Updates Related to Recent Executive Orders

Navigating NIH Foreign Components

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Navigating NIH Foreign Components

Penn State and many of our peer institutions have recently received inquiries from the National Institutes of Health (NIH) regarding foreign collaborators listed as co-authors on publications resulting (in whole or in part) from NIH funding.

The NIH is expressing concerns that Principal Investigators are utilizing “foreign components” in the performance of their NIH-funded work without seeking required NIH prior approval (NIH Grants Policy Statement 8.1.2.10). While the definition of a foreign component has not changed (NIH FAQ), the NIH is placing a heightened focus on international publications and co-authorships as a mechanism to identify possible foreign components.

Failure to secure prior approval for a foreign component before the work begins can result in the loss of current grant funding and restrict future federal funding.

The NIH Definition of a Foreign Component

See below for the NIH Grants Policy Statement (Definition of Terms 1.2) definition of a foreign component:

“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, (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.”

What Every NIH-funded Investigator Should Do

Do Not Respond to NIH Inquiries

If you receive an inquiry from your NIH Program Officer or Grants Management Specialist regarding a foreign co-author, a foreign affiliation on a publication, or an unapproved foreign component, do not respond on your own. Please forward the inquiry immediately to Robin Riglin at rbs15@psu.edu and the Office of Sponsored Programs at osp@psu.edu. We will work with you to draft an appropriate, compliant response and navigate the reporting requirements.

(Please include your Grant Number, the publication in question, and any context regarding the author’s physical location when the work was performed.)

Add Author Affiliation Notes in Publications (U.S.-Based Work Exception)

If you are publishing with a co-author who performed their work while in the U.S. who now lists a foreign institutional affiliation (see NIH FAQ #6), it is highly recommended that you explicitly state in the publication’s author notes that all work was performed while the researcher was in the U.S. Failing to include this explicit information in an author note or statement will likely flag the publication during NIH RPPR review.

Example: “Dr. [Name]’s contributions to this research were performed entirely while affiliated with and physically located at Penn State University.”

General Authorship Best Practices

Ensuring that authorship is attributed appropriately is important. For broader University guidance on authorship, please see the Office for Research Protections’ (ORP) webpage Authorship and Publication.

Seek Prior Approval from NIH

If you are planning a new collaboration that meets the definition of a foreign component, contact your College Research Office or OSP to initiate a formal request. NOTE: You must seek prior approval for each NIH grant and for each specific foreign component associated with that grant.

Frequently Asked Questions (FAQ)

Timeline & Scope

While the recent Notice outlines funding structures, the explicit inclusion of “collaborations… anticipated to result in co-authorship” is included in the NIH Grants Policy Statement (Definition of Terms 1.2) definition of a foreign component. We are bringing this to your attention now because the NIH is increasing their enforcement and auditing of this clause.

Failure to disclose foreign components or secure NIH prior approval can result in the termination of your current funding, or larger consequences such as your inability to receive future federal funding. Furthermore, the entire University could potentially be debarred from future funding.

  • If you receive an inquiry from the NIH about a past publication, do not respond on your own. Forward the inquiry immediately to OSP so we can help you manage the response.
  • If the research was NIH-funded and prior approval was granted: Ensure your College Research Office has verified the approval and then proceed.
  • If the research was NIH-funded but you did NOT seek prior approval: Please contact OSP. The resolution will depend heavily on the timing, the nature of the work, and the countries involved.
  • If the research was NOT funded by the NIH: It is still recommended to explicitly clarify in the author notes if work was done in the U.S. by researchers currently affiliated with foreign institutions. If the work involves collaborators from countries of concern, please consult the Research Security Office, as other federal agencies (such as DOE, DOD, and NSF) are also increasing their scrutiny.

This is not a new rule. PIs should subject any publications resulting from active or past NIH awards to greater scrutiny, dating back to when you first started receiving NIH funding.

Yes. National reporting indicates that posters and presentations are now triggering affiliation concerns for federal agencies.

Yes. If NIH funding is attributed in the publication, you should assume it will trigger a review. As a general rule for compliance, do not cite NIH funding on publications if the grant did not directly support the work.

Yes, all collaborators are required to disclose foreign components. As the PI, you are ultimately responsible for knowing what your Co-Investigators are doing in support of the project.

Yes. You need to seek prior approval for each grant and for each specific foreign component associated with that grant.

Affiliations, Visas & Students

No. Penn State employees, postdocs, and graduate students physically located in the United States while the research is done do not constitute a foreign component. (Similarly, dual citizens are considered U.S. persons and are not foreign components if the work is performed in the U.S.).

However, if that individual subsequently leaves Penn State and lists a new foreign affiliation on your publication, the NIH’s automated screening will most likely flag the paper. This is why it is important to utilize the U.S.-Based Work Exception Author Note (provided above) to explicitly state the work was done in the U.S.

Per NIH FAQ: “Generally, no. Because the first step in determining a foreign component is evaluating location, if all of the work is being conducted physically in the U.S., there is no foreign component.”

However, because specific circumstances vary, you should consult with OSP in advance of them joining the lab to ensure their funding is properly disclosed as Other Support. Additionally, if this scholar subsequently leaves Penn State and lists a new foreign affiliation on your publication, it will likely flag the paper during RPPR review. Please utilize the U.S.-Based Work Exception Author Note to explicitly state the work was done in the U.S.

If they are performing the work at Penn State as a Penn State employee, they do not constitute a foreign component. However, if they are performing the work at their secondary foreign institution, it may be a foreign component.

If students are funded in part by their home government, this must be properly disclosed in your Other Support documentation.

Independent & Past Collaborations

The NIH has no authority over non-NIH research; they are looking at publications that acknowledge the NIH as the source of funding. However, you must still properly disclose these relationships in your Other Support.

Yes. The purpose of this communication is to encourage you to subject your longstanding co-authorship arrangements to greater scrutiny and ensure all prior approvals are properly documented.

If it is related to your NIH grant AND meets the definition of a foreign component: Yes.

If the international collaboration involves a significant scientific element of your NIH-funded project, and the work was performed outside of the United States, it requires prior approval.

If you are named as a co-author on a U.S. collaborator’s publication that also includes a foreign collaborator, the NIH’s automated systems will likely flag the publication if your NIH grant is cited. Even if you did not actively collaborate with the foreign researcher yourself, the NIH may presume you did. Please consult OSP on how to properly document your due diligence in these scenarios to protect your funding.

The NIH definition flags collaborations “anticipated” to result in co-authorship. If an unanticipated contribution unexpectedly meets the standard for authorship (e.g., under ICMJE guidelines), please contact OSP. We will help you navigate a good-faith disclosure to the NIH.

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