FDA 483 - Oklahoma Blood Institute - IRB - February 27, 2006

An FDA inspection of Oklahoma Blood Institute - IRB in Oklahoma City revealed significant deficiencies in its Institutional Review Board operations. The firm failed to conduct research reviews at convened meetings, did not promptly notify investigators of approvals, and lacked proper record-keeping for consent documents and adverse event reports. These issues indicate a lack of adherence to established procedures for human subject protection.