Washington Update

FASEB Supports Proposal to Delay Compliance with New Common Rule Regulations

By: Elizabeth Barksdale
Thursday, May 24, 2018

On May 17, FASEB submitted comments to the Department of Health and Human Services (HHS) in support of a Notice of Proposed Rulemaking (NPRM) to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects (i.e., the Common Rule), while allowing three specific provisions from the revised Rule to be implemented.

Human research protection regulations have existed in the United States since 1974 and initially applied only to human subjects research funded or conducted by HHS. In 1991, the regulations were adopted by 15 other federal agencies, hence the “Common Rule” designation. Common Rule agencies proposed updates to the regulations in 2015; FASEB and over 2100 other organizations and individuals provided feedback.

The final revisions were announced January 19, 2017, with effective and compliance dates set for January 19, 2018. Then on January 22, 2018, the Common Rule agencies published an Interim Final Rule to delay the effective and compliance dates until July 19, 2018. The current NPRM would push back the compliance date an additional six months, but keep the July 2018 effective date.

FASEB supported the delayed general compliance date to give institutions needed time to revise or create systems and policies for implementation. The delay would also provide HHS’ Office of Human Research Protections additional time to publish guidance for educating and training the regulated community, FASEB noted. FASEB also endorsed the proposal to allow institutions to voluntarily implement three “burden-reducing” provisions during the transition period from July 19, 2018, until January 21, 2019.

The comment period was open from April 20 to May 21.