What is a clinical trial?
Clinical trials are structured research studies involving patients and are designed to safely test new drugs, devices, vaccines or ways of using known treatments. Most clinical trials concentrate on a specific disease or patient group; they might explore whether one drug is better than another or analyze data from a medical device used in treatment.
By participating in a clinical trial, you help make a difference in the lives of all patients.
For more information on participating in clinical trials at UChicago Medicine, contact the Office of Clinical Research at 866-670-6277.
Frequently Asked Questions About Clinical Trials
Clinical trials are a critical tool for improving our understanding and treatment of illnesses and disease. Anyone may be eligible to participate in clinical trials. As a potential clinical trial subject, you may be asked if you’re willing to participate in a clinical trial that is specific to your health needs or diagnosis. You may also be asked to participate in research that is not necessarily a clinical trial, such as donating blood or tissue for a genetic study. People volunteer to be in clinical trials for different reasons:
- In hopes of improving their own health
- To access treatments that may be new and not yet widely available
- To help others by contributing to medical advances
- There may be unpleasant, serious or even life-threatening side effects
- You may not benefit directly
- You may have to set aside time for travel to the study site, treatments, hospital stays and complex procedures
Federal and local regulations exist to protect volunteers in clinical trials. Federal regulations are determined by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) at the Department of Health and Human Services. Local regulations are determined by the University of Chicago Medicine Institutional Review Board (IRB).
Clinical trials must follow guidelines set forth by the FDA and/or OHRP, as well as the IRB. Before a clinical trial can begin, the IRB reviews the researchers’ proposal to ensure that the rights and well-being of those participating will be protected. Our Biological Sciences Division IRB consists of community volunteers, scientists and other institutional representatives.
You can contact our IRB at any time regarding your rights as a clinical trial volunteer:
Biological Sciences Division 773-702-6505
All of the known risks associated with a particular trial will be discussed with you before the start of the study. This is called the informed consent process, and this information will be included in a document from the study’s research staff. After this information has been provided to you and your questions have been answered, you’ll be asked to give your voluntary consent to participate by signing a form that has been approved by a University of Chicago Medicine IRB.
Each clinical trial has different enrollment requirements, and your doctor can help you identify suitable trials.
The following questions can also help you decide on whether a study is right for you:
- What’s the purpose of the study?
- Why am I being invited to participate in the study?
- How long will the study last?
- Where will the study take place?
- What will be done as part of the study?
- What will I have to do during the study?
- What are the risks?
- What are the possible benefits?
- Are other treatments or alternatives available?
- Who will see the information that is collected about me?
- What happens if I am injured during the study?
- What type of follow up is there after the study?
- Will I have to pay for any part of the study?
You can use this printable worksheet (PDF) version of these questions to discuss them with your doctor.
You’ll find many of the answers to these questions in the consent form you’ll be asked to sign.
Participating in clinical research is voluntary. If you decide not to, or if you withdraw your consent while volunteering for a study, your care at UChicago Medicine will not be affected.