FDA 483 - Howard University Institutional Review Board - May 19, 2022

The Food and Drug Administration (FDA) issued a Form 483 to Howard University Institutional Review Board following an inspection conducted from May 11 to May 19, 2022. The primary observation identified deficiencies in the preparation of meeting minutes for the Institutional Review Board. Specifically, the inspection revealed that attendance records in the meeting minutes did not consistently align with the actual number of members participating in votes across numerous meetings from January 2019 to February 2022.

For example, documented attendance figures frequently varied from the recorded voting participation, sometimes showing fewer members voting than present, and in one instance, more members voting than documented as attending. These inconsistencies indicate that the meeting minutes were not detailed enough to accurately reflect attendance, which is crucial for ensuring a proper quorum and transparent decision-making processes. This issue represents a deviation from regulatory requirements for Institutional Review Boards, which mandate meticulous record-keeping to ensure robust oversight of research involving human subjects. Howard University Institutional Review Board is expected to provide a detailed response outlining corrective actions to address these observations and ensure full compliance with regulatory standards.