FDA 483 - N.Y.S. Psychiatric Institute IRB - February 02, 2023

The N.Y.S. Psychiatric Institute IRB in New York, NY, was cited for multiple deficiencies related to its oversight of human subject research. Observations included failures to report serious noncompliance and unanticipated problems, inadequate informed consent documents, improper use of expedited review, and issues with IRB meeting quorum and composition. These findings indicate significant deviations from regulatory requirements for institutional review boards.