Changes to Common Rule Delayed

Thursday, January 18, 2018
By Holly Tiemann

 

On January 17, 2018, the Department of Health and Human Services announced a delay to the changes to the Common Rule that were scheduled to go into effect on January 19. The Interim Final Rule announced by the agency delays both the effective and compliance dates for the new Common Rule until July 19, 2018, with the option for further delay.The Federal Register is the official journal of the federal government of the United States that contains government agency rules, proposed rules, and public notices.

For investigators and study teams, this means that the new continuing review schedule, exempt categories, and other changes in the rule will not go into effect until July 19 at the earliest. The DUHS IRB will continue to review research under the guidelines of the pre-2018 rule until the new rule is implemented. However, the IRB is still requiring that study teams use the updated consent and waiver templates available on the IRB website for new studies. These include the additional elements required under the new rule and will allow for an easier transition when the rule does go into effect.

The IRB will continue to announce news via the Common Rule FAQ on its website and via the DOCR Newsletter.

The full announcement is available here: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for