When should an Institutional Review Board (IRB) or institution request a “407” review for research involving children as subjects?

Once an IRB determines that a protocol does not meet the requirements of 46.404, 46.405, or 46.406 for approval of research, but does meet the requirements for review under 45 CFR 46.407(a), the institution or the Institutional Review Board may request that the Office for Human Research Protections (OHRP), on behalf of the Secretary, HHS, conduct a 46.407 review. More.

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