Update on the 2018 Final Common Rule for Human Subjects Research

Update on the 2018 Final Common Rule for Human Subjects Research

Published May 3, 2018

As part of Delfino Madden’s higher education practice, we provide counsel on regulations pertaining to human subjects research and Institutional Review Boards (IRBs). We have been monitoring the 2018 Final Common Rule as it will simplify and modernize human subjects research regulations. The 2018 Final Common Rule was expected to come into effect on January 19, 2018, but the federal government has delayed the effective date to July 19, 2018. On April 20, 2018, several federal agencies, including the Department of Health and Human Services, issued a Notice of Proposed Rulemaking (“NPRM”) to further delay the effective date to January 21, 2019. This NPRM also contemplates whether institutions should be permitted to implement certain provisions of the 2018 Final Common Rule in the interim. For more information, the Federal Register website contains the full NPRM and the comment period is open until May 21, 2018.

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