Additional Delay in Timing of the Compliance to the Updates to the Common Rule. This is Your Opportunity to comment on changes!


The US Department of Health and Human Services along with 16 other agencies published a Notice of Proposed Rulemaking (NPRM) to delay the compliance date of the updated “Federal Policy for the Protection of Human Subjects,” also known as the “Common Rule,” published in the Federal Register on January 19, 2017. The January 2017 final rule is also known as the “2018 Requirements.”

When final, the delay provides additional time for regulated entities to comply with the 2018 Requirements. The effective date and compliance date for the new provisions was originally set for a year later, January 19, 2018. An Interim Final Rule was previously published January 22, 2018, which had delayed the effective date and compliance date of the 2018 Requirements to July 19, 2018. Published in the Federal Register on April 20, 2018, the NPRM would extend the compliance date until January 21, 2019.

A public comment period about the NPRM is open through the end of May 21, 2018 and can be accessed here to post or search comments.

-The Clinical Pathways Team

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