Financial Conflict of Interest
Federal regulations, state laws and Trinity Health institutional policies recognize that researchers may have financial interests in research sponsors and/or in entities with business interests closely related to their research. Therefore, researchers must submit financial disclosure forms at the time of proposal submission for research funding, when research funding is received, and when an application for protocol is submitted to the Institutional Review Board (IRB) for review of a human research study.
The term “conflict of interest in research” refers to situations in which significant financial or other personal considerations may compromise, or have the appearance of compromising a researcher's professional judgment in conducting or reporting research.
Conflict of Interest reporting applies to all personnel involved in the design, conduct, or reporting of a research project, contract, sub-contract, agreement or protocol. In addition, these individuals must complete the training and disclose Significant Financial Interests (SFIs) that reasonably appear to be related to their institutional responsibilities (i.e., research, teaching, professional practice, institutional committee memberships, and services on panels such as the IRB). This includes, but is not limited to:
- Principal Investigators
- Co-Investigators
- Research Coordinators
- Research Assistants
- Technical Staff
- Administrative Staff
- Residents and students
- Collaborators involved in the design, conduct, or reporting of a research project
Disclosures must include the SFIs of family members. This includes all persons related by blood or marriage, financial dependents, and persons in intimate relationships.
Significant Financial Interests (SFI) must be reported and include the following scenarios:
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- Publicly Traded Companies: An SFI occurs when there is a combined equity value (ownership of stock or stock options, etc.) and income exceeding $5,000 ( or an equivalent cash value) from any one entity during the preceding 12 months and, when aggregated for the investigator and family, appears to be related to institutional responsibilities.
- Privately Held or Non-Profit Companies: An SFI occurs when there is ownership in any dollar amount or income exceeding $5,000 (or the equivalent cash value) from any one entity and, when aggregated for the investigator and family, appears to be related to institutional responsibilities.
- Intellectual Property Rights: An SFI occurs when an individual has intellectual property rights (patents or copyrights, etc.) which result in any income or where the intellectual property appears to be related to institutional responsibilities.
- Sponsored Travel: An SFI occurs when an individual is paid or reimbursed directly by an organization other than an accredited U.S. institution of higher education or by any U.S. government agency (federal, state, or local) when the sponsoring organization appears to be related to your institutional responsibilities for travel and the aggregate dollar value of the travel exceeds $5,000 in the preceding 12 months.
- Paid Positions of Influence: An SFI occurs when an individual is in an authoritative or direction shaping role in any entity not affiliated with Trinity Health and the interests of the entity appear to be related to institutional responsibilities.
Significant Financial Interests must be disclosed at the time the research is proposed, annually, when an amendment is made, and within 30 days of any change in the financial interest.
If a financial interest and/or a possible conflict of interest is disclosed, each situation is reviewed by the Trinity Health Research Conflict of Interest Committee who will make a determination regarding the conflict and provide recommendations to manage or mitigate the conflict. For further assistance with Conflict of Interest, please submit a consultation request.
Helpful Links
Institutional Review Boards SOPs: