The Department of Health and Human Services (HHS) and 16 other federal departments and agencies June 19 issued a final rule to delay the general compliance date of the revised Federal Policy for the Protection of Human Subjects (“Common Rule”) until Jan. 21, 2019, with the exception of the cooperative research provision. Its compliance date remains Jan. 20, 2020.
This follows the Jan. 22 publication of an interim final rule delaying the Common Rule’s compliance date until July 19, 2018, [see Washington Highlights, Jan. 19] and a subsequent Notice of Proposed Rulemaking (NPRM) recommending an additional six-month delay to the general compliance date until Jan. 21, 2019 [see Washington Highlights, April 20].
The final rule permits regulated entities to adopt voluntarily three “burden-reducing” provisions during the six-month delay. They include:
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A revised definition of “research,” which deems certain activities not to be research for purposes of compliance with the Common Rule;
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The elimination of required annual review of certain categories of activities; and
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The elimination of required institutional review board (IRB) review of grant applications and other funding proposals related to research.
Along with the Association of American Universities, Association of Public and Land-grant Universities, and Council on Governmental Relations, the AAMC submitted a May 16 letter to HHS supporting the NPRM’s proposal to delay the general compliance date of the revised regulations until Jan. 21, 2019, as well as the adoption of the three-burden reducing provisions during the delay. The associations also urged HHS to promptly issue agency guidance to ensure consistent interpretation and implementation across institutions. The raised similar concerns in a June 2017 joint letter to the Office for Human Research Protections. Notably, the final rule recognizes the difficulties associated with implementing the 2018 requirements, stating that HHS will “strive to issue guidance on key aspects of the 2018 Requirements as quickly as possible, while also engaging stakeholders.”
Other than taking advantage of the opportunity to comply with three “burden reducing” provisions during the delay or implementing the provisions that do not conflict with the current Common Rule, institutions must continue to comply with the current Common Rule until Jan. 21, 2019.
The AAMC will continue to monitor developments related to the revised Common Rule.