NPRM Resources

Look to PRIM&R for everything you need to know about the NPRM and how it may impact your job, your office, and your institution’s research program.

On September 8, 2015, the Office of the Federal Register published the long-anticipated Notice of Proposed Rulemaking (NPRM) proposing 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.

On September 17, 2015, PRIM&R submitted this brief letter, requesting that the comment period be extended to 120 days to allow all interested parties sufficient opportunity to craft thoughtful comments that will assist the Federal government in the rulemaking process.

On December 23, 2015, PRIM&R began circulating its draft comments, in advance of submitting them to OHRP. PRIM&R submitted final comments to OHRP on December 30.

On June 29, 2016, the National Academies of Science, Medicine, and Engineering released part two of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. Among its proposals to reduce regulatory burden and optimize the research environment, the report scrutinizes the NPRM. Ultimately, the report calls for a withdrawal of the NPRM and recommends a more intensive review of the entire ethical and regulatory framework governing human subjects research before changes are made to the Common Rule. PRIM&R's executive director, Elisa A. Hurley, PhD, explores the report's analyses and recommendations in a blog post on Ampersand.

Government Resources

PRIM&R Resources

PRIM&R's NPRM Comments
On December 23, 2015, PRIM&R began circulating its draft comments, in advance of submitting them to OHRP. PRIM&R submitted final comments to OHRP on December 30.

Webinar recording: PRIM&R's Primer on the NPRM
PRIM&R hosted a webinar on September 15 aimed at helping those involved with human subjects protections understand the proposals put forward in the NPRM. A recording of this webinar is available for free to members by logging into the Knowledge Center. It is also available to nonmembers for purchase by downloading and completing the order form and sending it to us either via fax (617.423.1185) or email.

Comparative chart
For your reference, PRIM&R has created a chart comparing the current Common Rule with the proposed changes, section by section.

Members-only comment page
PRIM&R’s Public Policy Committee, which oversees the development of written comments on policy items relevant to PRIM&R's mission, will be responding to the proposed rule. We invited PRIM&R members to be involved in this process by sharing their input on the proposed changes in the NPRM. The comment period is now closed. Feedback submitted was shared with PRIM&R’s Public Policy Committee for review, and all comments are being considered as the Committee prepares its response.

Conference sessions
In the event that a revised Common Rule is published this fall, sessions will be added to the agenda of PRIM&R's upcoming 2016 Advancing Ethical Research Conference (AER16) to address any new federal regulatory requirements and their application to your work. 

Last year's 2015 Advancing Ethical Research (AER15) and Social, Behavioral, and Educational Research (SBER15) Conferences also included the below NPRM specific sessions. Many of these sessions are available through the SBER15 and AER15 conference proceedings. Attendees of AER15 and/or SBER15 can access the conference proceedings for free by logging in with the access code(s) sent to them following the conference. For those who did not attend, the conference proceedings for each conference are available for purchase: please complete this form and fax (617.423.1185) or email it back to PRIM&R. 

Sessions on the NPRM at SBER15 on November 12, 2015:

  • Keynote Address: Regulating Behavioral Research Behavior: Back to the Future? (audio, video, and slides available)
  • A Dialogue with OHRP on SBER Issues (no materials available)
  • Lunch Session: It's Here! A Review of the NPRM (slides available)

Sessions on the NPRM at AER15, November 13-15, 2015:

  • Proposed Changes: An In-Depth Discussion on the NPRM's Section on Proposed Changes to Informed Consent (slides available)
  • Tissue Research Now and in a Potential Post-Notice of Proposed Rulemaking (NPRM) World (slides and handouts available)
  • It's Here! A Review of the NPRM (slides and handouts available)
  • Town Hall Meeting: The NPRM and the Future of Human Subjects Protections (audio and video available)
  • Proposed Changes: An In-Depth Discussion on the NPRM's Sections Exclusions and Exemptions  (slides and handouts available)

PRIM&R's comments on relevant human subjects research regulations, policy, and guidance

Ampersand blog posts about relevant human subjects research regulations, policy, and guidance

Useful Resources from Friends of PRIM&R

Other items will be added as they are identified.  If you have an NPRM resource you think the community should know about, please email info@primr.org.