What is informed consent?
The process of learning the key facts about a clinical trial before agreeing to participate is called informed consent. The FDA requires that potential research subjects (or their parent/legal guardian in the case of a child) be given complete information about the trial in writing. Part of this process includes a meeting with the researcher(s) during which the possible risks and benefits are explained and any questions are answered. If you decided to enter the trial you will be asked to sign a consent form. The form will also include the signature(s) of the person(s) who obtained your consent. You will receive a copy of the signed consent forms.