FDA 483 - Morris Hospital and Silver Cross Hospital IRB - March 16, 2020

An FDA inspection conducted on March 12, 13, and 16, 2020, at Morris Hospital & Silver Cross Hospital IRB, identified significant deficiencies in their operations. The regulatory body issued a Form FDA 483, detailing four key observations regarding compliance with federal regulations for Institutional Review Boards. The primary issues included a lack of written procedures for promptly reporting serious or continuing noncompliance to the FDA, and a similar absence of procedures for reporting the suspension or termination of IRB approvals. Furthermore, the inspection revealed that for non-expedited reviews, the IRB did not consistently conduct reviews at properly convened meetings, specifically failing to ensure a majority of members were present, including a non-scientific member, and that all members properly voted. Lastly, the IRB allowed members with a conflicting interest to participate in and vote on the continuing review of FDA-regulated studies. To address these findings, Morris Hospital & Silver Cross Hospital IRB is expected to develop and implement robust written procedures, ensure adherence to meeting quorum requirements, and enforce strict conflict of interest policies.