Research Conflicts of Interest
The U.S. Department of Health and Human Services revised its regulation related to conflicts of interest in research for which Public Health Service (PHS) funding is sought (42 CFR Part 50). The University of Texas System then applied the regulation to all research at its component institutions (UT System "Model Policy for Disclosure of Significant Financial Interests and Management and Reporting of Financial Conflicts of Interest in Research-Health Institutions" UTS 175). UTHealth revised its Research Conflicts of Interest Policy effective August, 2012.
UTHealth is committed to ensuring that financial interests of researchers do not affect, or appear to affect, the design, conduct, or reporting of research or compromise the protection of research subjects. Therefore, researchers must disclose their financial interests and UTHealth must review and identify potential conflicts. The Policy does not preclude the conduct of research where a conflict exists; the university and the researcher will work together and in most cases will be able to develop successful strategies to manage, reduce, or eliminate an identified financial conflict of interest in research (see section at bottom of page).
Applies to all research. The RCOI Policy applies to all research without regard to funding source. It applies to research sponsored by extramural sources as well as research supported through internal sources such as institutional funds, gifts, school or department start-up funds, etc.
Requires identification of Covered Individuals. The RCOI Policy requires that any person responsible for the design, conduct, or reporting of research must be considered as a “Covered Individual” and comply with the Policy and its requirements. This is a broader definition than previously used. Principal Investigators are responsible for determining who is a Covered Individual on each research project, and the Policy provides guidance (consider research nurses, research coordinators, data managers, graduate students, and postdoctoral fellows).
Requires training. The RCOI Policy requires that all Covered Individuals receive training on research conflicts of interest prior to initiation of research and then every two years. UTHealth employees receive this education through the regular mandatory compliance training that all employees must take on a regular basis. Covered Individuals participating in UTHealth research who do not have access to the UTHealth mandatory compliance training module and have not taken RCOI training through another source can access a training module UTHealth maintains for non-employees on the CITI website.
Requires financial disclosures. Covered Individuals must submit an Annual Financial Disclosure Statement if they have not already submitted one (e.g., employees who submit the statement as a requirement for employment). The web-based statement is usually submitted in January/February/March of each year and must be on file before a Covered Individual may participate in research at UTHealth. If an individual identified as a Covered Individual on the OSP Review & Approval Form has not completed their current Financial Disclosure Statement, OSP will not submit the application.
Requires a Research COI Certification form for each proposal. This brief one-page form is required for all research conducted at UTHealth regardless of funding source. The form asks whether or not the Covered Individual has a "significant" financial interest related to the proposed research. "Significant" financial interests are specifically defined in the RCOI Policy and are listed on the form.
The form is to be included with: 1) all funding applications submitted to OSP; 2) all research protocols submitted to CPHS (human subjects); 3) research protocols submitted to AWC (animals) as requested by the AWC: and 4) all other proposed research projects using internal funds, endowments, startup funds, or gifts designated for a specific individual’s research.
For research proposals that are not processed through the university offices of OSP, CPHS, or AWC, the RCOI Certification forms should be maintained in the department, school, or other responsible area performing the funding review. If a Covered Individual discloses a "significant" financial interest with proposed research, the form should then be sent directly to the Conflict of Interest Program Office, UCT 1510, to initiate a review for potential conflicts.
- Applies to subcontracts from UTHealth. Research proposed to be carried out through investigators at other institutions is covered by the RCOI Policy. If an entity receiving a subcontract from UTHealth does not have a policy that meets the requirements, the sub-recipient entity must follow our Policy. UTHealth will not submit an application that involves a subcontract until it receives confirmation from the other entity that the researchers involved are in compliance with their entity's policy or our UTHealth RCOI Policy. This applies to all “entities” (e.g., private companies and foundations, not just other universities).
- Applies to subcontracts to UTHealth. Before another entity submits their application that contains a subcontract for a portion of the work to be performed at UTHealth, that entity will require our OSP to certify that any UTHealth employee participating in the research is in compliance with our RCOI Policy (e.g., has a current Annual Financial Disclosure Statement on file). If a Covered Individual is not in compliance with our RCOI Policy regarding research submission requirements, OSP will not provide the certification. (Note: Other entities will require that OSP, not individual investigators, provide the required assurance.)
Management of Financial Conflicts of Interest in Research. If a "significant" financial interest is subsequently identified as representing a potential conflict in the proposed research, and the conflict is determined to be manageable, UTHealth will implement a Research COI Management Plan with strategies to mitigate the potential for bias in the conflicted research. UTHealth posts information about each employee with a financial conflict of interest in research for whom a Research COI Management Plan has been implemented. To learn more about the identification, review, and management of research conflicts, continue reading...
See Overview of Research COI Policy Hoop 94 for additional guidance.
If you have any questions about the Policy or procedures, please contact us at: Research_COI@uth.tmc.edu