Protecting Research Participants
When conducting clinical trials, UT Southwestern Medical Center’s most important responsibility is to protect research volunteers through well-designed protocols, a dedicated Institutional Review Board (IRB) and a careful informed consent process.
Clinical Trial Protocol
A protocol is a detailed plan that explains what will be done in a clinical trial and why. It outlines how many people will participate, what medical tests they will receive and how often, and the treatment and monitoring plan. Researchers must follow the protocol approved by UT Southwestern’s Institutional Review Board (IRB).
If you have questions or concerns about safety while participating in a clinical trial, please contact a member of your clinical trial team. If you still have questions about the study or your rights as a participant, contact the Institutional Review Board (IRB) at 214-648-3060.
The Institutional Review Board
UT Southwestern has four Institutional Review Boards (IRBs). An IRB is a committee of people, such as doctors, nurses, scientists, dentists, chaplains, social workers, attorneys and patients who are responsible for protecting clinical trial participants and making sure that the trials follow federal laws.
Before a clinical trial can begin, the IRB reviews and approves the protocol to make sure that it is based on reliable scientific evidence. The IRB attempts to ensure that the protocol will not cause excessive harm to any patient.
After a clinical trial begins, the IRB monitors the trial at least once a year and stops it if any safety concerns arise. For example, if a patient developed dangerous side effects, then the trial would be stopped. It also may stop a clinical trial early if it becomes clear that the new treatment is much more effective than standard treatment, so that all participants may receive the better treatment.
The Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA) regulate UT Southwestern IRBs and researchers. OHRP and FDA officials also can visit UT Southwestern at any time to make sure all the regulations are being followed.
The Informed Consent Process
If you have the option to participate in a clinical trial, you will go through a process called informed consent. You will learn details about a specific clinical trial so that you may decide whether to participate. The informed consent process protects participants by ensuring that they understand the clinical trial’s plan before agreeing to participate.
The researcher or member of the clinical trial team will review the informed consent form in detail with you. This form explains a specific clinical trial’s purpose, procedures, risks and benefits.
You will be encouraged to ask questions about words or procedures that are confusing or you don’t understand. A family member or friend may be helpful by listening to the explanation, asking questions and recording answers.
You can take the informed consent form with you to think about whether you would like to participate in the clinical trial.