VOLUNTARY PARTICIPATION

Participation in a clinical trial is entirely voluntary. The decision not to participate will not have any negative effect on a patient or their medical care. Patients can decide to participate, but withdraw their consent at any time. To participate in a clinical trial, patients must first provide informed consent. Informed consent for a trial involves much more than just reading and signing a piece of paper. Rather, it involves two essential parts: a document and a process. The informed consent document provides a summary of the clinical trial. It is designed to begin the informed consent process, which consists of conversations between the patient and the clinical trial team. If the patient then decides to enter the trial, they give their official consent by signing the document. During the informed consent process patients should ensure that they are provided with answers to the following questions:

• Why is this study being done?
• Who is sponsoring the study?
• What are the potential immediate and long-term risks of the study?
• What are the potential benefits of the study?
• What other procedures or treatments are available to me?
• If the study involves a drug or device, is this drug or device FDA approved?
• What will I be asked to do if I take part in the study?
• How long will my participation in the study last?
• Other than attending study visits, what are my responsibilities during the study?
• Are there any foods, medications, procedures, or treatments that I must avoid during the study?
• What costs will I (or my insurance) be responsible for, and what will be paid for by the study?
• How will the confidentiality of my research information be protected?
• What happens if I withdraw or stop participating in the study?
• Will I be able to find out the results of the study?
• Will the clinical trial team release the results of my research tests to my regular doctor(s)?
• Who will provide my medical care after my participation in the study has ended?