483
Human Subjects Research CommitteeHuman Subjects Research Committee – FDA 483, Aug 22, 2025
Record Details
An FDA inspection of Hennepin County Med Ctr's Institutional Review Board (IRB) in Minneapolis revealed two significant observations. The IRB improperly used expedited review procedures for research that did not meet eligibility criteria. Additionally, the facility failed to retain copies of all initial research protocols submitted for review and approval.
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