Protecting U.S. Biomedical Intellectual Innovation

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's Office and Science and Technology Policy in June 2020.

Overview

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 Influence

The U.S. government has growing concerns about inappropriate influence 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 research support including other support, foreign components, in-kind, and other resources. 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 and resources to conduct the research. Additionally, NIH requires recipient institutions and investigators to comply with the requirements of 42 CFR 50, Subpart F, the Financial Conflicts of Interest (FCOI) Regulation. The information provided in the table below does not expand nor change the FCOI requirements outlined in the FCOI regulation nor have any changes been made to the regulations. Applicants and recipients can refer to the NIH Grants Policy Statement 4.1.10 Financial Conflicts of Interest.

Examples of What to Disclose to NIH about Senior/Key Personnel on Applications and Awards:*

Table 1: Recipients Must Report**

Type of Activity	Obtain Prior Approval and Report as Foreign Component in RPPR	Report as Other Support (RPPR)	Review for potential FCOI
All positions and affiliations, including volunteer positions, relevant to the application			If personal payments to the individual
Relevant appointments at foreign institutions – even if labeled as “guest,” “adjunct,” “honorary,” with or without salary support			If personal payments to the individual
The number of person-months devoted to projects, even if there is no salary support or direct personal payments to the scientist		If new
Income, salary, consulting fees, and honoraria in support of an individual's research endeavors		If new
Participation in a foreign talent or similar-type programs		If new
Ongoing and completed research projects from the past three years that the applicant wishes to highlight
All resources and other support, both domestic and foreign, for ongoing research projects, including those conducted at a different institution		If new
In-kind contributions from domestic and foreign institutions or governments that support research activities		If new
Performance of any significant part of an NIH project outside of the US, whether or not funds are expended	If new
Post-doc, student, or visiting scholar supported by a foreign government or institution		If new
Travel paid by a foreign institution or government over $5,000 per year
Financial interests received from a foreign Institution of higher education or a foreign government

*See NOT-OD-19-114 for additional examples
**This table will be adjusted as form updates are made.

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.

NIH Responsibilities

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

Contacts

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:

NIH Office of Extramural Research
Phone: 301-435-0949
Email: grantscompliance@od.nih.gov

For questions or concerns about a specific award:

Contact program and grants management staff at the NIH Institute or Center that are listed on the Notice of Award.

FAQs

FAQs on Other Support and Foreign Components

Related Guide Notices

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.

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
August 20, 2018: Letter from NIH Director to Grantee Community (PDF)
December 22, 2017: NIH Open Mike Blog: Assuring the Integrity of Peer Review

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