FDA 483 - Meharry Medical College Institutional Review Board - November 04, 2021

An FDA inspection of Meharry Medical College Institutional Review Board in Nashville, TN, revealed significant deficiencies in the preparation and maintenance of IRB meeting minutes. The firm failed to maintain sufficient detail regarding attendance, actions, and voting records, and did not adequately document review and approval processes for research protocols. Additionally, the IRB did not consistently follow its own written procedures for conducting initial and continuing research reviews, particularly concerning the documentation of alternate voters and designated reviewers.