FDA 483 - Santa Clara Valley Medical Center IRB - June 03, 2021

During an inspection conducted from May 26 to June 3, 2021, the Food and Drug Administration (FDA) issued a Form 483 to Santa Clara Valley Medical Center IRB. The inspection highlighted two significant observations regarding the Institutional Review Board's operations, indicating a need for corrective action to comply with regulations governing human subject protection.Firstly, the inspection revealed that for non-expedited research, the IRB did not consistently obtain approval from a majority of its present members. Several instances were documented where the number of attending members fell below the established quorum during meetings where FDA-regulated research, including adverse event discussions, protocol renewals, and new study approvals, was reviewed and voted upon.Secondly, the facility failed to maintain an accurate and complete roster of its IRB members. This roster, required to identify members by name, academic degrees, representative capacity, and relevant experience for deliberations, was found to be inconsistent. Numerous voting full board and alternate members identified in meeting minutes were not properly listed on the corresponding official rosters, indicating a lapse in record-keeping.These observations signify areas where the Santa Clara Valley Medical Center IRB must implement robust corrective actions to ensure proper oversight of clinical research and adherence to the regulatory framework for Institutional Review Boards.