Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and Office for Human Research Protections (OHRP)

30 March 2023 – the FDA published draft guidance on the review of research involving children as subjects for Review Boards, Investigators, and Sponsors. Submit comments by 30 May 2023.

This guidance is intended to assist institutional review boards (IRBs), institutions, investigators, and sponsors in understanding the processes used for review of research involving children as subjects that is not otherwise approvable by an IRB and has been referred to the Food and Drug Administration (FDA) under 21 CFR 50.54, the Office for Human Research Protections (OHRP) under 45 CFR 46.407, or both, for review.