NIH Applications and Foreign Components

Memo sent to RAC 4/18/25

Dear Colleagues,

This is an important reminder about the guidance from NIH regarding foreign components in proposal applications.

NIH requires that if you check “yes” to Question 6 on the R&R Other Project Information Form in an application, you must include a Foreign Justification attachment in Field 12, Other Attachments.  

The instructions state: If you have checked “Yes” to Question 6, you must include a “Foreign Justification” attachment in Field 12, Other Attachments. Describe special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment, and techniques), including the reasons why the facilities or other aspects of the proposed project are more appropriate than a domestic setting. In the body of the text, begin the section with a heading indicating “Foreign Justification” and name the file “Foreign Justification.”

6.a. If yes, identify countries:

This field is required if you answered “Yes” to Question 6. Enter the countries with which international cooperative activities are planned.

You may use abbreviations. Your entry is limited to 55 characters.

The forms I instructions can be found here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/general-forms-i.pdf, and the guidance on this section can be found starting on Page 63.

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. Activities that would meet this definition include, but are not limited to, (1) the involvement of human subjects or animals, (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 NIH Grants Policy Statement: 16 Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components).

In the past NIH would not withdraw applications for errors in this section but they have recently started enforcing compliance and withdrawing proposals that did not include the required attachment.

Please let me know if you have any questions.

Thank you,
Jill

Jill A. Frankenfield
Associate Vice President, Sponsored Programs Administration