FDA 483 - Abington Memorial Hospital, IRC - February 15, 2019

An FDA inspection of Abington Memorial Hospital, IRC, conducted from February 11-15, 2019, identified several issues regarding the operations of its Institutional Review Board (IRB). The inspection revealed deficiencies in documentation and procedural adherence related to human subject protection. A primary concern, noted as a repeat finding, involved the insufficient detail in IRB meeting minutes. Specifically, attendance records often did not align with member rosters, and written summaries of debated issues and their resolutions were consistently absent from 2017 and 2018 minutes. Furthermore, the IRB did not effectively inform its members about research proposals approved via expedited review procedures. An instance was cited where an expedited approval was documented retrospectively, and minutes were not subsequently reviewed or approved, preventing members from being updated on various submissions like study closures or safety reports. Lastly, for research requiring full IRB review, the hospital's IRB did not always ensure that convened meetings had a majority of members present, including the mandatory nonscientific representative, before approving proposed research or amendments. These observations indicate areas where Abington Memorial Hospital, IRC, needs to implement corrective actions to ensure its IRB operations comply with regulatory expectations for protecting human subjects in research. The FDA 483 serves as a formal notification, expecting the firm to address these findings.