ARTICLE IN PRESS Current Obstetrics & Gynaecology (2004) 14, 363–367
www.elsevier.com/cuog
Consent and the law Martin Lupton* Department of Obstetrics and Gynaecology, The Chelsea and Westminster Hospital, 369 The Fulham Road, London SW10 9NH, UK
KEYWORDS Consent; Autonomy; Duty; Voluntary; Competence; Informed; Refusal;
Summary English medical law has come about in a fairly ad hoc manner and the law governing consent has evolved both from statute and common law. A doctor needs a patient’s consent before he/she may lawfully touch them, and for that consent to be valid it needs to be given by an appropriately informed person who has the capacity to consent to the intervention in question. A competent adult may refuse any treatment for any reason. A competent minor, however may consent to treatment but may not always refuse it. In an emergency a doctor may act out of necessity in the best interests of their patient. & 2004 Elsevier Ltd. All rights reserved.
Necessity and best interests
The arrogance of the medical profession beggars belief. The way they treat patients as lesser beings who only need to know what they want us to know, who do they think they are?
The words of a mother caught up in the Alder Hay scandal.
the UK. It will also describe the important cases that have determined the legal tests of competence and ‘sufficient information’. It will also describe the requirements for valid consent to be realised.
The law Consent and the law A doctor needs to ask permission from their patient before they touch them. Without consent a doctor who touches a patient is open to the charge of battery and the doctor who operates on a patient without consent is open to the charge of grievous bodily harm (GBH). To protect himself from criminal or civil charges the doctor needs to have gained the patient’s consent. For the consent to be valid he needs to tell the competent patient about the ‘nature and purpose’ of the touching and provide sufficient information for the patient to make a choice freely. This article will give the context in which the law of consent has evolved in *Tel.: þ 44-208-746-8000. E-mail address:
[email protected] (M. Lupton).
An individual’s human rights have only recently been set out in English law with the passing of the Human Rights Act. Historically, it has been the rule of law that has protected an Englishman from violations of their person. In Britain there is no constitution and theoretically it would be possible for Parliament to authorise laws that could drastically affect the liberty and welfare of the individual (consider our new asylum and anti-terror laws). One need only to look back 60 years to see how tenuous the protections of domestic common law might be. A cultured nation state, technologically advanced and in many ways ‘civilised’ simply extinguished the concept of human rights. The Nazis passed laws that resulted in the annihilation of millions of Jews, Slavs, Gypsies and the mentally and physically handicapped. The Holocaust profoundly affected
0957-5847/$ - see front matter & 2004 Elsevier Ltd. All rights reserved. doi:10.1016/j.curobgyn.2004.06.009
ARTICLE IN PRESS 364
the way in which people viewed human rights. Before the Second World War the prevalent attitude had been that the protection of human rights was a matter primarily of domestic concern: following the war it became increasingly one of universal concern. No longer was it only sovereign states that were subject to international law but increasingly individual citizens who became bearers of international rights and obligations. Human rights became one of the four founding purposes of the United Nations and in 1948 the Universal Declaration of Human Rights was adopted without dissent. The declaration was followed by the European Convention on Human Rights, signed in Rome in 1950, which was only incorporated into UK law in 1998. It is still unclear how much the act will affect medical law. The absence of a human rights act did not prevent Parliament from legislating in many areas of human rights. The decriminalisation of suicide, the regulation of abortion and the compulsory detention of the mentally ill are all areas of legislation that concern human rights. But without the overarching principles of a constitution the law has come about in a rather ad hoc manner. Nevertheless, the common law has begun to develop a specific medical jurisprudence and the unifying legal and ethical theme in this ‘new’ medical law is respect for autonomy (self-rule). In practice the patient giving or refusing consent manifests this, and not even the courts (other than under certain statutory powers of the Mental Health Act, 1983) may consent to treatment on behalf of an adult. While protection of autonomy is the main legal principle governing medical law, the concept of ‘duty’ is the primary legal test for good medical practice and this includes proper consent. ‘Duty is the means by which the law regulates the conduct of the doctor towards the patient and that duty is a duty to exercise reasonable care and skill’. This duty applies to diagnosis, therapeutic management and the process of consent. The scope of a doctor’s duty has been set out in several important cases. The first and probably most famous is the case of Bolam vs. Friern Hospital Management Committee, which was decided in 1957. It was then that a Judge first stated ‘that a doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men, skilled in that particular art’. While the Bolam case considered the scope of the doctor’s duty in terms of treatment, the case of Sidaway considered the scope of a doctor’s duty to inform a patient. Sidaway was decided in the light of the Bolam judgement and the majority of the
M. Lupton
Law Lords eventually formed the opinion that the duty to disclose information was governed by the Bolam test which ‘was comprehensive and applicable to every aspect of the duty of care owed by a doctor to his patient’. Initially, the Law Lords had appeared uncomfortable with the prospect of accepting that the Bolam principle might govern the duty to inform patients, and Lord Scarmann summed this up in his dissenting judgement, writing that the ‘implications of a (Bolam centred) view’ when applied to consent ‘were disturbing (leaving) the determination of a legal duty to the judgment of doctors’. Nevertheless it was not until the 1990s that the pre-eminence of Bolam was properly challenged. In the case of Bolitho the courts decided that a judge, on rare occasions, could find professional opinion illogical and unreasonable. This represented a downgrading of Bolam ‘removing the trump card which Bolam had presented to the doctor’, and it means that the benchmark by which a doctor’s actions are evaluated is no longer solely that which is thought appropriate by other doctors, the courts must be satisfied as well. In the light of this evolving ‘medical law’, how should a doctor seek the consent of their patient for investigation or treatment?
The consent process ‘For consent to be valid it must be given voluntarily, by an appropriately informed person, who has the capacity to consent to the intervention in question. Acquiescence when the person does not know what the intervention entails is not ‘‘consent’’
D.O.H.: Reference Guide to Consent for Examination or Treatment. For a successful claim of negligence to be made the patient needs to demonstrate: * *
*
that the doctor had a duty of care towards them; that the doctor has been negligent in his performance of that duty; that harm has arisen as a result.
The doctor only needs to record consent in writing to help protect himself against a claim of negligence. Written consent has been described as a ‘Legal Flak Jacket’.
Consent must be voluntary A patient must be free to accept or refuse treatment. They should not feel pressured into
ARTICLE IN PRESS Consent and the law
consenting to a procedure by a relative, friend or their healthcare professional. They can, however, be persuaded (see ‘competence and persuasion’). Situations in which doctors should be concerned about the freedom of a patient to express a preference might be ones in which the patient speaks little English and a dominating family member is used for translation. Another example might be that the patient is a member of a religious group that ensures the presence of a coercive representative throughout the entire process of consent. The doctor is obliged to establish that the decision is truly that of the patient.
Competence Before consent can be sought the doctor needs to establish that their patient is capable of giving consent. To be capable of giving consent the patient needs to be competent. To be competent the patient must fulfil the requirements of a three stage test, named after the case of C. Mr. C was a schizophrenic patient who had a gangrenous leg. He was advised that it should be amputated and he declined to take the advice. He was subject to the strictures of the Mental Health Act at the time and his doctors turned to the courts for a ruling as to the legality of non-consensual treatment in his case. The judgement of the court was that Mr. C was capable of refusing treatment because he was competent and he was competent because 1. He was able to understand and retain the information given to him. 2. He was able to believe the information given to him. 3. He was able to weigh the information given to him in a balance with other considerations, when making his choice. These three requirements are now the legal test for competence in the UK (and Mr. C and his leg survived). While any doctor may make an assessment of competence, in complicated cases where a patient’s choice has significant consequences, a psychiatrist should be involved in the assessment of their competence.
Information To avoid a criminal charge of battery, the doctor need only demonstrate that the patient was aware of the ‘nature and purpose’ of the operation or touching. Thus, if a gynaecologist were to tell a patient with menorrhagia that they were going to
365
perform a myomectomy, which involved removing fibroids from the womb, they would avoid a criminal charge of battery. If, however, they failed to mention the risk of hysterectomy and they had to perform one, they would be open to an action for negligence. The reason for this is that the courts have determined that a doctor should tell a patient of any ‘significant risk, which would affect the judgement of a ‘‘reasonable patient’’’ (Pearce). The Australian High Court, in the case of Rogers vs. Whitaker, has gone further and begun to develop the concept of the ‘particular patient’ test. In this case Mrs. Whitaker had her eye operated on by Mr. Rogers. Though there was no question as to his clinical skill, he failed to mention a risk of 1 in 14 000 that Mrs. Whitaker might be left totally blind. The judges argued that while the risk was rare, it was ‘the one thing the patient feared most, other than death under the anaesthetic’. Because it mattered so much to the particular patient, they argued that the patient should have been informed of the risk. The court explained that ‘a risk is material if in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it’. The importance of this judgment is that while the UK courts have fought shy of the ‘particular patient’ test, the General Medical Council (GMC) has embraced it. In their guidance on consent they state that a doctor should ‘do their best to find out about the individual patient’s particular information needs (and give an) explanation of any risks to which they may attach particular significance’. The standard for information giving is therefore getting higher and the historical rule of thumb that risks had to be greater than 1 in a 100 for them to be mentioned is no longer safe (if you want to avoid a potential charge of negligence). The doctor needs to mention those risks that are frequent and those risks that are serious, he should also mention those risks that might matter specifically to the patient, even if they are rare.
Who should gain consent? The twin principles of respect for patient autonomy and the doctor’s duty of care to their patient inexorably lead to the conclusion that ‘the clinician providing the treatment is responsible for ensuring that the patient has given valid consent’. For the consent to be valid it needs to be sufficiently informed, and logically this means that the person seeking consent must understand both the risks and benefits of the procedure to a standard that
ARTICLE IN PRESS 366
would satisfy both the courts and GMC guidelines. This is a high standard and in my view it is preferable, if not always possible, for the person performing the procedure to seek consent from the patient. It is, however, acceptable for someone who is ‘suitably trained and qualified’ to obtain consent. What is not acceptable is the ‘whoever is available’ principle, which held sway when I was an SHO.
Refusal Provided that a patient is an adult and competent, they may refuse any treatment for any reason, be it rational or irrational. Nobody, not even the courts, can overrule the refusal of a competent adult. Doctors are allowed to try and persuade patients, though they are not allowed to coerce them. If the patient is a minor or incompetent their refusal may be overruled.
A minor To understand the law with regard to consent and patients under the age of 18 years, it is important to keep two principles in mind. The first principle is that the courts appear to dislike choices which may lead to death or severe injury and the second principle is that consent to treatment is in many ways ‘informed compliance’ rather than spontaneous and autonomous choice. Thus provided a minor (someone under the age of 18 years) is competent and over 16 years of age they may comply with medical advice and can consent to treatment. If they are under 16 years of age, and provided they are ‘Gillick competent’ (Gillick vs. West Norfolk and Wisbech Area Health Authority (1984). Mrs. Gillick objected to her daughters being exposed to information about contraception without her consent. The Law Lords determined that a minor could consent to medical treatment provided they were capable of understanding what it was they were consenting to), a minor may comply with medical advice and may consent to treatment. A doctor by the same token should respect a minor’s rights to confidentiality but should make every effort to persuade the minor to involve their parents or guardian in any decision made. If the child is not Gillick competent then a parent or the person responsible for the child (as laid down in the Children’s Act) may give consent for a treatment to take place, but that treatment must be in the ‘best interests’ of the child.
M. Lupton
While a minor may comply with medical advice and give consent, they do not have the same legal support for their ‘right’ to refuse treatment. A person with parental responsibility or the court may overrule the refusal of a minor to be treated, but they must be acting in the best interests of the minor and only when there is risk to the minor of suffering ‘grave and irreversible mental or physical harm’. In an emergency a doctor may overrule a minor’s refusal if the emergency treatment will preserve their life or prevent serious damage to their health. In this sort of situation a doctor is also allowed to break confidence. A minor seeking treatment for an ectopic pregnancy is an example of a case in which Gillick competence is important. The minor may choose not to tell their parents that they need an operation and provided they are Gillick competent, may consent to an operation to treat their ectopic pregnancy. If they refuse treatment for their ectopic pregnancy a doctor may break confidence and tell their parents or the courts, in an effort to overrule their refusal. If the minor has collapsed because the ectopic has ruptured, they are refusing treatment and it is impossible to find someone with parental responsibility or to contact the courts in time, the doctor may overrule the refusal for treatment. In cases such as this it is always worth getting a second opinion.
Emergencies No person, not even the courts, may consent on behalf of an adult. This means that in an emergency, while it is advisable to tell family members what is planned for their relative if at all possible, their consent is not required. Hunting after a relative for their signature is unnecessary and meaningless. In an emergency, when the patient is unable to give consent (if they have lost consciousness for example) a doctor may act in their best interests out of (the legal principle of) necessity. The treatment, however, must be limited to that which is absolutely necessary to prevent death or serious damage to the health of the patient.
The incompetent The principle theme governing consent and the incompetent is the protection of the patient’s human rights. If the patient is over 18 years of age nobody may consent on their behalf, however in an emergency a doctor may act in what they believe to be their best interests. The treatment
ARTICLE IN PRESS Consent and the law
must be limited to that which is absolutely necessary to preserve the life and health of the patient. If it is not an emergency the situation is far more complex. For instance if an incompetent 30 year old woman is brought to a gynaecologist by her desperate parents, who think that she should have a hysterectomy (it is very difficult for them to manage her periods), the doctor must decide whether this mutilating procedure is in the best interests of the patient rather than in the best interest of her parents. This sort of judgement is difficult and value laden. It is the sort of decision that requires a doctor to seek advice both from medical colleagues and legal advisors.
367
PRACTICE POINTS Consent should always be * Voluntary. * Sufficiently informed. * Given by a competent person. A competent adult is someone over the age of 18 who is able to * Understand and retain information. * Believe the information given to them. * Weigh the information given to them in the balance with other considerations, when making their choice.
Summary *
To summarise, in Britain a competent adult patient is protected by statute and the common law. In law nobody, not even the courts, can consent to medical treatment on behalf of an adult patient. The patient has the absolute right (subject to the Mental Health Act) to accept or refuse treatment for any reason, rational or irrational. The conduct of the relationship between a doctor and their patient is governed by the doctor’s duty of care. It is a relationship based on obligations. The actions of a doctor are subject to the scrutiny of their peers (often far harsher than any lawyer) and must be reasonable and rational. What doctors feel to be reasonable and rational is subject to the scrutiny of the courts and must withstand their analysis. For consent to be valid it must be: *
*
*
Voluntary: The patient must be free from any form of coercion. Informed: The patient should know what the medical intervention entails, including any frequently occurring risks and serious risks. Ideally, they should also be told of those risks that are specifically relevant to them. Given by a competent person.
In the preparation of this article I have extensively used the Department of Health’s Reference Guide to Consent for Examination or Treatment
A minor is A person under the age of 18. If they are competent (see above) they may comply with medical advice for treatment. They may not, however always refuse treatment. If they are incompetent then a parent or the person responsible for the child may give consent for treatment.
Further reading Bolam vs. Friern Hospital Management Committee. 2 All ER 118, 1957. Bolitho vs. Hackney Health Authority. 4 All ER 771, 1997. Irvine L. The patient, the doctor, their lawyers and the judge: rights and duties. Med Law Rev 1999; 7. Kennedy I, Grubb A. Medical law: text with materials. London: Butterworths; 1994. Kennedy I. ‘‘Treat me Right’’, 1991, London: Clarendon Press. Lupton M. Patient competence and medical persuasion. Curr Obstet Gynaecol 2003;13(1):57–60. Mason JK, McCall RA. Law and medical ethics. London: Butterworths; 1999. Rogers vs. Whitaker 67 A.L.J.R. 47. Seeking patients’ consent: the ethical considerations. London: GMC; 1999. Sidaway vs. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital AC 871 (HL), 1985.