FDA 483 - Children's Healthcare IRB #1 - February 03, 2023

An FDA inspection of Children's Healthcare IRB #1 in Minneapolis revealed a significant issue regarding the composition of its Institutional Review Board (IRB) meetings. The firm was cited because its IRB did not consistently include a nonscientific member during convened meetings for non-expedited research reviews, which is a critical component for ensuring comprehensive ethical oversight. This observation indicates a potential deficiency in the IRB's review process for protecting human subjects.