Research Protection Rules Standardized Under FDA Proposals (1)

Clinical researchers whose studies fall under both HHS and FDA jurisdictions will have a more consistent set of standards for protecting their study volunteers under a pair of proposed rules released Tuesday.

The Food and Drug Administration released two proposed rules Tuesday that 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 underwent a massive rewrite that was released in 2017 and largely went into effect ...