The theory of consent
Consent is a fundamental tenet of medical law. It is the guardian of autonomy; the protector against unwelcome intrusion. The basic rule is simple; no-one has the right to touch anyone else without lawful excuse. To do so may amount to battery and/or negligence.
This article refers to the law as it stands in England and Wales. The law in Scotland and Northern Ireland is very similar. In March 1999, the General Medical Council issued guidance on seeking patients’ consent which all registered medical practitioners in the United Kingdom should be aware of when counselling patients.
In the medical context, treatment may lawfully be given without consent, in limited circumstances only, for example in emergencies and to permanently incompetent adults, under the Mental Health Act which is not discussed further here.
For consent to treatment to be valid, three conditions must be satisfied. First, the patient must be competent. Second, he or she must have sufficient information to make an informed choice and lastly, the consent must be given voluntarily.
Unless there is reason to believe otherwise, it is assumed that adult patients are competent. The fact that a patient does not agree with the doctor’s recommendation or makes a decision which appears irrational does not automatically condemn the patient as incompetent. Nor does the existence of chronic mental illness, even where the patient is detained as a result of that illness.
This point is clearly illustrated by the case of Re C, in which a 68 year old chronic schizophrenic was discovered to have gangrene of his foot. The patient was referred to surgeons who advised amputation but the patient refused consent and instructed lawyers to apply for an injunction to prevent the doctors from amputating his foot without his express written consent.
The Judge stated that the decision-making process comprised three stages. First, does the patient understand the treatment information – in other words, the implications of accepting or rejecting the various treatment options. Second, does the patient believe it, and third, can he weigh it in the balance to arrive at a choice. If the answer to all three questions is yes, then the patient is competent and entitled to decide what treatment to accept or reject, even if that decision may result in permanent injury or death.
Competence is therefore not an all or nothing phenomenon. Patients may possess the capacity to consent to some treatment but not others. Other patients may exhibit fluctuating competence, and on this point the GMC has given specific advice in their guidance.
They say “Where patients have difficulty retaining information, or are only intermittently competent to make a decision, you should provide any assistance they might need to reach an informed decision. You should record any decision made while the patients were competent, including the key elements of the consultation. You should review any decision made whilst they were competent, at appropriate intervals before treatment starts, to establish that their views are consistently held and can be relied upon.”
In children, the situation is more complex. The Family Law Reform Act 1968 Section 8 (1) states that the consent of a minor who has attained the age of 16 years to any medical or surgical treatment which, ……. should be as effective as if he were of full age; [and] ……. it shall not be necessary to obtain consent for it from his parent or guardian.
So competent patients between the age of 16 and 18 can give valid consent to treatment. What was less clear until the Gillick case in 1986 was whether competent children under the age of 16 could also give consent to treatment. The House of Lords ruled that a child under the age of 16 who was capable of understanding the proposed treatment, of expressing his or her own wishes, could lawfully consent to treatment.
However, their Lordships did not expressly state that a child under the age of 16 could reject treatment which was considered to promote that child’s best interests and in a subsequent case [Re R] the Courts held that in the case of minors (ie. individuals under the age of 18) there were a number of people who could give valid consent to treatment: a competent child, anyone with parental responsibility and the Courts in wardship. Of these, the Courts will have the final say in relation to any question put before them, as they did in the case of Re R.
The rejection of treatment by a competent child which may result in death or permanent injury is a matter which may require consideration by the Courts, and is certainly an issue which should be discussed with an expert medico-legal adviser.
Competent patients cannot be expected to make any decision unless they have sufficient information on the pros and cons of the various treatments available. In California and many other north American jurisdictions, the doctrine of informed consent has been adopted. This was first set out in Canterbury –v- Spence heard in 1972.
The Plaintiff had consulted Dr. Spence because of severe pain between his shoulder blades. After X-rays and a myelogram, surgery was recommended to establish the true nature of the problem, thought to be in the region of the fourth thoracic vertebra. Prior to the procedure, the Plaintiff, who was 19 years old, did not raise any objection or ask about any of the procedure’s implications. Dr. Spence undertook a laminectomy which revealed a number of problems which he sought to deal with. Subsequently, the patient suffered incontinence and experienced difficulty in walking. The Plaintiff alleged that the doctor had failed to warn him of the risk of serious disability inherent in the laminectomy.
The Court found in favour of the Plaintiff. The Judge stated “In our view, the patient’s right of self decision shapes the boundaries of the duty to reveal. That right can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The scope of the physician’s communications to the patient, then, must be measured by the patient’s need, and that need is the information material to the decision. Thus the test of determining whether a particular peril must be divulged is the materiality to the patient’s decision; all risks potentially affecting the decision must be unmasked. To safeguard the patient’s interests in achieving his own determination on treatment, the law itself must set the standard for adequate disclosure.”
So, in north America, the law requires the patient to be given all relevant information. This has been termed the “prudent patient test”. In England, the law is different. Here, in the Sidaway case in 1985, the House of Lords rejected the doctrine of informed consent and decided that determining what information should be given to the patient was primarily a matter of clinical judgment and therefore for the doctor to decide – a formulation which has since been dubbed the “prudent doctor test”.
So what information should be given to a patient contemplating treatment? First, the patient must be informed of any serious risk, even if that is of low frequency. Second, the patient should be warned about transient and less serious risks which occur more commonly. The duty to disclose is, to some extent, dependent upon the risk:benefit ratio of treatment so, in aesthetic procedures, failure to disclose even remote risks may be difficult to justify.
The GMC give more specific advice in their booklet:
“The information which patients want or ought to know, before deciding whether to consent to treatment or an investigation, may include:
- details of the diagnosis and prognosis, and the likely prognosis if the condition is left untreated;
- uncertainties about the diagnosis including options for further investigation prior to treatment;
- options for treatment or management of the condition, including the option not to treat;
- the purpose of a proposed investigation or treatment; details of the procedures or therapies involved, including subsidiary treatment such as methods of pain relief; how the patient should prepare for the procedure;and details of what the patient might experience during or after the procedure including common and serious side effects;
- for each option, explanations of the likely benefits and the probabilities of success; and discussion of any serious or frequently occurring risks, and of any lifestyle changes which may be caused by, or necessitated by, the treatment;
- advice about whether a proposed treatment is experimental;
- how and when the patient’s condition any side effects will be monitored or reassessed;
- the name of the doctor who will have overall responsibility for the treatment and, where appropriate, names of the senior members of his or her team;
- whether doctors in training will be involved, and the extent to which students may be involved in an investigation or treatment;
- a reminder that patients can change their minds about a decision at any time;
- a reminder that patients have a right to seek a second opinion;
- where applicable, details of costs or charges which the patient may have to meet.”
If the doctor believes that disclosing risks to a patient is likely to cause serious harm to the mental or physical health of the patient, he is entitled to withhold that information. This is know as the doctor and therapeutic privilege. However, it is not a licence for paternalistic medicine, the emphasis being on the likelihood of disclosure causing serious harm.
In the Australian case of Rogers –v- Whittaker, an ophthalmic surgeon was found negligent for failing to warn of the risk of sympathetic ophthalmitis following a cosmetic procedure to an eye which had been injured in childhood and in which there was no sight. The chance of this happening was put at between 1 in 4 and 1 in 14,000. The surgeon argued that it was such a rare complication that he did not consider it appropriate to provide this information to the patient. The Court disagreed and awarded compensation to the Plaintiff. No similar case has been tried in the English courts but the outcome is likely to have been the same.
Any degree of coercion, fear, force or fraud may invalidate an otherwise apparently valid consent.
This point is illustrated by the case of Re T. Miss T, who was 20 years old and 34 weeks pregnant, was admitted to hospital with pneumonia. She was not herself a Jehovah’s Witness but had been brought up as one by her mother. The day following admission Miss T suddenly announced that she did not want a blood transfusion because of her religious beliefs. At that time, no transfusion had been contemplated but later on that day she went into labour and it was decided to deliver the baby by Caesarean section.
Due to various complications, a blood transfusion was subsequently necessary. Miss T was in a sedated and critical condition. It was held that her refusal was not valid as at the time she made her comments she had not anticipated the specific complication that she now faced.
In the Court of Appeal, Staughton LJ held that apparent consent or apparent refusal to treatment may not be true consent or true refusal and may be inoperative for one of three reasons:
- There may be such degree of external influence as to persuade the patient to depart from her own wishes to an extent that the law regards it as undue influence
- An apparent consent or apparent refusal to consent may not have been made with reference to the particular circumstances in which it turns out to be relevant, and
- At the time the patient may not for the time being be a competent adult or understanding may be seriously reduced by drugs or other circumstances although she is not actually unconscious. The decision of a doctor as to the existence or refusal of consent will not protect him if the law subsequently decides otherwise.
See our Kirwan example