Participating in a Diabetes Clinical Trial

Participating in Research

Participating in a research study at Texas Diabetes Institute is always voluntary. You as the patient must decide on your own if the study is right for you. The three most common reasons people decide to take part in a research study are:

  1. Hope of some personal therapeutic benefit
  2. Confidence in their physician's recommendation to enter a trial
  3. Hope of benefiting others

The three most common reasons people decide not to take part in research are:

  1. Fear of placebo or randomization
  2. Too far to travel
  3. Desire to have the physician choose the treatment rather than accept a process that uses randomization to assign patients to a treatment group

About University Health System

The University Health System has served as a Clinical Research site since 1968. We conduct research under the Federalwide Assurance of Protection of Human Subjects FWA00003754 filed with and approved by the Office of Human Subjects Research Protections (OHRP) in Washington, DC.

The UT Health Science Center at San Antonio (UTHSCSA) serves as our Institutional Review Board (IRB).

If you or a family member have concerns or questions regarding the conduct of research that cannot be answered by the Principal Investigator or their research staff please feel free to contact:

UHS: Clinical Research Coordinator
Phone: 210-358-0086
Fax: 210-358-8496
UTHSCSA IRB
Phone:
210-567-2351

Frequently Asked Questions

What is a clinical trial?

Clinical trials, also called clinical studies, are research studies with people. Each trial seeks to answer specific scientific questions and to find better ways to prevent, detect, or treat diseases or to improve care.

What is informed consent?

Informed consent means you, as the patient, are given information so you can understand what is involved in a trial, including any potential benefits and risks, and then decide freely whether to participate or not participate.

You can ask any questions concerning the study, both before agreeing to be involved and during the course of the study. The list of questions you may want to as is provide for you in this brochure.

Your investigator will provide you a copy of the informed consent.

Can I leave the trial at any time?

Yes, you can change your mind at any time after entering the trial. You may also refuse to take part in any aspect of the research. This decision will not affect your right to receive the care you would receive if you were not in the study.

In order for you to decide if the study is right for you, here are some questions you should ask before consenting to participate in the study.

  • What is the purpose of the study?
  • Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
  • What is the researcher's reason for doing the trial? Is he/she receiving payment for each research subject's participation?
  • How long will the trial last?
  • What tests and treatments does the study involve? Will I be hospitalized?
  • What are the short-term and long-term risks and benefits of this trial? How will the trial affect my daily life?
  • Could my condition become worse during the study? What will happen if it does?
  • What do you do to monitor patient safety throughout the trial?
  • What type of long-term follow up care is part of the study?
  • Who will pay for the treatment and all other expenses related to the study?