For NIH, foreign engagement and other support should be disclosed in proposals, and in interim and final Research Performance Progress Reports. Note that NIH also requires specific disclosure of "Foreign Components" on its Research and Related Other Project Information Form submitted with proposals (see separate section below).
For more detailed information see NIH Notice NOT-OD-19-114 and NIH FAQS Other Support and Foreign Components. The Council on Government University Relations (COGR) has also published guidance on the NIH disclosure requirements.
In July 2020, NIH posted a new webpage on Protecting U.S. Biomedical Intellectual Innovation, which summarizes NIH’s position on international collaborations and foreign influence, and provides additional guidance on the disclosure of other support, foreign relationships and activities, and conflicts of interest.
On October 27, 2020 NIH gave a presentation entitled "Commitment Transparency" at its Virtual Seminar on Program Funding and Grants Administration. During this presentation, NIH advised that it would soon be issuing a notice that provides clarifications to researcher disclosure obligations for Biosketches and Other Support. Among the anticipated new requirements is that institutions must provide NIH with copies of contracts that researchers have with foreign entities. The new requirements are expected to take effect in early 2021.
What to Disclose
NIH states that Other Support "includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes resource 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.)."
- List all positions and scientific appointments both domestic and foreign-held by senior/key personnel that are relevant to an application including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary). As of January 25, 2022 use of new biosketch formats will be required (see NOTICE NOT-OD-21-073).
- Report all resources and other support for all individuals designated in an application as senior/key personnel – including for the program director/principal investigator (PD/PI) and for other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation. Information must be provided about all current support for ongoing projects, irrespective of whether such support is provided through the applicant organization, through another domestic or foreign organization, or is provided directly to an individual that supports the senior/key personnel’s research efforts.
- As of January 25, 2022 applicants must provide copies of supporting documentation, including copies of contracts, grants or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution for all foreign activities and resources that are reported in Other Support. An English translation must be provided if the original contracts, grants or other agreements are not in English. Please note, however, that NIH may request copies of foreign contracts prior to mandatory implementation of Notice NOT–OD-21-073 on January 25, 2022.
- Report all current projects and activities that involve senior/key personnel, even if the support received is only in-kind (e.g. office/laboratory space, equipment, supplies, employees). All research resources including, but not limited to, foreign financial support, research or laboratory personnel, lab space, scientific materials, selection to a foreign "talents" or similar-type program, or other foreign or domestic support must be reported.
- Provide the total award amount for the entire award period covered (including facilities and administrative costs), as well as the number of person-months (or partial person-months) per year to be devoted to the project by the senior/key personnel involved.
When to Disclose
All active and pending support at the time of application submission and prior to award must be reported using "Just-in-Time Procedures" by providing all information indicated above. Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted Just-in-Time information up to the time of award, including "Other Support" changes that must be assessed for budgetary or scientific overlap. Further, if other support, as described as above, is obtained after the initial NIH award period, from any source either through the institution or directly to senior/key personnel, the details must be disclosed in the annual Research Performance Progress Report (RPPR). Post-award, recipients must address any substantive changes by submitting a prior approval request to NIH in accordance with the NIH Grants Policy Statement section on Administrative Requirements—Changes in Project and Budget.
As of May 25, 2021, when a recipient organization discovers that a PI or other Senior/Key personnel on an active NIH grant failed to disclose Other Support information outside of Just-in-Time or the RPPR, as applicable, the recipient must immediately submit updated Other Support to the Grants Management Specialist named in the Notice of Award as soon as it becomes known.
What to Disclose
NIH requires recipients to determine whether activities it supports include a foreign component, defined as "the existence of any 'significant scientific element or segment of a project'…" outside of the United States. This includes:
- Performance of work by a researcher or recipient in a foreign location, 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.
If a recipient determines that a portion of the project will be conducted outside of the U.S., the recipient then will need to determine if the activities are considered significant. If both criteria are met, then there is a foreign component that must be disclosed in Item 6 of the Research & Related Other Project Information Form. See item B2 in the NIH FAQS for further guidance how about to determine if activities are significant.
The addition of a foreign component to an ongoing NIH grant continues to require NIH prior approval, as outlined in the NIH Grants Policy Statement, Section 8.1.2, Prior Approval Requirements.
Note: If an activity does not meet the definition of foreign component because all research is being conducted within the United States, but there is a non-U.S. resource that supports the research of an investigator and/or researcher, it must be reported as other support. For example, if a PD/PI of an NIH-funded grant has a collaborator outside of the U.S. who performs experiments in support of the PD/PI’s NIH-funded project, this would constitute a foreign component, regardless of whether the foreign collaborator receives funding from the PD/PI’s grant. Additional funding from a foreign source for the NIH-supported research of a PD/PI at a U.S. institution would not constitute a foreign component but would necessitate reporting as other support.