FDA 483 - Avera McKennan Hospital IRB #1 DBA Avera IRB #1 - July 26, 2018

During an FDA inspection conducted from July 23-26, 2018, Avera Central Services IRB #3 was issued a Form FDA 483, detailing significant observations regarding their oversight of human subject research. The inspection revealed critical issues related to the maintenance of Institutional Review Board (IRB) meeting documentation and adherence to established protocols, which are essential for ensuring participant safety and data integrity in FDA-regulated studies. Key violations included a failure to maintain sufficiently detailed IRB meeting minutes, specifically lacking proper documentation of voting outcomes (for, against, abstaining) for multiple FDA-regulated studies. There were also discrepancies between documented attendance in meeting minutes and the electronic system, making actual attendance unclear for several meetings. The facility did not consistently follow its own standard operating procedures (SOP 301) for meeting administration, such as documenting members' comings and goings, distributing draft minutes, and ensuring a licensed medical professional was present when reviewing FDA-regulated research. Furthermore, the IRB did not always ensure that a required quorum, including a non-scientific member, was present for non-expedited research reviews, with numerous instances cited. A significant conflict of interest was also observed where an IRB member participated and voted on a compassionate use study despite having a documented conflict. These observations require Avera Central Services IRB #3 to develop and implement robust corrective actions to ensure full compliance with federal regulations governing IRB operations.