NIH Foreign Collaborator Research Guidance Updated

Updated NIH Guidance Regarding Research with Foreign Collaborators

The National Institutes of Health (NIH) has substantially revised its approach to funding and managing research conducted in collaboration with foreign institutions and investigators. These updates reflect the NIH’s commitment to ensuring transparency, maintaining research integrity, and supporting legitimate international scientific collaboration while addressing national security and oversight concerns. As of September 2025, researchers planning international collaborations must understand and comply with the new application structures, disclosure requirements, and funding mechanisms established by these policy changes.

Overview of Policy Changes

In May 2025, the NIH announced a significant shift in how it will fund foreign components of research projects. The agency determined that traditional foreign subaward and consortium structures failed to meet federal reporting and oversight requirements. To address these concerns, NIH implemented a new award structure that eliminates nested foreign subawards under parent awards and instead establishes foreign collaborations as distinct, independently tracked components. This restructuring enhances transparency and accountability while maintaining the NIH’s commitment to supporting high-quality international research partnerships.

Key Policy Objectives

The updated guidance pursues several critical objectives. First, it strengthens oversight and accountability of federal funding used in international research settings. Second, it enhances transparency regarding how NIH funds support foreign research activities. Third, it ensures proper stewardship of federal resources and protects national security interests. Fourth, it maintains support for legitimate international scientific collaboration conducted through secure and responsible channels. Finally, it establishes clearer mechanisms for tracking and evaluating the contributions and outcomes of foreign research components.

New Application Structure for International Collaborations

Effective September 25, 2025, the NIH no longer accepts new applications that request funds for foreign components using the traditional grant subaward or consortium structure. Instead, all applications involving international research components must follow a new comprehensive multi-project format using revised activity codes.

Required Activity Codes

Applicants must use specific new activity codes depending on the award type. For grants, the activity code is PF5. For cooperative agreements, the activity code is UF5. These new codes identify applications that include international collaboration components structured under the revised policy. The foreign organizations themselves receive distinct grant numbers in the NIH research portfolio system (RePORTER), identified with codes RF2 for foreign grants or UL2 for foreign cooperative agreements.

Three-Component Application Structure

All applications involving foreign components must now include three distinct components:

Overall Component: This section describes the collaborative project’s overarching goals, the relationship between the domestic and international components, and how the foreign research activities contribute to the overall project aims. Applicants must clearly articulate why international collaboration is necessary and how it strengthens the research.

Research Project Component: This portion covers the scientific and technical details of the domestic research activities, including research design, methodology, timelines, and expected outcomes related to work conducted by the U.S.-based applicant organization.

International Project Component: This section details the specific role, responsibilities, and contributions of the foreign collaborator or collaborating institution. Each funded foreign collaborator or institution must have its own distinct International Project component, allowing the NIH to evaluate and track each foreign contribution separately.

Application Requirements and Institutional Roles

The new structure establishes clear institutional requirements for both domestic and foreign applicants. The primary applicant organization must be U.S.-based and must include at least one Principal Investigator (PI) or Project Director (PD) from the U.S. organization. This requirement ensures that NIH funding flows through and remains accountable to a domestic institution.

Foreign Organization Participation

Foreign organizations participating in NIH-funded research must formally acknowledge their role by submitting a letter of support. This letter must indicate that the foreign organization will serve as the recipient organization for its disaggregated award component and confirm their commitment to fulfilling their defined role in the research project. This documentation creates a clear record of mutual understanding and commitment between the domestic applicant and foreign collaborators.

Identification of Principal Investigators

Applications must identify distinct principal investigators for both the domestic applicant organization and for each international organization involved. This requirement ensures clear accountability for research activities conducted at each site and facilitates oversight and communication among collaborating institutions.

Peer Review and Evaluation Process

The NIH maintains its commitment to rigorous scientific peer review while adapting review procedures to accommodate the new structure. Applications are reviewed as comprehensive wholes, with the Overall Impact score reflecting the entire project’s scientific merit and feasibility.

Evaluation Criteria for Foreign Components

Each International Project Component undergoes evaluation based on specific criteria that assess the necessity and value of international collaboration. Reviewers examine whether the project presents special opportunities that are not readily available within the United States or whether it augments existing U.S. resources in meaningful ways. Additionally, reviewers assess whether the proposed international research has specific relevance to the NIH Institute or Center mission and objectives and demonstrates potential for advancing U.S. health sciences.

Peer Review Comments

Reviewers provide specific comments addressing the review criteria for each individual project component. This targeted feedback helps applicants understand reviewer perspectives on both the overall project and the specific contributions and appropriateness of international collaboration components.

Disclosure and Compliance Requirements

NIH has intensified its scrutiny of international research partnerships and requires comprehensive disclosure of all foreign relationships and financial arrangements. Researchers must maintain strict compliance with disclosure obligations to ensure regulatory adherence and research integrity.

Mandatory Disclosures

Researchers must disclose all foreign relationships and arrangements in appropriate application documents. Specifically, all affiliations with foreign institutions must be documented. In-kind contributions from foreign entities—such as data access, laboratory space, equipment use, or personnel support—must be fully disclosed. Financial relationships, including any payments, honoraria, grants, or contracts from foreign entities, must be listed. These disclosures should be included in the Other Support section of the application and referenced in the Biosketch document for all key personnel involved in the research.

Biosketch and Other Support Documentation

For any key personnel with joint appointments or current funding from foreign entities, these arrangements must be clearly documented. The Biosketch should list all joint appointments with foreign institutions, along with relevant dates and institutional affiliations. The Other Support document must enumerate all current and pending support from foreign sources, including grants, contracts, and other funding mechanisms. This comprehensive documentation enables NIH program officers and reviewers to fully understand potential conflicts of interest or competing obligations.

Structuring and Formalizing Collaborations

The NIH strongly encourages researchers to formalize all international collaborative relationships through appropriate legal and administrative mechanisms. Informal or unfunded foreign collaborations that are not properly documented and disclosed may be viewed with suspicion, particularly if they involve sensitive technologies, data transfer, or intellectual property arrangements.

Memoranda of Understanding and Material Transfer Agreements

Researchers should use Memoranda of Understanding (MOUs) or Material Transfer Agreements (MTAs) to formalize international collaborations. These documents should be vetted by institutional offices of sponsored programs or compliance offices to ensure they clearly define roles, responsibilities, intellectual property rights, publication policies, and data-sharing arrangements. Formal agreements create transparent records of collaborative relationships and help prevent misunderstandings regarding expectations and obligations.

Letters of Collaboration

All international collaborators, whether receiving compensation or contributing on an unpaid basis, should provide letters of support explaining their specific role in the project and any arrangements for transfer of funds, knowledge, or materials. These letters should explicitly acknowledge whether collaborative publications or joint intellectual property are anticipated outcomes of the arrangement.

Defining Foreign Components in Research

NIH defines a “foreign component” broadly to encompass any aspect of a project that occurs outside the United States, whether conducted by the grantee organization or by external researchers. This definition ensures comprehensive disclosure of all international research activities.

Activities Constituting Foreign Components

Several types of research activities meet the definition of a foreign component and must be disclosed and justified. These include:

• Collaborations with investigators at foreign sites that are anticipated to result in co-authorship or joint publications
• Use of specialized facilities, instrumentation, or resources available only at foreign institutions
• Receipt of financial support, in-kind contributions, or other resources from foreign entities
• Involvement of human subjects or animal subjects at foreign research sites
• Extensive foreign travel by research staff for data collection, subject recruitment, sampling, biological specimen collection, or similar substantive research activities
• Any research activities that may impact U.S. foreign policy through project staff involvement in the affairs or environment of foreign countries

Note: Foreign travel for consultation, conference attendance, or brief advisory meetings does not typically constitute a foreign component and does not require the same level of justification.

Coordination with Institutional Offices

Before initiating or continuing work with foreign collaborators—especially in sensitive research fields or with institutions in countries of concern—researchers must coordinate with institutional offices to ensure compliance with all applicable policies and regulations. This coordination should occur early in the research planning process to identify any potential compliance issues before they develop.

Office of Sponsored Programs

The Office of Sponsored Programs (or equivalent institutional research administration office) should review all proposed international collaborations to ensure proper structuring under the new NIH policy. This office can advise on appropriate documentation, help draft MOUs and MTAs, and ensure that applications follow current NIH requirements.

Office of Compliance and Research Integrity

The Office of Compliance or Office of Research Integrity should review international collaborations for potential legal, regulatory, and national security concerns. This office can identify any countries or research areas subject to export controls, sanctions, or other government restrictions that might impact the proposed collaboration.

Implementation Timeline and Transition

The NIH established a phased implementation timeline for these policy changes. In May 2025, the NIH announced the new policy. In July 2025, guidance on implementation for existing active projects was issued. Most importantly, the new application structure became mandatory effective September 25, 2025, for all applications involving foreign components submitted after that date.

Grandfathering of Existing Awards

The policy applies prospectively to all new, renewal, and non-competing continuation applications submitted after the effective date. Importantly, the policy does not apply retroactively to existing NIH awards. Foreign subawards in currently active grants and cooperative agreements will not be automatically revised or eliminated during their current budget periods, except in cases where special circumstances require modification, such as significant concerns regarding human subjects safety.

Best Practices for International Research Collaboration

To successfully navigate the updated NIH guidance on foreign collaborations, researchers should adopt several best practices. First, plan international collaborations early in project development and involve institutional compliance and research administration offices from the outset. Second, comprehensively document all foreign relationships, contributions, and financial arrangements. Third, use formal agreements such as MOUs and MTAs to clarify roles, responsibilities, and intellectual property arrangements. Fourth, ensure that all key personnel disclose foreign affiliations and current foreign funding in their Biosketch and Other Support documents. Fifth, clearly justify the necessity of international collaboration and explain why the proposed foreign research cannot be conducted more effectively within the United States.

Frequently Asked Questions (FAQs)

Q: What is considered a foreign component in NIH-funded research?

A: A foreign component is any aspect of an NIH-funded project performed outside the United States, including collaborations with foreign investigators, use of foreign facilities, receipt of foreign funding or resources, involvement of foreign subjects, or extensive foreign travel for substantive research activities. Foreign travel for brief consultation or attendance at conferences typically does not constitute a foreign component.

Q: Must I disclose informal collaborations with foreign researchers?

A: Yes. All foreign relationships and collaborations, whether funded or unfunded, formal or informal, must be disclosed in your Other Support and Biosketch documents. Informal undisclosed collaborations involving technology transfer or publication agreements may raise compliance concerns.

Q: Can NIH still fund foreign collaborators under the new policy?

A: Yes, the NIH remains committed to supporting international scientific collaboration. However, foreign collaborations must now be structured as independent International Project Components rather than as traditional subawards nested under a parent award. This new structure enhances oversight and transparency while maintaining support for legitimate international research partnerships.

Q: What activity codes should I use for applications with international components?

A: Use activity code PF5 for grant applications with foreign components or UF5 for cooperative agreement applications with foreign components. Foreign organizations receiving direct awards will receive grant numbers identified as RF2 for grants or UL2 for cooperative agreements.

Q: What documents should foreign collaborators provide?

A: Foreign collaborators should provide a letter of support confirming their role in the project, their commitment to fulfilling their responsibilities, and any arrangements for funds, knowledge, or material transfer. All collaborative publications or intellectual property arrangements should be explicitly acknowledged in this letter.

Q: When does the new application structure take effect?

A: The new application structure became mandatory on September 25, 2025, for all applications submitted after that date that include foreign components. Existing awards are not retroactively affected, except in special circumstances such as human subjects safety concerns.

Q: Do I need institutional approval before proposing foreign collaborations?

A: Yes. Researchers should consult with their Office of Sponsored Programs and Office of Compliance before initiating international collaborations, particularly in sensitive research fields or with institutions in countries subject to government restrictions. Early coordination helps identify compliance requirements and prevent problems during the application process.

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medha deb

 

Medha Deb is an editor with a master's degree in Applied Linguistics from the University of Hyderabad. She believes that her qualification has helped her develop a deep understanding of language and its application in various contexts.

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