A Financial Conflict of Interest in Research 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.
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. 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:
- Patient consent disclosure
- Team disclosure
- Publications and presentations
- NIH/other collaborators
- Public announcements (press release, social media, etc.)
- Limitations on study activities
- Equity management
- Oversight requirements
- Guidelines for Students and Trainees
Non-compliance with Financial Conflicts of Interest in Research Committee Policy or Process
The Financial Conflicts of Interest in Research Committee (FCOIR) provides detailed information on the actions taken to remediate non-compliance violations with the FCOIR policy or process as described in three levels. The FCOIR Committee Chair will retain discretion to impose a higher level of action than the standard for a particular step if warranted by the nature of the violation.
For violations involving NIH sponsored studies, the FCOIR will evaluate possible impact of violation and notify NIH if required by PHS policy.