International Collaboration

Collaborating with Researchers and Institutions outside the U.S.

Wake Forest University School of Medicine is committed to fostering dynamic research collaborations domestically and globally, while also complying with all federal regulations and sponsor requirements. Since 2018, federal agencies that support research, federal intelligence agencies, federal security agencies, and Members of Congress have all expressed concern about security threats posed by inappropriate foreign influence in research.

The concerns revolve around three main areas:

Diversion of intellectual property to foreign entities
Disclosing confidential grant application information by NIH peer reviewers to third parties
Failure of researchers to disclose research resources and support provided by other organizations, including foreign entities

Federal funding agencies have advised that there will be a heightened focus on ensuring compliance with respect to mandatory reporting of all sources of research support, financial interests and relevant affiliations, as well as steps to reduce risk to IP security.

Agency-Specific Communications:

The 2019 JASON Report Fundamental Research Security, commissioned by the National Science Foundation, asserts research integrity requires full disclosure of all actual or potential conflicts of interest. It also recommends NSF and recipients investigate and adjudicate non-compliance issues.

National Security Presidential Memorandum, NSPM-33, calls on federal research funding agencies to require a research security program at recipient organizations receiving more than $50 million annually in federal research funding. NSPM-33 also seeks consequences for non-disclosure and provides guidance for sharing information on violations across federal research funding agencies.

The CHIPS and Science Act of 2022 defines and directs agencies to prohibit membership in malign talent recruitment programs.

The NSPM-33 implementation guidance provided additional clarity on research security program requirements including details on training requirements, foreign travel security, and cyber security. Final guidelines were published on July 9, 2024, for agency implementation.

National Institutes of Health (NIH)

August 2018 Letter to grantees
NOT-OD-19-114: Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components
FAQs on Other Support and Foreign Components
NOT-OD-18-160: Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests

National Science Foundation (NSF)

July 2019 Dear Colleague Letter

Department of Defense (DOD)

Department of Energy (DOE)

To ensure compliance with federal requirements we ask that the Wake Forest School of Medicine researchers take a series of simple steps:

1. Update “Other Support”

All research personnel whose research is supported with federal funding should update their other support documentation. This includes NIH Other Support, for awarded projects or projects that are pending issuance of a new award.

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.).”

NIH Applicants must:

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).
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.
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 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 NIHGPS section on “Administrative Requirements—Changes in Project and Budget—NIH Standard Terms of Award.”

2. Review and update biosketches

Biosketches should be current and thorough, review and update as necessary based on the information in this communication and the referenced resources, as well as the guidelines below:

3. Ensure appropriate disclosure of foreign components

The current NIH Grants Policy Statement defines “foreign component” as 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.

What to disclose?

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. Examples of 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.

When to disclose?

The addition of a foreign component to an ongoing NIH grant continues to require NIH prior approval, as outlined in the NIHGPS, 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.

4. Update progress reports appropriately

As you work on progress reports, always remember that you should indicate any change in support for Key Personnel that occurred over the last budget year. Be sure to include the new items noted above and defined in NIH NOT-OD-19-114. If you wish to make a change to your project that requires prior approval, the progress report is NOT the place to do that; prior to the report being submitted, a formal prior approval request should have been sent to NIH via the OSP office.

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International Collaboration

Agency-Specific Communications:

National Institutes of Health (NIH)

National Science Foundation (NSF)

Department of Defense (DOD)

Department of Energy (DOE)

To ensure compliance with federal requirements we ask that the Wake Forest School of Medicine researchers take a series of simple steps:

1. Update “Other Support”

What to disclose?

NIH Applicants must:

When to disclose?

2. Review and update biosketches

3. Ensure appropriate disclosure of foreign components

What to disclose?

When to disclose?

4. Update progress reports appropriately

5. Review and update Conflict of Interest and Conflict of Commitment disclosures

6. Follow export control requirements

7. Follow peer review confidentiality requirements