FDA 483 - St Mary's Hospital IRB - November 21, 2017

An FDA inspection of St Mary's Hospital IRB in Madison, WI, conducted from November 14 to November 21, 2017, identified two significant observations regarding the Institutional Review Board's documentation practices. The first observation noted that IRB meeting minutes were not prepared with sufficient detail to reflect actions taken and the corresponding vote counts, including the number of members voting for, against, and abstaining. This deficiency was observed across multiple meeting dates in 2016 and 2017 for various actions such as continued reviews, study amendments, and compassionate use approvals. Specifically, one instance involved a study that was tabled, but no vote for this decision was recorded, despite an approval letter for its amendments being issued. The second observation highlighted the hospital's failure to maintain a complete list of IRB members for 2016 and 2017, which should detail members' earned degrees, representative capacities, anticipated contributions to deliberations, and any employment or relationships with the institution. These findings indicate a need for improved record-keeping to ensure compliance with regulatory expectations for IRB oversight. The firm is expected to address these observations and implement appropriate corrective actions.