Informed consent is a process that acts as a safeguard to protect clinical trial participants. Informed consent means that you must be given all the facts about a study before you decide whether to take part. This includes details about the treatments and tests you may receive and the possible benefits and risks they may have. The doctor or nurse will give you an informed consent form that goes over key facts. If you agree to participate in the study, you will be asked to sign the informed consent form. At all times throughout the trial, your personal and medical information will be kept confidential.

Informed consent documents include the following general types of information:

• Purpose of a clinical trial
• Treatment procedures and schedule
• Potential risks and benefits
• Participant rights
• Alternatives to participation
• Contact information for ongoing communication about the trial

The informed consent process continues throughout the study. For instance, you will be told of any new findings regarding your clinical trial, such as new risks. You may be asked to sign a new consent form if you want to stay in the study.

Because clinical trial participation is voluntary, people enrolled in clinical trials have the right to leave the study at any time.