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HHS Delays Common Rule Again

On January 22, 2018, the White House again delayed the effective date of revisions to the Federal Policy for the Protection of Human Subjects, referred to as the Common Rule.  Final revisions were published on January 19, 2017.  On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies published a Notice of Proposed Rulemaking (NPRM) proposing revisions to each agency’s codification of the Federal Policy for the Protection of Human Subjects, originally promulgated as a Common Rule in 1991.  80 Fed. Reg. 53931.  On January 19, 2017, HHS and other federal departments and agencies published a final rule revising the Federal Policy for the Protection of Human Subjects.  82 Fed. Reg.  7149.  The revised policy, referred to as the “2018 Requirements,” was scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018, with the exception of the revisions to the cooperative research provisions for which the compliance date is January 20, 2020

After publication of the 2018 Requirements, representatives of industry, including organizations representing recipients of federal human subjects research awards, expressed concern regarding their ability to implement all of the 2018 Requirements by the scheduled general compliance date.  Stakeholders requested a delay in the general compliance date of the 2018 Requirements with the exception of certain burden-reducing provisions of the 2018 Requirements, including certain carve-outs from the definition of “research” exemptions, elimination of the continuing review requirements for certain categories of research, and the elimination of the requirement that institutional review boards (IRB) review grant applications.  The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) also recommended in August 2017 that implementation of the 2018 Requirements should be delayed.  The new effective date is July 19, 2018.  Comments are due by March 19, 2018.

©2018 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Margaret Graham, Environmental Science and Policy Paralegal, Bergeson Campbell Law firm
Paralegal

Margaret R. Graham (Maggie), a paralegal with Bergeson & Campbell, P.C. (B&C®), holds a Masters degree in Environmental Science and Policy, and has over a decade of paralegal experience, including eight years focused in federal regulatory law.  Her understanding of environmental policy and the administrative and legislative process involved in regulatory compliance makes her an invaluable resource to B&C staff and clients, who rely on her research, project management, and writing and editing skills to complete efficiently briefs, pleadings, and other documents.

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