FDA 483 - University Of Michigan - IRBMED - September 02, 2022

The University of Michigan - IRBMED, an Institutional Review Board, underwent an FDA inspection from August 29 to September 2, 2022. The inspection highlighted critical observations concerning the IRB's adherence to its own written procedures and federal expectations for human subject protection.

The primary issue (Observation 1) involved the IRB's failure to follow established procedures for continuing review of research. Specifically, "Other Reportable Information or Occurrence" reports were not submitted for studies experiencing lapses in approval, with several historical examples cited. Furthermore, numerous research applications or submissions remained in an "expired state" for prolonged periods without administrative termination, conflicting with the IRB's own documented procedures or practices.

Another significant observation (Observation 2) noted that while the IRB utilized an expedited review process for research proposals, it did not adequately inform all board members of these approvals. A particular instance was identified where a study's continuing review, approved via expedited process, was not communicated to the full board.

These findings indicate a requirement for the University of Michigan - IRBMED to review and improve its compliance with internal policies and regulations governing Institutional Review Boards, particularly regarding research approval oversight and communication practices. The institution is expected to address these observations by implementing appropriate corrective actions to strengthen its human research protection program.