Thus simply handing patients an explicit consent form may not be considered enough by the courts unless the issues are discussed with patients and they have an opportunity to ask further questions. The courts, however, require information to be disclosed to the patient in a discussion with the physician. The informed consent forms would start with a discussion of the anatomy and physiology of the heart and then shift to the intervention being recommended: what happens, how long the procedure will take, who will perform the procedure, and the risks of each aspect of the procedure. For example, in university medical centres, groups of cardiologists often develop elaborate informed consent forms that explicitly explain the sequence of events that can be expected for patients referred for, say, angiography.
Each of these risks has to be weighed against the possible benefits both in general and for the particular patient.ĭoctors may adopt specific practices to accommodate the requirements of informed consent in their particular practice settings. Thus a surgeon recommending surgical removal of the gall bladder of a patient with gall stones may discuss the intervention in the context of the risks of continued episodes of abdominal discomfort the risks of surgical removal alternative treatments, including non-intervention and the risks of delay if more opinions are obtained. The judicial doctrine of informed consent in clinical care has been based primarily on one type of medical decision-when one medical intervention surfaces as medically justifiable and is recommended by the physician. Cultural issues may also arise-for example, in Japan, the cultural practice has been not to inform a patient that he or she has a terminal illness. However, the question remains whether family members or partners should be informed if the patient does not want to be told about risks. If a patient makes an explicit instruction not to be told of risks, this request should be honoured. Judge Robinson recognised the potential harm that information on risk could cause, yet he also recognised that extensive use of the privilege of non-disclosure would overwhelm the obligation to secure a patient's informed consent. Indeed, court views of informed consent also include a therapeutic privilege for physicians not to inform a patient who may be harmed by the disclosed information. Only derivatively is informed consent a prospective view on what a physician should say to a patient. The primary use of the concept of informed consent in the courts is in retrospective decision making after an injury.
5 States in the United States are about evenly divided, half following the professional standard and half following the reasonable person standard. 3 Courts in England and Australia are also moving towards it 4: an Appeal Court judgment in England in 1998 applied this standard. The reasonable person standard was established by Judge Robinson in 1972 in a landmark US Federal case Canterbury v Spence and has been adopted by the Supreme Court of Canada. Under a reasonable person standard, the decision about whether a patient should have been informed of a risk is based on whether a reasonable person in that patient's position would want to be informed. The judicial, medical, and ethical interpretations of informed consent created much controversy, prompting the creation of a new judicial standard-the reasonable person standard. 2 It too was considered under a professional standard of disclosure. The term “informed consent” was first introduced into the judicial lexicon in 1957 in the written opinion of an appellate judge in California. It was much later that the notion of information became linked to consent. The judge concluded that obtaining a patient's consent was a custom of physicians and ruled for the patient that consent should have been obtained by the particular physician as part of the duties of his profession. Physicians called into court to testify reported that physicians usually secured their patients' consent before embarking on a medical intervention, but there was little said in the judge's written opinion about what should be said to patients before an experimental intervention, as opposed to a clinical intervention. 1 In that case the physician initially set the patient's femoral fracture in accordance with practice at the time but at a follow up visit rebroke the healing fracture and placed the rebroken bone in a mechanical device with teeth.
The professional standard of consent to treatment has been espoused as a judicial concept since a British case in 1767.