The “informed consent” process provides potential participants with information about the clinical study they may participate in before they even enroll. The informed consent is intended to protect participants and provide information to help understand the benefits and potential risks of the trial, as well as treatment alternatives to the study. The research coordinator will explain the informed consent with the participant at the first visit. Signing an informed consent document is not a contract and participants may withdraw from a study at any time, even if the study has not closed. 

Every federally supported and conducted clinical trial is regulated by the Food and Drug Administration (FDA) and must be reviewed, approved and monitored by an Institutional Review Board (IRB). An IRB is made up of physicians, researchers, and members of the community. The IRB supervises the trial and ensures that the rights and welfare of participants are protected.

Clinical trials have criteria which dictate who may be eligible to participate. In many studies, researchers seek participants who are diagnosed with a certain illness or condition, while others may seek healthy participants.  Although some studies are limited to a predetermined group of people who are directly asked by researchers to enroll based on a specific set of criteria. The factors that allow someone to participate in a clinical trial are called inclusion criteria and the factors that disqualify from participating are called exclusion criteria. These criteria are often based on factors such as:

• Age
• Sex
• A specific medical diagnosis
• Previous treatment history
• Type and stage of the illness
• Other medical conditions

By participating in clinical research, people help doctors and researchers to evaluate potential new medications, medical devices and alternative ways to diagnose, treat or prevent a disease or condition. As a study goes on, the doctor and researchers are able to gather more information about the study drug, device, or condition. The results of the research may show that the study medication or device improves a patient’s disease or condition, causes side effects, or is not very effective. All of these results are important because they advance medical knowledge and help improve patient care.

There are many benefits of participating in a clinical trial, including:

• The opportunity to contribute to the development of medical treatments for you and others
• Further understanding of your diagnosis, how to treat it, and how to minimize problems from it
• Study-related medication, lab tests, exams, and evaluations  at no cost to you
• Study-related treatment from compassionate, highly-trained study staff, who are passionate about patient-centered care.
• Monetary compensation for time and travel (amount varies per study)

The risks of participating in a clinical trial may include: 

• There may be side-effects of treatment
• The treatment may not be effective

Yes. A participant may leave a clinical trial after joining. However, when withdrawing from a clinical trial the participant should make the study coordinator aware of their decision and their reason for leaving. 

Yes. Participants will continue to see their primary doctor for routine medical care while participating in a clinical trial. Only study-related visits will be scheduled with the doctor involved in the research study.

A placebo is an inactive pill, injection, or other form of medication that looks like a study medication but does not contain any medicine or active ingredients. In many clinical trials, study drugs are compared to placebo to assess the effectiveness of the treatment. Therefore in some studies, certain participants receive a placebo while others receive the active drug or treatment.