483
Seattle Children's Hospital IRBSeattle Children's Hospital IRB – FDA 483, Mar 3, 2026
Record Details
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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