May 8, 2021

Volume XI, Number 128

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HHS Finalizes Overhaul of Federal Human Subjects Research Protections

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.

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© 2021 McDermott Will & EmeryNational Law Review, Volume VII, Number 18
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TRENDING LEGAL ANALYSIS

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About this Author

Jennifer S. Geetter, McDermott Will & Emery LLP, Attorney
Partner

Jennifer S. Geetter is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., office.  She focuses her practice on emerging biotechnology and safety issues, advising hospital, industry, insurance and provider clients on matters relating to research, drug and device development, off-label use, personalized medicine, formulary compliance, privacy and security, electronic health records and data strategy initiatives, patient safety, conflicts of interest, scientific review and research misconduct, internal hospital disciplinary proceedings,...

202 756 8205
Associate

Chelsea M. Rutherford is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office.  She focuses her practice on matters affecting a wide range of clients in the health care industry.

Chelsea received her J.D., cum laude, from the Boston University School of Law, and graduated with honors from the health law concentration.  While in law school, she served as the Editor-in-Chief of the American Journal of Law and Medicine and was named an Edward F. Hennessey Distinguished...

202 756 8789
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