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Research Volunteer Protection Rules Move Toward Agency Harmony (1)

April 11, 2022, 3:28 PMUpdated: April 11, 2022, 4:36 PM

FDA regulations to protect research volunteers will catch up to their HHS counterpart in a significant rulemaking step that’s more than three years past the deadline.

The White House Office of Management and Budget received two proposed rules that aim to harmonize the Food and Drug Administration’s human subject protection regulations (21 CFR 50; 21 CFR 56; 21 CFR 812) with Health and Human Services Department regulations known as the Common Rule (45 CFR 46). OMB receipt and review of rules typically mark the final step before public release.

The initiative means that the research infrastructures ...