Short-Term Supplement Model for Human Subjects Research Supported by Foreign Subawards

To address concerns for participant safety risks for ongoing projects, NIH has established a short-term supplement model to support clinical research and clinical trials conducted under an active foreign subaward (NOT-OD-25-130). The supplement approach is in place while NIH finalizes the implementation of a new award structure replacing foreign subawards, meant to transparently and reliably report on each dollar spent on foreign collaborations (NOT-OD-25-104 and this NIH Extramural Nexus article). 

We remain committed to supporting properly conducted and overseen international collaborations that are necessary for our country to remain competitive and have the potential for significantly advancing the health sciences domestically. Such collaborations present special opportunities to further research programs through the use of unusual talents, resources, populations, or environmental conditions not readily available in the United States, or that augment our existing resources.

To continue ensuring these foreign collaborations benefit the public health of Americans, we announced on May 1, 2025 that the structure of these collaborations will change to enhance the integrity, accountability, oversight, and national security of NIH-funded research. As a reminder, effective with the next NIH award cycle, all NIH-funded research involving foreign subawards must be structured as subprojects directly linked to the prime award. Applications submitted after the issuance of NOT-OD-25-104 that propose foreign subawards will not be accepted. Learn more in this NIH Extramural Nexus article.

We are committed to ensuring minimal disruption over the course of the next few months. This includes identifying potential strategies to minimize impacts on existing studies and collaborations, such as renegotiating awards with a foreign subaward. And because the health, safety, and privacy of participants involved in NIH-supported clinical trials is crucial, recipients may request funds for safe and orderly shutdowns at foreign sites that involve human participants. The funding NIH Institute or Center may also allow for a wind down period accounting for the time needed for the recipient to notify the Institutional Review Board, develop a plan to promptly notify participants, and ensure there is appropriate therapy and follow-up for participants.

Through the new alternative approach recently announced, NIH and the recipient can renegotiate the award structure to financially remove the foreign subawards from the primary award, turning them into an administrative supplement (Type 3) award with separate financial reporting. This approach is meant for clinical trials or other clinical research in certain situations, such as where there may be potential risks to human safety or moving the project to a domestic site is impractical.

This short-term approach is in addition to previously outlined options and further provides enhanced tracking of obligations to foreign entities. NIH continues to develop the new structure for funded foreign collaborations that will apply to upcoming applications and any planned renewals (expected by September 30, 2025).

Additional related Frequently Asked Questions are available here.