Common Rule

The ‘Common Rule’ is the Federal Policy for the Protection of Human Subjects, as set forth in 45 CFR 46 subpart A, and parallel regulations promulgated by agencies such as the FDA.

The "2018 Revised Common Rule" became effective January 21, 2019. Office for Human Research Protections maintains both "pre-2018 requirements" and links to "2018 requirements" for reference on its Regulatory Text webpage.