NIH: Foreign Component Guidance

Page Updated: March 1, 2024

NIH is interested in knowing when any aspect of a project will take place outside of the United States. When a “significant scientific element or segment of a project” is performed outside of the U.S., the NIH may consider it a foreign component. A foreign component may be approved as part of the original award, or it may need prior approval if added after an award is made.

RSP recommends seeking guidance in advance if a PI intends to do one of the following:

  • Have someone working on the project (paid or unpaid) from outside of the United States
    • This includes UW–Madison faculty, staff, postdocs, or students.
      • An employee working on an NIH award outside the U.S. may constitute an NIH foreign component. Email or have the individual submit a remote work agreement. RSP may contact NIH to confirm whether or not the situation is a foreign component.
    • This also includes anyone from another organization or institution (i.e., from outside of UW–Madison).
  • Collaborate with an organization or institution outside of the United States
  • Obtain services from an entity or consultant outside of the United States

The PI should contact RSP if planning to collaborate with or obtain services from an entity or individual outside of the United States for an NIH award. RSP will contact the NIH Program Officer (PO) and the Grants Management Specialist (GMS) as needed. The PO and GMS should be able to advise if the work being contemplated constitutes a foreign component that requires prior approval. The preference is to obtain guidance from the NIH on a potential foreign component before including new information to the NIH in an RPPR.

NIH defines a “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.” Significant activities include, but are not limited to:

  • The involvement of human subjects or animals
  • Extensive foreign travel by 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

Activities that may meet this definition include:

  • 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.

See the full NIH Definition of Foreign Component at this link:

To help determine if the circumstances meet the definition of foreign component, please be prepared to provide the following information or respond to the following questions.

For an individual:

  • Name of individual, their position, and their contact information (email address, physical address, and phone number). If the individual is not a UW–Madison employee, provide the name of the entity with which they are affiliated.
  • Brief narrative description of work to be performed in a foreign location
  • Will there be any work on human or animal subjects in the foreign country? If yes, indicate human or animal subjects’ involvement.
  • Will the individual be collaborating with anyone in the foreign country?
  • Will the individual be working at a facility or using equipment there?
  • Will the individual be receiving any financial resources or support from a foreign entity?
  • Is the individual anticipated to be a co-author on any publications for the award?
  • Is there an upcoming RPPR, or was the individual mentioned in a previous RPPR as working outside the U.S.?
  • If the individual in question is the PI or senior personnel, will there be an adjustment in the individual's level of effort?

For an organization or entity:

  • Name of organization or entity
  • If there is a PI leading the work at the organization or entity, the individual’s name and contact information, or the contact person for the service contract and their contact information.
  • Brief narrative description of work to be performed in a foreign location.
  • Will the organization or entity receive funds from the NIH award for the work performed?
  • Type of relationship anticipated (see Outgoing Subawards website for guidance)