Understanding Clinical Research
Clinical research is medical research that involves people like you. People volunteer to participate in carefully conducted studies that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. Without volunteers, clinical research is not possible.
There are many kinds of clinical research. Some clinical research studies test new medicines or devices. These are called clinical trials. Other studies use interviews or surveys to learn about health problems. We conduct all types of clinical research at UT Southwestern, and we need volunteers for many different kinds of studies. Here are some important things to know about clinical research before you participate.
Informed consent is an essential part of participating in clinical research. It is the process of learning the key facts about clinical research before deciding whether or not to participate. If you are interested in participating in a study, the research team will provide you with an informed consent document that includes details about the study, such as its purpose, duration, required procedures, potential risks, and whom to contact with questions or issues. It is the responsibility of the research staff to help you understand the information about the study and to give you time to decide if you want to participate. You should feel comfortable to talk about any concerns you might have with the research team. The process of informed consent (providing additional information) does not end when you sign the informed consent document. It is a process that continues with ongoing conversations between the research staff before, during, and after the research study. If you decide you do not want to participate in the study, you can withdraw at any time.
Are There Risks?
Protections are in place to ensure that each study is as safe as possible, but these methods of protection do not eliminate all possibility of risk. You should take the time to review the informed consent document carefully and decide if you feel comfortable with participating in the study. Our Institutional Review Board (IRB) oversees all clinical research at UT Southwestern. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected.
Types of Clinical Research
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare two or more interventions that are already available.
In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or undergo procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.
Now that you understand more about clinical research, learn how to enroll in UT Southwestern’s Research Participant Registry or begin to explore current studies. Questions? ResearchRegistry@UTSouthwestern.edu.