Common Rule Revisions Compliance Date Delayed

Open calendar book with pen and three green paper clips

On January 19, 2017, the US Department of Health and Human Services (HHS) and fifteen other federal agencies issued revisions to the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.” These were the first major revisions to this policy since it was promulgated in 1991.

Institutions were required to update policies, documents, and practices to comply with the new Common Rule by the compliance date, which was January 19, 2018. On January 17, 2018, an interim final rule was released. This interim final rule delays the effective date and compliance date of the revised Common Rule for six months. The new compliance date is July 19, 2018.

Why Was the Rule Delayed?

The delay allows institutions additional time to prepare to implement the changes in the revised Common Rule. It also allows the federal agencies time to issue guidance documents related to the implementation of the revisions in the Common Rule.

What Does this Mean for My Research?

The MHRI IRB office will be working to prepare to implement the changes in the revised Common Rule over the next few months. Research that is currently approved or that will be approved prior to the new compliance date of July 19, 2018, will not be affected by the revisions to the Common Rule.

Questions?

If you have questions about the delay of the Common Rule revisions, contact the Office of Research Integrity at [email protected] or (301) 560-2912.