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Human Subjects Research

CLINICAL RESEARCH = HUMAN SUBJECT RESEARCH

Clinical research can be defined as any systematic investigation conducted through an intervention or interaction with human subjects or on material of human origin such as tissues, specimens and cognitive phenomena. Types of human subject research include:

    • Patient-oriented research studies (mechanisms of human disease, therapeutic interventions, clinical trials, development of new) technologies
    • Epidemiologic and behavioral studies
    • Outcomes research and health services research.

A clinical researcher, including students and trainees, is one that engages in clinical research activities.

 

The Office of Research oversees the facilitation of clinical trials by UT Health Science Center researchers. We provide support for human subjects research through the Clinical Trials Unit.

CITI Certification
UTHSC IRB
ClinicalTrials.gov
ResearchMatch

 

CLINICAL TRIALS 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 xxxx to find potential collaborators via our informatics gateway, ties panels, partner network, and other team science platforms. [LEARN MORE - UAB links to a "Partner Network" page]

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 (CTU) 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 (CTU) 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.

xxxx staff are experts in building budgets for clinical trials. Watch budget best practices video.
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 CTU 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 (CTU) research personnel can help you keep the participants you enroll. 

Research Nursing Support through the Clinical Trials Unit (CTU) 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 [xxxxx] will help collect and enter your study's data. LEARN MORE
The Office of Research offers a library of helpful implementation tools for clinical trials. LEARN MORE
The Clinical Research Center (CRC) 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 billlables.. LEARN MORE

 

 

 

May 8, 2024