Financial Conflict of Interest
Guidance for Determining If a Financial Conflict of Interest Is Related to PHS‐Funded Sponsored Projects
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The university designated official(s) (Department Chair or Supervisor) reviews financial conflict of interest disclosures related to an Investigator’s institutional responsibilities to determine if a financial conflict of interest (FCOI) exists.
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Determine if the FCOI could directly and significantly affect the design, conduct, or reporting of the research.
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The designated official(s) (may involve the University Conflict of Interest Committee) must determine whether the financial interest is related to PHS research. A financial interest is related to the research when the interest could be affected by the research; or is in an entity whose financial interest could be affected by the research results and outcomes.
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The designated official(s), in consultation with the Investigator, will determine appropriate mitigation measures to manage, reduce, or eliminate the financial interest by requiring a management plan to ensure the research is free from bias or financial conflicts resulting from investigator’s financial interests.
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If the financial interest is related to PHS sponsored research, the department chair/supervisor composes a management plan and forwards confidential packet to the Office of Research Compliance and Assurance. As defined by the Public Health Service, the required key elements of a management plan are outlined in the USA Conflict of Commitment/Financial Conflict of Interest policy, page 10.
The designated official (departmental chair or supervisor) and/or University Conflict of Interest Committee shall consider, but not limited to, the following factors:
- Financial interest is affiliated in an entity that is part of a consortium or will otherwise participate in the research.
- The investigator is involved in research under a subaward from an entity in which he/she has an financial interest.
- Entity in which the investigator has an financial interest is a sub‐recipient under the research
- The investigator has a financial interest in an entity which research space is or will be leased or from which research space will be rented.
- Intellectual property developed by the investigator is being used, tested or further developed in the research.
- Intellectual property owned by the institution and optioned/licensed to an entity in which the investigator has a financial interest is being used, tested or further developed in the research.
- Financial interest is affiliated in an entity whose products/services are related to the subject of the research, but research subjects will not receive treatment using the entity’s products.
- Products/services are being provided by or purchased from a company in which the investigator has a financial interest.
- The investigator has a financial interest in a company which manufacturers or sells a concomitant or comparator drug or device, or procedure.
- The investigator is a founder of, holds a management/executive position with, serves on a Board of, is a consultant to (with or without compensation), and/or has received travel income/reimbursement from an entity whose products or services will be used in, are the subjects of, and/or closely aligned with the research.
Research Compliance page - https://www.southalabama.edu/departments/research/compliance/conflict-of-interest/policies-guidelines.html