Louisiana State University Health Science Center IRB – FDA Warning Letter, Jul 26, 2023

The FDA issued a Warning Letter to Louisiana State University Health Science Center (LSUHSC) Institutional Review Board (IRB) following an inspection from July 17-26, 2023. The inspection, part of FDA's Bioresearch Monitoring Program, aimed to assess compliance with 21 CFR parts 50 and 56 regarding human subject protection in clinical investigations.

The letter identified two primary violations: 1. **Failure to conduct continuing review of research at least annually [21 CFR 56.109(f)]**: The IRB failed to perform timely continuing reviews for two FDA-regulated protocols, leading to lapses in approval for 12, 78, 59, and 46 days. During one 78-day lapse, study activity, including subject enrollment and protocol deviations, continued. The IRB attributed this to KUALI system failures and acknowledged manual identification issues. Their proposed corrective actions, including revised notification schedules, were deemed insufficient as they lacked details on how the IRB would ensure timely reviews, not just investigator reminders. 2. **Failure to prepare, maintain, and follow written procedures for prompt reporting of suspensions/terminations to FDA [21 CFR 56.115(a)(6) and 56.108(b)(3)]**: The IRB's procedures did not explicitly detail reporting suspensions or terminations of IRB approval to