Recently, FDA and HHS’s Office for Human Research Protections (OHRP) published Draft Guidance on Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board in the Federal Register. The purpose of the Draft Guidance is to help institutional review boards (IRBs), institutions, investigators, and sponsors understand the processes used for review of research involving children as subjects that is not otherwise approvable by an IRB.
In short, if research involves greater than minimal risk and offers no prospect of direct benefit to individual subjects, then the research cannot proceed unless both IRB and government officials find that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children (alongside other requirements related to consent and ethics).
The referral and approval processes are complicated; thus, the Draft Guidance aims to provide clarity.
There is an ongoing public comment period during which you may provide feedback on the Draft Guidance. To do so, go to Write a Comment on Regulations.gov and follow the listed instructions.
The deadline to submit a response is May 30, 2023. Contact OHRP’s Dr. Natalie Klein at 240-453-6900 or 866-447-4777 if you have any questions.