FDA 483 - AtlantiCare Regional Medical Center IRB - February 10, 2023

An FDA inspection of AtlanticCare Regional Medical Center IRB in Atlantic City, NJ, revealed significant deficiencies in its Institutional Review Board operations. Observations included an IRB member participating in a review with a conflict of interest, the inappropriate use of expedited review for research involving greater than minimal risk, and a failure to prepare complete records for continuing review activities. These findings indicate a need for improved adherence to regulatory requirements and internal procedures for human subject protection.