Consent to Treatment

Dr. Michael J Powers QC

Medical Law Group: 4 Paper Buildings, Temple.
www.clinneg.co.uk

• Introduction
• Elements of Consent
• Capacity
• Voluntariness
• Information
• Causation
• Emergency Situations
• The Principle of Necessity
• The Best Interests Principle
• Experimental
• Conclusion
• References

Introduction

Any consideration of consent to treatment has to start with the recognition of each human being to control his own life.

"First, it is established that the principle of self-determination requires that respect must be given to the wishes of the patient, so that if an adult patient of sound mind refuses, however unreasonably, to consent to treatment or care by which his life would or might be prolonged, the doctors responsible for his care must give effect to his wishes, even though they do not consider it to be in his best interests to do so..."¹

The requirement for consent protects that right. Treatment without consent is both a crime and a civil wrong. Under Article 3 of the European Convention on Human Rights², the Commission has held that experimental medical treatment may amount to inhuman treatment if not torture in the absence of consent³. This could be of wide application. Treatment which is not properly established may be considered "experimental". Arguments are also likely to be developed (under Article 8) that a failure by a hospital to provide essential information on the treatments breaches the right to respect of private life⁴.

Society has moved a long way in the last 30 years. The days are gone when treatment would be administered with little discussion. There was an assumption that consent would be granted. The very attendance upon a doctor, or the admission to hospital would be taken as sufficient. Consent was often implied. It was rarely informed. Refusal was taken as the mark of insanity⁵ and treatment was occasionally given notwithstanding full knowledge that consent had been withheld.

There is now a professional obligation upon the doctor to be aware of the legal principles set by the relevant case law and that the law should be considered the minimum requirement of good practice⁶.

This paper considers the several different types of situation in which consent is required:

1. Elective
2. Emergency
3. Experimental - therapeutic
4. Experimental - non-therapeutic

Elements of Consent

There are 3 components to "real consent":

1. Capacity
2. Voluntariness
3. Information as to the general nature of the proposed procedure

When all are present there will be no grounds for a claim in battery, but alone they are not sufficient to protect a doctor from a charge of negligence.

Capacity

Legal capacity is a matter of fact and law. A doctor should have in mind 3 categories of potential difficulties with capacity:

1. 1. Above 16 but under 18, may give consent: "the age of consent"⁷. However a child over 16 but not yet 18 does not have the capacity to refuse consent. The Family Law Reform Act has no application in respect of a refusal⁸.
   2. Those under 16 years of age may give consent if the minor, in the opinion of the doctor, is capable of understanding the nature and possible consequences of the procedure or treatment⁹. However such a "Gillick competent" child does not have the capacity to refuse treatment. Moreover, those with parental responsibility cannot override the refusal of a Gillick competent child¹⁰. Whether or not the treatment should proceed has to be determined by the Court.
   3. Save as above, the parent or legal guardian of a minor may consent on its behalf.
      
      

2. Persons detained under the Mental Health Act 1983

   It has to be remembered that there is no power under the Act to treat conditions other than those affecting mental health - without express consent¹¹. If the mental condition for which the patient is detained renders the patient insufficiently capable to give consent then the procedure may be undertaken if the Court¹² declares it to be lawful. Effectively the procedure is done with the consent of the Court. In an emergency, without the consent of the Court the doctor may be protected by acting in the patient's best interest¹³.

3. Persons with insufficient capacity.

   To have sufficient capcity there must be¹⁴:

   1. an ability to comprehend and retain information
   2. a belief in the information
   3. an ability to balance the pros and cons and make a choice

Voluntariness

For consent to be valid it must:

1. be freely given
2. not be obtained by fraud
3. not be given under duress

Information

Sufficient information has to be given to enable the general nature of the procedure to be understood. Consent to clip an aneurysm is not consent for an appendicectomy or a frontal lobotomy. To avoid a charge of negligence or a charge of professional misconduct however the surgeon must clear each of these additional hurdles:

1. He must communicate the information relevant to the patient's decision making process as recognised by all responsible bodies of expert opinion would consider to be necessary at the relevant time (in accordance with the Bolam principle) . This information has to be given to the patient in terms which the patient can understand. If the patient does not have the ability to understand, he does not have the capacity to consent.
2. He must answer any questions the patient may ask in a full and truthful manner. This is not governed by the Bolam principle. Even if no other doctor asked to impart the true risks would impart the whole truth, this will provide no protection to the surgeon who is alleged not to have properly informed the patient.
3. He must communicate those risks which are so "obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it"¹⁵ - regardless of "responsible medical opinion". The surgeon who does not will not be saved by expert opinion.

4. The Senate of Surgery published a document in 1998 entitled "The Surgeon's duty of Care: Guidance for Surgeons on Legal and Ethical Issues". It stated that surgeons should:

   "...inform adult patients aged 16 and above of the nature of their condition, along with the type, purpose, prognosis, common side effects and significant risk of any proposed surgical treatments. Where appropriate, alternative treatment options (including non-surgical) should also be explained together with the consequences of no treatment. This information should be provided in the detail required by a reasonable person in the circumstances of the patient to make a relevant and informed judgment..."

   This is likely to be the Bolam standard introducing by the front door that which the medical profession successfully resisted in Sidaway¹⁶, namely a doctrine of informed consent.

5. The GMC¹⁷ says:

   "When providing information you must do your best to find out about patients' individual needs and priorities. For example, patients' beliefs, culture, occupation or other factors may have a bearing on the information they need in order to reach a decision. You should not make assumptions about patients' views, but discuss these matters with them, and ask them whether they have any concerns about the treatment or the risks it may involve. You should provide patients with appropriate information, which should include an explanation of any risks to which they may attach particular significance. Ask patients whether they have understood the information and whether they would like more before making a decision."

To be on the safe side the surgeon would be wise to inform fully and fairly. No longer can this be regarded as a defensive practice. It is the only proper practice¹⁸.

It is not sufficient to give this information to a spouse, relative or friend. The information has to be given to the patient and the consent has to be obtained from the patient. The only exceptions are:

1. The patient is a minor, under the age of 16 and not Gillick competent: the relevant information must be given to and consent obtained from the parents or legal guardian.
2. The patient is a minor who is over the age of 16 or Gillick competent who refuses consent: a parent may not consent on the minor's behalf. A strong 17 year old child who refuses to consent to surgery can present a practical and ethical problem. The approval of the Court should be sought. This is particularly important where the procedure is entirely elective and does not have any obvious therapeutic benefit¹⁹.
3. The patient is under incapacity: This includes all patients who do not have the capacity to consent, whether this be the consequence of intellectual deficit, mental illness or temporary physical incapacity such as unconsciousness. Where the patient is a minor, the consent may be obtained from the parents or legal guardian (see above). Where the patient is of age, save in an emergency, consent can be obtained from the Court. In deciding whether or not to grant consent the Court will need to be provided with the categories of information set out above.

Causation

In a civil claim for damages in negligence, the difficulty faced by a claimant seeking damages for the non-negligent manifestation of a risk of surgery of which he was (negligently) not warned is in proving that if he had been warned he would not have consented to the operation.

In principle the Court has to decide what the claimant would have done. It is a subjective test. Since this is an almost impossible task as the claimant has suffered the injury which in prospect was only a risk, the Court adopts a mixed subjective/objective test. In practice, unless there is something exceptional and peculiar to the claimant, the Court places considerable reliance upon the proportion of other patients who consent to the procedure when properly informed as to the risks.

Emergency Situations

The same principles apply. An adult who is not under incapacity may refuse consent to life saving treatment for "reasons which are rational, or irrational, or for no reason"²⁰. There is no authority which a doctor can obtain to override a refusal. No Court has the power to override this fundamental right to autonomy.

There are, however, situations where the validity of a refusal of consent by an adult may be challenged. It is upon each of the elements of consent:

1. the capacity of the patient is temporarily insufficient by virtue of some agent, illness or emotion and/or
2. the refusal is not voluntarily given²¹
3. the patient is not in possession of sufficient information as to consequences of refusal

All this simply means that the refusal of consent cannot be taken as a definitive position. The procedure proposed cannot proceed without consent. An urgent application has to be made to the Court where an assessment is made. If the refusal is valid, the Court can do nothing even though the patient (and any unborn child) may die. On the other hand, where a person is under some incapacity or the refusal is not voluntary, the Court will consider what is in the best interest of the patient and may give consent on behalf of the patient.

The Principle of Necessity

Under the Common Law, there was no jurisdiction in the Court to approve or disapprove medical treatment for those who were incapable of making the choice themselves, but acting as an agent of necessity may render lawful an action that would otherwise be tortuous²² to make a declaration that proposed treatment is in the best interest of a patient. Effectively by declaring the treatment to be lawful (absent consent) consent is not otherwise required.

The Best Interests Principle

This principle is founded on the principle of necessity. The moot point is how far beyond the agency of necessity a doctor may go without risking his action to be declared unlawful. If the patient is unconscious or under some other temporary incapacity and time does not permit to obtain what is in effect substituted consent from the Court²³ a doctor may proceed without express consent provided:

1. it is not known that the patient would not consent to the treatment, if the patient were able to do so; and
2. it is in the "best interests" of his patient;
3. the urgency is such that the lawfulness of the proposed procedure cannot be declared by the Court in the time available.

The best interests authority is strictly limited. It is effectively a defence to what would otherwise be a battery. It may well mean that 2 operations/anaesthetics are made necessary in order to provide the patient with the opportunity to give or withhold consent to other procedures which are not immediately necessary for the preservation of life.

The GMC describes the "Best Interests' Principle" in this way:

"Best interests' principle:

In deciding what options may be reasonably considered as being in the best interests of a patient who lacks capacity to decide, you should take into account:

• options for treatment or investigation which are clinically indicated;
• any evidence of the patient's previously expressed preferences, including an advance statement;
• your own and the health care team's knowledge of the patient's background, such as cultural, religious, or employment considerations;
• views about the patient's preferences given by a third party who may have other knowledge of the patient, for example the patient's partner, family, carer, tutor-dative (Scotland), or a person with parental responsibility;
• which option least restricts the patient's future choices, where more than one option (including non-treatment) seems reasonable in the patient's best interest."

Where there is sufficient time for an application to be made to the Court, it is for the Judge and not the doctor to decide what is in the patient's best interest²⁴ - because it incorporates broader issues - ethical, social, moral - in addition to what is medically in the patient's best interest. The first step is for the Judge to be satisfied that the treatment proposed was within the range of acceptable procedures using the Bolam test²⁵. Once it was found to be then Bolam became irrelevant - the best interest test should provide the answer to the question what is the best treatment for this patient - it is not enough to identify a range of Bolam acceptable treatments and leave a doctor or a relative to select what they consider to be best.

Experimental

The same principles apply. There are two categories:

1. Therapeutic

   1. Where there is capacity and consent is voluntarily given:

      Consent will be real where the general nature of the treatment is communicated to the patient but the experimenter will be at risk if there is a failure to disclose the full risks and the difficulty of "patient volunteers" acting voluntarily is considered in the Royal College of Physician's Guidelines on the practice of Ethics Committees in Medical Research involving Human Subjects - 3rd Edition August 1996²⁶.

   2. Where the patient does not have capacity:

      Save that a parent or guardian may give consent on behalf of a non-Gillick competent child, the experimenter will have to obtain consent from the Court. The Court will be unlikely to grant consent unless satisfied that the experimental therapy is in the best interest of the patient.

2. Non-Therapeutic

   This is an extremely difficult area. Whilst an adult of full capacity may give consent to non-therapeutic experimentation on himself, there are limits²⁷ - and it most unlikely that ethic committee approval would be obtained if there were to be more than minimal risk²⁸. A person injured by such non-therapeutic experimentation would have an unanswerable claim for damages.

   Where the subject does not have capacity, it is doubtful that parents could give an effective consent on behalf of a child and it is most unlikely that a Court would give its consent on behalf of any subject, child or adult, as the "best interests" test could not be satisfied. Furthermore one cannot countenance an ethics committee giving its approval to non therapeutic experimentation on subjects who are mentally defective.

Conclusion

To ensure that any bodily interference is lawful, a doctor must pay careful attention to the age and mental capacity of his patient to consent to the general nature of the proposed interference. Consent always has to be voluntary and obtained in advance from the patient - save in an emergency situation when the doctor may be afforded a defence provided he can justify his actions as being in the patient's best interest. It is not in the patient's best interest to override any known objection of the patient to the procedure - whatever view the doctor may have of his patient's better interests.

Notwithstanding Sidaway, the law is moving towards a doctrine of informed consent as a consequence of the medical profession slipping towards an objective standard of disclosure. A doctor needs to be particularly careful to disclose all the material risks of procedures to patients. It is no longer a relevant consideration that such information will cause distress to the patient or even persuade him to change his mind.

The more experimental the treatment proposed or the less therapeutic a procedure becomes the greater the duty upon the doctor/experimenter to inform the patient/subject of all known risks. Non therapeutic experimentation carrying any material risk probably cannot be lawfully performed upon any person who does not have the requisite capacity to consent.

References

1. Lord Goff of Chieveley in Airdale NHS Trust v Bland [1993] AC 789 at 864
2. To become part of domestic law under the Human Rights Act 1998 which comes into effect on 2nd October 2000
3. X v Denmark 32 DR 282
4. See Guerra v Italy (1998) 26 EHRR 357 where applicants' rights to relevant information to their well being in their health and homes were found to have been breached where details of the environmental hazards from a chemical factory were not communicated to them by the authorities
5. The GMC guidance: Seeking Patient's Consent (Feb 1999) para 19 now makes it clear that a refusal of consent simpliciter is not evidence that the patient lacks the capacity to consent
6. The GMC Guidance ib. Para 2
7. S.8(1) Family Law Reform Act 1969
8. W (A Minor) (Medical Treatment: Court's Jurisdiction) [1992] 3 Med LR 317
9. This is known as "Gillick competence" after Gillick v West Norfolk and Wisbeach Area Health Authority and DHSS [1986] AC 112 (HL)
10. See Lord Donaldson: In Re W (A Minor) (Medical Treatment - Court's Jurisdiction) [1993] 64 at 76 (CA)
11. See F v West Berkshire HA [1989] 2 All ER 545
12. See the doctrine of necessity below
13. See below
14. In Re C (Adult: Refusal of Medical Treatment) [1994] 1 All ER 819 (CA). Presumption in favour of patient's right to self-determination not displaced. Although general capacity of 68 year old man to consent to amputation of gangrenous leg was impaired by his schizophrenia, the evidence failed to establish that he lacked sufficient understanding: he had understood and retained the relevant information, believed it and had arrived at a clear choice.
15. Lord Bridge in Sidaway v Board of Governors of Bethlem Royal Hospital [1985] 1 AC 871 at 900
16. Ibid
17. Seeking Patient's Consent (Feb 1999) para 6
18. The author, the law and to large extent the medical profession is pushing the Bolam test on standard of informed consent towards a full doctrine of informed consent. In Smith v Tunbridge Wells [1994] 5 Med LR 334 at 339 said that the surgeon "in stating that he owed a duty to warn, was reflecting not only the generally accepted proper practice, but also the only reasonable and responsible standard of care to be expected from a consultant..."
19. Whatever a Court may consider to be in patient's best interests, it is most unlikely to compel doctors to treat a patient against their clinical judgment
20. Lord Templeman in Sidaway v Board of Governors of Bethlem Royal Hospital [1985] 1 AC 171 at 904
21. See Re T: (Adult: Refusal of Treatment) [1992] 4 All ER 649 (CA) where on the facts, the doctors had been justified in disregarding T's instructions and in administering a blood transfusion to her as a matter of necessity since the evidence showed that T had not been fit to make a genuine decision because of her medical condition and that she had been subjected to the undue influence of her mother, which vitiated her decision to refuse a blood transfusion.
22. Following the decision of the House of Lords in Re F (Mental Patient: Sterilisation) [1990] AC 1 See Lord Goff at 74: "We are concerned here with action taken to preserve the life, health or well-being of another who is unable to consent to it. Such action is sometimes said to be justified as arising from an emergency; in Prosser and Keeton, Hornbook on Torts, 5th ed. (1984), p. 117, the action is said to be privileged by the emergency. Doubtless, in the case of a person of sound mind, there will ordinarily have to be an emergency before such action taken without consent can be lawful; for otherwise there would be an opportunity to communicate with the assisted person and to seek his consent. But this is not always so; and indeed the historical origins of the principle of necessity do not point to emergency as such as providing the criterion of lawful intervention without consent. The old Roman doctrine of negotiorum gestio presupposed not so much an emergency as a prolonged absence of the dominus from home as justifying intervention by the gestor to administer his affairs. The most ancient group of cases in the common law, concerned with action taken by the master of a ship in distant parts in the interests of the shipowner, likewise found its origin in the difficulty of communication with the owner over a prolonged period of time - a difficulty overcome today by modern means of communication. In those cases, it was said that there had to be an emergency before the master could act as agent of necessity; though the emergency could well be of some duration. But when a person is rendered incapable of communication either permanently or over a considerable period of time (through illness or accident or mental disorder), it would be an unusual use of language to describe the case as one of "permanent emergency" - if indeed such a state of affairs can properly be said to exist. In truth, the relevance of an emergency is that it may give rise to a necessity to act in the interests of the assisted person, without first obtaining his consent. Emergency is however not the criterion or even a pre-requisite; it is simply a frequent origin of the necessity which impels intervention. The principle is one of necessity, not of emergency."
23. See Re F (above)
24. Re S (Adult patient: Sterilisation) The Times 26th May 2000 (CA)
25. Bolam v Friern Hospital Management Committee [1957] 2 All ER 118
26. Para 7.7
27. See Brown & Others v R [1994] 1 AC 212 (HL) where defendant could not rely upon a defence of consent to a criminal charge in respect of injuries caused in acts of sado-masochism
28. Defined by R H Nicholson (1986) Medical Research with Children: Ethics, Law and Practice: Oxford University Press and adopted by the Royal College of Physicians - as including everyday risks such as travelling by public transport and private motor car but excluding travel by pedal or motor cycle