COVID-19 Response: Clinical Trials Restricted
In an effort to minimize the risks of COVID-19 to our patients, research participants, and researchers, UT Southwestern is placing temporary restrictions on clinical trials, effective Monday, March 16.
Under this temporary policy:
- Only treatment-related visits for drug therapies, medical devices, or interventions will continue.
- All in-person, nonessential research visits are suspended. That includes trials that may require direct participant interaction but do not have therapeutic benefit.
- Home visits for studies that have no direct or therapeutic benefit to participants will also be placed on hold.
- When alternative methods of interacting with research participants can be implemented, such as phone calls, Skype meetings, email, or U.S. mail, select trials may continue. When that is the case, participants will be informed by a member of the research team.
UT Southwestern will regularly evaluate these restrictions and adjust them as warranted. We appreciate your patience and participation in these valuable research projects. Keeping our patients, participants, and community safe is our top priority. Check the COVID-19 website for daily updates, the most current guidelines, and frequently asked questions about clinical trials.
UT Southwestern is committed to providing excellent and innovative patient care through our leadership in biomedical research. To develop new treatments, improve diagnosis, and help prevent diseases, UT Southwestern conducts clinical studies to add to existing knowledge about diseases and conditions. Discover UT Southwestern's current clinical trials.
As a UT Southwestern patient, you may be contacted for possible participation in a clinical study. It is your choice, but we hope if you are contacted that you consider participating.
If you do not wish to be contacted about clinical studies, please let us know one of the following ways:
- Let us know when you register at your next UT Southwestern doctor’s appointment.
- Log in to UT Southwestern MyChart: You will find participation preferences under Medical Record > Medical Tools > Research Studies.
- Email us at firstname.lastname@example.org.
- Call us at 214-648-5055.
- Write us at UTSW Research Registry, 5323 Harry Hines Blvd, Dallas, TX 75390-8592 and provide your full name, address and date of birth.
Please note that even if you opt-out of contact, you may still be contacted about research studies by your physician or people on your care team.
Why Do People Volunteer?
Different people have different reasons for becoming a research volunteer. Some possible reasons people participate in research studies are to:
- Help improve medical care
- Make a difference
- Improve their own health
- Access treatment options that might not be available outside the research setting
Understanding Clinical Research
Clinical research is medical research that involves people who 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.
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 participating.
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 to participate.
If patients are interested in participating in a study, the research team will provide 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 patients understand the information about the study and give them time to decide if they want to participate. Patients should feel comfortable discussing with the research team any concerns they might have. The process of informed consent (providing additional information) does not end when patients 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 patients decide they do not want to participate in the study, they 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. Patients should take the time to review the informed consent document carefully and decide if they 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 might be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials might compare a new medical approach to a standard one that is already available, a placebo that contains no active ingredients, or 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 might 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 might observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.