Clinical Research Participant FAQs

Clinical research is the study of illness and health in people. Through clinical research, we aim to answer specific questions about new or existing treatments, and how they work to improve health.

Through clinical research, we can learn about

• New uses for existing treatments
• New treatments
• How to prevent illnesses

When you participate in clinical research, you are helping other people by contributing to medical research. You may also have the chance to try new treatments before they are available to others.

Each trial has different guidelines for who can participate. There are both inclusion criteria (characteristics you must have to participate) and exclusion criteria (characteristics that you must not have to participate). Before you can join a trial, we will screen you for inclusion and exclusion criteria. We are usually seeking both healthy participants as well as participants with illnesses/conditions.

Informed consent is the process of learning about a trial before you decide whether or not you want to participate. Informed consent continues throughout the trial, meaning that our researchers will keep you up-to-date with information about the trial.

In order to help you decide whether or not to participate in the trial, the researchers will explain the details of the trial to you. Then, they will give you a written document with information about the trial. This document includes information about:

• The purpose of the trial
• How long the trial will last
• Procedures that are involved during your participation
• Contact information for the Principal Investigator
• Risks and potential benefits of participation

After reviewing the document, you will decide whether or not you want to sign it.

The informed consent document is not a contract. It does not require you to participate in research. You can withdraw from the trial at any time.

A list of open studies and information about how to enroll can be found here. Enrollment instructions can be found within each study's description.

We have sponsors for most of our clinical trials. Our sponsors may include:

• Government agencies such as National Institutes of Health (NIH)
• Private organizations such as Stanley Medical Research Institute
• Universities
• Other health systems and hospitals
• Drug and device manufacturers

A placebo is a substance or treatment that does not have any therapeutic effect. These are sometimes called “sugar pills,” “sham treatment,” or “saline injections.”

In clinical research, the placebo functions as a ‘control.’ This gives our researchers data to compare the difference between active treatment and no treatment.

An Institutional Review Board (IRB) reviews all research activities that involve human participants before studies begin. The Sheppard Pratt IRB meets on a regular basis to review all research done at Sheppard Pratt.

The primary responsibility of the IRB is to protect trial participants from risk and loss of personal rights and dignity.

There are three primary principles when considering research:

• That participation is voluntary (free and informed consent)
• There is a balance between potential benefits and potential risks to the participant
• That procedures and outcomes are fair when selecting research participants

Many of our studies do provide some compensation for time/travel. For more information, please contact the research staff.

Each of our studies is designed differently. Some of our trials only require a few hours over the course of a few months, and some trials require much more of a commitment. For more information about the trial you’re interested in, please contact the research staff.

We take every precaution to ensure that our clinical trials are designed and executed in a safe and effective manner. However, some treatments we are testing may have unpleasant side effects. It is possible that a treatment may be ineffective for some people. In addition, some participants may receive a ‘sham’ or ‘placebo’ treatment, meaning they are not receiving active treatments or medication.

Any side effects experienced in our clinical trials are generally mild to moderate in nature. As part of the clinical trial, you will report any side effects you may experience at each study visit, or by calling the research office.

If you are experiencing a medical emergency, you should go to the nearest Emergency Room or call 911. The study doctor can be reached at any time.

Most studies offer treatment in a “double blind” fashion (meaning neither participants or research staff know if the real drug/treatment or a placebo is being given). This means there is a chance you could receive a placebo treatment. The study staff will explain this in more detail prior to your participation.

You can find out if you got the active treatment after the entire study has been completed across all study sites.

Yes, participants can leave a study at any time. Please inform our research team if you will be leaving the study, as well as why.

Participation in all of our studies is voluntary; you can choose to not participate at any time with no penalties.

Our researchers do not maintain outpatient practices and are unable to see trial participants long-term after they complete studies. However, we are happy to work with participants to find an appropriate outpatient provider.