Division of Research

NIH Requirements for Disclosure of Foreign Components

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NIH Requirements for Disclosure of Foreign Components

The National Institutes of Health (NIH) requires researchers to disclose any foreign components on research applications and awards.

The inclusion of a foreign component must be reviewed and approved by NIH via either inclusion in the approved proposal documents or the Prior Approval action after an award is made. These activities are carefully scrutinized by the agency, and it is important to carefully review the section below and understand what activities may constitute a foreign component.

How does NIH define “Foreign Component”?

According to NIH’s Grants Policy Statement, a foreign component is defined as performance of any significant element or segment of the project outside 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 the following:

  • The involvement of human subjects or vertebrate animals at a foreign site.
  • Extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities.
  • 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,  including, but not limited to;
    • Unique materials, reagents or biological lines created in foreign collaborators lab
    • Data or Results from experiments performed in foreign Collaborators lab  

Foreign travel exclusively for consultation is not considered a foreign component.

Publications with co-authors based in foreign countries

NIH may review publications that are included in progress reports and that cite support from NIH grants, and will flag publications involving co-authors with foreign affiliations for further review, especially if no foreign component was requested or approved. 

Questions can sometimes arise when publications occur after one of the co-authors departs from Brown. It is important to remember that most scholarly journals request that the primary affiliation for each author should be the institution where the majority of their work was done.

If you are unsure if a proposed element of your award will represent a foreign component, we strongly recommend contacting your Program Officer and your Pre-Award Specialist in OSP or BMRA for further guidance.  As a reminder, the addition of a new foreign component requires advance Prior Approval from NIH. 

Disclosing Foreign Components

There are multiple ways in which foreign components can be appropriately disclosed to NIH, including:

  • Identifying a “foreign component” in an NIH grant application
  • Listing a “non-U.S. performance site”
  • Identifying foreign relationships and activities in a Biosketch
  • Checking “yes” to the question “Does this project involve activities outside of the United States or partnerships with international collaborators?” on the Cover Page Supplement Form
  • Selecting “Add Foreign Component” in section G.9 of the annual Research Performance Progress Report (RPPR)

Related Resources

NIH Foreign Interference Policy

The NIH Foreign Interference policy outlines its position on international collaborations and foreign influence and provides additional guidance on the disclosure of other support, foreign relationships and activities and conflicts of interest.

FACTS Overview

The NIH employs the Foreign Award and Component Tracking System (FACTS) system to record all activities involving foreign countries.