FDA 483 - Columbia University Medical Center IRB - August 31, 2022

An FDA inspection conducted from August 15 to August 31, 2022, at the Columbia University Medical Center IRB, resulted in the issuance of a Form FDA 483, detailing two significant observations. These observations highlight deviations from regulatory requirements concerning the operation and documentation of Institutional Review Board meetings for FDA-regulated research. The first observation noted that for non-expedited reviews, the IRB did not consistently ensure that proposed research was reviewed at convened meetings with a majority of members present, including at least one nonscientific member. Specific instances cited include the absence of a nonscientific member, individual members simultaneously participating and voting in multiple board meetings, and the failure to meet the required IRB majority for certain protocol reviews. The second observation addressed deficiencies in meeting minutes. The FDA found that minutes were not prepared and maintained with sufficient detail to accurately reflect meeting attendance and the voting record, including the number of members voting for, against, and abstaining. Examples included incorrect voting tallies and the complete absence of recorded votes for several FDA-regulated protocols. These observations indicate the need for the Columbia University Medical Center IRB to review and enhance its procedures for conducting and documenting research ethics reviews to ensure full compliance with federal regulations governing human subject protection. The firm is expected to respond to the FDA 483 by outlining its corrective actions.