Agnesian Healthcare IRB – FDA EIR, Jun 17, 2014

An FDA inspection of Agnesian Healthcare IRB in Fond Du Lac, WI, conducted from June 12-17, 2014, identified three repeat violations of federal regulations governing Institutional Review Board operations. This inspection was a follow-up to a 2012 inspection and a subsequent Warning Letter, conducted under the FDA's Compliance Program for Institutional Review Boards. The main issues documented on an FDA-483 were: 1) The IRB failed to promptly notify investigators in writing of its decisions on proposed research activities, relying solely on verbal communication. 2) The IRB did not maintain complete records of all correspondence between itself and investigators, including formal approval letters, expedited approvals, or acknowledgements of adverse events and protocol deviations. 3) IRB meeting minutes were insufficiently detailed, failing to accurately record the number of votes (for, against, abstaining) for actions, and not summarizing discussions of disputed issues, such as informed consent changes or decisions on subject reconsenting. Management acknowledged these deficiencies and committed to providing written notifications to investigators for all IRB actions, maintaining comprehensive correspondence records, and improving the accuracy and detail of IRB meeting minutes, including documenting controverted discussions. They also agreed to evaluate potential conflicts of interest for sub-investigators and ensure proper reporting of adverse events and protocol deviations.