HHS Streamlines Kids Research Review Process Across Department

March 30, 2023, 4:03 PM UTC

US health officials are looking to streamline processes for a high-level, national review on children’s research when ethics boards can’t approve those studies on their own.

The Food and Drug Administration issued draft guidance Thursday on research involving children as subjects that isn’t otherwise approvable by ethics boards known as institutional review boards.

Once finalized, the new document will consolidate and replace two similar guidances issued by two agencies within the Department of Health and Human Services: a 2006 FDA guidance on handling referrals to FDA and a 2005 guidance from the HHS Office for Human Research Protections.

“This guidance ...

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