- Staff person name, title and role with respect to 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.
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."
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.
"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.
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:
All CCMB staff who have been delegated a role specific to research with NIH funding must follow the steps below: