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 is 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 is applicable 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 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: Significant Financial Interest do not include:

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 Financial Conflict Of Interest (FCOI) training tutorial (click on the link to take you to the training) 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 CIO office attention: Ethics & Regulatory Affairs Secretary, Room ON4030E.
  2. Complete a Financial Interests Report Form (clink on the link to access the 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/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 and 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: