NIH and the biomedical research enterprise have a long history of International collaborations with rules of engagement that allow science to advance while also protecting intellectual capital and proprietary information of the participating countries. These rules of engagement also are designed to limit bias in the design, conduct, and reporting of NIH-supported research. This page describes actions that NIH, institutions, and researchers can take to protect U.S. biomedical intellectual innovation. The principles described here align with those announced by the White House Office and Science and Technology Policy in June 2020.
NIH research is built on a set of bedrock principles of scientific excellence, unassailable integrity, and fair competition. NIH expects applicants for and recipients of NIH-supported research — both domestic and foreign — to abide by these principles.
It is critical for NIH-supported institutions and their researchers to be wholly transparent about financial support from and affiliations with international institutions. Such transparency ensures that NIH's funding decisions are fair and appropriate, and that U.S. institutions and the American public benefit from their investment in biomedical research.
The biomedical research workforce continues to be greatly enriched and strengthened by scientists working together from many parts of the world. The extraordinary contributions of foreign nationals to American science are indisputable. The overwhelming majority of researchers participating in NIH grants, both in the U.S. and in other countries, are honest contributors to the advancement of knowledge that benefits us all. The research community must find ways to build and continue these important and successful relationships with foreign scientists around the world while simultaneously protecting the Nation's biomedical innovations and intellectual property.
Inappropriate Foreign Government Interference
The U.S. government has growing concerns about inappropriate interference by foreign governments over federally funded research. In August 2018, the NIH Director issued a statement about incidents that violate core principles and threaten the integrity and academic competitiveness of U.S. biomedical research and innovation, including:
- failure to disclose all conflicts of interest, foreign affiliations, conflicts of commitment, and other support in applications for NIH grants;
- diversion of proprietary or pre-publication information disclosed in grant applications or produced by NIH-supported research to those not authorized to receive it; and
- breaches of confidentiality in peer review.
NIH has taken a number of steps to address these risks, including convening a working group of the Advisory Committee to the Director (ACD) to deliberate on the matter and advise him on how best to address it. The ACD delivered a set of recommendations, many of which are being implemented by NIH.
Requirements for Disclosure of Other Support, Foreign Relationships and Activities, as well as Conflicts of Interest
Full transparency in NIH applications and throughout the life of an NIH grant is critical. NIH requires the disclosure of all sources of research support, foreign components, and financial conflicts of interest. NIH uses this information when making its funding decisions to determine if the research being proposed is receiving other sources of funding that could be duplicative, has the necessary time allocation, or if financial interests may affect objectivity in the conduct of the research.
Examples of What to Disclose to NIH about Senior/Key Personnel on Applications and Awards can be found on NOT-OD-19-114 and this resource here
Applicant and Recipient Institution Responsibilities
- Work with faculty and other staff to make sure that all applications, progress reports (Research Performance Progress Reports), and Just in Time submissions include an accurate and complete account of all sources of research support, and relevant affiliations for individuals named as senior/key personnel
- Ensure that all researchers working on a grant disclose their significant financial interests in accordance with regulation and institutional policy
- Ensure that all reports and communications submitted to NIH are complete and accurate
- Protect proprietary information and sensitive and confidential data as part of proper stewardship of federally funded research
- Take all reasonable and appropriate actions to prevent the inadvertent disclosure, release or loss of sensitive personal information
- Immediately notify NIH of developments that have a significant impact on NIH-supported activities
- Disclose information throughout the grant process, from updating a principal investigator's biosketch and other support, submitting an application, progress reporting, and submitting final reports, or anytime there is a significant change that impacts the NIH award
- Obtain NIH prior approval for inclusion of any foreign components to an NIH award
NIH appreciates the proactive efforts many institutions are taking to address these serious issues, such as updating institutional disclosure policies, providing outreach to faculty and staff regarding reporting requirements, and initiating reviews to ensure compliance with NIH terms and conditions of award. When instances of noncompliance are identified, NIH works with institutions to help protect the research and research funds.
- Maintain oversight of our grant awards
- Review and approve updated “other support” information for senior/key personnel, including the principal investigator, prior to and after making an award
- Review requests for the addition of a foreign component to an NIH project and approve if appropriate
- Work with institutions to ensure compliance with the terms and conditions of the grant award
- Promote the integrity, including confidentiality and security, of the peer review process
- Contact institutions when potential issues arise related to grants compliance
- Provide information, guidance, and technical assistance to applicants and recipients
When potential issues related to disclosing other support, foreign components, and FCOI are identified, notify NIH. If in doubt, ask!
For general questions and concerns:
For questions or concerns about a specific award:
Format Pages, Instructions, and Samples
Related Guide Notices
- NOT-OD-22-044: Maintaining Security and Confidentiality in NIH Peer Review: Rules, Responsibilities and Possible Consequences
- NOT-OD-19-114: Reminders of NIH Policies on Other Support and Policies Related to Financial Conflicts of Interest and Foreign Components
- NOT-OD-18-160: Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests
- NOT-OD-18-115: Maintaining Integrity in NIH Peer Review: Responsibilities and Consequences
Selected NIH Grants Policy Statement Sections of interest
- 2.5.1: Other Support and Just-in-Time
- 8.1: Changes in Project and Budget
- 8.1.2, Prior Approval Requirements
- 8.5: Specific Award Conditions and Remedies for Noncompliance
- 2.3.12: Protecting Sensitive Data and Information
- 4.1.10: Financial Conflict of Interest
NIH Statements and Reports
NIH leadership statements, blogs, related articles, and other references about NIH's continuing commitment to protecting NIH-supported innovation.
- Brief Summary of NIH Foreign Interference Cases (as of December 26, 2021)
- July 30, 2021: Foreign Interference in National Institutes of Health Funding and Grant Making Processes: A Summary of Findings From 2016 to 2021
- April 22, 2021: Dr. Michael Lauer’s Testimony before the Senate Health, Education, Labor and Pensions Committee, Hearing on Protecting U.S. Biomedical Research: Efforts to Prevent Undue Foreign Influence
- July 8, 2020: NIH Open Mike Blog: Addressing Foreign Interference and Associated Risks to the Integrity of Biomedical Research, and How You Can Help
- June 12, 2020: Advisory Committee to the NIH Director update on Foreign Influences on Research Integrity
- July 11, 2019: NIH Open Mike Blog: Clarifying Long-Standing NIH Policies on Disclosing Other Support
- March 22, 2019: Science journal letter from NIH leaders addressing concerns of Chinese American biomedical professional societies
- December 13, 2018: Report and Presentation from the Advisory Committee to the NIH Director Working Group on Foreign Influences on Research Integrity
- November 15, 2018: NIH Open Mike Blog: Working Together to Protect the Integrity of NIH-funded Research
- August 23, 2018: NIH Director's Statement on the Protection of the Integrity of Biomedical Research in the United States
- December 22, 2017: NIH Open Mike Blog: Assuring the Integrity of Peer Review
- White House Office of Science and Technology Policy Blog - Guidance for U.S. Scientific Research Security that Preserves International Collaboration
- White House Office of Science and Technology Policy - Guidance for Implementing National Security Presidential Memorandum-33 (NSPM-33) on National Security Strategy for United States Supported Research and Development
- Presidential Memorandum on U.S. Government-Supported Research and Development National Security Policy and related Fact Sheet
- White House Office of Science and Technology Policy - Recommended Practices for Strengthening the Security and Integrity of America’s Science and Technology Research Enterprise (PDF)
- White House Office of Science and Technology Policy – Enhancing the Security and Integrity of America's Research Enterprise (PDF)
- Center for Strategic and International Studies Report on America's Challenges to China's National Talent Programs
- JASON Report: Fundamental Research Security (PDF)
- Federal Register: Notice of request for information (RFI) on the American research environment
- Hoover Institution Report: China's Influence & American Interests: Promoting Constructive Vigilance
- Senate Homeland Security & Governmental Affairs Permanent Subcommittee on Investigations Hearing: Securing the U.S. Research Enterprise from China's Talent Recruitment Plans (Hearing and Reports)
- White House Office of Science and Technology Policy letter to the U.S. research community (PDF)
- National Security Strategy for the United States of America
- Commission Report on the Theft of American Intellectual Property
- American Association of Universities and American Public and Land Grant Universities Survey (PDF)
Department of Justice Announcements
- Harvard University Professor Convicted of Making False Statements and Tax Offenses
- Department Of Justice Reaches Million-Dollar Settlement With Van Andel Research Institute To Resolve Allegations Of Undisclosed Foreign Ties To NIH Grants
- University Researcher Pleads Guilty to Lying on Grant Applications to Develop Scientific Expertise for China
- Hospital Researcher Sentenced to Prison for Conspiring to Steal Trade Secrets, Sell Them in China
- University Researcher Sentenced to Prison for Lying on Grant Applications to Develop Scientific Expertise for China
- Former Emory University Professor and Chinese “Thousand Talents” Participant Convicted and Sentenced for Filing a False Tax Return
- Department Of Justice Reaches $5.5 Million Settlement With Van Andel Research Institute To Resolve Allegations Of Undisclosed Chinese Grants To Two Researchers