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The evolution of informed consent

The common law links continents. A recurring clinical legal question across the original British Commonwealth territories relates to the information that must be disclosed before operation, so that a patient can decide whether to agree to treatment. The judgments that have influenced modern attitudes have evolved over many years. As surgical standards become increasingly globalized, many countries will need to adapt existing practices surrounding the process historically covered by the term ‘informed consent’. In 1930s Canada1, a woman with Dupuytren’s contracture was advised that immediate surgery would restore function within 3 weeks. Instead, permanent injury resulted. She claimed that if she had known the risk she would have refused surgery. The appeal court held that the surgeon’s duty of disclosure did not extend to warnings ‘... calculated to frighten or distress the patient’. In England 20 years later2, a woman with goitre chose surgery. Left with a vocal cord palsy, her surgeon admitted that he had asserted that there was no risk to her voice. Encouraged by the judge, the jury dismissed the case. These cases begged the question of whether the standard for disclosure should be set not by the reasonable doctor, but by the reasonable patient. In 1970 in Canada3, a 44-yearold Hungarian man presenting with headache had carotid atheroma diagnosed. Elective endarterectomy was proposed, to avoid a stroke. The court found that the surgeon knew, or ought to have known, that the operation posed a 4 per cent risk of death and a 10 per cent risk of iatrogenic stroke. These risks were not disclosed, for fear of frightening or distressing Mr Reibl. Perioperative stroke, paralysis and impotence ensued. The patient asserted that he would have foregone elective surgery until his retirement pension crystallized midway through 1972. He would have ‘... opted for a shorter, normal life rather than a longer one as a cripple’. The court found that Mr Reibl should have been warned; and that a reasonable person in the patient’s position would have opted against surgery at that particular time, had they been given disclosure of an acceptable standard. From this, it can be deduced that in 1980s Canada the standard of disclosure was measured against that required by a reasonable patient. In childhood, an Australian patient, Maree Whitaker4, had a penetrating right eye injury, leaving it sightless. Forty years later, a surgeon suggested the appearance (and possibly function) of her damaged eye could be improved surgically. Before operation, she explicitly asked the surgeon what the possible consequences of surgery could be, but she did not ask whether surgery on the right eye could lead to contralateral damage. This occurred, leaving her permanently blind. The Australian court, adopting the reasonable patient standard, found that this risk of sympathetic ophthalmia should have been disclosed. In the USA, a commission appointed by President Carter in 1982 concluded that ethically valid consent was a process of shared decision-making. However, it was not until 2007 that the state of Washington enacted legislation to establish that a practitioner who engages in shared decision-making with a patient, including the use of a certified patient decision aid, will be deemed to have met the requirements for informed consent. In the meantime, English courts remained close to equipoise as to reliance upon the reasonable surgeon or the reasonable patient. Mrs Sidaway5 suffered cord damage following cervical surgery. Her surgeon had warned her of a 2 per cent risk of nerve root damage, but had omitted disclosure of the risk of cord damage, assessed at this time as less than 1 per cent. The trial judge had found that, despite this omission, the surgeon nevertheless adhered to a body of reasonable contemporary medical opinion, and the claim initially failed. On appeal to the House of Lords, a bare majority found that the Bolam test (the medical, not patient standard) applied to disclosure. However, two of the five judges disagreed, finding that the court (on behalf of the reasonable patient) should use this standard, not that of a medical expert. Mrs Pearce6 consulted her obstetrician 14 days after term with her sixth baby, begging for admission and induction, or for a caesarean section. Her obstetrician refused, asserting that she should not behave like a child; she should await a natural birth. He did not disclose the risk that the baby might be stillborn. Although upset, Mrs Pearce accepted his advice. Days later, her baby died in utero. She claimed she should have been advised of the risk of stillbirth. In this case, the Court of Appeal set out a standard for disclosure that remains very closely followed in 2017: ‘ ... (If) there is a significant risk which would affect the judgement of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient