483
Indiana University IRBIndiana University IRB – FDA 483, Feb 14, 2020
Record Details
An FDA inspection of Indiana University IRB in Indianapolis, IN, conducted from February 6-14, 2020, identified a significant procedural deficiency. The Institutional Review Board failed to report research proposals approved under expedited review procedures back to the full board. This practice deviates from the IRB's own written procedures, indicating a lapse in oversight.
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