FDA 483 - Georgetown University IRB - March 11, 2020

During an inspection conducted by the FDA from March 4-11, 2020, Georgetown University IRB, located in Washington, DC, received a Form FDA 483 detailing significant observations. The primary issue identified was the failure to adequately prepare and maintain minutes of Institutional Review Board (IRB) meetings. These minutes lacked sufficient detail regarding attendance and the voting process, specifically the number of members voting for, against, and abstaining on actions. The inspection revealed several specific discrepancies. For instance, meeting minutes sometimes documented vote tallies as missing or incomplete, even when recording members as present. In one case, a Principal Investigator was noted as present for the continuing review of their own protocol, with no clear indication of recusal during the vote. Furthermore, minutes occasionally showed absent members actively participating as primary reviewers or being documented as present during discussions. A recurring observation across multiple meetings was that the number of members participating in voting was fewer than the number documented as present. These observations indicate a need for improved adherence to regulatory requirements for IRB record-keeping, ensuring transparency and integrity in the review process of research involving human subjects. While the FDA 483 itself does not mandate specific actions, Georgetown University IRB is expected to evaluate these findings, propose, and implement corrective actions to address the identified deficiencies in their meeting documentation and operational procedures.