FDA EIR - Mother Frances Hospital IRB - April 02, 2013

During an FDA compliance follow-up inspection of Mother Frances Hospital IRB, Tyler, TX, conducted from March 25 to April 2, 2013, several significant issues were identified. This inspection followed a previous 2011 review that led to an Official Action Indicated (OAI) classification and a Warning Letter with six observations, which the firm reported had been voluntarily corrected. The current inspection, governed by CPGM 7348.809 for Institutional Review Boards, resulted in a three-item FDA Form 483. Key violations included the IRB's failure to adhere to its written procedures for continuing review of research. Specifically, a non-clinical staff member reviewed clinical adverse events, required reviewer signatures were missing on critical unanticipated problem/adverse event forms, IRB meeting minutes were not consistently reviewed at subsequent meetings, and necessary review checklists for expedited processes were not completed. Furthermore, the IRB failed to accurately communicate study approval expiration dates to investigators, as seen when a six-month approval was incorrectly conveyed as one year in an official letter. The firm also did not maintain all required correspondence, such as deleting email notifications sent to investigators regarding continuing review applications. These issues represent non-compliance with regulatory frameworks including 21 CFR 56.108(a)(1) and 21 CFR 56.115(a)(4). Mother Frances Hospital IRB management stated they would submit a written response to these observations, outlining corrective actions.