On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often referred to as the Common Rule, were originally developed in 1991 and have been adopted by multiple federal departments and agencies. OMB review is the last step before final publication and suggests that HHS is trying to release a final rule before President Obama leaves office on January 20, 2017.

Through its Office for Human Research Protections (OHRP), HHS initially published an Advanced Notice of Proposed Rulemaking in July 2011. The Advanced Notice generated significant controversy and OHRP did not publish a notice of proposed rulemaking (Proposed Rule) for over four years, ultimately doing so on September 8, 2015. The Proposed Rule, like its earlier Advanced Notice counterpart, suggested major changes to the Common Rule, including changes to its overall jurisdictional scope, requirements relating to secondary use of biospecimens and individually identifiable information, and the general research review and oversight process.

Since the Proposed Rule’s publication, OHRP has received significant feedback from both industry and expert advisory groups about the proposed changes and their overall impact. While certain proposed changes have been applauded, the Proposed Rule has also generated considerable concern and uncertainty among stakeholders.

The current status of OMB’s review is pending.