FDA 483 - 3M Company IRB - April 14, 2017

The FDA conducted an inspection of the 3M Company IRB in St. Paul, MN, from April 4 to April 14, 2017. The inspection identified critical issues regarding the IRB's adherence to regulatory frameworks for human subject protection. A key observation was the approval of research involving child subjects without confirming compliance with 21 CFR Part 50, Subpart D, which mandates specific protections for this vulnerable population. Furthermore, the IRB lacked and failed to follow adequate written procedures for the initial and ongoing review of research. This included insufficient documentation for risk determinations (significant/non-significant risk), absence of specific written procedures for reviewing studies with children, and improper delegation of final approval for certain full board-reviewed studies to sub-committees. Lastly, the inspection revealed that the IRB had no written procedures for promptly reporting critical events to the FDA, such as unanticipated problems, serious noncompliance, or the suspension/termination of IRB approvals. Corrective actions are necessary for the 3M Company IRB to address these deficiencies and ensure full compliance with regulatory requirements governing Institutional Review Boards.