Informed consent.

DEFINITION: Informed consent is the process whereby a patient decides whether to accept the risks of a major medical procedure, such as a biopsy, surgery, radiation, or chemotherapy, and to undergo that procedure. Its purpose is to protect the rights and welfare of patients. This decision-making process involves receiving comprehensive information about a proposed medical treatment, procedure, surgery, or clinical drug or medical device trial and its possible risks; having all questions satisfactorily answered; and signing a consent form to undergo the proposed course of action or refusing to sign the consent form and thereby refusing to undergo the procedure. By signing this form, patients are providing legal documentation that they have received all necessary information to make an informed decision and are giving permission for a physician to proceed with the proposed course of action. A parent, legal guardian, or court-authorized person may complete the process if the patient is a child or mentally or physically unable to participate in the process.