DHHS Releases Long-awaited Proposed Changes to the Common Rule

On September 2, the Office of the Federal Register made available a pre-publication version of a much-anticipated Notice of Proposed Rulemaking (NPRM) that proposes changes to the Federal Policy for the Protection of Human Subjects, or the “Common Rule.”

The release of the NPRM comes four years after the publication of an Advance Notice of Proposed Rulemaking (ANPRM), which first put forward proposals to modernize the regulations governing human subjects research in the United States. The NPRM, which was issued by the Department of Health and Human Services (DHHS), as well as fifteen other Federal agencies, is the next step in the process leading to a final rule. Its contents have been influenced by ongoing dialogue and debate in the years since the release of the ANPRM, as well as by recent policy proposals, including the Office for Human Research Protections’ “Draft Guidance on Disclosing Reasonable Foreseeable Risks in Research Evaluating Standards of Care” and the National Institutes of Health’s “Draft Policy on the Use of a Single IRB for Multi-Site Research.”

The NPRM, which is 519 pages long, puts forward eight major proposals that address improving the informed consent process; strengthening consent requirements for the research use of stored biospecimens; adding categories of activities that are not subject to regulation under the Common Rule; calibrating the level of review to the level of risk involved in research; limiting the use of waivers or alterations of consent for research involving biospecimens; mandating the use of a single IRB for cooperative research; modifying requirements for continuing review; and extending the scope of the Federal Policy for the Protection of Human Subjects.

For each proposed change, DHHS outlines the goal of the change, the current rule, the discussion generated by the ANPRM proposal on that topic (if applicable), and the NPRM proposal. The document also puts forward a number of questions for public comment. The comment period for the NPRM will be 90 days, and the official deadline for comments will be made available once the NPRM is published in the Federal Register, which is scheduled to happen on Tuesday, September 8.

Over the next several weeks, PRIM&R will be synthesizing, analyzing, and digesting the proposed changes for our community. We will post a descriptive chart comparing the current regulations with the proposals in the NPRM next week. We will also be featuring a series of blog posts closely examining the proposals contained in the NPRM here on Ampersand

PRIM&R’s Public Policy Committee, which oversees the development of written comments on policy items relevant to PRIM&R’s mission, will also be considering the proposed rule. The Public Policy Committee invites and encourages PRIM&R members to be involved in this process by sharing your input on the proposed changes. Feedback shared with PRIM&R by September 29, 2015 will be provided to PRIM&R’s Public Policy Committee for review, and all comments will be considered as the Committee prepares its response.

We will also be hosting several events aimed at fostering understanding of the proposed changes. On September 15, Heather H. Pierce, JD, MPH, senior director for science policy and regulatory counsel in scientific affairs at the Association of American Medical Colleges, and P. Pearl O’Rourke, MD, PRIM&R board member and director of human research affairs at Partners HealthCare Systems, Inc., will facilitate a webinar aimed at helping all those involved with human subjects protections understand the proposals put forward by DHHS. The webinar will be free to PRIM&R members. And in November, the issues and questions raised by the NPRM will be highlighted throughout the 2015 Social, Behavioral, and Educational Research Conference and the 2015 Advancing Ethical Research Conference, which are being held November 12-15 in Boston, MA. We encourage you to join us for these exciting events as we explore the future of human subjects research.