Notice of Proposed Rulemaking for Revisions to the Common Rule

HHS Announces Proposal to Improve Rules Protecting Human Research Subjects

Changes proposed to ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to the regulations for protection of human subjects in research. A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register. The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.  It is expected that the NPRM will be  published in the Federal Register on September 8, 2015, when the docket will be open for submitting public comments. 

• Read a brief summaryof the proposed changes
• Read the public display copy of the NPRM online.
• Access the September 2, 2015 Press Release describing the NPRM
• Access information about the 2011 Advanced Notice of Proposed Rulemakingthat preceded the NPRM

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Steve Pierson
Director of Science Policy
American Statistical Association
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