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# Research on Some Child Subjects Guidance
- URL: https://www.fdaweb.com/research-on-some-child-subjects-guidance/
- Published: 2023-03-30T12:00:00.000Z
- Updated: 2026-09-14T18:22:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154100

FDA has published a guidance, *Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP*, 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 FDA, the HHS Office for Human Research Protections (OHRP), or both, for review. When final, the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/research-involving-children-subjects-and-not-otherwise-approvable-institutional-review-board-process?utm%5Fmedium=email&utm%5Fsource=govdelivery) will replace an FDA 12/2006 final guidance and a 5/26/2005 guidance issued by OHRP.