The Common Rule was initially promulgated in 1991, and amended 2005. We refer to this version of the Common Rule as the “pre-2018 Requirements.” The Common Rule was substantially revised in 2017, and has been amended twice to delay the date that regulated entities must comply with the revised version of the rule. We refer to this version as the “revised Common Rule,” the “2018 Requirements,” or the “2018 Rule.”
OHRP's Division of Policy and Assurances (DPA) has compiled documents relevant to the revised Common Rule, including federal register notices, articles, and background information. Access those documents here: DPA Revised Common Rule Page.
OHRP has developed educational materials to assist the regulated community in understanding, implementing, and complying with the revised Common Rule. Access these educational materials using the tiles below.