FCOI Policy

FCOI Policy: The Federal Government requires Investigators in many grant applications to disclose to the Company by the time the application is submitted to the NIH all known Significant Financial Interests that 1) would reasonably appear to be affected by the NIH research; and 2) in entities whose financial interests would reasonably appear to be affected by the research.

“Investigator” refers to the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research funded by the NIH or proposed for such funding, including Investigators working for sub-grantees/contractors/subcontractors/collaborators.  The term Investigator includes the Investigator’s spouse and dependent children. Note that these responsibilities are not limited to the Principal Investigator or key personnel, but, rather, apply to all individuals who are responsible for the design, conduct, or reporting of research. 

The term “Significant Financial Interest” is defined by the regulation as anything of monetary value, including but not limited to:

• salary or other payments for services (e.g., consulting fees or honoraria);

• equity interests (e.g., stocks, stock options, or other ownership interests);

• intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

The term "Significant Financial Interest" does not include:

• salary, royalties, or other remuneration from the Institution;

• any ownership interests in the Institution, if the Institution is an applicant under the SBIR and STTR Programs;

• income from seminars, lectures, or teaching engagements sponsored by public or  nonprofit entities;

• income from service on advisory committees or review panels for public or nonprofit entities;

• an equity interest that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, meets both the following tests:  1) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and 2) does not represent more than a five percent ownership interest in any single entity; or

• salary, royalties or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next twelve months are not expected to exceed $10,000

Any conflicts of interest should be reported by Investigators to the Company President as soon as possible. In addition, each investigator in a grant should submit to the Company President by the time of application, a list of his/her known Significant Financial Interests (and those of his/her spouse and dependent children) 1) that would reasonably appear to be affected by the NIH research; and 2) in entities whose financial interests would reasonably appear to be affected by the research;

• During the period of award, the Company President or his/her designee will be responsible for updating all financial disclosures, either on an annual basis or as new Significant Financial Interests are obtained 1) that would reasonably appear to be affected by the NIH research; and 2) in entities whose financial interests would reasonably appear to be affected by the research