What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before you decide if you would like to volunteer. It is also a continuing process during the study that provides information for participants. The purpose of informed consent is to protect you and other volunteers by providing you with information that will help you make informed choices. This brochure explains the informed consent process and provides some tips on how to get the most from it. You will also learn about your rights as a clinical trial participant.

How does informed consent work?

If you are thinking of volunteering for a clinical trial, the informed consent process starts when you contact study representatives for the first time. Study doctors and nurses will provide you with information about the study and answer any questions you might have. After considering this basic information, if you are still interested in volunteering, the study team will provide you with an informed consent document. This document is a key part in the informed consent process.

The informed consent document has a very detailed description of the clinical trial. It includes the purpose of the study, what procedures are planned and when they will be done, the potential risks and benefits to you, alternatives to participating in the trial and other important information. Study staff will discuss the document with you and answer any questions you have.

If you then decide you want to participate in the trial, you indicate this by signing the "consent form" that is part of the document. It is recommended that you keep a copy that you can refer to later. During (and even after) the trial, you will be able to ask questions and raise any concerns that you may have.

It is important to remember that if you choose not to participate, your regular medical care will not be affected. Even if you have signed a consent form, you are free to change your mind. You always have the right to leave a clinical trial at any time, for any reason, without fear of penalties.

Getting the most from informed consent

Informed consent is much more than reading the informed consent document and signing a consent form. The most important part of the process is your relationship with the study team. You should always feel free to ask questions about your participation, whether it is before, during and after the trial. Below are some tips to help you get the most from the informed consent process, so that you feel comfortable in reaching a decision that is best for you or your child.

• Before meeting with the study coordinator or doctor, write down any questions you might have about the study
• Discuss what you learn with your friends and family; consider bringing someone you trust with you to your initial study visit
• Don't be afraid to ask questions of study staff or to indicate that you don't understand something; their job is to help you understand and they are happy to help
• Doctors are a valuable source of advice and information - however, only you can make the decision. No one - not even medical experts - can predict whether an experimental treatment will work for you
• Remember - enrolling in a trial does not mean you can't get out of it; even if you consent to participate, you can withdraw from the study at any time, for any reason you choose.