NIH Foreign Component Guidance

NIH Notice NOT-OD-26-084, issued on May 27, 2026, serves as a reminder of the National Institutes of Health’s (NIH’s) definition of a foreign component. While the notice does not introduce new requirements, it reinforces existing guidance and underscores NIH’s heightened scrutiny of foreign collaborations and activities associated with NIH-funded research. 

As part of its heightened focus on foreign collaborations, NIH has recently inquired about foreign collaborators serving as co-authors on publications supported, in whole or in part, by NIH funding at CU Boulder. NIH may contact Principal Investigators (PIs) to clarify foreign collaborations or affiliations that were not previously disclosed. If you receive an inquiry regarding a foreign co-author, foreign affiliation, or a potential unapproved foreign component, please follow the guidance below. 

What is a Foreign Component?

The NIH Grants Policy Statement defines “foreign component” as:  

“The performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to, (1) the involvement of human subjects or animals at a foreign site, (2) extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. Examples of other grant-related activities that may be significant are: 

  • 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. 

Foreign travel for consultation is not considered a foreign component. (See Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components chapter in IIB).” 

As far as practical applications, what constitutes a foreign component is considered on a case-by-case basis. Contact your OCG Proposal Analyst or Grant Officer to discuss specific cases. The following are some general guidelines –  

  • Co-authorship resulting from a research relationship may indicate that the activity is considered a significant collaboration. 
  • Occasional discussions or consultations generally do not constitute a research collaboration. 
  • Research conducted within the United States is generally not considered a foreign component. 
  • Research conducted outside the United States is generally considered a foreign component, even when no NIH funds are provided to the foreign entity or activity. 
  • Publication affiliations should reflect the institution or location where the research was performed. 
  • The location where a manuscript is reviewed, edited, or prepared for publication typically does not determine whether a foreign component exists. 

Key Reminder:

NIH requires prior approval before initiating any activity that may qualify as a foreign component. This approval may occur:   

  • At the proposal stage through submission of a Foreign Justification with the application, or  
  • After award as a formal prior approval request.  

Guidance at Proposal Stage

Although foreign subawards are not permitted, foreign components can still exist within a project. If a paid foreign collaboration is anticipated, a Collaborative International Research Project (PF5) must be proposed. 

  • Review NIH's definition of a foreign component early in the proposal development process to ensure activities and collaborations are properly identified and disclosed. 
  • Check the applicable NIH Notice of Funding Opportunity (NOFO) for any requirements or restrictions related to foreign components. 
  • Consult NIH guidance, including Acknowledging Foreign Components throughout NIH Application and Award Processes, for examples of activities that do and do not qualify as foreign components. 
  • Identify international collaborations and activities on the Proposal Submission Request (PSR) Form. If you are uncertain whether an activity constitutes a foreign component, consult your Proposal Analyst for assistance. 

If a foreign component is identified:

  • Include a Foreign Justification with your proposal materials. Your Proposal Analyst can provide guidance.  
  • If awarded, inclusion of this justification typically reflects NIH prior approval. NIH may request additional information during the Just-in-Time (JIT) stage.  

Steps to Report Previously Undisclosed Collaborations

  • Contact your OCG Grant Officer as soon as you become aware of, or plan to establish, a foreign collaboration on an active award. 
  • Notify your OCG Grant Officer even if the foreign component is identified after the award period has ended. 
  • Work with your Grant Officer to determine whether NIH prior approval is required and to prepare the necessary documentation. 
  • Prior approval requests must be submitted through the eRA Commons Prior Approval Module and include all required additional supporting documentation, which can be found here. Follow the guidelines specifically listed under the "Prior Approval Other Request Instructions" section. 
  • NIH will review the request and may request additional information before making a determination. 

What to Know During RPPR Reporting

  • Review your Notice of Award (NoA) and follow the annual reporting timeline for your Research Performance Progress Report (RPPR). 
  • Watch for reminders from OCG. The OCG Compliance Team will send a reminder approximately 30 days before your RPPR due date. 
  • Disclose foreign components completely and accurately in your RPPR, including any activities, collaborations, or research conducted outside the United States. 

Other Considerations

  • Update your annual DEPA to accurately reflect any international collaborations or activities. 
  • Review co-author affiliations when preparing manuscripts and publications. 
  • Contact your OCG Grant Officer if foreign involvement is identified or anticipated to ensure appropriate approvals and reporting are completed. 

Additional Resources