Research related financial interests of investigators or the institutions create potential conflicts of interest that may bias the design, conduct or reporting of research; jeopardize the protection of human research subjects; detract from employees’ teaching, research, clinical or administrative responsibilities; inappropriately influence the research training of students or fellows; or result in improper transfers of state resources to research sponsors or licensees. The Institution therefore requires investigators to disclose significant research related financial interests1 (HOOP 23.10 Research Conflicts of Interest).  Disclosures are reviewed by UTHSC-H’s Research Conflicts of Interest Committee, and it assesses if the potential conflicts can/should be managed, reduced, or eliminated in order for the research to be approved. When reviewing significant financial interests in human subjects research, the Committee applies a rebuttable presumption standard (i.e., individuals with significant financial interests may not conduct the research unless there are compelling circumstances). Compelling circumstances include factors such as unique investigator expertise; unique institutional resources; unique access to particular patient populations; nature of science; level of risk for human subjects; and degree to which financial interests and research are linked

The Research Conflicts of Interest Committee forwards its recommendations to the Executive Vice President for Research (EVPR) and, if the research involves human subjects, the CPHS. The EVPR determines if potential conflicts can be appropriately managed by implementing a conflict of interest management plan, but the CPHS makes the ultimate determination as to whether a plan can appropriately protect human subjects. Protocols that involve research where investigators have significant research related financial interests cannot receive final CPHS review and approval until the CPHS reviews/considers the recommendations of the Research Conflicts of Interest Committee for addressing the financial interests.

Significant financial interest in research refers to anything of monetary value that would reasonably appear to be affected by the outcome of the proposed research, regardless of whether that entity is sponsoring the research. Such interests include, but are not limited to:

• Salary or other payments for services (e.g. consulting fees or honoraria) that have in the prior 12 months exceeded $10,000, or are expected to exceed that amount in the next 12 months from a single entity. This does not include salary or other remuneration from UTHSC-H or, as applicable, other academic institutions.
  
• Equity interests (e.g. stocks, stock options, or other ownership interests) that exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value or represent more than a 5% ownership interest in any single entity. This does not include interest in mutual funds where the individual has no control over the selection of holdings.
  
• Any equity interests in a non-publicly traded for-profit financially interested entity.
  
• Intellectual property rights (e.g. patents, patents in which the investigator has a financial interest, copyrights, and royalties from such rights).
  
• Payments or entitlements paid by the sponsor in connection with the research, including bonus or milestone payments, that are not directly related to the reasonable costs of the research.
  
• Service as an officer, director, or fiduciary for a financially interested company.
  In addition to the exceptions noted above, the term significant financial interest in research does not include:
• Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
  
• Income from service on advisory committees or review panels for public or nonprofit entities.

Investigators should also disclose other significant financial interests not specifically required by the Policy if they have concerns the interests would reasonably appear to be affected by the proposed research (e.g. significant financial interests of family members other than a spouse or dependent children).