FA 2019 page 264: A process (not just a document/signature) that
requires: Disclosure: discussion of pertinent information (using medical interpreter, if
needed), Understanding: ability to comprehend, Capacity: ability to reason a nd make one's, own decisions (distinc t from competence, a legal determination), Voluntariness: freedom from coercion and manipulation.
Patients must have an intelligent understanding of their diagnosis and the risks/benefits of proposed treatment and alternative options, including no treatment.
The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention. In seeking a patient’s informed consent (or the consent of the patient’s surrogate if the patient lacks decision-making capacity or declines to participate in making decisions), physicians should:
(a) Assess the patient’s ability to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision.
(b) Present relevant information accurately and sensitively, in keeping with the patient’s preferences for receiving medical information. The physician should include information about:
The diagnosis (when known)
The nature and purpose of recommended interventions
The burdens, risks, and expected benefits of all options, including forgoing treatment
(c) Document the informed consent conversation and the patient’s (or surrogate’s) decision in the medical record in some manner. When the patient/surrogate has provided specific written consent, the consent form should be included in the record.
In emergencies, when a decision must be made urgently, the patient is not able to participate in decision making, and the patient’s surrogate is not available, physicians may initiate treatment without prior informed consent. In such situations, the physician should inform the patient/surrogate at the earliest opportunity and obtain consent for ongoing treatment in keeping with these guidelines.
AMA Principles of Medical Ethics: I, II, V, VIII