FDA EIR - Oklahoma Blood Institute - IRB - February 27, 2006

The FDA conducted an inspection of the Oklahoma Blood Institute's Institutional Review Board (IRB) in Oklahoma City, OK, from February 14 to February 27, 2006. The inspection aimed to assess compliance with regulatory requirements under CP 7348.809 for Institutional Review Boards. The previous inspection in August 2003 resulted in a 4-item FDA 483, which highlighted issues such as lack of quorum at IRB meetings, failure to conduct annual reviews, insufficient meeting minutes, and incomplete by-laws and procedures. These issues have since been addressed.

During the current inspection, an FDA 483 was issued to Maribeth D. Snapp, the IRB Chairman, identifying several violations. These included failure to review and approve studies during convened IRB meetings, failure to notify investigators in writing about study approvals and the specific version of consent forms approved, and failure to maintain copies of all approved consent documents and adverse event reports.

The inspection involved discussions with key personnel, including Ms. Snapp, Margarett Moore-Payne (Director of Compliance/Regulatory Affairs), Charles Mooney (Vice President Ancillary Services), Martha Elane Moore (Research Manager), and Pandora Crawford (Director of Quality Assurance). The IRB committed to responding in writing to the observations noted in the FDA 483.

Post-inspection correspondence is directed to Maribeth D. Snapp, via Margarett Moore-Payne at the Oklahoma Blood Institute. The inspection did not involve any refusals or sample collections.