Special Conditions Involving Human Subjects
All members of the UTHealth research community should be sensitive to the potential impacts of financial interests and/or non-financial relationships with commercial sponsors or other external entities on the conduct of research and the participation and protection of human research subjects. In compliance with federal regulations and guidance and UTHealth policies, the Committee for the Protection of Human Subjects (CPHS) must consider such relationships and determine, in conjunction with the Research Conflicts of Interest (RCOI) Committee, whether they might influence or appear to influence the outcome of a research project involving human subjects, the objectivity of the researcher during the performance of such a project, or the researcher's interactions with research subjects who participate in the project. Accordingly, CPHS solicits and reviews relevant information regarding possible conflicts of interest of all researchers, including investigators and key study personnel participating in a protocol involving human research subjects prior to approving or re-approving that protocol.
While the thresholds for disclosure are the same for all types of research, additional diligence in evaluation and management is required for research with potential risks to human subjects or with potential implications for medical care and the practice of medicine. The RCOI Committee applies the rebuttable presumption standard when reviewing significant financial interests in human subjects research, 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; the nature of the science; the level of risk for human subjects; and the degree to which financial interests and the research are linked.
While there is a simultaneous review of a proposed research proposal by both the RCOI Committee and the CPHS, the RCOI Committee review process is completed and the report forwarded to the CPHS before the protocol receives final CPHS review and approval. The CPHS may request revision of any recommendation in the RCOI Management Plan if it feels the proposed Plan requires additional strategies to appropriately manage the financial conflict of interest in the research.
These two committees work in conjunction with each other and the RCOI Committee process will provide sufficient information to the CPHS to ensure that, as applicable, financial conflicts are managed and research participants are appropriately informed of an investigator's significant financial interests related to the research.
For more information regarding the role and responsibilities of the CPHS, visit the website for the Office of Research Support Committees (ORSC).