FDA 483 - Bellin Health System Inc., IRB - May 09, 2019

An FDA inspection of Bellin Health System Inc., IRB, in Green Bay, WI, conducted from May 6 to May 9, 2019, identified a critical observation concerning its oversight of clinical research. The FDA Form 483 issued documented that the Institutional Review Board (IRB) did not perform continuing review of a clinical research study at the required annual intervals. Specifically, a request for continuing review was submitted on January 22, 2019, for a study where participants were actively receiving an investigational product. This review was due by April 9, 2019, to ensure the ongoing safety and ethical conduct of the study, which was classified as greater than minimal risk. However, by the inspection's conclusion on May 9, 2019, the IRB had not convened to discuss or authorize the study's continuation, indicating a lapse in compliance with federal regulations for human subject protection. Bellin Health System is expected to implement corrective actions to ensure all research protocols undergo timely and compliant continuing review, upholding subject safety and regulatory standards.