Before you can join any study, you will be given the opportunity to learn everything you can about the research study. Because all research carries some risk, it is important that you know as much as possible about the research study. For example, sometimes research procedures and drugs cause discomfort, unwanted side effects or both. All of the risks and side effects of the research may not be known when you start the study. Only after you have a clear understanding of what will take place in the study, your role and rights in the study, the benefits and harms you may face, can you make the best choice for yourself.

This process of education before participation is called an "informed consent". Your informed consent begins when a member of the research staff explains the key facts of the study to you. The research staff will also give you a "consent form" which has the study details written down. You should take your time when you read the consent form. If there is anything that bothers you, be sure to ask questions. If you do not understand the answer to one of your questions, ask the question again until you feel comfortable. Below is a list of questions you might ask. Feel free to bring someone with you at any time who can help you to understand the language or facts of the study. You can also bring the information home with you and discuss it with your family, friends, or a health care provider while you make your decision.

If you decide to take part in the study, you will be asked to sign the consent form to show that you understand the study and want to volunteer. However, the informed consent process continues after you sign the form. During the course of the study, you will be updated on any new findings, benefits or risks that may change your mind about staying in the study. As a volunteer, you may decide to change your mind and leave the study at any time. If you decide to leave the study, you will be encouraged to see the study doctor. Your doctor will explain any study exit procedures that are necessary for your safety and discuss other treatment options with you.

• Who is doing this study and what question might it answer?
• How does the new treatment compare with the usual treatment that doctors approve?
• Will this research help my condition? If so, how?
• What tests or procedures will be done?
• Is it possible that I will get a placebo (an inactive substance) instead of medicine?
• Will I have to make extra trips to the clinic?
• What could happen to me, both good and bad, if I take part in the study?
• How long will the study last?
• What will happen to any samples that I give?
• Who has reviewed and approved of this study?
• Could my condition get worse during the study? What will happen if it does?
• What other options or choices do I have if I decide not to take part in the study?
• Who will be in charge of my care? Will I be able to see my own doctor?
• Will I be charged anything or paid anything to be in this study?
• If I decide to participate in this study, how will it affect my daily life?
• What will happen to me at the end of the study?
• Will I be told the results of the study?
• Who will find out that I am taking part in this study?
• How do I end my participation in this study if I change my mind?
• Whom do I contact for questions and information about the study?