FDA 483 - Larkin Community Hospital IRB - November 19, 2021

During an FDA inspection conducted from November 12-19, 2021, Larkin Community Hospital IRB received a Form FDA 483 detailing several significant observations. The inspection focused on the Institutional Review Board's oversight of clinical investigations. Key issues identified include the failure to ensure a nonscientific member's presence at all convened IRB meetings for initial research reviews, impacting the approval process for multiple studies. The IRB also did not maintain adequate records for continuing review activities or documentation of study closures for several protocols. Furthermore, the facility failed to provide complete documentation to FDA representatives upon request, including specific meeting minutes and initial study approval letters. The IRB also lacked complete and current membership rosters, essential for demonstrating compliance with board composition requirements. Finally, informed consent documents for multiple studies were found to be missing the mandatory statement regarding ClinicalTrials.gov, a critical component for participant transparency and regulatory compliance. These observations highlight areas where Larkin Community Hospital IRB must implement corrective actions to ensure full adherence to regulations governing institutional review boards and the protection of human subjects in research.