FDA WARNING_LETTER - Mother Frances Hospital IRB - March 04, 2011

The FDA issued a Warning Letter to Mother Frances Hospital IRB following an inspection from February 28 to March 4, 2011, which identified significant violations of federal regulations governing Institutional Review Boards, specifically 21 CFR Part 56, 50, and 812, related to investigational devices. The inspection revealed three primary deficiencies. First, the IRB failed to maintain adequate written procedures for its operations, lacking steps for prompt reporting to the FDA of unanticipated problems, noncompliance, or suspension/termination of IRB approval, as required by 21 CFR 56.108(b)(1), (2), and (3). Second, the IRB did not consistently follow its written procedures for conducting annual continuing review of research, resulting in multiple studies experiencing significant delays in their reviews, violating 21 CFR 56.108(a)(1) and 56.109(f). Third, the IRB failed to prepare and maintain adequate documentation of its activities, particularly in meeting minutes, which did not record the actual number of members voting for or against actions, contrary to 21 CFR 56.115(a)(2). The FDA requires the hospital to provide written documentation of corrective actions, a plan to prevent recurrence, and a monitoring plan within fifteen working days. Failure to comply may result in further regulatory action.