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

A routine, comprehensive FDA inspection of Mother Frances Hospital IRB in Tyler, TX, was conducted from February 28 to March 4, 2011. The inspection, carried out by the Center for Devices and Radiological Health's Bioresearch Monitoring division, focused on the Institutional Review Board's compliance with regulations governing research oversight, particularly for medical device studies. The inspection revealed six significant observations, documented on an FDA Form 483. Primary issues included the IRB's failure to conduct continuing review of medical device studies at least annually, as required by regulatory standards (21 CFR 56.109(f)). Deficiencies were also noted in IRB meeting minutes, which lacked consistent attendance records, documented votes, and rationale for requested research changes. Furthermore, the IRB was cited for inadequate or missing Standard Operating Procedures (SOPs). These procedural gaps pertained to determining when research required more frequent review than yearly, ensuring verification of study changes from independent sources, and establishing clear processes for reporting serious noncompliance, unanticipated health risks, or the suspension/termination of IRB approvals to the FDA. In response to these findings, Mother Frances Hospital IRB is required to submit a written reply addressing the FDA Form 483 observations to the FDA within 30 business days of the inspection's conclusion.