Project Management

Financial Conflict of Interest (FCOI)

Summary of Reporting Requirements

A “significant financial interest” is defined as anything of monetary value, with exceptions (see 42 CFR § 50.603 for a full definition of significant financial interest).

The minimum threshold established in the regulation for an investigator’s significant financial interest is $10,000 in value or a 5% ownership in a single entity.

1. At the time of application: Investigators must submit significant financial interests to the institution.
2. Prior to the expenditure of funds: The institution must report a financial conflict of interest to NIH and assure that it has been managed, reduced, or eliminated.

3. FCOI identified after the initial report: The institution must report within 60 days of identifying a FCOI and assure that it has been managed, reduced, or eliminated.

The “Investigator” is the principal investigator (PI) and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding. The term “investigator” includes the investigator’s spouse and dependent children.

All reports should be sent to the Sponsored Programs Office who will report the funding to the appropriate grants management officer (GMO).

Source: Excerpted from a presentation by Leo F. Buscher, Jr., director of the Office of Grants and Research Administration for the National Cancer Institute.  Refer to slides numbered 78-81.  Link: www.aaci-cancer.org/pdf/2006_ameeting/buscher.pdf.  Reprinted from Report on Research Compliance, Volume 4, Number 4, April 2007, page 7.