Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest

Scope Note

Learn about applicant, recipient institution, and NIH responsibilities as well as which activities need to be disclosed and where and when to disclose them.

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 for senior/key personnel on research applications and awards. 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.

NIH is part of ongoing fed-wide efforts to harmonize disclosures, including implementation of the National Security Presidential Memorandum (NSPM-33), which is designed to “strengthen protections of United States Government-supported R&D against foreign government interference and exploitation” while “maintaining an open environment to foster research discoveries and innovation that benefit our nation and the world.”

Applicant and Recipient Institution Responsibilities

Applicants and recipient organizations must:

  • 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 “Investigators” (42 CFR 50.603) who plan to participate in, or are participating in NIH-funded research, disclose their “significant financial interests” to the institution in accordance with regulation and institutional policy for the institution’s determination and management of a financial conflict of interest
  • 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 senior/key personnel’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.

Note
Small businesses have additional foreign disclosure requirements per the SBIR and STTR Extension Act of 2022. These policy changes were announced June 12, 2023 through this Notice: Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements (NOT-OD-23-139). See Foreign Disclosures and Risk Management on the NIH SEED site for more information and resources.

Pre-award and Post-award Disclosures Requirements Related to Biographical Sketch and Other Support for Sr./Key Personnel

Type of
Activity

Biographical
Sketch

Other
Support

Annual Project
Reports

Post-Award Information
Terms & Condition

Disclosure
Not Required

Professional preparation (e.g., educational degrees)

X

 

 

 

 

Organizational Affiliations and Appointments

X

 

 

 

 

Academic, professional, or institutional appointments, whether or not remuneration is received, and whether full-time, part-time, or voluntary

X

 

 

 

 

All projects currently under consideration from whatever source, and all ongoing projects, irrespective of whether support is provided through the proposing organization, another organization or directly to the individual, and regardless of whether or not they have monetary value (e.g., even if the support received is in-kind such as office/laboratory space, equipment, supplies, or employees.)

 

X

X

X

 

Recently completed support or support that has ended

 

 

 

 

X

Current or pending participation in, or applications to, programs sponsored by foreign governments, instrumentalities, or entities, including foreign government-sponsored talent recruitment programs

X

(Appropriate placement may be contract-dependent)

X

(Appropriate placement may be contract-dependent)

 

 

 

In-kind contributions not intended for use on the project/proposal being proposed

 

X

X

X

 

Visiting Scholars in Labs funded by an external entity

 

X

 

X

 

Students and postdoctoral researchers funded by an external entity

 

X

X

X

 

Consulting that falls outside of an individual’s appointment; separate from institution’s agreement

 

X

X

X

 

Consulting that is considered part of an individual’s appointment/agreement with their home institution (e.g., a PI at a foreign institution’s retention contracts within their home institution)

 

 

 

 

X

Travel supported/paid by an external entity to perform research activities with an associated time commitment

 

X

X

X

 

Travel supported/paid by an external entity to attend a conference or workshop

 

 

 

 

X

Honoraria or other payments given for the purpose of conferring distinction or to symbolize respect, esteem, or admiration unrelated to research oversight, supervision, or co-authorship

 

 

 

 

X

Teaching commitments

 

 

 

 

X

Startup company based on organization-licensed Intellectual Property (IP)

 

 

 

 

X

Startup packages provided to the individual from the proposing/home institution

 

 

 

 

X

Startup packages from organizations other than the proposing/home institution

 

X

X

X

 

Training awards, prizes, and gifts. Gifts are resources provided where there is no expectation of anything, (e.g., time, services, specific research activities, money, etc.) in return

 

 

 

 

X

Mentoring as part of an appointment, or mentor/mentee arrangements that do not involve the individual’s research activities

 

 

 

 

X

Academic year salary, or salary provided to the individual by the home institution

 

 

 

 

X

Core facilities and/or shared equipment that is broadly available

 

 

 

 

X

F&A Reimbursement provided to the proposing/home institution

 

 

 

 

X

Certification by the individual that the information disclosed is accurate, current, and complete (e.g., signature of the researcher)

 

X

X

 

 

Supporting Documentation (e.g., contracts, grants, other agreements)

 

X

 

 

 

Significant Financial Interests: Disclosure Not Required in Other Support. See NIH FCOI Policy NIH GPS 4.1.10. Disclosures must be made in FCOI module.

 

 

 

 

X

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

Contact

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: [email protected]

Report Allegations

[email protected]


This page last updated on: October 22, 2024
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