The U.S. Food and Drug Administration (FDA) has released a draft guidance for industry titled Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP. This draft guidance intends to aid IRBs, institutions, investigators, and sponsors in comprehending the processes used for the review of research involving children as subjects that is not otherwise approvable by an IRB and has been referred to the FDA, the Office for Human Research Protections (OHRP), or both, for review. The FDA has issued this guidance in compliance with their good guidance practices regulation.
This draft guidance replaces the final guidance issued by the FDA in 2006 and the guidance issued by the OHRP in 2005. While this guidance is not yet in effect, the FDA is inviting comments on the draft guidance until May 30, 2023, to ensure that it considers the relevant stakeholders’ thoughts and feedback before finalizing it.
Visit the official notice page to download complete draft guidance and to submit a formal comment.
