NIH: Does work outside of the U.S. require prior approval?

Foreign components are defined as a significant scientific element or segment of a project outside of the United States.

Significant work performed by a researcher in a foreign location qualifies as a foreign component, whether or not NIH funds are expended.

All foreign components must receive NIH prior approval.

Other examples include, but are not limited to:

• the involvement of human subjects or animals at a foreign site,
• extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities,
• collaborations with investigators at a foreign site anticipated to result in co-authorship,
• use of facilities or instrumentation at a foreign site; or
• receipt of financial support or resources from a foreign entity.

All foreign components must receive NIH prior approval. If a PI is unsure if foreign activity may qualify as a foreign component, err on the side of seeking prior approval.

NOTE: The NIH has not yet provided guidance for how to request the addition of more international project components to an existing awarded PF5 project. NOT OD-25-155.

International activities may also require the UW’s International Activities Assessment.

What if significant work needs to be added to a project?

If the work is considered significant:

• Draft a prior-approval request for the activity including the location on department letterhead
  • If the request is to add international senior/key personnel (not part of an international component project)
    confirm they are not debarred or suspended.
    • Include their name and email along with where they will carry out the work and the estimated total cost
    • Include a copy of the individual’s completed Biographical Sketch, and/or current and pending support documentation including disclosure of all foreign interests
  • If the request is to add a foreign consultant:
    • Confirm they are not debarred or suspended
    • Include the foreign consultant name and email along with where they will carry out the work and estimated total cost
• Address the request to the NIH Grants Management Specialist (GMS)
• Create an Award Modification (MOD) request in SAGE attaching the letter, follow appropriate steps for the type of MOD you are requesting.
• OSP will submit a formal prior approval request to NIH and place the MOD on Hold
• After NIH approves the request, OSP will process the request in SAGE’

Failure to achieve explicit NIH prior approval for foreign components may result in return of funds to NIH, termination of the award, or other measures as determined by NIH.

Other federal sponsors have similar requirements. Please confirm sponsor requirements before proceeding with a foreign component.
Note: NIH released policies regarding a new structure for projects with international collaborators. See NOT-OD-25-155.

Related Resources

• NIH Prior Approval Requirements
• NIH: NOT-OD-09-114 Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components
• NIH: Definition of Terms Foreign Component
• NIH: Other Support FAQ: What are some examples of a “significant element of a project” when making determinations regarding a foreign component?
• NOT-OD-25-155: New Application Structure for NIH-Funded International Collaborations
• UW FAQ: Is it considered prior approval when I report upcoming work in a foreign location within my RPPR and receive continuation funding for the next year?
• NIH Foreign Subaward FAQs

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