Last updated: Thursday, June 19, 2025

As you may be aware, on May 1, 2025, the National Institutes of Health (NIH) released an Updated NIH Policy on Foreign Subawards (NOT-OD-25-104) (the “Policy”).   

What is affected  

Effective immediately, the NIH will prohibit new foreign subawards to be issued and monitored by prime awards (i.e., lead awards directly funded by NIH). This will include all prospective subawards to UCalgary researchers.  

The Policy is not being applied retroactively, meaning that existing subawards to UCalgary researchers are not automatically terminated. However, all renewals and non-competing continuations of NIH awards (i.e., annual notices of award) must comply with the updated Policy, and as a result, UCalgary subawards will likely be terminated at the end of their current budget period.

The NIH Institutes and Centers will be allowing, but not requiring, their prime grant holders to remove subawards to foreign entities and replace them with domestic recipients. If you have any questions about the status of your project or your relationship with the prime grant holder, or are contacted by the prime grant holder in relation to the Policy, please contact nihgrant@ucalgary.ca first to discuss.  

Proposed new award structure  

The NIH indicates that it intends to implement a new ‘linked’ award structure for foreign subawards by no later than September 30, 2025, and prior to Fiscal Year 2026. Under this new structure, foreign subsites would hold independent awards with the NIH, which will be linked to the prime grant.   

The NIH’s stated purpose is to improve the transparency and reliability of reporting on the utilization of NIH funding. However, it remains to be seen if the NIH will significantly reduce its contributions to foreign recipients once it has obtained a complete picture of foreign subaward activity.  

Impact for applicants 

The Policy will also affect all applications to NIH that are currently under review or pending funding decision. 

For UCalgary researchers, this means that all NIH applications involving subawards to UCalgary faculty will be paused or rejected by the NIH. Similarly, the NIH will prohibit UCalgary from subawarding any NIH funding to other non-U.S. entities (e.g. other Canadian institutions).  

Applicants are therefore strongly encouraged to delay applications to NIH to a later cycle once NIH has provided greater clarity on funding for foreign organizations. If your application as a UCalgary subawardee cannot be delayed, please contact the Research Services Office at 
nihgrant@ucalgary.ca to discuss. 

What is not affected  

Direct (prime) awards from the NIH to UCalgary researchers are not affected by the Policy, except in the case of prime grants with foreign (non-U.S.) subawardees. At this time, the NIH states that it continues to support direct foreign awards.   

Communications and questions  

We encourage all current awardees or those planning to apply for an NIH grant to contact the Research Services Office team to discuss any questions or concerns you may have by emailing nihgrant@ucalgary.ca.  

When planning a University of Calgary-led NIH application, take special note of the difference in internal Research Services deadlines between:

• single-site proposals (i.e., projects in which the University of Calgary is to be the sole institution conducting the research)
• and consortium proposals (i.e., projects in which the University of Calgary is to conduct a portion of the research and subgrant NIH funds for work done at ≥1 “sub-site” institutions)

Complete and final single-site applications are to be made available for review (e.g., within ASSIST) by Research Services no later than 12pm noon (MT) 2 business days in advance of the NIH deadline. (Previously 4 business days, being shortened on a piloted basis).

Conversely, for consortium application: 1) the subsite supporting documents are to be sent 2 weeks in advance of the agency deadline and 2) the complete and final ASSIST/Workspace application is to be made available for review by RSO no later than 12pm noon (MT) 1 week in advance of the NIH deadline.

The additional time for consortium applications is to accommodate the complexity of coordinating review across multiple institutions and research offices (e.g., consortium applications necessarily involve multiple site-specific budgets and supporting documentation) and to ensure error-free submission of the application through the relevant submission portal.

R01 – Research Project Grant

• Used to support a discrete, specified research project
• NIH’s most commonly used grant program
• Budget – costs appropriate for the project, typically <$500,000 per year
• Generally awarded for 3-5 years

R21 – Exploratory/Development Research Grant Award

• New, exploratory & development projects, supports early stages of project
• Limited to up to two years of funding
• Budget for direct costs for the two year project period up to $275,000

U01 – Research Project Cooperative Agreement

• Supports discrete, specified projects to be performed by investigator(s) in an area representing specific interests and competencies
• No specific dollar amount – amount and years specified in FOA

Beginning on January 25, 2018, all NIH applications will use revised application packages, which include the Public Health Service Human Subjects and Clinical Trials Information Form. This form requests human subject and clinical trial information at the study level in order to identify proposed research projects as clinical trials, given the NIH definition of a clinical trial. More specifically, this form will require you to answer the below four questions.

• Does the study involve human participants?
• Are the participants prospectively assigned to an intervention?
• Is the study designed to evaluate the effect of the intervention on the participants?
• Is the effect that will be evaluated a health-related biomedical or behavioural outcome?

If your answer is “yes” to each of these four questions, the proposed research will be classified by NIH as a clinical trial. In this case, the Calgary Centre for Clinical Research (cccr@ucalgary.ca) is available for guidance

View: UofC’s compliance with this policy
Contact: FCOI@ucalgary.ca

A Financial conflict of Interest disclosure is required by all Investigators (and key team members) who hold or are applying for Public Health Services (PHS) funds including NIH. Investigators and team members are required to complete the University’s disclosure form which is reviewed by the University’s FCOI Review Committee to determine the existence of a Financial Conflict of Interest.

Investigators must submit Financial Interest Disclosure Forms at the following times:

• At the time of any application for PHS funding, whether directly from PHS or through another institution as a subaward;
• At minimum, annually, within the term of an existing grant or subaward;
• Within thirty (30) days of any new Significant Financial Interest or change in status of any Investigator’s financial interests within the term of an existing grant or subaward;