Larkin Community Hospital Institutional Review Board – FDA Warning Letter, Nov 19, 2021

The FDA issued a Warning Letter to Larkin Community Hospital Institutional Review Board (IRB) following an inspection conducted from November 12-19, 2021. The inspection, part of FDA’s Bioresearch Monitoring Program, aimed to evaluate the IRB’s compliance with FDA regulations (21 CFR parts 50 and 56) concerning the protection of human subjects in clinical investigations. The FDA identified three significant violations. First, the IRB failed to review proposed research at convened meetings with a majority of members present, including a nonscientific member, as required by 21 CFR 56.108(c). Second, the IRB failed to prepare and maintain adequate documentation of IRB activities, specifically a complete and detailed list of IRB members, violating 21 CFR 56.115(a)(5). Third, the IRB failed to ensure that informed consent documents for applicable clinical trials included the mandatory statement about clinical trial information submission to a registry databank, as per 21 CFR 56.109(b) and 21 CFR 50.25(c). The FDA found the IRB's December 6, 2021, response to the Form FDA 483 inadequate, citing a lack of sufficient detail and a comprehensive corrective action plan. The IRB is required to respond within 15 business days, outlining corrective actions and submitting a compliant membership list. Failure to adequately address these deficiencies may lead to further regulatory action.