FDA 483 - Children's National Medical Center IRB - June 06, 2019

An FDA inspection conducted from May 29 to June 6, 2019, identified significant deficiencies at the Children's National Medical Center IRB. The inspection report, known as an FDA Form 483, detailed three main observations related to regulatory compliance for Institutional Review Boards overseeing human subject research.

First, the IRB failed to follow its written procedures for promptly reporting instances of serious or continuing noncompliance to the FDA. Specifically, a Principal Investigator's serious noncompliance, which led to the suspension of a protocol and all their study activities, was not reported. Additionally, the suspension of a compassionate use study involving this PI was not communicated to the FDA.

Second, the IRB did not consistently ensure that proposed research, excluding expedited reviews, was reviewed at convened meetings with the required quorum, including a nonscientific member. This issue affected four FDA-regulated studies, where votes occurred with an insufficient number of members present.

Third, the IRB failed to adequately prepare and maintain a comprehensive list of its members. The membership rosters lacked essential details such as earned degrees, representative capacity, experience, and institutional relationships for all voting members and alternates. Furthermore, unlisted individuals were documented as voting and, in some cases, were crucial for meeting quorum during several committee meetings.

These observations highlight the need for Children's National Medical Center IRB to implement corrective actions to ensure full compliance with regulatory requirements and proper oversight of research protocols.