NIH Clarifies Foreign Component Requirements for International Collaborations

NIH recently reaffirmed that its longstanding definition of a foreign component has not changed. However, questions from the research community regarding international co-authorship and collaborations have prompted NIH to provide additional guidance and practical examples.

What Is a Foreign Component?

A foreign component exists when a significant scientific element or segment of an NIH-funded project is conducted outside the United States, regardless of whether NIH funds are provided to the foreign collaborator.

NIH emphasized that:

• International collaboration is not prohibited and is often scientifically valuable. ]
• Foreign collaborations that meet the definition of a foreign component generally require prior NIH approval.
• Each situation must be evaluated individually. Foreign co-authorship alone does not automatically create a foreign component.

Key Takeaways for Investigators

Not Every Foreign Co-Author Creates a Foreign Component

A foreign component likely exists when a foreign researcher:

• Provides substantive scientific input to an NIH-funded project;
• Routinely collaborates with project personnel;
• Contributes significantly to research design, methods, analysis, or interpretation; or
• Performs a meaningful scientific element of the project while located outside the U.S.

These circumstances can constitute a foreign component even when no NIH funds are transferred internationally.

Pay Attention to NOFO Requirements

Investigators should carefully review the Notice of Funding Opportunity (NOFO) for their award. Some funding opportunities restrict or prohibit foreign components. If NIH identifies indicators of an undisclosed foreign component, the Institute or Center may request additional information and documentation.

Best Practices for Publications

Use Accurate Institutional Affiliations

Authors should identify the institution where the NIH-funded work was actually performed. Using only a current foreign affiliation may create confusion regarding where the research activities occurred.

Cite Only Grants That Supported the research

Investigators should avoid attributing publications to NIH awards that did not support the work being reported. NIH cautioned that inaccurate grant attribution could lead to compliance concerns.