Human Subjects and Clinical Research
HUMAN SUBJECTS RESEARCH, CLINICAL RESEARCH, AND CLINICAL TRIALS
The UT Health Science Center Institutional Review Board (IRB), Clinical Trials Unit and the Clinical Research Center support the conduct of human subjects clinical research and clinical trials by UT Health Science Center faculty, staff, and students in the course of their UT Health Science Center position, responsibilities or academic program, or that uses UT Health Science Center resources or facilities.
The UT Health Science Center IRB is responsible for the regulatory review, approval, support, and oversight of all UT Health Science Center research involving human subjects.
The Clinical Trials Unit and Clinical Research Center provide support, resources, equipment, and shared space for researchers conducting clinical research.
CLINICAL RESEARCH LIFECYCLE
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Feasibility studies help measure if your target population is out there. This can be done through ResearchMatch and TriNetX. Consult with a biostatistician at the BERD UNIT early on to help determine the necessary power and sample size for your study. The Center for Biomedical Informatics (CBMI) supports investigator access to clinical data.
The Clinical Trials Unit can help you assess the feasibility of your trial.
Protocol registration on ClinicalTrials.gov is required make study information publicly available to facilitate enrollment in clinical trials. The Clinical Trials Unit can help you get started with this.
Contact the UT Health Science Center IRB for required training and study approval before you begin your project.
Information on IND/IDE forms and FDA and internal audits, can be found on our Regulatory Support page.
IMPLEMENTATION
Read our Retention Quicklinks doc for info to help you keep the participants you enroll.
Clinical Trials Unit research personnel can help you keep the participants you enroll.
Research Nursing Support through the Clinical Trials Unit can help coordinate all study procedures for subjects, aid in informed consent, help treat and monitor subjects, coordinate data and safety
REPORTING/PUBLISHING
Your ClinicalTrials.gov registration will allow you to meet federal reporting requirements, disseminate your study findings, and ensure access to peer-reviewed journals for publication of research outcomes. LEARN MORE
The Office of Scientific Writing can help you improve the writing quality of your scientific manuscript
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