New Notice on Reminder: Application Requirements for Projects Involving Activities Outside of the United States or Partnerships with International Collaborators

April 25, 2025
CFAR Special Update

Dear CFAR Community,

Guidance came out today from the NIH on the foreign component justification for grants going in to the next deadline (May 7, 2025) and we wanted to ensure you saw this. The NIH has always required a foreign component justification for research involving work done in a country outside the United States, but this will now be strictly enforced. Any new grant going in (including on May 7) which does not have this component will not advance to study section. The notice is here:

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-098.html

We have copied the notice text below. HIV research will naturally lend itself to grants based in countries with high burden. Of note, South Africa is not singled out in this notice. Research should be able to be proposed in that country with a foreign justification. 

NIH will support properly conducted and principled international collaborations that are integral for our country to remain competitive. These international collaborations must present special opportunities for furthering research programs through the use of unusual talents, resources, populations, or environmental conditions in other countries which are not readily available in the United States, or which provide augmentation of existing United States resources. In addition, collaborations must have specific relevance to the mission and objectives of the awarding Institute, Center or Office, and have the potential for significantly advancing the health sciences in the United States.

In order for NIH to fully assess all foreign activities and collaborations prior to award, the SF-424 R&R Other Project Information Form requires applicants to indicate whether the project involves activities outside of the United States or partnerships with international collaborators. If the applicant checks “Yes” to this question, they must include a “Foreign Justification” attachment in Field 12, Other Attachments. This justification must 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.”

As a reminder, this attachment is required for all applications that involve activities outside of the United States or partnership with international collaborators, regardless of whether the foreign component will receive funds from the NIH award. Applications that do not include this attachment, as required, will be withdrawn and will not be reviewed. 

Please contact CFAR Leadership via Lauren Sterling (lauren.sterling@ucsf.edu or text at 206-579-0834) if you have any questions about this policy. 

Contacts