Draft Guidance on Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) have announced draft guidance, “Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections.” Notice of this draft guidance is included in the March 31 issue of the Federal Register (88 FR 19310) and can be accessed at https://www.federalregister.gov/documents/2023/03/31/2023-06649/research-involving-children-as-subjects-and-not-otherwise-approvable-by-an-institutional-review, links to an external website.

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 FDA under 21 CFR 50.54, OHRP under 45 CFR 46.407, or both, for review.

The text of the draft guidance document appears on OHRP’s website (https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-research-involving-children-as-subjects/index.html) and is also available on the FDA website (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/research-involving-children-subjects-and-not-otherwise-approvable-institutional-review-board-process, links to an external website).

This draft guidance has a public comment period of 60 days, closing on May 30, 2023. See the Federal Register Notice for details regarding how to submit public comment. Thank you.