The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data repositories and use of those repositories for secondary research. All stakeholders involved in federally funded research should be aware of the Final Rule’s changes and prepare to implement them.
On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.” These are the first revisions to the Common Rule since its original enactment in 1991, and have been in progress since HHS first published an Advanced Notice of Proposed Rulemaking in July 2011. According to the press release accompanying the final rule, HHS made “significant changes” to its most recent proposals (published in September 2015) in response to the 2,100+ public comments they received.
The majority of the Common Rule’s changes and new provisions will go into effect in 2018. We are reviewing the final rule in detail, and a summary of changes and new provisions is forthcoming.