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 guidance (RCOI Review Process for Projects Involving Human Subjects). 

While there is a simultaneous review of a research proposal by both the RCOI Committee and the CPHS, the RCOI Committee will provide sufficient information to the CPHS to ensure that, as applicable, financial conflicts of interest are managed. The CPHS may request additional strategies in the Plan to appropriately manage the financial conflict of interest in the research after their review.  Final CPHS review and approval is obtained only after the RCOI Committee review is completed.