483
Seattle Children's Hospital IRBFDA 483 - Seattle Children's Hospital IRB - March 03, 2026
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An FDA inspection of Seattle Children's Hospital IRB identified two significant issues regarding the composition of its Institutional Review Board. The IRB failed to consistently include members with primary non-scientific concerns and lacked adequately identified unaffiliated members in a substantial percentage of reviewed meetings. These findings indicate deficiencies in ensuring diverse and independent oversight of research protocols.
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