Published April 1, 2026, via Research News
NIH Grants Policy Statement (GPS)
The National Institutes of Health (NIH) released an updated version of their Grants Policy Statement (GPS) via NIH Guide Notice NOT-OD-26-057.
The revised GPS (dated March 2026) applies to all NIH grants and cooperative agreements with budget periods beginning on or after Wednesday, October 1, 2025. This update incorporates new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes since the previous version of the NIHGPS dated April 2024.
This version of the NIHGPS includes policies and requirements that have been published via Guide Notices in effect as of Tuesday, March 17, 2026. The updates published in this version of the NIHGPS consolidate all such Guide Notices and supersede the April 2024 version of the NIHGPS.
Significant changes can be found in this summary document.
Prior Approval Requirement for Changes to Domestic Subawards
NIH announced, via NIH Guide Notice NOT-OD-26-062, effective Monday, June 1, 2026, all prime recipients are required to obtain NIH prior approval when adding a new domestic subaward to a project post-award, when the arrangement was not originally a part of the peer-reviewed and approved application.
The new prior approval requirement is intended to ensure that NIH is aware of all subaward activities for each NIH project, so that NIH can monitor the prime recipient and ensure compliance with subaward monitoring and reporting requirements.
Requests must be submitted in the eRA Commons Prior Approval Module using the “Other Request” type.
As a reminder, effective Thursday, May 1, 2025, NIH no longer recognizes foreign subawards. Recipients seeking to initiate a new international collaboration must utilize the new application structure for NIH-funded international collaborations (PF5/UF5).
Harmonizing the NIH Definition of “Intervention” with the Common Rule
NIH announced, via NIH Guide Notice NOT-OD-26-063, effective Friday, March 27, 2026, NIH is harmonizing the NIH definition of “Intervention” with the Common Rule which is defined as:
Both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
NIH adopted an implementation approach that operationalized these definitions in a similar manner. However, to ensure consistency and harmonize implementation of the Common Rule across federal agencies, effective with the publication of this Notice, NIH is adopting the definition of an intervention as defined in 45 CFR 46, Subpart A, above. The NIH will make revisions to its websites and forms, as needed, to reflect this change.
Guidance on determining whether a research study with human subjects is considered by the NIH to be a clinical trial, a basic experimental study involving humans (BESH), or an observational study can be found on the Is My Project a Clinical Trial, Basic Experimental Study Involving Humans (BESH), or an Observational Study Involving humans webpage.
If you have any questions about this material, please contact Krystina Gross or Teri Medley.