National Institutes of Health (NIH) Research Security Guidance
Overview
The National Institutes of Health (NIH) supports international scientific collaboration while promoting transparency, research integrity, and responsible stewardship of federally funded research. NIH research security requirements are intended to safeguard the research enterprise from inappropriate foreign interference, undisclosed research relationships and resources, and other activities that may affect the integrity of NIH-supported research.
NIH implements research security requirements through federal requirements, NIH policies, funding opportunities, award terms and conditions, disclosure requirements, certifications, and other sponsor requirements.
The Office of Research Security (ORS) assists investigators throughout the NIH award lifecycle by providing guidance on international collaborations, foreign appointments and affiliations, foreign research support, foreign talent recruitment programs, restricted entities, export controls, and other NIH research security requirements.
NIH Research Security Framework
NIH's approach to research security emphasizes transparency regarding research relationships, resources, commitments, and activities while supporting appropriate international scientific collaboration.
Research security considerations may arise when NIH-supported research involves foreign relationships or resources, international research activities, foreign talent recruitment programs, restricted or otherwise concerning organizations, or other circumstances that may affect the integrity or security of federally funded research.
Foreign Appointments, Affiliations & Research Support
NIH requires transparency regarding resources and relationships associated with Senior/Key Personnel participating in NIH-supported research.
Foreign appointments, affiliations, employment, research support, in-kind resources, and other research relationships may be relevant to NIH research security requirements and sponsor disclosures.
Investigators should ensure that applicable foreign relationships and research resources are appropriately reported to the University and disclosed to NIH when required.
For detailed information regarding NIH disclosure documents and requirements, see Federal Sponsor Disclosure Requirements.
International Collaborations
International collaboration is an important component of biomedical research and is supported by NIH when conducted in accordance with applicable sponsor and institutional requirements.
Certain international collaborations may require additional review depending on the participating individuals and organizations, research activities, sources of support, information or resources involved, and applicable NIH requirements.
ORS can assist investigators in evaluating proposed international collaborations and identifying applicable research security, export control, sponsor, or institutional requirements.
Foreign Talent Recruitment Programs
Federal and NIH requirements restrict participation in certain foreign talent recruitment programs.
Individuals who are a current party to a Malign Foreign Talent Recruitment Program (MFTRP) are not eligible to serve as Senior/Key Personnel on an NIH grant or cooperative agreement.
Investigators should contact ORS before accepting or participating in a foreign talent recruitment program or similar arrangement.
For additional information, see Foreign Talent Recruitment Programs.
Restricted Entities & Foreign Relationships
Research relationships involving certain foreign organizations or individuals may present additional research security considerations because of U.S. Government restrictions, federal research security requirements, or other circumstances associated with the proposed activity.
ORS conducts Restricted Entity Screening when appropriate to identify applicable U.S. Government restrictions and determine whether additional institutional review may be required.
The presence of an international relationship does not, by itself, indicate a research security concern. Reviews consider the specific individuals, organizations, activities, resources, and applicable sponsor or federal requirements.
Research Security Training
NIH requires Senior/Key Personnel identified on NIH grant applications to complete research security training and certify completion in accordance with applicable NIH requirements.
Research security training addresses principles such as research security, international collaboration, foreign interference, disclosure, conflicts of interest and commitment, cybersecurity, and responsible stewardship of federal research funds.
Investigators should complete required research security training within the timeframe established by NIH and the University.
Before Proposal Submission
Investigators should review the applicable NIH Notice of Funding Opportunity and identify research security requirements that may affect the proposed project.
Contact ORS Before Proposal Submission If Your Project Involves
- International collaborators or foreign organizations.
- Foreign appointments or affiliations.
- Foreign research support or in-kind resources.
- Foreign talent recruitment programs.
- Foreign-sponsored or foreign-supported research activities.
- Organizations or individuals that may be subject to U.S. Government restrictions.
- Research involving sensitive or export-controlled technologies.
- Export-controlled equipment, software, technology, or technical information.
- International transfers of research equipment, materials, software, technology, or technical information.
- Other circumstances that may present NIH research security considerations.
- Questions regarding NIH research security requirements.
ORS can assist investigators in identifying applicable requirements before proposal submission and coordinating additional institutional review when necessary.
During an NIH Award
Research security responsibilities continue throughout the life of an NIH award.
Investigators should contact ORS when circumstances change in ways that may affect previously reviewed research security considerations, including:
- Establishing a new international collaboration.
- Accepting a new foreign appointment or affiliation.
- Receiving new foreign research support or in-kind resources.
- Participating in or receiving an offer to participate in a foreign talent recruitment program.
- Adding a new foreign organization or international research relationship.
- Beginning activities involving an organization or individual that may be subject to U.S. Government restrictions.
- Providing international collaborators access to export-controlled equipment, software, technology, or technical information.
- Transferring export-controlled research assets internationally.
- Other significant changes involving foreign relationships, research resources, or activities relevant to NIH research security requirements.
Depending on the circumstances, updated sponsor information, NIH notification, additional institutional review, or other action may be required.
Investigators should also contact ORS if NIH requests additional research security information, documentation, or institutional review during an active award.
Activities That May Require Additional Review
NIH-supported research may require additional institutional review when it involves:
- Foreign appointments or affiliations.
- Foreign research support or in-kind resources.
- Foreign talent recruitment programs.
- International collaborations.
- Foreign organizations participating in research activities.
- Organizations or individuals subject to U.S. Government restrictions.
- Foreign-sponsored or foreign-supported research activities.
- Export-controlled equipment, software, technology, or technical information.
- International transfers of controlled research assets.
- Other circumstances that may present research security concerns under applicable NIH or federal requirements.
The existence of one of these factors does not necessarily prevent a research activity from proceeding. ORS will assist investigators in identifying applicable requirements and determining whether additional review or other action is appropriate.
Activities That May Affect Funding Eligibility
Certain activities or circumstances may affect an individual's eligibility to participate in NIH-supported research or result in sponsor or institutional action.
Examples include:
- Participation in a prohibited Malign Foreign Talent Recruitment Program.
- Materially incomplete or inaccurate information provided to NIH.
- Failure to disclose research relationships, resources, appointments, affiliations, or support required under applicable NIH requirements.
- Undisclosed scientific, budgetary, or commitment overlap.
- Failure to comply with applicable NIH research security certifications or requirements.
- Other circumstances identified by NIH as affecting eligibility for federal research funding.
Investigators who are uncertain whether an activity could affect participation in NIH-supported research should contact ORS before proceeding.
How ORS Can Help
ORS assists investigators with:
- NIH research security requirements.
- International collaboration reviews.
- Foreign appointment and affiliation reviews.
- Foreign research support considerations.
- Foreign talent recruitment program reviews.
- Restricted Entity Screening.
- Export control determinations.
- International research activities and transfers.
- Research security consultations.
- Coordination with Sponsored Programs and other University offices, as appropriate.
ORS assists investigators in identifying and addressing research security considerations before proposal submission and throughout the life of an award, helping to support compliant, collaborative, and internationally engaged research.
Related ORS Guidance
| Resource | Description |
|---|---|
| Federal Sponsor Risk Matrices | Overview of sponsor-specific research security risk considerations and guidance for federally sponsored research. |
| Federal Sponsor Disclosure Requirements | Guidance regarding Biographical Sketches, Current and Pending (Other) Support, Common Forms, certifications, and other sponsor disclosure requirements. |
| Foreign Talent Recruitment Programs | Guidance regarding foreign talent recruitment programs, Malign Foreign Talent Recruitment Programs, applicable federal prohibitions, and institutional review. |
| Countries of Concern | Information about countries subject to federal research security requirements or heightened institutional review. |
| Restricted Entity Screening | Guidance regarding screening individuals and organizations against U.S. Government restricted party and restricted entity lists. |
| Research Activities & Guidance | Activity-based guidance for international collaborations, foreign-sponsored research, international travel, visitors, agreements, information sharing, and other research activities. |
| Export Controls | Information about U.S. export control requirements applicable to research equipment, software, technology, technical information, international transfers, and foreign person access. |
| Research Security Training | Information about University and federally required research security training. |
Federal Resources
For current NIH research security policies, requirements, notices, and related guidance, visit the NIH Foreign Interference resources.
NIH requirements may change over time and may vary by funding opportunity or award. Investigators should review the requirements applicable to each proposal and award.
Need Assistance?
Questions regarding NIH research security requirements should be discussed with ORS as early as possible during proposal development, before initiating new international research activities, or whenever circumstances change during an active award.
ORS can assist investigators in identifying applicable NIH requirements, coordinating institutional review, and addressing research security considerations throughout the award lifecycle.