Clinical trials – a guide for CAB members (page 10)

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“Informed Consent” is the process of learning the facts about a clinical trial before deciding whether to volunteer for the study. The informed consent process that helps people learn about the study and about their rights as research participants. The consent process also includes informing volunteers about the privacy of the information they give for the study.
The research team also must provide a written document (called the informed consent form) that gives details about the study. The informed consent form must be written in a language the volunteer understands. If a volunteer cannot read or write, special help will be given to ensure the volunteer understands the study and the informed consent form.
To help a person to decide, the doctors and nurses involved must clearly explain the details of the study, answer all questions, and ensure that the volunteer understands what to expect. This may take more than one visit with the research team. Many people also choose to discuss the research and other options for treatment with trusted family or friends.
The volunteer decides whether to sign the informed consent after s/he understands details of the trial and the alternatives to participating.