FDA 483 - MercyOne North Iowa Medical Center IRB - June 21, 2019

During an inspection conducted from June 17-21, 2019, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to MercyOne North Iowa Medical Center IRB, detailing significant observations regarding their compliance with Institutional Review Board (IRB) regulations. The inspection highlighted three primary issues. Firstly, the IRB failed to maintain required records, including initial and continuing review materials, original meeting minutes, and correspondence, for at least three years following the completion of research, as mandated by 21 CFR 56. Specifically, records for several active studies were prematurely destroyed. Secondly, the IRB did not consistently provide prompt written notifications to clinical investigators regarding research approvals, disapprovals, or necessary modifications. These critical communications were sometimes delivered verbally or were entirely absent. Lastly, the meeting minutes for the IRB lacked sufficient detail. Observations included inaccurate counts of voting members, missing documentation of votes for certain agenda items, and a failure to record when non-voting guests were excused prior to voting sessions. These observations indicate a need for MercyOne North Iowa Medical Center IRB to address its record-keeping practices and communication protocols to ensure full compliance with the regulatory framework governing IRBs, specifically 21 CFR Part 56. The firm is expected to implement corrective actions to rectify these identified deficiencies and prevent recurrence.