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Common Rule

The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. It does not apply to federal agencies that have not signed the agreement (e.g., Department of Labor, etc.) The main elements of the Common Rule include:
    Requirements for assuring compliance by research institutions

    Requirements for researchers' obtaining and documenting informed consent

    Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.

The Common Rule includes additional protections for certain vulnerable research subjects. An institution with a DHHS approved Federal Wide Assurance typically agrees to apply DHHS regulations to all research regardless of the funding source, including research that is internally funded and collaborative research across institutions
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Chapter 2
Quick Links

Research in Humans

History of Rules About Research in Humans


Federal Mandate

Respect for Persons



Common Rule

IRB Mission



Chapter 2 Download (PDF)