FDA EIR - Abington Memorial Hospital - June 18, 2015

An FDA surveillance inspection of Abington Memorial Hospital's Institutional Review Board (IRB) from June 12-18, 2015, identified several significant issues concerning its operations and adherence to regulatory requirements. The inspection, guided by FDA regulations for Institutional Review Boards, resulted in the issuance of a seven-item Form FDA 483 (Inspectional Observations).

Key violations included the IRB's failure to consistently meet quorum requirements for reviewing proposed research at convened meetings, as mandated by regulations. The hospital also lacked written procedures for determining Significant Risk (SR) and Non-Significant Risk (NSR) for device studies, and these decisions were not properly documented. Furthermore, the IRB did not adequately maintain comprehensive lists of its members, missing details like representative capacity and experience for several years.

Additional issues involved insufficient record-keeping for continuing review activities, particularly for studies that were administratively closed without proper follow-up documentation. Meeting minutes were found to lack sufficient detail regarding attendance and member roles, showing discrepancies with official rosters. The IRB improperly used expedited review procedures for research that required a full board review, such as initial Humanitarian Use Devices (HUDs). Finally, there was a failure to promptly report the suspension or termination of IRB approvals to institutional officials and the FDA.

Management, including the IRB Chairman, acknowledged all observations and committed to implementing corrective actions, promising a written response to the FDA 483 within 15 business days.