Financial Conflict of Interest Policy for Federally Sponsored Research


To promote objectivity in research by establishing standards that preserve the integrity of research, protect the rights and safety of research subjects, and prevent bias in the design, conduct, and reporting of research funded under Public Health Services (PHS) grants or cooperative agreements that may result from any financial conflict of interest.


All programs that apply for, or that receive, PHS funding through a grant or cooperative agreement for the purposes of research, and to the project director or principal investigator and any other person, regardless of title or position who is responsible for the design, conduct or reporting of research funded by the PHS, or proposed for funding. This may include collaborators or consultants. This regulation also covers the spouse and dependent children of the above-referenced persons.

Failure to Comply:

Failure to comply with this policy may lead to disciplinary or corrective action including but not limited to, removal from a research project, suspending or terminating the project, imposition of award conditions such as denying use of funds for parts of or all activities, suspension of funding, withholding further awards from project or program, and any other remedies that may be legally available.



Investigator: All principal investigators, project directors, senior/key personnel,
and any others, e.g. postdocs, who are responsible for the design, conduct or reporting
of PHS-funded research in a substantive, measurable way, whether or not they receive
salary or other remuneration.

Manage: Taking action to address a FCOI, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

PHS: The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).

Significant Financial Interest (SFI):

A Significant Financial Interest includes:

All investigators, as defined above, must disclose any SFI consisting of one or more of the following interests that is related to their institutional responsibilities, including:

  1. With regard to any publicly-traded entity: an SFI exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure, when combined with the value of any equity interest in the entity at the time of the disclosure, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value as of the date of disclosure;
  2. With regard to any non publicly-traded entity: the value of any remuneration received in the 12 months prior to the date of the disclosure, which when aggregated exceeds $5,000 or any equity interest (includes stock, stock option, or other ownership interest) held by the Investigator (or their
    spouse, registered domestic partner or dependent children) regardless of value.
  3. Any payments received from a foreign institution of higher education or the government of a foreign country.
  4. Any travel reimbursement or payment in excess of $5,000 per entity made by any entity (profit or non-profit) other than those listed below within the past 12 months, regardless of value made to or on behalf of the Investigator related to their Institutional Responsibilities.
    The following travel details are required:

    1. Purpose of the trip;
    2. Name of sponsor/organizer;
    3. Destination (city and state or country if outside the U.S.);
    4. Duration of the trip; and
    5. Total cost of the trip including lodging; registration; fare for the mode of travel (air, train, car, etc.); per diem, and any other miscellaneous expenses.

A Significant Financial Interest excludes:

  1. Payments (including, salary, royalties, or other remuneration paid to the investigator if he/she is currently employed or otherwise appointed by the institution. This includes intellectual property rights assigned to Zaiput and agreements to share in royalties related to such rights;
  2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly exercise investment decisions made in these vehicles;
  3. Income from seminars, lectures, or teaching engagements or service on advisory committee or review panels, e.g., NIH peer review, sponsored by a U.S. federal, state, or local government agency; an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or
  4. Travel reimbursed or sponsored by U.S. federal, state, or local government agency, an institution of higher education as defined by 20 U.S.C. 1001(a),
    an academic teaching hospital, a medical center, or research institute
    affiliated with a U.S. institution of higher education.

Subrecipient: An organization or researcher that participates in research with the awardee Institution (e.g. subcontractors or consortium members).