Ascension Health – FDA 483, Nov 9, 2017

An FDA inspection of Wheaton Franciscan Healthcare IRB #1, an Institutional Review Board, was conducted from November 2 to November 9, 2017. The inspection identified two significant observations related to the management and documentation of IRB membership and meeting minutes, indicating a need for improved compliance with regulatory standards.

The primary issue noted was the failure to maintain an accurate and updated roster of IRB members. Specifically, the prepared list of members, which should detail names, degrees, representative capacity, and experience, did not consistently reflect the actual individuals attending and voting at various IRB meetings throughout 2016 and 2017. This discrepancy was observed in multiple meeting minutes, suggesting a systemic lack of timely updates to membership records.

Secondly, the inspection found that minutes of IRB meetings were not sufficiently detailed, particularly concerning attendance and voting records. There were documented inaccuracies in the minutes for several meetings in 2016 and 2017 regarding which members were present, appointed, or participated in voting. This indicates a deficiency in maintaining clear and precise records of IRB proceedings.

These observations, issued under a Form FDA 483, highlight concerns regarding the integrity of the IRB's operational documentation, which is crucial for ensuring the proper oversight of human subject research. While the FDA 483 document does not explicitly list "required actions," Wheaton Franciscan Healthcare is expected to address these observations by implementing appropriate corrective actions to bring its practices into full compliance with relevant FDA regulations. The firm has the opportunity to discuss its objections or planned corrective actions with the FDA.