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

An FDA inspection conducted at an Institutional Review Board (IRB) Panel from October 2, 2021, to November 2, 2021, identified several significant observations regarding adherence to regulatory requirements for human subject protection. The primary issues cited in the FDA Form 483 relate to inadequate documentation practices for IRB meetings and a failure to consistently follow established written procedures. Specifically, observations highlighted that meeting minutes lacked sufficient detail, failing to comprehensively record attendance, voting outcomes (including member numbers for, against, and abstaining), and the rationale behind decisions, particularly when requiring changes to or disapproving research. Documentation for expedited reviews was also found to be deficient. Furthermore, the IRB Panel did not consistently adhere to its own written procedures for the initial and continuing review of research, including the proper documentation of alternative voting procedures. The regulatory framework for these observations aligns with FDA requirements for the operation of IRBs and the protection of human subjects. As a result, the inspected entity is required to submit a comprehensive written response to the FDA. This response must detail the corrective and preventive actions implemented or planned to address each observation, ensuring full compliance with regulatory standards and the IRB’s own operating procedures.