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

The goal of this guide is to enable continuing and future interactions among NIH scientific staff and foreign scientists under circumstances where the NIH PI and NIH as an institution are satisfied that the circumstances of such interactions do not allow undue foreign influence on NIH-supported research.

Summary Points to Consider:

1. The NIH values collaborations and interactions with foreign scientists, and this guide should empower principal investigators to engage in collaborations, not dissuade them from such activities.
2. Exercise due diligence in bringing foreign national scientists to work in labs and clinics at the NIH.
3. Documentation is highly recommended for collaborations with scientists from other countries.
4. All necessary approvals of travel, material transfer, and equipment loans must be obtained.
5. All applicable federal regulations, policies, and guidelines must be followed for collaborative research in foreign countries.

Introduction

Biomedical research is an international enterprise accelerated by international collaborations, training experiences in other than home countries, and the sharing of appropriately vetted information. The U.S. biomedical community, in general, and the NIH intramural program, most certainly, have greatly benefited from a rich supply of talented foreign scientists. Some have come to the United States for training as predoctoral fellows or postdoctoral fellows in our visiting fellows programs; others have been recruited to the NIH as world-class principal investigators; and still others have join the extended NIH family through formal and informal collaborative activities.

The vast majority of our interactions with foreign scientists are beneficial to the NIH mission and lead to lifelong 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, some of which appeared in news coverage, and questions from various Congressional committees have implied that a very small percentage of our international collaborations pose a potential risk to U.S. national economic security. In very rare cases, the motives of a visiting scientist are not focused on the advancement of biomedical research but primarily on personal financial gain or achieving a competitive or commercial advantage for a foreign country or company. The intent may not be premeditated nor obvious, and thus a heightened awareness of the potential for exploitation is needed. We want to facilitate the positive interactions we have with foreign scientists, while protecting the NIH from exploitative relationships where intellectual property is appropriated for commercial purposes without legal authority. To this end, our discussion will focus on four situations that require special attention: (1) the invitation to a visiting fellow, predoctoral fellow, or other foreign national scientists (including non-US citizens who are not permanent residents) to work in an NIH laboratory; (2) the invitation from foreign institutions to NIH scientific staff to establish, oversee, participate in, or otherwise advise overseas research programs or commercial activities; (3) the request for material support or letters of reference to enable NIH trainees to establish research laboratories in other countries; and (4) the establishment of collaborations with scientists from other countries.

Guidance for Principal Investigators at the NIH

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

If the appointment authority is the NIH visiting program, and the NIH is providing support for the incoming scientist under that program, the following due diligence is expected:

• The Division of International Services (DIS) will review the candidate’s scholarly credentials to ensure they meet NIH policy requirements.
• The Office of Human Resources (OHR) will require candidates for FTE positions to obtain an evaluation of foreign credentials equating to a U.S. degree for onboarding purposes.
• NIH security investigators will confirm that there are no outstanding criminal charges or concerns about other practices considered suspicious by the intelligence community.
• The hosting PI should check references, especially from sources known to the PI if possible, and should use publicly available search engines and information sources (such as Google) to check on the candidates. (The latter can be difficult for candidates with common names, but it's worth a try).
• The hosting PI should understand the underlying motivation for the candidate to want to work at the NIH.

If any suspicions emerge about the motivation of the applicant, please contact the NIH Intelligence Coordinator at 301-496-9862 for further guidance. 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 any analysis about the suitability of the appointment. Any additional outside compensation received by foreign nationals who are Special Volunteers, Guest Researchers, or on-site Collaborators during the time of their appointment at the NIH must be reported to DIS. However, even permanent residents, who would be hired as IRTAs or CRTAs, may have entanglements in their home countries, such as business activities or foreign research support that create financial conflicts of interest, and PIs 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 PIs and NIH security for additional scrutiny.

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. Due diligence is needed by the PI 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. It is expected that scientists coming to the NIH as unaffiliated Special Volunteers or Guest Researchers would receive more detailed scrutiny as indicated above.

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

NIH employees and trainees (or fellows) cannot accept compensation for any activities that overlap with their research activities at the NIH; nor may they 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. 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, stating that no compensation will be received, reviewed by the PI’s supervisor and Scientific Director, and routed for formal approval by the ethics office. Any official duty travel should be approved through the usual travel approval process. If the requesting NIH scientist is a foreign national, the activity must also be reviewed and approved by the 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 PIs, as supervisors of multiple trainees, are frequently asked to write letters of support to 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 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. It is recommended that such collaborations be documented in memos or e-mails that can be reviewed and approved by the PI’s immediate 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 Scientific Director. 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 signed by the SD or their designee. Transfer of certain materials, such as clinical samples, requires IRB review and approval (also see section (4) below). It is important to uphold and expect the highest standards of research integrity in interactions with foreign national scientists. For example, foreign scientists should not be re-publishing NIH work in predatory or other journals based in foreign countries or using proprietary research information that comes from their NIH collaborations to apply for funding from foreign sources.

(4) Establishing collaborations with scientists from other countries

In addition to official NIH collaborations which are generally well-documented, NIH scientists are frequently approached by scientists from other countries to initiate collaborations, both clinical and laboratory-based. For informal collaborations, especially if the foreign scientist is not well-known to the PI, special attention to the qualifications and motivations of the scientist requesting the collaboration is needed; and if doubts arise, the NIH Intelligence Coordinator should be consulted. As noted above, it is recommended that all such collaborations be documented and approved by the PI’s immediate supervisor. All applicable federal regulations, policies, and guidelines must be followed for these collaborations (for a summary, see https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/guidelines-conduct_research.pdf). 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 USDA Animal-Welfare Assurance (AWA). See also item (2) above regarding DIS review of outside activity of foreign national scientists.