A Financial Conflict of Interest in Research (“FCOIR”) arises when a financial interest or other opportunities for personal financial gain could affect or have the appearance of affecting the design, conduct, or reporting of research.
Every person listed on a research project must complete their Disclosure Profile in eDMS and must complete a project-specific disclosure form (Research Trigger Form). Click here for more information on project-specific financial disclosures.
The following questions are asked when evaluating financial interests for potential conflicts of interest in research:
- Would a reasonable person be concerned that the financial interest/financial relationship might affect your objectivity in the design, conduct, and reporting of the research?
- Would a reasonable person be concerned that you might be engaging in the research primarily because of your financial interest?
- Would a reasonable person be concerned that your financial interest/financial relationship might put you in a position where you will share results/proprietary information/IP that would otherwise not be shared?
- Would a reasonable person be concerned that your financial interest might influence how lab resources are utilized, how partnerships with industry are pursued, and how projects are assigned to student/trainees?
- Could the results of the study be important to the entity in which you have a financial relationship? (Important = financial implications, business planning implications, etc.)
- Could study results enhance or diminish the value of your financial interest(s)?
Research Management Plan
A research management plan is issued when it is determined that a financial interest represents a potential conflict of interest. Please note: it is the COI Office under the direction of the Financial Conflicts of Interest in Research Committee (FCOIR) Chairperson that determines whether there are institutional or individual financial interests that are related to the research and pose a potential FCOIR. A written management plan is required, which specifies how to manage, reduce, or eliminate the individual and/or institutional conflicts.
The elements of a research management plan include but are not limited to :
- Disclosures
- Patient consent disclosure
- Team disclosure
- Publications and presentations
- NIH/other collaborators or sponsors
- Public announcements (press release, social media, etc.)
- Limitations on study activities
- Equity management
- Oversight requirements
- Independent statistician and data analysis plan
- Guidelines for Students and Trainees
Non-Compliance with Financial Conflicts of Interest in Research Committee Policy or Process
In accordance with the Financial Conflicts of Interest in Research Committee (FCOIR) Policy, non-adherence to the policy, management plans, or reporting requirements will be reviewed on a case-by-case basis by the FCOIRC and will be reported to the Department Chair and/or to the Dean as appropriate. The FCOIR Committee Chair will retain discretion to impose a higher level of action than the standard for a particular violation, if warranted. For violations involving NIH-sponsored studies, the FCOIR will evaluate possible impact of violation and notify NIH if required by PHS policy.
Instructions and Guidance