Guide for NIH Intramural Principal Investigators to Navigate International Interactions and Avoid Inappropriate Foreign Interference with Their Research

The goal of this guide is to enable continuing and future interactions among NIH scientific staff and foreign scientists and institutions without enabling undue foreign interference with NIH-supported research and without violation of applicable federal laws, regulations, policies, or guidelines. The goal is also to satisfy NIH requirements for appropriate conduct in collaborations with foreign entities. This guide is intended to apply to the NIH intramural research program (IRP), not to research conducted solely by extramural research institutions.

Summary Points to Consider:

1. The NIH values collaborations and interactions between NIH staff and foreign scientists and institutions, and this guide is intended to empower NIH scientific staff to engage in collaborations, not to dissuade them from such activities.
2. Full disclosure about the nature and scope of an NIH staff member’s collaboration and/or a relationship with another institution is paramount. Complete documentation is essential for collaborations with scientists and/or institutions from other countries.
3. NIH staff must exercise due diligence in bringing foreign national scientists to work in labs and clinics at the NIH. NIH staff sponsoring foreign scientists are required to ensure all applicable disclosures are fully understood by the candidate prior to an offer of employment or other status (e.g. IRTA, CRTA, Special Volunteer or Guest Researcher). The foreign scientist must understand the requirement for full disclosure as soon as the foreign scientist engages in a covered activity, such as service on an editorial board or as a consultant with a private company. This disclosure requirement includes: any obligation (a professional activity that is documented in an agreement or contract) to foreign governments, any obligation to foreign institutions, all sources of foreign compensation, all outside support for similar or identical research funded by the NIH, and any potential conflicts of interest that might jeopardize the reputation of the NIH.
4. All necessary approvals for NIH staff of travel, material transfer, and equipment loans shall be obtained in advance, and the purposes for each shall be fully disclosed. Throughout this document, disclosures refer to those that are initially made to one’s direct supervisor or ethics coordinator, annually or when triggered by an event.
5. All applicable federal laws, regulations, policies, and guidelines shall be followed for collaborative research performed in the US or in foreign countries.

Introduction

Biomedical research is a global enterprise that may be facilitated through international collaborations, training experiences in other than home countries, and the sharing of appropriately vetted scientific information. The United States (U.S.) biomedical research community in general, and the NIH IRP, most certainly, have greatly benefited from the presence of talented foreign scientists in U.S. laboratories. Some foreign scientists have come to the United States for training as predoctoral fellows or postdoctoral fellows in the NIH visiting fellows programs; others have been recruited to the NIH as world-class principal investigators; and still others have joined the extended NIH family through formal and informal collaborative activities.

The vast majority of our professional interactions with foreign scientists and institutions are beneficial to the NIH mission and lead to enduring collaborations and major scientific advances. A very recent example (among many) includes the award of the 2018 Nobel Prize in Physiology or Medicine to Dr. Tasuku Honjo of Kyoto University in Japan for his work on immune checkpoint regulation. Dr. Honjo did his postdoctoral training at the NIH in the 1970s and returned over several years in the 1990s as a Fogarty Scholar to advance his award-winning studies through collaborations with NIH’s outstanding immunology community.

Recent events and questions from various Congressional committees, have demonstrated that some of our international collaborations may pose a potential risk to U.S. national/economic security. We have discovered, in some cases, that the motives of scientists are not focused on the advancement of NIH funded biomedical research but primarily on personal financial gain, or achieving a competitive or commercial advantage for a foreign country or company. We want to facilitate the positive interactions we have with foreign scientists and institutions, but also protect the U.S. from exploitative relationships, including circumstances in which confidential or proprietary information or intellectual property may be misappropriated. To this end, this guide will focus on four situations that require special attention or review:

1. The invitation extended by an NIH scientific staff to a Visiting Fellow, Predoctoral Fellow, or other foreign scientist (defined as not a U.S. citizen or not a U.S. permanent resident) to work in an NIH laboratory;
2. The invitation extended by foreign institutions, especially those institutions affiliated with a foreign government (including a public or government-run academic institution), to NIH scientific staff to establish, oversee, participate in, or advise overseas research programs or other activities;
3. The request by foreign institutions, especially those institutions affiliated with a foreign government, for material support from NIH or requests for letters of reference by NIH to enable former NIH trainees to establish research laboratories in other countries; and
4. The establishment of collaborations between NIH scientific staff and scientists from other countries.

Guidance for Investigators in the NIH IRP

(1) Deciding whether to invite a foreign scientist to work or train in an NIH IRP laboratory

If the appointment authority for the foreign scientist is the NIH Visiting Program, and the NIH is providing support for the incoming scientist under that program, the following due diligence is expected by the following parties:

• NIH scientific staff, and the host PI in particular, should interview the candidate, check references, especially from sources known to the host PI if possible, and should use publicly available search engines and information sources such as PubMed to check on the candidate’s publications, research experience, and research interests, to understand and document why working at the NIH would be of mutual benefit to the candidate and to NIH. NIH scientific staff are responsible for determining whether the candidate possesses the scientific research credentials for the designation offered.
  • If it is determined that the candidate will have an ongoing contractual relationship (such as an employment contract or an agreement to provide instruction) with a foreign institution during their period of stay at NIH, then the host PI needs to confirm the appropriateness by reviewing the questions outlined below in the “Guidance for Oversight at the NIH” section. ICs are responsible for informing the Division of International Services (DIS) of a candidate’s ongoing relationship with a foreign institution.
• DIS will review the supporting documentation, including the candidate’s academic credentials. The candidate must be cleared by DIS to ensure they meet NIH policy requirements for the Visiting Program. Clearance is required before the assignment may commence.
• NIH Office of Research Services (ORS) will conduct the necessary checks and/or background investigation in accordance with Federal regulations and/or policy to include review of candidate’s criminal history, federal forms, and any pertinent information prior to granting badge authorization or retainment in Federal service.

If any questions or concerns emerge about undue foreign interference relating to an applicant, please contact the NIH Compliance, Oversight, and Assessment Group¹ (NCOAG) at [email protected] for further guidance. NCOAG may review the credentials of foreign nationals independently, as part of ongoing measures to limit undue foreign interference at NIH. In general, foreign scientists offering their services as Special Volunteers (working for us), Guest Researchers (working on their own projects), or on-site Collaborators, with other sources of compensation should receive the most scrutiny and the source(s) of support should be determined and be part of the documented analysis about the suitability of the appointment. Any additional outside compensation received or employment relationships maintained by foreign nationals during their duration in the Visiting Program (i.e., FTE or non-FTE) must be reported in writing to DIS prior to foreign scientists’ appointment, or when a new appointment is offered while the foreign national is affiliated with NIH. However, even permanent residents, who would be appointed as IRTAs or CRTAs, may have activities in their home countries, such as business activities or foreign research support that create financial conflicts of interest, and NIH scientific staff should be alert to this possibility. Note that permanent residents are not processed or cleared for employment by DIS, so ICs will need to rely on alert NIH scientific staff for a thorough assessment.

Formal fellowship programs, such as the Japanese JSPS, Korean KIST and KHIDI, or the African Post-doctoral training initiative (APTI) are based on official agreements between the NIH Director, the Fogarty International Center, and official representatives of the funding country. That said, due diligence (looking at the appropriate documentation and assessing its validity) is still needed by NIH staff to assure that the candidates coming to their laboratories or clinics as part of these centrally vetted programs are qualified for the work they will be doing here.

(2) Invitations to establish, oversee, or advise on research programs in foreign countries

NIH scientific staff may be invited to become affiliated with an academic or scientific institution they are collaborating with, or may be approached by an institution when there is no ongoing collaboration. However, the following points must be considered:

• Federal employees, contract employees, individuals serving under IPAs, and SGEs other than peer reviewers, who are engaged in intramural research are prohibited from participating in any foreign talent recruitment program or malign talent recruitment program². This prohibition does not include outside visitors or guests, or participants in the NIH Visiting Program (except for Title 42 Investigators), who are temporarily engaged in intramural research at NIH. The Guidelines for Federal Agencies Regarding Foreign Talent Recruitment Programs (February 14, 2024) do not prohibit participation in appropriate international collaboration activities³, so long as the activity is not funded, organized, of managed by an academic institution or a foreign talent recruitment program listed under the National Defense Authorization Act.
• NIH scientific staff cannot establish or supervise research laboratories at external institutions as part of their official duty without prior written approval from their supervisor and the IC Deputy Ethics Counselor (DEC). NIH employees may not engage in any outside activities, regardless of compensation, without review and approval by the IC ethics officer and (in many cases) the central NIH Ethics Advisory Committee.
• NIH employees and NIH trainees (or fellows) cannot accept compensation for any official duty activity or for any outside activities that overlap with their research activities at the NIH. To have an activity considered as an official duty activity (i.e., participation in an international consortium or formal collaboration), this activity must be well-described as an official duty activity, explaining the expected benefit the NIH will receive from the collaboration.
• NIH employees and trainees (or fellows) must disclose and get prior approval for any resource support including sponsored travel, and support for laboratory personnel and provision of high-valued materials that are not freely available, such as biologics, chemicals, model systems, technology, etc.
• NIH employees and trainees (or fellows) must disclose prior to acceptance of all appointments with external institutions, including titled academic, professional, or institutional appointments, whether or not remuneration is received, and whether this appointment is full-time, part-time, or voluntary (including adjunct, visiting, or honorary). A full explanation must be given to the supervisor as to why such an appointment is necessary for the success of the collaboration.
• Non-FTE NIH trainees are expected to apply the ethical principles of federal employees as a guide to their conduct, as outlined in the Guidelines for Non-FTEs (Trainees) for NIH-Related Activities, Outside Activities, and Awards. Documentation of supervisor approval to perform appropriate official duties for non-FTE trainees (such as engaging in research collaborations or participating in professional societies) requires completion of the Review Form.

This information must be very carefully reviewed by the NIH employee’s supervisor and Scientific Director, then routed for formal approval by the ethics office. If either the supervisor or SD are involved in the collaboration (or are engaged in a similar type of collaboration), then the proposed collaboration must be forwarded to the Deputy Director for Intramural Research (DDIR) for review and approval. Each official duty travel related to the activity should be approved prior to any trip through the usual NIH travel approval process, and the NIH scientific staff should carefully justify the sponsorship. It is not appropriate to receive sponsored travel from an external institution if the NIH scientific staff is currently engaged in an active collaboration with researchers from that institution, unless the sponsored travel is to attend a conference, symposium, workshop, meeting or seminar and other similarly situated speakers are receiving the same travel package. If the requesting NIH scientific staff is a foreign national, the activity must also be reviewed and approved by DIS. DIS approval is required regardless of whether or not the activity is considered an official duty activity or an outside activity.

(3) Writing of letters of reference for foreign scientists; provision of material support for foreign research activities

NIH employees, as supervisors of multiple trainees, are frequently asked to write letters of reference to help enable their trainees to secure research positions in other countries. This activity is part of the responsibility of a scientific mentor and advocate. Such letters should be consistent with standard letters of reference for scientists and not include any promises of further NIH research support or material support. However, sometimes research projects begun at the NIH are continued as collaborations with scientists who have relocated to other countries. Research collaborations should be documented, reviewed and approved by a designee of the SD, such as a supervisor. If collaborations involve loan of equipment or provision of materials, this should be specified in the letters of collaboration and approved by supervisors and the IC SD. In addition, any equipment loans must be documented using the NIH standard form 2489-1 which must be signed off by the Chief of the Property Management Branch, the Director of the Division of Logistics Services, the SD, and the DDIR. Generally, use of publicly available databases is encouraged, but transfer of large datasets and materials must be approved through the standard Materials Transfer Agreement that is coordinated by the IC Technology Transfer Office. Transfer of certain materials, such as clinical samples, requires IRB review and approval (also see section (4) below). Materials transferred should not be further transferred to a third party without permission. It is important to uphold and expect the highest standards of research integrity in interactions with all scientists. For example, scientists are discouraged from re-publishing NIH work in non-credible journals (the NIH Library may assist in the determination of which journals are reputable) or using non-public research information that comes from their NIH collaborations to apply for funding from foreign sources. It is important that departing staff and employees adhere to the NIH record retention policy, prohibiting the removal of official records, and to the Guidance on the Conduct of Research, requiring supervisor approval prior to removal of copies of records (such as laboratory notebooks).

(4) Establishing collaborations with scientists from other countries

In addition to official NIH collaborations that are generally well-documented, NIH scientists are frequently approached by scientists from other countries to initiate collaborations, both clinical and laboratory based, or they approach a potential foreign collaborator. For informal collaborations (collaborations that are not yet documented by an agreement), especially if the foreign scientist is not well-known to the NIH employee, special attention to the qualifications and scientific justifications made by the scientist requesting the collaboration is needed; if doubts or questions arise, NCOAG¹ should be consulted. As noted above, collaborations should be documented and approved by the NIH research staff’s immediate supervisor. Collaborations that involve the exchange of biological materials or research data must be formalized by the IC Technology Transfer Office or other appropriate reviewers. All applicable federal laws, regulations, policies, and guidelines must be followed for these collaborations (see the summary). For example, for clinical collaborations, if patients are being seen at foreign sites, these sites must have approved Federal-Wide Assurances (FWAs), and for collaborative animal studies abroad, the foreign institution must have a PHS Animal Welfare Assurance (filed with the Office of Laboratory Animal Welfare). See also item (2) above regarding DIS review of outside activity of foreign national scientists.

Guidance for Oversight at the NIH

It is not always readily appreciated by NIH employees when informal interactions with a foreign institution substantively change such that the employee now needs approval of the activity either as an official duty activity, or as an outside activity. There are two approaches to bridging the gap: 1) Having a thorough discussion between the researcher and a supervisor, and an ethics official at the time of an ethics disclosure, such as the review of an official duty memorandum or outside activity disclosure, to be certain that all relevant aspects of the relationship are disclosed; 2) Considering all related approval processes that may be taking place in parallel (such as sponsored travel and research agreement approval) within a Laboratory, Branch, Division or Institute/Center (IC). For both of these approaches, it should be made clear, from the time of onboarding to the time at which regular evaluations and progress checks are performed, that discussion and disclosure prior to initiation of these activities is critical to protecting the individual and the institution. Examples of topics covered by these two complementary approaches are outlined below.

When a new official duty activity opportunity is disclosed that involves a foreign academic or research institution or government, it is essential to discern the true scope of that activity and whether it can actually be considered an official duty activity. The following questions can help guide that discussion:

• Is there remuneration?
• Is there an employment contract or agreement with the foreign academic or research institution or government?
• Will there be an appointment into a titled position, including an honorary title?
• Will that honorary title or institutional affiliation be used in any publications or on any web page at the foreign institution?
• Will the activity likely include agreements such as MTAs, RCAs, CRADAs or MOUs? Check with the IC Technology Transfer Office for a discussion of the implications of any type of an agreement with a foreign institution, as additional approvals may be necessary.
• Will the activity likely entail co-submission of contracts or applications for any grants or cooperative agreements? Will the researcher serve on any NIH study sections during this collaboration, or serve as a reviewer for grant applications emanating from that country?
• Is the activity likely to produce confidential or proprietary information or intellectual property? Is it likely to lead to clinical trials?
• Does the activity entail hosting foreign nationals at NIH that are paid by that entity?
• Will sponsored travel be involved, for what purpose, and at what frequency? How will the NIH laboratory be managed during those absences? Will the researcher plan to take personal leave to attend to activities in the foreign laboratory?

When an approver in a Laboratory, Branch, Division or IC is provided with any of the following documents for approval, the approver should consider how that proposed approval action integrates with other, approved activities. The sole purpose of the integrative approach is to be sure that the approver is using a holistic view of how a single approval, in context of parallel approvals, might lead to a perception (or reality) of undue foreign interference. It allows the approver to decide if an additional conversation with the NIH employee is warranted. The types of documents relevant to the holistic approach include, but are not limited to:

• Annual ethics disclosures.
• Disclosures of official duty activities from a foreign country.
• Sponsored travel to a foreign country.
• Appointments of Special Volunteers or Guest Researchers largely from one foreign country.
• Grants, contracts, or cooperative agreements that include participants from a foreign country.
• NIH Annual Report to identify whether external collaborators are largely from one foreign country, rather than a variety of foreign countries.
• Extended or regular (e.g., one week per month over a period of a year) annual leave requests to determine if they abut periods of sponsored travel.
• New RCA, MTA, CRADA or MOU approvals that include participants from a foreign country.
• Patents and licenses coordinated by the Technology Transfer Office and involving participants from a foreign country.

Researchers must disclose all relevant information when providing their supervisor with a document for approval that entails a foreign activity or institution. Supervisors should solicit input from appropriate IC support staff (such as the IC Deputy Ethics Counselor, Ethics Coordinator, or Ethics Specialist) and must carefully consider whether the information provided in one document, in the context of other approved activities, might lead to a perception (or reality) of undue foreign interference.

Selected Relevant Policies

• NIH Manual Chapter 2400-01 – Introduction to Government Ethics at the NIH and statutes (18 USC) cited within the Policy

[1] NCOAG is a component of the NIH Counterintelligence/Insider Threat program established, pursuant to a June 4, 2019 Memorandum between HHS Deputy Secretary and the Assistant Deputy Secretary for National Security, following a 2012 Presidential Memorandum, National Insider Threat Policy and Minimum Standards for Executive Branch Insider Threat Programs. NCOAG is a team of professionals (i.e., science, intelligence, cyber security investigative, compliance and counterintelligence analysts) from across NIH, responsible for information integration, analysis, and response activities to address threats and concerns to NIH and national security.

[2] A foreign talent recruitment program is any program, position, or activity that includes compensation in the form of cash, in-kind compensation, including research funding, promised future compensation, complimentary foreign travel, things of non de minimis value, honorific titles, career advancement opportunities, or other types of remuneration or consideration directly provided by a foreign country at any level (national, provincial, or local) or their designee, or an entity based in, funded by, or affiliated with a foreign country, whether or not directly sponsored by the foreign country, to an individual, whether directly or indirectly stated in the arrangement, contract, or other documentation at issue. [Guidelines for Federal Agencies Regarding Foreign Talent Recruitment Programs, February 14, 2024.] A detailed definition for a “malign foreign talent recruitment program,” a subset of foreign talent recruitment programs, is provided in these Guidelines.

[3] Appropriate international collaboration activities include: making scholarly presentations and publishing written materials regarding scientific information not otherwise controlled under current law; participating in international conferences or other international exchanges, research projects or programs that involve open and reciprocal exchange of scientific information, and which are aimed at advancing international scientific understanding and not otherwise controlled under current law; advising a foreign student enrolled at an institution of higher education or writing a recommendation for such a student, at such student's request; engaging in the international activities that are partly sponsored or otherwise supported by the United States; involvement in national or international academies or professional societies that produce publications in the open scientific literature that are not in conflict with the interests of the federal research agency; taking a sabbatical, serving as a visiting scholar, or engaging in continuing education activities that are not in conflict with the interests of the federal research agency; receiving awards for research and development which serve to enhance the prestige of the federal research agency. [Guidelines for Federal Agencies Regarding Foreign Talent Recruitment Programs, February 14, 2024.]