FDA EIR - Nationwide Children's Hospital IRB - March 11, 2019

An FDA inspection of Nationwide Children's Hospital IRB was conducted from March 5-11, 2019, with a closing date on March 26, 2019. The inspection assessed compliance with FDA regulations for Institutional Review Boards (IRBs) under the CBER/CDER framework and Compliance Program P1. While no formal FDA Form 483 (Inspectional Observations) was issued, the inspection identified four significant discussion items related to the IRB's failure to adequately prepare and maintain meeting minutes. Key issues included insufficient detail in attendee lists to confirm the presence of non-scientist and community members at the start of meetings, a lack of clarity regarding the order of study reviews and member participation (joining/leaving) in specific meetings, discrepancies between the number of voting attendees and votes cast, and the documentation of an unlisted individual as a voting member. Management indicated they would not formally respond to these discussion points. However, the IRB had already taken steps to address these deficiencies by implementing a software upgrade designed to enhance the documentation and tracking of meeting minutes. This internal corrective action aims to improve compliance with regulatory requirements for record-keeping.