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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 UTHSC position, responsibilities or academic program, or that uses UT Health Science resources or facilities.

The UT Health Science Center IRB is responsible for the regulatory review, approval, support, and oversight of all UTHSC 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

 

START UP

The BERD UNIT is a resource that can review and provide feedback on the implementation of your study design. LEARN MORE
Contact your department head to find potential collaborators across UTHSC. Additionally, we maintain a network of partnerships with the medical community in Memphis and across the state through our affiliated hospitals.

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 UTHSC 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.

Staff in the Clinical Trials Unit and the Clinical Research Center are experts in building budgets for clinical trials.
The OSP can help you negotiate better terms for your trials contracts. LEARN MORE

 

IMPLEMENTATION

UTHSC is a member of ResearchMatch.org, a free participant recruitment and feasibility analysis tool for researchers at participating institutions. The Clinical Trials Unit can help develop and seek IRB approval for recruitment plans. 

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

Trained, experienced, and certified coordinators in the Clinical Trials Unit will help collect and enter your study's data. 
The Office of Research offers a library of helpful implementation tools for clinical trials. LEARN MORE
The Clinical Research Center offer nutritionists, clinical laboratory personnel, a variety of laboratory equipment, and more. LEARN MORE

 

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

 

CLOSEOUT

IRB staff can help your team with close out steps, like archiving data, record retention, and separating from the institution (if applicable).  See also the UTHSC policy on research data retention and ownership.
The OSP Post-Award Management Team can help with close out steps like invoicing final billables. LEARN MORE

 

 

 

Jul 11, 2024