Proposal to Harmonize Research Protection Rules Clears Review

An FDA proposal to align its research volunteer protections with those of the HHS has cleared White House review and can be published at any time.

The Food and Drug Administration’s proposed rule (RIN: 0910-AI07) will aim to iron out inconsistencies between the agency’s human subject protection regulations (21 CFR 50; 21 CFR 56; 21 CFR 812) and Health and Human Services Department regulations known as the Common Rule (45 CFR 46).

The Common Rule governs federally funded research at nearly 20 agencies, including the National Institutes of Health, whereas the FDA’s regulations govern drug ...