The U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies Jan 17 issued an interim final rule (IFR) to delay the implementation of the revised Federal Policy for the Protection of Human Subjects (“the Common Rule”) for six months, until July 19, 2018, to provide regulated entities additional time to make the necessary preparations to implement the revised regulations. This rule marks a delay for both the effective and general compliance dates of the revised regulations, which were issued on Jan. 19, 2017 [see Washington Highlights, Jan 19, 2017], and originally scheduled to go into effect on Jan. 19, 2018. Institutions conducting federally funded research are expected to comply with the pre-2018 regulations until July 19, 2018.
The AAMC on June 21 joined the Association of American Universities, the Association of Public and Land Grant Universities, and the Council on Government Relations in a letter to the HHS Director of the Office for Human Research Protections Jerry Menikoff, MD, JD, requesting a delay in the compliance date to January 19, 2019, one year from the Jan. 18 effective date. Signatories to the letter expressed concern regarding the time needed for institutions to update their policies and processes, also noting the several guidance documents and templates that have not been issued and which institutions will need to rely on [see Washington Highlights, June 23]. Notably in the IFR, HHS cites AAMC’s joint letter stating, “[…] representatives of the regulated community, including organizations representing recipients of federal human subjects research awards, expressed concern regarding the regulated community’s ability to implement all of the 2018 Requirements by the scheduled general compliance date.”
The IFR will be published in the Federal Register on January 22, 2018. The federal agencies and departments that are signatories to the Common Rule may issue a notice of proposed rulemaking seeking comment on a further delay on the implementation, to January 21, 2019.
Additional resources and updates can be found on the AAMC’s Common Rule website.