Financial Conflict of Interest

The National Institute of Health (NIH) as part of the US Public Health Services (PHS) has a financial conflict of interest (FCOI) regulation that includes disclosure, reporting, and training requirements (42 CFR Part 50, Subpart F, Promoting Objectivity in Research).

The purpose of the FCOI regulation is to "promote objectivity in research by establishing standards to ensure there are no reasonable expectations that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator."

Applicability

This regulation applies to each institution (including foreign institutions) that applies for or receives NIH grants or cooperative agreements for research and to each investigator planning to or participating in such research. This includes sub-grantees, contractors, consortium participants, collaborators, and consultants.

For purposes of financial disclosure only, the regulation covers the investigator's interests (and those of their spouse and dependent children) that reasonably appear to be related to the investigator's institutional responsibilities (i.e. your professional responsibilities related to teaching, research and service on behalf of CCMB).

Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e. that which is paid on behalf of the investigator and not reimbursed to the investigator), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a 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.

Definition of Investigator

"Investigator" means 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 (e.g., NIH), or proposed for such funding, which may include, for example, collaborators or consultants. Institutions should consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of an investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty) the risk is that an unidentified FCOI may compromise the research enterprise increases.

In addition, the Investigator's spouse and dependent children have been eliminated from the definition of "Investigator" under the 2011 revised regulation; however, they are referenced in the definition of "Significant Financial Interest" because the Investigator must also disclose Significant Financial Interests of his/her spouse and dependent children.

Definition of FCOI

FCOI means "a significant financial interest that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research."

Significant Financial Interest include:

  • Compensation and other payment for services > $5,000 (e.g. consulting fees, paid authorship, and honoraria);
  • Equity interests (e.g. stocks, stock options, and other ownership interests); and
  • Intellectual property rights (e.g. patents, copyrights, and royalties).

Significant Financial Interest does not includes:

  • Salary, royalties, or other remuneration paid by CCMB to the investigator if the investigator is currently employed or otherwise appointed by CCMB, including intellectual property rights assigned to CCMB and agreements to share in royalties related to such rights;
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles;
  • Income from seminars lectures, or teaching engagements sponsored by a 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
  • Income from service on advisory committees or review panels for a 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.

Procedure

All CCMB staff who have been delegated a role-specific to research with NIH funding must follow the steps below:

  1. Complete the NIH FCOI training tutorial required upon hiring and every 4 years thereafter. The training takes approximately 30 minutes to complete. Upon completion of the FCOI online tutorial, print and forward your certificate of completion to the CTU office attention: Ethics & Regulatory Affairs Secretary, Room ON4030E.
  2. Complete a Financial Interest Report Form to declare financial interests for you, your spouse and dependent children (if applicable). The form is required upon hiring and will be requested annually thereafter. The form must also be submitted if you acquire a significant financial interest through purchase, marriage or inheritance. Print, sign and date, and forward the form to the attention of CCMB’s Director of Finance ON4022c.

CCMB Responsibilities

If a significant financial interest has been declared, CCMB's designated official, the Director of Finance, will assess whether a FCOI exists and whether any significant financial interest relate to NIH-funded research. If the existence of a FCOI is confirmed, the Director of Finance will implement a management plan to manage such FCOI.
 
If a significant financial interest is deemed to be a FCOI is found to be related to NIH-funded research, has been disclosed, and is still held by the staff, CCMB is required to make this information publically accessible on its website. Specifically, CCMB must make the following information available for at least three years:
  • Staff person name, title, and role for the research project;
  • Name of the entity in which the investigator has an FCOI; and
  • The nature of the significant financial interest and its approximate dollar value.