NIH: Foreign Subawards with Human Subjects

On 7/17/2025, NIH announced updated guidance on Foreign Subawards for Active Projects (NOT-OD-25-130). 
NIH is allowing for type 3 supplement awards for foreign subawards with human subjects involvement (including clinical trials and clinical research) at the foreign site. The supplement structure provides separate tracking of the foreign subaward and is an alternative to previously announced options of: 

• Removing foreign subaward activities completely. In this case, the funds must be removed and cannot be rebudgeted.

• Prime recipient completing research activities: Remove the foreign subaward and allow the prime recipient to complete the activities. Funds may be rebudgeted.

• Domestic subrecipient completing research activities: Remove the foreign subaward and allow for a domestic subrecipient to complete the activities. Funds may be rebudgeted

Process for impacted awards:

If the PI wishes to proceed with the type 3 award structure: 

1. NIH will require a PHS 398 detailed budget and budget justification for each individual foreign subaward for all remaining years of the project. Submit an OSP/GCA SAGE MOD as NIH requires AOR approval and submission.

2. NIH will review and then if approved, move the confirmed funds from the primary award to the type 3 award.

3. When the UW receives the reissued award/supplement from NIH, OSP will set up OSP/GCA Award Modifications in SAGE and route them to the PI / department for completion. The primary award and the supplemental award(s) will each have their own SAGE MOD, due to the award numbering convention that NIH will use.

4. PI/Campus need to route the MOD(s) back to OSP, including the updated SAGE Budgets. Review the following guidelines for setting up your SAGE Budget Worksheets. In all cases totals must match the Notice of Award from NIH:

   • Type 5 (non-competing renewal) Award: make sure SAGE Budget worksheet does not include foreign subaward(s) supplement totals and that the overall total matches the Notice of Award from NIH.

   • Type 3 supplement (foreign subaward): Create SAGE Budget Worksheet under prime Budget worksheet for each foreign subaward being reissued as a Type 3 supplement, with the following:

     • GCA recommends this Budget Worksheet naming convention: Subaward | Foreign Subaward - Subawardee Name -[Insert Federal Award Number with the supplement suffix (i.e. 3R01AA123456-02S1)]

   • Use 0% UW F&A rate on the foreign subaward amount for budget worksheet (foreign subrecipient may receive F&A)

5. Submit a request to modify the existing subaward in SAGE Subaward Module.

   • Include a note in the Special Instructions section of your Subaward Modification request that indicates the “funds come from an administrative supplement for a foreign component”.

See updated UW NIH FAQs.

Both the primary award and foreign supplement(s) will be removed from the streamlined non-competing award process (SNAP) and automatic carryover authority. The primary award and each foreign supplement will be issued with a distinct federal document number and will need to have separate annual Federal Financial Reports (FFR, SF-425) submitted. To do this, the UW will set up a new award line for each of the Type 3 supplements being issued. 

Note that rebudgeting between the primary and the supplement within the budget period will not be allowed, though you may use the RPPR process to request future reallocation of funds. 

NIH informs that this structure is permitted only for the current competitive segment. It does not replace the new award structure announced in   NOT-OD-25-104  that will apply to upcoming applications, including any planned renewals. 

Thank you, 
The Office of Sponsored Programs & Grant and Contract Accounting