NPRM 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 published in the Federal Register on September 8, 2015. 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. 

• Read a brief summary of the proposed changes
• Read the NPRM  (PDF 1063 KB)
• Read the Notice Extending Comment Period to 1/6/2016
• Read about the October 20, 2015 Public Town Hall Meeting
  • Deadline for submission of questions extended to October 15
  • See the meeting agenda
  • The video archive of the October 20, 2015 Public Town Hall Meeting can be seen here
  • See the meeting transcript
• Access the OHRP webinars on the NPRM
• Access the September 2, 2015 Press Release describing the NPRM
• Access information about the 2011 Advance Notice of Proposed Rulemaking that preceded the NPRM

•  How to submit a comment regarding the NPRM

• You may submit comments in one of three ways (no duplicates, please):
  1. Electronically. You may submit electronic comments on specific issues in this regulation. (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.)
     • In another tab or window, access www.regulations.gov:
     • Copy and paste, or just retype, the docket number HHS–OPHS–2015–0008, into the regulations.gov box that is labeled “Search”.  
     • The first answer should be the HHS Federal Register notice. 
     • Click on “Comment Now” button to the right of the notice title.
  2. By mail. You may mail written comments (one original and two copies) to the following address ONLY: Office for Human Research Protections (OHRP), 1101 Wootton Parkway, Suite 200,Rockville, MD 20852.
     Please allow sufficient time for mailed comments to be received before the close of the comment period.
  3. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to the Office for Human Research Protections (OHRP), 1101 Wootton Parkway, Suite 200,Rockville, MD 20852.

•  How to browse comments that have been submitted regarding the NPRM.

• In another tab or window, access www.regulations.gov:
• Copy and paste, or just retype, the docket number HHS–OPHS–2015–0008, into the regulations.gov box that is labeled “Search”.  
• The first answer should be the HHS Federal Register notice. 
• Click on “Open Docket Folder” at the upper right corner of that result. 
• There should be a heading labeled “Comments” part-way down the page. 
• Click on “View All” next to the "Comments" heading. 
• Now you should have access to all of the comments, and can use the search box at the top to search among them.
• Also, a list of comments received and posted should display, and can be opened one at a time.

For many comments, the substance of the comment is in an attachment, which  can be opened by clicking on the "View Attachment" format icon in the "Attachment" section of the screen showing that individual comment.