Keeping up with NIH process, policy changes

From: Office of the Vice Chancellor for Research
Sent: Monday, May 12, 2025, 12:00 p.m.
To: KU Lawrence/Edwards NIH investigators

Dear NIH researchers,

We want to make you aware of several announcements from the National Institutes of Health that may impact your current or future projects and/or proposals:

No-cost extensions
On May 7, NIH announced via Updated NIH Processes for No-Cost Extensions (NOT-OD-25-110) that the NCE module is being disabled in eRA Commons. While NIH reviews awards to ensure mission congruence, NCEs must be requested via the prior approval request module instead.

It is appropriate to request an NCE if there are project activities that will not be accomplished by the original end date and funds remain in the awarded budget to support these activities. Please contact your assigned award management staff member to assist with NCE requests. Please be aware that NIH’s prior approval may take longer than previous NCE requests, so please plan to request any necessary NCE early in the final 90 days of your award.

Dual Use Research of Concern (DURC) and PEPP
NIH announced via email on May 6 that NOT-OD-25-061: NIH Implementation of the U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) is on hold and will not be implemented due to the May 5 Executive Order on Improving the Safety and Security of Biological Research, which pauses research that could or will make a naturally occurring pathogen or toxin more dangerous to American citizens and directs the director of the Office of Science & Technology Policy and the national security advisor to work with funding agencies to develop such a policy within 120 days. This new policy is intended to replace the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential and supersedes its implementation at NIH.

The Office of Research will provide updates as they become available.

Foreign subawards
On May 1, NIH announced via Updated NIH Policy on Foreign Subawards (NOT-OD-25-104) that they are establishing a new structure for awards that include international subawardees. This award structure is anticipated to:

  • include a prime award with linked, but independent, awards to foreign collaborating organizations, which will allow NIH to track the project’s funds individually.
  • allow scientific progress to be reported collectively by the primary institution under the Research Performance Progress Report.
  • be implemented no later than Sept. 30, 2025, prior to fiscal year 2026.

While NIH has indicated they will not retroactively revise ongoing awards to remove foreign subawards, they have stated that they will not issue awards (new, renewal or non-competing continuation) that include a subaward to a foreign entity, nor will they approve requests to add a new foreign component or subaward to an ongoing project. In all cases, NIH will allow institutes, centers and offices to renegotiate awards — whether new, renewal or non-competing — to remove subawards to foreign entities and, where the work can be performed domestically, allow the funds to be rebudgeted for use by the prime recipient (domestic or foreign) or a domestic subrecipient. If a project is no longer viable without the foreign subaward, NIH will work with the recipient to negotiate a bilateral termination of the project, taking into consideration any need to support patient safety and/or animal welfare.

At this time, we are advising researchers with pending proposals that include foreign subawards to allow their proposal to go through the standard review process and await a request for revision from their program officer, which might allow time for the new structure to be implemented. Impacted researchers should be prepared to justify why the work must take place at a foreign entity and could not be performed domestically. If you have questions, please contact Brad Bernet (bbernet@ku.edu) in Pre-Award Services. Researchers with active NIH awards that are impacted will be contacted directly to address this new requirement.

Data access policy
NIH announced on April 30 via Revision: Notice of Updated Effective Date for the 2024 NIH Public Access Policy (NOT-OD-25-101) that the effective date of the policy is now July 1, 2025. The policy was originally slated for a Dec. 31 implementation date. The main difference from the current public access policy is the removal of the embargo period for submitting manuscripts to PubMed Central. Under the new policy, manuscripts must be submitted upon the official date of publication. Supplemental guidance — at NOT-OD-25-049 and NOT-OD-25-048 — will continue to apply. More information to assist in the implementation of the policy will be available on NIH’s Public Access Policy webpage.

Researchers funded by NIH should review the embargo policies of the journals in which they publish to ensure that they meet these new requirements. Josh Bolick and Heather Mac Bean from KU Libraries can provide additional assistance with making scholarly communications publicly available.

Thank you for your attention to these updates and corresponding guidance. Please contact us if you have questions.

Respectfully,
KU Office of Research