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Financial Conflict of Interest

The NIH is committed to preserving the public’s trust that the research we supports is conducted without bias and with the highest scientific and ethical standards. The regulation on promoting objectivity in research establishes the standards to provide a reasonable expectation that the design, conduct, and reporting of NIH research will be free from bias resulting from investigators’ financial conflicts of interest.

Definition

A financial conflict of interest exists when the recipient's designated official(s) reasonably determines that an investigator's significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

Summary of Current Regulation

NIH requires recipient institutions and investigators (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of 42 CFR 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought" (FCOI Regulation), as implemented in the 2011 Final Rule for grants and cooperative agreements. 

The requirements promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from any conflicting financial interest of an investigator. An "investigator" is someone:
  • defined as the PD/PI and any other person, regardless of title or position
  • who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding
  • which may include, for example, collaborators or consultants.
Each Institution shall maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with the regulation and make the policy available via a publicly accessible Web site. 

These FCOI requirements do not apply to Federal employees or Federal agencies. Federal agencies have their own set of rules governing financial conflicts of interest for employees.

When submitting a grant application, the signature of the Authorized Organization Representative (AOR) certifies the applicant institution's compliance with the requirements of 42 CFR 50, Subpart F, including that:
  1. There is in effect at the Institution an up-to-date, written and enforced administrative process to identify and manage Financial Conflicts of Interest (FCOI) with respect to all research projects for which NIH funding is sought or received;
  2. The Institution shall promote and enforce Investigator compliance with the regulation's requirements including those pertaining to disclosure of Significant Financial Interests;
  3. The Institution shall identify and manage FCOIs and provide initial and ongoing FCOI reports to the NIH consistent with this subpart;
  4. When requested, the Institution will promptly make information available to the NIH/HHS relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of an FCOI;
  5. The Institution shall fully comply with the requirements of the regulation. 
When the Institution determines that an FCOI exists (see #3 above), the Institution must report to the NIH awarding Institute or Center through the submission of an initial (Original) and annual FCOI report using the eRA Commons FCOI Module (learn how to submit a report through eRA Commons). 

For full FCOI requirements, see the NIH Grants Policy Statement and the Final Rule.

Elements of an FCOI Report 

The FCOI regulation requires institutions to submit the following information when reporting an FCOI:  

  • The name of the investigator with the FCOI
  • The name of the entity with which the investigator has an FCOI
  • The nature of the Significant Financial Interest (SFI)  
  • The value of the financial interest 
  • Description  of how the financial interest relates to the NIH-funded research and why the institution determined that the financial interest conflicts with such research
  • Description of the key elements of the institution’s management plan, including other required information

Submitting an FCOI Report

Report FCOIs for grants and cooperative agreements through the eRA Commons FCOI Module. For contracts, contact the NIH Contracting Officer identified on the contract.

Learn how to submit a grant-related FCOI report through eRA Commons:
eRA FCOI module information: 

Resources

This page last updated on January 10, 2020
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