FASEB Supports Proposal to Delay Compliance with New Common Rule Regulations

May 24, 2018

On May 17 FASEB submitted comments to the Department of Health and Human Services (HHS) in response to a Notice of Proposed Rulemaking (NPRM) seeking to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects, i.e., the Common Rule, while allowing implementation of three specific provisions from the revised Rule.
FASEB supported delaying the general compliance date from July 19, 2018, until January 21, 2019, in order to give institutions needed time to revise or create systems and policies necessary to implement the 2018 Requirements. The delay would also provide the Office of Human Research Protections additional time to publish guidance to assist with educating and training the regulated community, FASEB noted. Additionally, FASEB endorsed the proposal to allow institutions to voluntarily implement three “burden-reducing” provisions during the transition period from July 2018 until January 2019.

Categories: Clinical and Translational Research; Science Policy & Advocacy;