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Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

Background

NIH has recently received questions regarding whether there has been a change in the definition of a foreign component, and whether a foreign co-author on a publication that cites an NIH grant award automatically results in a foreign component.  
 

Applicability

All NIH grants, cooperative agreements and other transaction agreements.
 

Purpose

This notice reminds the extramural community of NIH's longstanding definition of foreign components. While NIH has increased its oversight of foreign collaborations, we have not expanded the definition of foreign components. As outlined in the NIH Grants Policy Statement, a foreign component is:

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 at a foreign site, 
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. 

Most instances of co-authorship represent a foreign component. The NIH recognizes, however, that certain contributions are so minor that they do not constitute an actual collaboration. For example, the provision of a single reagent might not be a collaboration but could result in co-authorship. In addition, occasionally co-authorship arises through indirect association, such as when an NIH-funded researcher and a foreign researcher both independently work with the same domestic collaborator but only learn of this fact when a manuscript is prepared describing the work. In all cases, NIH recipients should report foreign co-authorship to the funding Institute or Center as soon as they are aware of it to determine what steps, if any, need to be taken.

Recipients must pay close attention to the Notice of Funding Opportunity (NOFO), which outlines whether foreign components are permitted. For awards that are issued from NOFOs that do not allow foreign components, publications and other research projects generally should not include foreign co-authors or collaborators. For example, funds from Institutional Development Award (IDeA) program grants may not be used to support organizations outside of IDeA states, including foreign components. When NIH identifies indicators of potential foreign components that have not been disclosed, the funding Institute or Center may request additional information to confirm that a foreign component exists and will work with the recipient to ensure compliance with the NIH Grants Policy Statement.

To support full transparency and acknowledgement of federal funding, recipients are reminded of the Stevens amendment requirements outlined in the NIH GPS 4.2.1. All NIH recipients must acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid invitations, and other documents describing projects or programs funded in whole or in part with Federal money. Importantly, this requirement applies to all publications describing NIH-funded work. Recipients are required to state (1) the percentage and dollar amounts of the total program or project costs financed with Federal money and (2) for NIH programs requiring cost sharing, the dollar amount of the total costs financed by non-governmental sources (i.e., percentage and dollar amount of support from federal and non-federal sources). In general, NIH programs do not have a legislative requirement for cost sharing. Any cost sharing requirements will be outlined in the NOFO. 

Attributing publications to grants that did not actually support the described work does not align with NIH policy and could inadvertently result in compliance actions. If the NIH grant only supported a specific part of the published work, this should be made clear in the grant citation in the publication and in the Research Performance Progress Report.  In addition, NIH-funded investigators should take care to accurately list their affiliations on publications to reflect where they performed the NIH-funded work rather than using their current address if it is different from the performance site. 

Inquiries

Please direct all inquiries to:

Office of Policy for Extramural Research Administration 
[email protected]