/Office for Research and Innovation
Research Security

National Institutes of Health (NIH) Research Security Guidance

The National Institutes of Health (NIH) is committed to supporting open scientific collaboration while ensuring that federally funded research is conducted with transparency, integrity, and appropriate stewardship of public resources. As part of its research security program, NIH evaluates disclosures, international research activities, foreign relationships, and other factors that may affect the integrity of the research enterprise.

The Office of Research Security (ORS) assists investigators throughout the NIH award lifecycle by helping identify applicable requirements, reviewing proposed international activities, and providing guidance on disclosure, foreign collaborations, export controls, research data protection, and other research security considerations.

How NIH Evaluates Research Security

NIH reviews research security primarily through the principles of transparency, disclosure, and responsible stewardship. Rather than evaluating international activities solely based on country or collaborator, NIH considers whether relationships and activities have been fully disclosed, whether they create scientific or administrative concerns, and whether they comply with NIH policy.

NIH's research security reviews commonly consider:

Transparency and Disclosure

  • Current and Pending (Other) Support
  • Professional appointments and affiliations
  • Foreign research support and in-kind resources
  • Foreign components
  • Institutional and sponsor disclosures
  • Research Security Training certifications

International Research Activities

  • International collaborations
  • Foreign organizations
  • International research sites
  • Visiting scientists and collaborators
  • International data collection
  • International research agreements

Scientific and Administrative Considerations

  • Scientific overlap
  • Budgetary overlap
  • Commitment overlap
  • Foreign components
  • Financial Conflicts of Interest (FCOI)
  • Conflict of Commitment

Research Security Considerations

  • Foreign Talent Recruitment Programs
  • Malign Foreign Talent Recruitment Programs
  • Controlled-access research data
  • Human genomic data
  • Sensitive biological research
  • Sponsor cybersecurity and data protection requirements

Proposal Development

Before submitting an NIH proposal, investigators should ensure that:

Disclosures

  • Biographical Sketch and Current and Pending (Other) Support Common Forms are complete and accurate.
  • All professional appointments and affiliations are disclosed, as required.
  • Foreign research support, including in-kind resources, is disclosed.
  • Information is consistent across NIH forms and University disclosures.

International Activities

  • Foreign collaborators and participating organizations are identified.
  • Foreign components are accurately described.
  • International activities comply with the applicable Notice of Funding Opportunity (NOFO).

Research Security

  • Senior/Key Personnel complete required NIH research security training and certifications.
  • Participation in a Malign Foreign Talent Recruitment Program is prohibited for Senior/Key Personnel.

Contact ORS Before Proposal Submission If Your Project Involves

  • Foreign collaborators or institutions
  • International research activities
  • Foreign sponsors
  • Controlled-access research data
  • International transfer of research materials
  • Sensitive technologies
  • Export-controlled research

Just-in-Time (JIT)

During the Just-in-Time process, investigators should review whether any information has changed since proposal submission.

Notify ORS if there are changes to:

  • Current and Pending (Other) Support
  • Professional appointments or affiliations
  • Foreign collaborations
  • Foreign components
  • International research activities
  • Senior/Key Personnel
  • Research security training certifications
  • Controlled-access data activities

Changes identified during JIT may require updates to NIH disclosures or additional institutional review.

Award Management

During an active NIH award, investigators should consult ORS before:

  • Establishing a new international collaboration.
  • Adding a foreign component.
  • Sending research data or materials outside the United States.
  • Providing foreign collaborators access to controlled-access data.
  • Hosting foreign researchers who will participate in the NIH-funded project.
  • Accepting a new foreign appointment related to the project.
  • Entering into a new agreement with a foreign organization.
  • Making significant changes to the approved research activities.

Depending on the activity, NIH prior approval or additional institutional review may be required.

Post-Award Responsibilities

Research security responsibilities continue throughout the life of the award.

Investigators should promptly notify ORS regarding:

  • New professional appointments or affiliations
  • New foreign collaborations
  • New foreign research support
  • Changes in Current and Pending (Other) Support
  • Changes in effort or overlapping research commitments
  • New foreign components
  • Changes affecting controlled-access data
  • Changes reported through the Research Performance Progress Report (RPPR)

Early consultation allows the University to determine whether NIH notification or prior approval is required before implementing the proposed change.

Activities That May Require NIH Prior Approval

Depending on the award and the proposed activity, NIH prior approval may be required for changes such as:

  • Adding or modifying a foreign component.
  • Certain changes in project scope.
  • Changes in Senior/Key Personnel.
  • Certain new domestic or international subrecipient activities.
  • Significant changes involving controlled-access data or other award-specific requirements.

Investigators should consult ORS before implementing these changes.

Activities That May Affect Funding Eligibility

Certain activities may affect an investigator's eligibility to participate in NIH-funded research or may require corrective action.

Examples include:

  • Failure to disclose required appointments, affiliations, or research support.
  • Failure to disclose foreign components.
  • Material inconsistencies in NIH disclosures.
  • Participation in a prohibited Malign Foreign Talent Recruitment Program.
  • Scientific, budgetary, or commitment overlap that has not been appropriately disclosed or managed.
  • Unauthorized access to or sharing of NIH controlled-access data.
  • Activities that are inconsistent with the approved Notice of Award or applicable NIH requirements.

How ORS Can Help

ORS works collaboratively with investigators, departments, Sponsored Programs, Information Security, and other institutional offices to help researchers navigate NIH research security requirements throughout the award lifecycle.

Services include:

  • NIH disclosure guidance
  • International collaboration reviews
  • Foreign component reviews
  • Export control guidance
  • Research data protection consultations
  • Controlled-access data coordination
  • Research security training
  • International visitor and travel consultations

Early engagement with ORS helps identify applicable requirements, minimize administrative delays, and support successful management of NIH-funded research.