Implementation of U.S. Federal Research Regulations Delayed

"Common Rule" Governs Research Involving Human Subjects


The implementation of a newly revised U.S. policy that regulates research using human subjects (known as the Common Rule) has been delayed six months. The announcement from the U.S. Department of Health and Human Services was made on Jan. 17, 2018, just two days before the federal policy was scheduled to take effect. The six-month delay pushes the effective date to July 19, 2018.

COSSA (the Consortium of Social Science Associations), of which NCFR is a member, reports that further delays can be expected: 

According to the Federal Register notice, the 16 federal agencies subject to the Common Rule are “in the process of developing a proposed rule to further delay implementation of the 2018 requirements,” and the six-month delay will allow time for comments on the proposal. Details on what this second delay would entail—including whether the agencies are considering more substantive changes to the revisions—are not provided. A statement issued by the Department of Health and Human Services suggests a possible proposed implementation date of Jan. 21, 2019, but this could change. 

A number of the changes to the Common Rule were designed to make the regulations less burdensome for research that posed no or minimal risk to participants, like a lot of social and behavioral research. Until the changes are implemented, research involving human subjects will continue to be guided by the existing regulations, which have not been updated since 1991.

Read COSSA’s ongoing coverage of this issue here.