FDA 483 - Creighton University IRB - April 07, 2022

An FDA inspection of Creighton University IRB, conducted from March 28 to April 7, 2022, identified significant procedural and record-keeping deficiencies. The observations, detailed in an FDA Form 483, indicate non-compliance with regulatory requirements for Institutional Review Boards under 21 CFR Part 56.

Key issues included the failure to maintain comprehensive records for the required three-year period, with specific concerns regarding insufficient documentation of IRB member pre-reviews, unclear approval criteria, and inadequate reporting requirements within policies for emergency INDs and expanded access studies. Additionally, the IRB lacked and did not consistently follow written procedures for the initial and continuing review of research. This manifested in outdated membership rosters, members participating in reviews before formal appointment or completing mandatory training, and inconsistencies in informed consent form language.

Furthermore, meeting minutes were found to lack sufficient detail, often omitting critical information such as reasons for tabling studies, pre-review comments, discussions on conflicts of interest, and clear documentation of member attendance or final approval processes. Creighton University IRB is expected to address these observations by implementing appropriate corrective actions and submitting a response to the FDA.