The Common Rule

The Common Rule

The Common Rule is a set of a federal regulations that governs research involving human subjects. In 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Belmont Report, which set forth basic ethical principles for research involving human subjects. In 1981, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) revised existing federal regulations governing human subjects research to make those regulations compatible with the contents of the Belmont Report. The Belmont Report is available via HHS here.

The Federal Policy for the Protection of Human Subjects was published in 1991 by HHS as part 46 of Title 45 of the Code of Federal Regulations (CFR). Fifteen Federal departments and agencies subsequently codified this policy in their respective regulatory titles, earning the regulations the name "The Common Rule." In addition to these fifteen departments and agencies, three other departments and agencies comply with the contents of The Common Rule, but have not codified it into regulation. The complete regulatory text of 45 CFR Part 46 is available here.

Contents of the Common Rule

Disclaimer: the following information only applies to the pre-2018 update to the Common Rule.

Subpart A of the Common Rule is generally applicable to all research involving human subjects that is conducted or supported by the relevant department or agency. Subparts B-D include additional protections applicable to special populations (Subpart B, pregnant women, human fetuses, and neonates; subpart C, prisoners; and subpart D, children). Subpart A outlines requirements for Institutional Review Boards (IRBs), informed consent, and Assurances of Compliance for institutions conducting research.

Access our complete summary of Subpart A here.

 

Read our one-pager Fast Facts on the Common Rule here.

While other federal statutes and regulations have requirements related to research, such as the HIPAA Privacy Rule, the Common Rule is the primary set of requirements applicable to human subjects research.

Read our Myth Buster about the differences in the way HIPAA and the Common Rule regulate research here.

Updating the Common Rule

In July of 2011, HHS and the FDA published an advanced notice of proposed rulemaking (ANPRM) requesting public feedback on how the Common Rule should be modernized and updated to be more effective. Given that the Common Rule was published over twenty years ago, HHS contends that the regulations have not "kept pace with the evolving human research enterprise" and could be strengthened through its proposed changes. The ANPRM is available here. No changes came out of the ANPRM. 

On September 8, 2015 the HHS announced a Notice of Proposed Rulemaking (NPRM) seeking comments on proposals to update the Common Rule to better protect human subjects, while reducing burden, delay, and ambiguity for investigators. The public was allowed to comment on these proposed changes through October 2016. The full NPRM detailing the proposed changes can be found here. 

On January 19, 2017, the final rule to revise the Common Rule was released, detailing which changes were to be made after considering comments on the NPRM. The final rule is available here. On January 19, the effective date of the Common Rule updates was delayed to July 19, 2018. Since then the general compliance date has been further delayed to January 21, 2019. Until then, institutions are not required to implement all of the changes made to the Common Rule. 

A summary detailing the Common Rule will be added once the rule goes into effect in January, 2019.