FDA WARNING_LETTER - New York State Psychiatric Institute IRB - February 02, 2023

This Warning Letter, FDA Ref No: 24-HFD-45-03-01, dated March 21, 2024, was issued to Ms. Rogers of the New York State Psychiatric Institute (NYSPI) Institutional Review Board (IRB) following an FDA inspection from January 23 to February 2, 2023. The inspection, part of FDA’s Bioresearch Monitoring Program, assessed the IRB’s compliance with 21 CFR parts 50 and 56 regarding human subject protection in clinical investigations.

The FDA identified two main violations: 1. **Failure to prepare, maintain, and follow required written procedures for prompt reporting [21 CFR 56.108(b) and 21 CFR 56.115(a)(6)]**: * The IRB failed to report an unanticipated problem (subject death by suicide) to the FDA, despite determining it as such on August 9, 2021. * The IRB failed to promptly report instances of serious or continuing noncompliance by investigators to the FDA for three clinical studies (e.g., enrollment of ineligible subject, unauthorized medication tapers, failure to report SAEs, poor documentation). * The IRB’s written procedures lacked explicit provision for reporting suspensions or terminations of IRB approval to FDA, and a suspension of approval for Protocol