FDA 483 - National Institutes of Health IRB - October 11, 2023

An FDA inspection of the National Institutes of Health IRB in Bethesda, MD, revealed that for non-expedited reviews, research approved by the IRB did not consistently receive the required majority approval from members present. This was specifically due to a lack of quorum during several meetings between July and September 2023, where an insufficient number of primary members voted on FDA-regulated studies.