Subjects and Volunteers, Clinical Research

Clinical research studies are designed to answer specific questions concerning prevention, diagnosis and treatment of illness. A clinical trial is one type of clinical research study which generally focuses on testing investigational drugs and devices. The University of Chicago is a leader in conducting clinical research--performing more clinical trials than any other hospital in Illinois.

People of all ages, genders, races and ethnic groups can volunteer to participate in research studies. This includes healthy volunteers and patients with specific diagnoses.

Current areas of study include:

• Gastroenterology
• Autoimmune Disorders
• Cancer
• Infertility and High Risk Pregnancy
• Cardiovascular Disease
• Behavior Disorders
• and more

Some of these studies involve investigational treatments such as drugs and devices, while others involve surveys and behavioral observations.

Clinical trials are structured research studies conducted to answer specific questions concerning new therapies, devices, vaccines, or new ways of using known treatments. At the University of Chicago Medical Center, we are committed to advancing biomedical innovation and furthering the knowledge of healthcare professionals. We put this commitment into practice every day by conducting clinical trials. We are a leader in clinical trials - performing more than any other hospital in Illinois.

Our research helps healthcare professionals around the country - and around the world - to better treat many diseases, conditions and disorders. Plus, it gives our patients access to new treatments and therapies.

Details of some open clinical trials may be found at the University of Chicago Medical Center Clinical Trials web site.

• In hopes of improving their own health
• To access treatments that might not be available otherwise, often because they are new and not yet widely available
• To help others by contributing to advances in medicine

• There may be unpleasant, serious, or even life-threatening side effects to treatment or procedures involved in the study
• Volunteers may not receive any direct benefit from the treatment
• The protocol may require more time and responsibility on the part of the volunteer than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays, complex procedures, or complex dosage requirements

All of the known risks associated with a particular study will be discussed during the informed consent process and are explained in detail in the informed consent document that you will receive from the research staff.

There are federal and local regulations that protect volunteers in research studies. The federal regulations are determined by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) within the Department of Health and Human Services. The local regulations are determined by the Institutional Review Board (IRB). The primary charge of the IRB is the protection of human subjects. The IRB is comprised of volunteers from the community and institutional experts. The IRB committees review all research studies involving human subjects and approve only those studies that have met the criteria for the protection of participants. All research studies must follow the guidelines set forth by the FDA and/ or OHRP as well as the local IRB.

Participation in clinical research is voluntary. After information has been provided to you and your questions have been answered, you will be asked to give your voluntary consent to participate by signing a form that has been approved by the IRB.

Please be sure that you discuss your interest in participating in an clinical trial with your physician prior to giving consent to participate.

You may contact the IRB at any time regarding your rights as a participant in a clinical trial.

Institutional Review Board

University of Chicago

773.702.6505

Your participation in clinical research is voluntary. If you choose not to participate in a clinical trial, or if you choose to withdraw your consent while enrolled in a study, your care at the University of Chicago Medical Center will not be affected.

National Institute of Health

Food and Drug Administration

Medicare and Clinical Trials Brochure

ClinicalTrials.gov

University of Chicago, Office of Clinical Research

1-866-670-6277

If you have already been given a consent form, you can find contact information for the principal investigator and the IRB on the first page of the form.

Many of these questions are answered in the consent form that you will be asked to sign.

• What is 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 also download this worksheet to keep track of the information that you learn about a particular study.

 

Thank you for your interest in Clinical Research at the University of Chicago!