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Regulations

OHRP makes available the full text of the HHS regulations for the protection of human subjects in research (45 CFR 46), the Common Rule (45 CFR 46 Subpart A), and FDA human subject protection regulations.

Regulatory Text 45 CFR 46 tile

Regulatory Text

Read the text of the pre-2018 Requirements, the 2018 Requirements, or a redline comparison of the two.

Common Rule

Common Rule Departments and Agencies

Subpart A of 45 CFR part 46 is often referred to as the Common Rule. Many other federal departments and agencies have also codified the text of the Common Rule in their own sections of the Code of Federal Regulations (CFR). Read more about these departments and agencies here.

Delay of Revisions to the Common Rule - Final Rule Revising the Common Rule

Revised Common Rule

In 2017, HHS and other Common Rule departments and agencies finalized comprehensive changes to the Common Rule. The revised Common Rule is effective July 19, 2018. You can read more information about the revised Common Rule here.
Content created by Office for Human Research Protections (OHRP)
Content last reviewed on January 19, 2017