New York State Psychiatric Institute IRB Warning Letter Details

Summary

The New York State Psychiatric Institute IRB failed to maintain and follow required written procedures for prompt reporting of unanticipated problems and adverse events to the IRB, institutional officials, and FDA, as mandated by 21 CFR 56.108(b) and 21 CFR 56.115(a)(6). During the FDA's Bioresearch Monitoring Program inspection conducted January 23 through February 2, 2023, investigators identified objectionable conditions indicating the IRB did not adhere to applicable statutory requirements of the Federal Food, Drug, and Cosmetic Act and FDA regulations governing the protection of human subjects in clinical drug investigations. The IRB's February 2023 response to the inspection observations was deemed insufficient to address the regulatory deficiencies identified.