FDA WARNING_LETTER - St Vincent Hosp And Hlth Care - August 26, 2013

The FDA issued a Warning Letter to St. Vincent Health following an inspection of the St. Vincent Hospital and Health Care Center Institutional Review Board (SVHHCC IRB) conducted from August 12-26, 2013. The inspection, part of the Bioresearch Monitoring Program, aimed to ensure compliance with 21 CFR parts 50 and 56 for human subject protection. The FDA concluded the IRB did not adhere to applicable statutory requirements and regulations.

Two significant violations were identified. First, the IRB failed to determine at the time of initial review that clinical investigations involving children complied with 21 CFR part 50, subpart D (Additional Safeguards for Children in Clinical Investigations) [21 CFR 56.109(h)]. This was observed in 31 active pediatric studies, and the IRB's corrective action response was deemed inadequate for the majority. Second, the IRB failed to fulfill membership requirements [21 CFR 56.107] by allowing nonmembers to vote on clinical investigations, as evidenced in multiple meeting minutes.

The FDA acknowledged the IRB's corrective actions for membership issues, including SOP updates and training, appear adequate if properly implemented. However, the IRB must provide written assurance and documentation of completed subpart D reviews for all remaining pediatric studies. The letter requires a written response within fifteen business days detailing corrective actions, documentation, and projected completion dates. Failure to adequately address these violations may result in further regulatory action, emphasizing the critical need for full compliance to protect human subjects.