Federal Requirements for Reporting Foreign Influence in Research

Background

Federal and state agencies have issued statements expressing concerns about threats to the integrity of U.S. biomedical research, specifically:

Diversion of intellectual property (IP) in grant applications or produced by federally supported biomedical research to other entities, including other countries;
Sharing of confidential information on grant applications by peer reviewers with others, including foreign entities, or otherwise attempting to influence funding decisions; and
Failure by some researchers working at federally-funded institutions in the U.S. to disclose substantial resources from other organizations, including foreign governments, which threatens to distort decisions about the appropriate use of federal funds.

One issue that has moved to the forefront is the failure of federally-funded researchers at U.S. institutions to disclose their relationships and activities with foreign institutions and funding agencies. Several Federal agencies have indicated that failure to disclose foreign relationships and activities may jeopardize eligibility for future funding.

Rush encourages international collaborations. However, Rush recognizes that it is important to be transparent about foreign relationships and activities to mitigate risk and prevent undue foreign involvement in research. U.S. government agencies such as the Federal Bureau of Investigation (FBI), federal funding agencies such as the National Institute of Health (NIH), National Science Foundation (NSF) and the Department of Defense (DoD), have issued guidance for the academic and research community to effectively identify, educate, and mitigate the risk of undue interference and influence in all research activities.

Click for more information on Foreign Interference and Influence in Academia and Conflict of Interest Office for when, what and how to disclose possible conflicts. All related COI policies are listed within the Conflict of Interest Office website.

Questions

If you have any questions regarding sponsor requirements for disclosure at the proposal or award stage, reach out to Sponsored Programs Administration.

Foreign Activity Reporting Guidance by Sponsor

The National Institutes of Health (NIH)

Definition of a Foreign Component

According to 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:

The involvement of human subjects or animals at a foreign site
Extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities
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 considered 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.

Dislcosure of Foreign Activity on NIH Grants

In order to comply with Foreign Influence guidance issued in the NIH Notice (NOT-OD-21-073), individuals are required to disclose all foreign research activities on NIH grant applications, at the time of funding, on Research Performance Progress Reports (RPPR) through the lifecycle of the grant and ad-hoc as changes arise.

When and Where to Disclose Foreign Activity

Pre-Award: Grant Application

Research & Related Other Project Information page of the SF424 application

If the applicant organization is a foreign organization OR a foreign component is involved in the project, a foreign justification must be included on this page indicating how it meets the definition of a foreign component.

Biographical Sketch (biosketch)

All senior/key personnel and Other Significant Contributors, who are foreign residents, as part of a grant proposal should complete a biosketch. For more information, check out NIH biosketch instructions and templates.
The following information specific to foreign activity should be disclosed in the biosketch:
- Section A: Personal Statement: Ongoing and completed foreign research projects from the past three years relevant to the project should be highlighted.
- Section B: Positions, Scientific Appointments and Honors: List all foreign positions and scientific appointments, including volunteer positions and affiliations with foreign organizations, institutions or governments (including guest, adjunct, or honorary appointments).

Just-in-Time (JIT)

Other Support

Information on active and pending support may be requested by the NIH at the time of funding decision to determine scientific, budgetary, or commitment overlap and potential foreign influence. Other Support is requested from all individuals designated as senior/key personnel in the application, including foreign residents. Other Support is not requested for individuals defined as Other Significant Contributors. Other Support should not include gifts or information on Training grants.
For more information click NIH Other Support instructions and a templates.
The following information should be disclosed for all ongoing and pending research projects, including those conducted at a foreign institution, organization, or government entity:
- All financial support (income, salary, consulting fees, honoraria)
- Non-financial resources (In-kind contributions, office/lab facilities, project personnel paid from other sources of support)
- Involvement in a foreign talent program
- Effort represented in person-months, even if no salary support
- Other project personnel being supported by a foreign entity
- Overlap statement noting any scientific, budgetary or commitment overlap
- Signature from the senior/key personnel on their Other Support file
- Copies of contracts, grants or consulting agreement specific to senior/key personnel with foreign appointments and/or employment

Post-Award: Research Performance Progress Report (RPPR)

Other Support

The information requested for Other Support as noted under JIT above is also required at the time an interim or final RPPR is due for an active grant from all senior/key personnel if there has been a change in other support. Each activity that changed should be marked and include a short description of the change that occurred.

The National Science Foundation (NSF)

In the Summer 2020, the NSF released an updated version of its Proposal and Award Policies and Procedures Guide (PAPPG) which provided key reporting updates related to foreign influence. NSF, similar to the NIH, provides guidance on key areas where foreign activity must be reported. These areas are outlined below.

Pre-Award: Grant Application

Biosketch

NSF requires a biosketch for all senior-key personnel listed on an application.

Biosketches for senior personnel must include the following disclosure relating to foreign involvement:

All individual’s foreign academic, professional, or institutional appointments, beginning with the most recent appointment, outside of their appointment at the applicant organization and including that appointment if it is foreign.

Current and Pending Support

Current and Pending Support by NSF is used to assess the capacity of the individual to carry out the research as proposed, as well as to help assess any potential overlap/duplication/foreign influence with the project being proposed.

Current and Pending Support for senior/key personnel must include the following disclosure relating to foreign involvement:

All foreign resources made available to an individual in support of and/or related to all of his/her current and pending research projects, regardless of whether or not they have monetary value
In-kind contributions such as but not limited to:
- office/laboratory space
- equipment
- supplies
- non-compensated employees, students
Consulting by a foreign collaborator that involves research should be reported
Overlap with a foreign project or foreign component, whether scientific or budgetary

Gifts do not need to be reported in Current and Pending Support.

Post-Award: Research Performance Progress Report (RPPR)

Current and Pending Support

At the time of technical progress report submission (RPPR), the Principal Investigator (PI) must provide an updated Current and Pending Support file and include the same foreign disclosure information as outlined above if there has been a change in their active other support since the last reporting period.

On 10/5/2020, NSF added the following question related to foreign activity to the RPPR.

What percentage of the award’s budget was spent in a foreign country

Department of Defense (DoD)

The FY2019 National Defense Authorization Act (NDAA), signed into law in August 2018, directs the Secretary of Defense in Section 1286 to establish an initiative to work with academic research institutions on: limiting undue foreign influence (including through talent recruitment programs); supporting the protection of intellectual property and information about national security relevant technologies; and developing domestic talent in relevant scientific and engineering fields. In response to the NDAA, on March 20, 2019, the DoD issued a Memorandum titled “Actions for the Protection of Intellectual Property, Controlled Information, Key Personnel and Critical Technologies.” In this memorandum, DoD outlined disclosure requirements for research and research-related educational activities supported by DoD grants. Subsequently the general application instructions for Congressionally Directed Medical Research Programs were updated with similar instruction to NIH on reporting foreign activity in the biosketch and what they call “Previous/Current/Pending Support.”

When and Where to Disclose Foreign Activity

Pre-Award: Grant Application

Previous/Current/Pending Support

Senior/Key Personnel on DoD Research grants are required to submit the following information as part of Previous/Current/Pending Support in the Senior/Key Person Profile section of the SF424 application, including information on foreign projects or collaborations: For more details see the DoD Congressionally Directed Medical Research Programs General Application Instructions.

A list of all current, active projects the individual is working on and any future support the individual has applied to receive, regardless of the funding source.

Title and objectives of each project listed

The percentage per year to be devoted to each project

The total amount of support $$ the individual is receiving or will receive if the project is pending

Name and address of the sponsor
Period of performance

Post-Award: Progress Report

Previous/Current/Pending Support

At the time of annual progress report, any updates to Current Support should be submitted to the DoD and ad-hoc as changes arise. The same information as outlined in the pre-award process applies to Previous/Current/Pending Support provided at the time of Progress Report.