The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies April 19 issued a Notice of Proposed Rulemaking (NPRM) to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects (“the Common Rule”) for an additional six months, from July 19, 2018, to January 21, 2019, to “provide additional time to regulated entities for the preparations necessary to implement the 2018 requirements.” This NPRM follows the January 22, 2018, publication of an Interim Final Rule (IFR) delaying the revised Common Rule’s effective and compliance date until July 19, 2018 [see Washington Highlights, January 19, 2018].
The NPRM seeks comment by May 21, 2018, on the new proposed compliance date and whether to allow institutions to implement three “burden reducing” provisions included in the revised rule prior to the 2019 general compliance date. The three provisions for which comments are requested include: 1) the revised definition of research that excludes certain research from oversight; 2) the ability to discontinue mandatory annual continuing review for certain categories of research; and 3) the elimination of the requirement that institutional review boards review research grant applications or other funding proposals. If implemented as proposed, institutions would be required to comply with all other requirements of the current Common Rule during the delay period.
The AAMC along with the Association of American Universities (AAU) and the Association of Public and Land-grant Universities (APLU) submitted a letter on March 19 to HHS in response to the IFR, urging further delay of compliance date to January 21, 2019, or later. Signatories to this letter expressed concern for the confusion and uncertainty within the research community in the year following publication of the revised rule in addition to noting the several guidance documents and templates that have not been issued [see Washington Highlights, March 23, 2018]. Additional updates and resources are available at www.aamc.org/commonrule.