informed consent

Voluntary consent given by a person or a responsible proxy ( e.g., a parent) for participation in a study, immunization program, treatment regimen, invasive procedure, etc., after being informed of the purpose, methods, procedures, benefits, and risks. The essential criteria of i. are that the subject has both knowledge and comprehension, that consent is freely given without duress or undue influence, and that the right of withdrawal at any time is clearly communicated to the subject. Other aspects of i. in the context of epidemiologic and biomedical research, and criteria to be met in obtaining it, are specified in International Guidelines for Ethical Review of Epidemiologic Studies (Geneva: CIOMS/WHO 1991) and International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS/WHO 1993).

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in·formed consent in-.fȯrmd- n consent to surgery by a patient or to participation in a medical experiment by a subject after achieving an understanding of what is involved

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a legal requirement that physicians or researchers inform a patient undergoing surgery or invasive tests or a subject involved in a clinical trial of the nature, risks, and probable outcome of the treatment or research. The patient signs an agreement stating that he or she has been informed and accepts the treatment, surgery, or research protocol. Without informed consent, the physician or researcher is violating the patient's rights, regardless of whether the treatment is appropriate and successful.

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voluntary permission given by a subject or guardian for participation in a study or investigation, or for medical care, after having been informed of the purpose, methods, procedures, benefits, and risks.