International Connections and Foreign Influences
National Institutes of Health (NIH)
Below is a summary of specific NIH guidance related to foreign influence and reporting obligations. Note: For additional clarification and updates, always consult NIH’s Biosketches and Other Support FAQs.
An improper influence (foreign or domestic) exists when a relationship affects the integrity of NIH supported research. Such a “relationship” could be with a collaborator, an outside employer, an external appointment relationship, etc. The “impact” could be real or apparent, and the “compensation” could be of any type or level; NIH has not established a de minimis level of compensation and considers all types of support, in-kind or otherwise.
NIH expects relationships to be reported under “Other Support” if there is overlap with NIH supported work in the following areas:
- A potential Financial Conflict of Interest
Other Support: NIH requires that all PDs/PIs and other senior key personnel devoting measurable effort to the project to disclose all “Other Support” at the JIT stage. Any substantive changes to these disclosures must be reported by PDs/PIs and other senior Key personnel when submitting RPPRs.
If the PD/PI or any senior Key Personnel fail to disclose this requested or required information at the JIT and/or RPPR stages, SPO should be notified as soon as possible. (NIH expects notification within 30 days of discovery.) Upon notification SPO will need to submit updated supplementary documentation for Other Support to the Grants Management Specialist named in the Notice of Award.
NIH defines “Other Support” as resources made available to a researcher in support of and/or related to all of their research endeavors whether or not the resources have monetary value and whether or not the resources are based at the institution the researcher identifies for the current grant.
This includes resources and/or financial support from Berkeley and resources and/or financial support from all foreign and domestic entities, including but not limited to, financial support for laboratory personnel, and provision of high-value materials that are not freely available (e.g., biologics, chemical, model systems, technology, etc.).
Note: Institutions need only go back three years in reporting as Other Support materials that were received from external collaborators.
“Other Support” also includes:
- Consulting agreements, that fall outside of an individual’s appointment, are reportable when the PDs/PIs and other senior key personnel will be conducting research as part of the consulting activities. Note:
- NIH has indicated that it uses the Common Rule’s definition of “research” [45 CFR 46.102(l)] as a benchmark for determining whether a researcher’s activities constitute research.
- Co-authorship on a publication stemming from such activities may be an indicator that the activities constituted research.
- Consulting should be estimates for the amount paid, rather than time and effort reflected in calendar months. Therefore, it will not count towards the 12 calendar months of effort.
- In-kind contributions, e.g., office/laboratory space, equipment, supplies, or employees or students supported by an outside source. Note:
- If the time commitment or dollar value of the in-kind contribution is not readily ascertainable, the recipient must provide reasonable estimates.
- There is no de minimis dollar or time commitment thresholds that would serve as a trigger for reporting in-kind contributions.
- Unpaid volunteers if the unpaid volunteers support the research endeavors of the PD/PI and other senior key personnel.
NIH does not require that the following be reported as “Other Support”:
- Resources and/or financial support for non-research endeavors
- Non-research consulting activities
- Training awards, prizes
- Gifts, but only if the gift is clearly given with no expectation of anything in return
- Institutional resources, such as core facilities or shared equipment that are broadly available
- Recently completed support
- Post-docs or graduate student relationships that are solely a mentor/mentee arrangement, with no research activities involved
Supplementary Documentation: As of January 25, 2022 (or earlier if NIH decides the information is needed), PDs/PIs and other senior key personnel will need to provide supplementary documentation for all foreign activities and resources under “Other Support” in Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs).
Supplementary documentation includes copies of contracts, grants or any other agreement specific to foreign appointments and/or employment with a foreign institution held by PDs/PIs and other senior key personnel. Note: Information may not be redacted from contracts, agreement or other supporting documents that are submitted to NIH. If a researcher has a foreign appointment, affiliation, and/or employment with a foreign institution, they must provide supporting documentation of that relationship, even if they do not have a formal agreement in place.
If the contracts, grants, or other agreements are not in English, recipients must provide translated copies. Note: NIH funds cannot be used to translate these documents, but Google translations are acceptable.
As of January 25, 2022, PDs/PIs and other senior key personnel also will be required to electronically sign their respective Other Support form as a PDF prior to submission verifying that the information is true and accurate. Other Support submissions at Just-in-Time and in the RPPR must be submitted as a flattened PDF, after all signatures are obtained. Note: A typed name is not an electronic signature and is not considered acceptable.
Foreign Components: NIH and other PHS agencies also require PIs to indicate at the proposal stage if any significant scientific element or segment of the NIH project will take place 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. This is considered a “foreign component.” Note: This type of collaboration may require U.S. State Department approval, depending on the nature of the collaboration. If a foreign collaboration begins during the NIH award period, it must be disclosed to NIH in the next annual RPPR.
NIH provides the following examples of a foreign component:
- Performance of work by a researcher or recipient in a foreign location, including use of facilities or instrumentation at a foreign site whether or not NIH grant funds are expended and/or
- Performance of work by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended.
Other indications of a foreign component are:
- Collaborations with investigators at a foreign site anticipated to result in co-authorship
- Use of facilities or instrumentation at a foreign site
- Receipt of financial support or resources from a foreign entity
Note: Foreign travel for “consultation” purposes is not considered a foreign component.
If a foreign component is to be involved, the PI must attach a justification to the proposal describing why the facilities or other aspects of the proposed project are more appropriate than a domestic setting.
If the PI adds a foreign component after NIH makes the award, NIH prior approval will be required. See: NIHGPS, Section 8.1.2, Prior Approval Requirements. As stated above, a foreign component involves a “significant” aspect of the project. NIH does not specifically define what is meant by “significant.” However, when in doubt, always disclose.
For more information, consult:
- NIH Grants Policy Statement: 16 Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components) and
- NIH FAQs on Other Support and Foreign Components
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