Guidance Regarding Foreign Influence in University Research

The current regulatory landscape informing the research enterprise includes serious growing concerns by the US Government concerning inappropriate influence by foreign entities over federally funded research.  As a result, academic research institutions have a heightened interest in understanding the affiliations and dealings faculty members may have with foreign governments and entities. The University of Kentucky encourages international collaboration, and recognizes it is important for investigators to be transparent about their foreign relationships and activities.

Background

Federal agencies have issued statements expressing growing concerns over the potential for foreign influence in the following areas:

  1. failure by some researchers to disclose substantial contributions of resources from other organizations, including foreign governments;
  2. diversion of intellectual property to foreign entities;
  3. sharing of confidential information by peer reviewers with others, including in some instances with foreign entities, or otherwise attempting to influence funding decisions.

In August 2018, Francis Collins, director of the NIH, alerted the research community to threats from foreign entities, and the FY19 National Defense Authorization Act included a provision alluding to the restriction of federal funding to institutions doing business with certain Chinese telecommunications companies.

Disclosure of Foreign Relationships and Activities

All investigators on sponsored projects should check the sponsor’s current disclosure requirements carefully and, if in doubt, contact OSPA at 859-257-9420 for disclosure assistance or further guidance.  In addition, investigators should take the following actions:

  • Review and update Other Support and Current and Pending Support information in proposals
  • Review and update biosketches
  • Ensure appropriate disclosure of foreign components for NIH-supported projects
  • Review COI disclosure and update as necessary
  • Report all reimbursed or sponsored travel related to PHS-supported projects
  • Reach out to OSPA’s Export Control Specialist for guidance related to export control regulations
  • With the assistance of the Office of Technology Commercialization, enter into a material transfer agreement or nondisclosure agreement when sharing or exchanging materials or information

Guidance regarding the types of relationships and activities that University of Kentucky investigators are expected to disclose are explained below.

Transparency in Disclosure

Disclosure to Sponsors

  • Foreign components of federally funded research should be disclosed in proposals, progress reports, and final technical reports in compliance with sponsor requirements. 

Researchers should be thorough and complete in accounting for all forms of research support, including from foreign sources and gifts, in NIH’s Other Support, the NSF’s Current and Pending and similar documentation submitted to other sponsors.

Under the NIH Grants Policy Statement, a Foreign Component is defined as “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.” The definition of foreign component includes “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.” Other sponsors have similar requirements to disclose foreign components.

There are multiple ways in which foreign components should be disclosed, including 

  • Identifying a foreign component in an NIH grant application;
  • Listing a non-U.S. performance site;
  • Identifying foreign relationships and activities in a biosketch;
  • Answering “yes” to the question on the R&R Other Project Information Form asking, “Does this project involve activities outside of the United States or partnerships with international collaborators?”

Financial resources should be disclosed even if they relate to work that is performed outside of a researcher’s appointment period. For example, if a researcher with a 9-month appointment spends two months at a university outside of the U.S. during the summer conducting research under a foreign award, that activity should be disclosed.

Principal Investigators (PIs) should review all pending proposals and active awards to ensure that all foreign components have been disclosed. If a PI identifies an omission or error in a previously submitted proposal, the PI should contact the Office of Sponsored Projects Administration (OSPA) Research Administrator (RA) for assistance in correcting the error.

  • All ongoing or proposed research projects and sources of support should be included in Other Support, Current and Pending Support or Just-in-Time response as required by federal sponsors

"Other Support” may include resources and/or financial support, domestic or foreign, available in support of a researcher’s research endeavors. Such support should be disclosed on an Other Support or Current & Pending form, as required by the sponsor. Sponsor guidelines typically specify that all sources of support be disclosed, regardless of whether they are awarded by another sponsor or provided by the University of Kentucky (e.g., department/college or faculty start-up funds). 

NIH’s most recent guidance can be found at NOT-OD-19-114 and its FAQ encourages full transparency and advises recipients to “err on the side of disclosure.” 

NSF’s current Proposal and Award Policies Guide (PAPG) requires that “the proposed project and all other projects or activities requiring a portion of time of the PI and any other senior personnel must be included, even if they receive no salary support from the project(s).”

Participation in foreign talent programs, such as China’s Thousand Talents Program, must be disclosed to federal sponsors.

PIs should review all pending proposals and active awards to ensure that all Other Support has been disclosed. If a PI identifies an omission or error in a previously submitted proposal or progress report, he or she should contact their College Grant Officer (CGO) for assistance in correcting the error.

Disclosure to the University

  • Significant financial interests received from any foreign entity, including governments and universities, must be disclosed, per University of Kentucky Administrative Regulation AR 7:2 Financial Conflicts of Interest (COI) in Research.

AR 7:2 applies to Investigators on any sponsored agreement that is in preparation, has been submitted to a sponsor or is currently funded, and to Investigators involved in research funded by the University. Investigator includes the project director or principal investigator/program director, co-investigator, collaborator, senior/key personnel, faculty associate, and any other person, regardless of title or position, who is responsible for the design, conduct, reporting, or proposing of research or other activity that is sponsored by an extramural agency. Postdoctoral scholars and fellows may be considered investigators if designated as such by the Principal Investigator on a case-by-case basis.

Investigators who apply for or receive funding through a Public Health Service, should disclose reimbursed travel and travel paid on behalf of the Investigator that reasonably appears related to their institutional responsibilities within 30 days of the completion of such travel.

Effective July 15, 2019 all COI disclosures include questions specifically related to affiliations with foreign entities, including appointments or positions at entities outside of the United States, incentives, gifts or money from any entity or agency outside of the United States as well as any promises in exchange for work from a non-US entity or agency.  In the updated COI disclosure, faculty are asked to provide a description of any of work performed at or on behalf of a non-US entity or agency that is similar to work at the University of Kentucky.

All Investigators are required to file annual COI disclosures and promptly provide updated disclosures within thirty (30) days of changes in their COI status.  The COI-Smart system can be accessed at https://uky.coi-smart.com/ using your LinkBlue ID and password.

Export Controls

U.S. export control laws and regulations, which are complex and constantly evolving, exist to maintain national security and protect U.S. economic vitality. These regulations control the shipment of both tangible items and technical data outside the United States, prohibit access to export-controlled technical data, materials, or equipment to non-U.S. persons within the United States, known as a deemed export, and impose sanctions and embargoes on transactions or exchanges with designated countries, entities and individuals.  Researchers must comply with US export control regulations when collaborating with international partners, making financial transactions, shipping materials, transferring technology, traveling abroad, or using restricted materials for research.

Most of the research at the University of Kentucky is considered fundamental research, where export laws do not apply. However, some items/technologies fall under the reach of these U.S. export control laws. Sponsored programs may have export restrictions on particular items, equipment, technology and data. Additionally, the research may have restrictions on the participation of foreign nationals and/or freedom to publish the results of the research.

Researchers should contact John Craddock at John.Craddock@uky.edu with questions related to compliance with the federal export control regulations.

Additional information is available on the Policies and Procedures tab of the OSPA website at https://www.research.uky.edu/office-sponsored-projects-administration/policies-procedures.

Intellectual Property

When materials or data will be shared with foreign institutions a material transfer agreement (MTA) or nondisclosure agreement (NDA) should be in place, governing the use of those materials or data. Having an agreement allows the University to complete all required internal controls and checks. The Office for Technology Commercialization (OTC) provides guidance on these agreements. Additional information is available on OTC’s website at https://www.research.uky.edu/office-technology-commercialization. 

A Material Transfer Agreement (MTA) is an agreement that governs the transfer of tangible research materials between two organizations. This agreement typically lays out the terms for exchanging the material and determines how this material can be used by the receiving party. When a material is leaving the University for another institution or an industry research partner, an MTA is required to secure the rights of the University and that of the individual researchers including publication rights. When a material is coming into the University, the other institution may require an MTA to be signed. The MTA request form is located at https://www.research.uky.edu/uploads/material-transfer-agreements.

A Non-Disclosure Agreement (NDA) is sometimes referred to as a Confidential Disclosure Agreement. These agreements govern the terms for exchanging confidential information between the University and an outside party. An NDA can be implemented to protect confidential information that is leaving the University for a variety of reasons. An NDA will determine what is confidential information and what is not, how the information is disclosed, how long the information must be kept secret, who the information can be disclosed to, as well as a variety of other topics depending on the individual agreement. An NDA is needed when confidential information is being communicated to someone outside the University of Kentucky. This includes licensing, sponsored projects, commercialization, and research collaboration communications. The NDA request form is located at https://www.research.uky.edu/uploads/confidential-disclosure-form.

Only OTC has an authorized signatory authority for all such agreements. Agreements cannot be signed by individual researchers on behalf of the University.

Questions about the MTA and NDA should be directed to Ali Bocook Yankey, Senior Contracts Coordinator at Ali.Yankey@uky.edu.

To ensure that IP is protected and, when required, appropriately reported to sponsors, promptly disclose any potential inventions or other intellectual property to the Office of Technology Commercialization.

Agency Specific Guidance

The National Science Foundation (NSF)

The National Science Foundation (NSF) issued a Dear Colleague Letter: Research Protection from Director France Cordova on July 11, 2019 clarifying multiple steps NSF is taking to mitigate risks from “activities threatening our research community, such as certain foreign-government-sponsored talent requirement programs.”  NSF has proposed clarification of the proposal disclosure requirements and reporting requirements for both current and pending support and professional appointments. Those clarifications are included in the draft Proposal and Award Policies and Procedures Guide (NSF 20-1) .  Effective January 2020, NSF also proposes to use an electronic format for submission of biographical sketches, including disclosure of all appointments, and disclosure of current and pending support information.

The National Institutes of Health (NIH)

The National Institutes of Health (NIH) issued a Notice on July 10, 2019, reminding research institutions that NIH-funded researchers must “report foreign activities through documentation of other support, foreign components, and financial conflict of interest to prevent scientific, budgetary, or commitment overlap” (NOT-OD-19-114). 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.” An FAQ can be found here.

The Department of Energy (DoE)

The Department of Energy issued a directive dated June 7, 2019, mandating that “federal and contractor personnel fully disclose and, as necessary, terminate affiliations with foreign government-supported talent recruitment programs” on new DOE contracts and subcontracts. DOE is expected to issue a separate policy directive to implement the requirement on DOE grants and cooperative agreements.

The National Aeronautics and Space Administration (NASA)

NASA has long-standing restrictions on using NASA funds to enter into agreements “to participate, collaborate, or coordinate bilaterally in any way with China or any Chinese-owned company, at the prime recipient level or at any subrecipient level, whether the bilateral involvement is funded or performed under a no-exchange of funds arrangement” (grant restrictionscontract restrictions).