When you first express interest in a clinical trial, a process called informed consent begins. Informed consent is the term used to describe the ongoing sharing of information by the trial team before, during and after the clinical trial.
To start the process, the clinical trial team gives you an informed consent document that provides detailed written information about the trial. The informed consent document contains:
- a summary about the study, such as its purpose and length (duration)
- key contacts
- the examinations and lab tests you'll need to undergo with the treatment
- the study's risks and potential benefits
The doctors and nurses involved in the clinical trial explain the study to you to help you decide if you want to participate. You'll be encouraged to ask questions during your first meeting and follow-up meetings so you have all the information you need to make a decision about participating. (A language interpreter is provided for people who request one.)
You'll be given time to review the clinical trial details in the informed consent document. You'll be able to take the document home to read and discuss with your doctor, your family members or others you trust.
Once you and the trial team are satisfied that you understand the clinical trial protocol (procedures), you must agree to sign an informed consent document before you can begin. It affirms that you fully understand the nature of the study. The informed consent document is not a contract: You're free to leave the study if any new information leads you to want to do so. In fact, you're free to leave the study at any time, for any reason.
New information may become available to the research team as the trial goes along. The clinical trial protocol may also change over time. The informed consent process requires that members of the research team update you as such changes are made. You may also be asked to sign a new informed consent document.