informed consent

Syllable breakdown

Dictionary meaning

the ethical and legal process by which a patient or research participant voluntarily agrees to a proposed medical intervention or participation in research after being given adequate information about the nature of the procedure, its risks and benefits, alternatives, and the consequences of refusal, and having had the opportunity to ask questions; informed consent operationalises the principle of patient autonomy — the right of competent individuals to make decisions about their own bodies; its elements include disclosure of relevant information, patient comprehension, voluntariness (freedom from coercion), and a competent patient's express agreement; special provisions apply to patients who lack decision-making capacity, for whom surrogate decision-makers act in the patient's best interests; informed consent requirements are central to both medical ethics and research ethics, codified in the Helsinki Declaration and national legislation