FDA EIR - Nationwide Children's Hospital IRB - May 26, 2017

An FDA surveillance inspection of Nationwide Children's Hospital IRB was conducted from May 22-26, 2017, under Compliance Program 7348.809 (Institutional Review Boards). The inspection assessed the IRB's adherence to regulatory frameworks, including 21 CFR Parts 50 and 56, particularly regarding studies involving FDA-regulated products and additional safeguards for children (21 CFR Part 50, Subpart D). The review encompassed IRB written procedures, meeting minutes, study files, and membership rosters.

Crucially, this inspection identified no objectionable conditions, and therefore, no FDA Form 483 "Inspectional Observations" was issued. This positive finding indicates successful resolution of two observations from a previous inspection in January 2013. Those prior issues related to the IRB's documentation of benefit-to-risk ratios for studies involving children and the lack of sufficient detail in meeting minutes regarding attendance. Nationwide Children's Hospital IRB demonstrated adequate correction of these previous concerns. The IRB exhibited compliance with its established standard operating procedures for initial and continuing review, expedited review processes, emergency research protocols (including 21 CFR 50.24), and informed consent requirements, specifically pediatric assent.