Children's Healthcare IRB #1 – FDA 483, Jan 31, 2020

An FDA inspection of Children's Healthcare IRB #1 in Minneapolis, MN, revealed multiple significant deficiencies in its operations. The firm failed to ensure proper informed consent processes, inappropriately used expedited review for high-risk studies and adverse events, and did not adhere to its own written procedures for reporting unanticipated problems and conducting continuing reviews. Additionally, the IRB did not maintain adequate records of its members or follow its own membership requirements.