Dr Maria Dyban explores case law and guidance on patient consent and explains how the patient has the right to accept or refuse treatment
- Informed consent is necessary before examining or treating a competent patient
- Mentally competent adults have the right to refuse medical treatment
- Adults are presumed to have mental capacity to give consent
- Consent can be oral, written, and implied
- Consent must be given voluntarily
- It is best practice for the person who is providing medical treatment to obtain consent
- Consent can be withdrawn by a competent patient at any time
- Patients should be given sufficient information about benefits and risks.
Consent to treatment is a voluntary and continuing permission of the patient to receive a particular treatment based on an adequate knowledge of the purpose, nature, and likely risks of the treatment, including the likelihood of its success and any alternatives to it.1
Consent and the patient’s right to self-determination
A mentally capable person’s right to self-determination to choose medical treatment is well established in English law. Lord Donaldson stated in Re T:2
‘Prima facie every adult has the right and capacity to decide whether or not he will accept medical treatment, even if a refusal may risk permanent injury to his health or even lead to premature death.’
A mentally competent person has the right to refuse treatment or to make irrational decisions regarding their treatment and does not have to give reasons for his or her decision.
In Re MB, Dame Butler-Sloss LJ stated:3
‘A mentally competent patient has an absolute right to refuse to consent to medical treatment, for any reason, rational or irrational, or for no reason at all, even where that decision may lead to his or her own death.’
A patient’s mental capacity should be presumed unless you have any reason to doubt it. If the patient is making irrational or unwise decisions, the clinician should not assume that the patient lacks mental capacity.
A patient’s own decision-making may also be protected by several articles of the Human Rights Act.4 They include Article 2 (Right to life), Article 3 (The right not to be subject to inhuman and degrading treatment), Article 5 (The right to liberty), Article 8 (Respect for private and family life), and Article 9 (Respect for religious views).
What about the rights of self-determination of a pregnant woman, especially in cases where proposed treatment would benefit an unborn baby? English law is now clear that a fetus is not a legal person until it is born, as Baker P stated in the Paton case5 that: ‘The fetus cannot, in English law, in my view, have any right of its own at least until it is born and has a separate existence from the mother.’6
In the case of St George’s Healthcare NHS Trust v S,7 it was established that a competent woman had the right to refuse a caesarean section even if it would lead to the death of her 36-week-old fetus. In this case, Judge LJ stated that:8
’Pregnancy does not diminish [a woman’s] entitlement to decide whether or not to undergo medical treatment. Her right is not reduced or diminished merely because her decision to exercise it may appear morally repugnant.’
The Royal College of Obstetricians and Gynaecologists had previously issued a guideline that stated:9
‘It is inappropriate, and unlikely to be helpful or necessary, to invoke judicial intervention to overrule an informed and competent woman’s refusal of a proposed medical treatment, even though her refusal might place her life and that of her fetus at risk.’
Therefore, a mentally competent pregnant woman has the same right to accept or decline proposed medical treatment as any other competent adult.
The purpose of consent and the clinician’s liability
Good medical practice states:10
‘You must be satisfied that you have consent or other valid authority before you carry out any examination or investigation, provide treatment or involve patients or volunteers in teaching or research.’
The purpose of obtaining consent to treatment is protection of the patient’s autonomy as well as the protection of a clinician involved in a case from potential liability.11 If treatment is provided without consent, a clinician can incur either criminal liability for battery or a civil liability of clinical negligence.
Cases of criminal liability for battery are rare against doctors. Liability for battery may be incurred if treatment is provided when:12
- a mentally competent patient refuses treatment
- a patient is treated without their consent
- consent is obtained by fraud or duress
- a different procedure is performed from the procedure for which consent was obtained.
In an action for battery, it is not necessary to establish that any harm has been caused by the procedure.
Liability in negligence, a civil liability, can be brought against a clinician if consent has been obtained, but inadequate information given by the doctor about risks. Cases of clinical negligence are more common.
To prove a charge of negligence, all three of the following components must be present:13
- the doctor must owe the claimant a duty of care
- the doctor must be in breach of that duty
- harm must have been caused by the breach.
Types of consent and validity
Consent can be verbal, written, and implied. Implied consent is compliance by patient with a particular treatment or examination in a non-verbal way. An example of implied consent would be a patient lifting up his shirt if a clinician asks to examine his chest. However, the patient must understand what examination is intended and why, otherwise such consent is not valid. According to General Medical Council (GMC) guidance on consent,14 it is sufficient to have verbal or implied consent in cases of minor or routine investigations or treatments. Written consent is required by law for fertility treatment and organ donation.
General Medical Council guidance advises that written consent should also be obtained if:14
- the investigation or treatment is complex or involves significant risks
- there may be significant consequences for the patient’s employment, or social or personal life
- providing clinical care is not the primary purpose of the investigation or treatment
- the treatment is part of a research programme or is an innovative treatment designed specifically for their benefit.
For consent to be valid, the patient must have the capacity to consent, the consent should be voluntary, and the patient must understand the nature of the proposed treatment.15 Permission given by the patient under unfair pressure or duress is not consent. Such pressure, for instance, could come from the patient’s partner, family, clinician, or employer
Responsibility for seeking consent
According to GMC guidance on consent, it is advisable that consent for any investigation or treatment should be obtained by the clinician providing the treatment. In cases where this is not practical, obtaining consent can be delegated to a person who:16
- is suitably trained and qualified
- has sufficient knowledge of the proposed investigation or treatment, and understands the risks involved
- understands, and agrees to act in accordance with, the guidance in [the guidance booklet].
The consent to treatment once obtained can be valid indefinitely. However, if significant time has passed since the consent has been obtained, the patient’s condition has changed, or if there have been new relevant medical developments since consent was given, then new consent should be sought.17
A mentally competent patient has the right to withdraw their consent at any time, even during the procedure. In the case of the latter, the clinician has to distinguish between genuine withdrawal of consent and anxiety or pain during the procedure. The clinician should then address the patient’s concerns and explain the consequences of not completing the procedure. In cases when stopping the procedure would put the patient’s life at risk, the procedure should be continued until the risk no longer applies.18
What information should be given?
In its guidance on consent, the GMC states what information must be given to patients regarding proposed investigations or treatment. It includes diagnosis, prognosis, uncertainties, treatment options, purpose of treatment with potential benefits, risks, and likelihood of success.19 The list is not exhaustive and it is important that you familiarise yourself with this guidance.
For consent to be informed, there must be sufficient information given to the patient regarding benefits, risks, and alternative procedures. The patient must know to what exactly they are consenting.
How much information should be given?
The standard is the prudent or reasonable patient test. The doctor must give as much information to a patient as a reasonable patient would want to know. However, patients can attach different weight to harm and benefits, depending on their current circumstances, beliefs, and previous experience.
Lord Woolf MR stated in Pearce v United Bristol Healthcare NHS Trust:20
‘In determining what information to provide a patient, a doctor must have regard to all relevant circumstances, including the patient’s ability to comprehend the information and the physical and emotional state of the patient. Normally, it is a doctor’s legal duty to advise a patient of any significant risks which may affect the judgment of a reasonable patient in making a treatment decision.’
In Chester v Afshar,21 a surgeon failed to disclose a 1%–2% risk of paralysis following properly performed spinal surgery. The House of Lords judgment held that a failure to warn a patient about a risk, however small the probability is, denies the patient the chance to make an informed decision about their treatment. It is therefore advisable that clinicians provide information about all significant possible risks and make a record of the information given. Most patients would like to know the most common risks and the most severe or significant risks of proposed treatment. What defines a significant risk?
‘When one refers to a "significant risk”, it is not possible to talk in percentages, but I note, and it may be purely coincidental … that one of the expert doctors … gave the following answer … if the risk, however, was of the order of 10 per cent, for instance, then of course it would be my duty to warn against such a level of risk.’20
This judgment suggests that risks which are around 10% should be disclosed to a patient. Although the probable risk may be much lower, if the damage from a risk would be serious, that risk must be disclosed to the patient.
In Rogers v Whitaker,22 an ophthalmic surgeon failed to disclose a 1:14,000 risk of blindness in a good eye following an operation on a bad eye. In this case, Maree Whitaker, who was almost blind in one eye, wanted to know the risks of the surgery and kept asking the surgeon about them. He failed to disclose the risks and as a result of the operation she lost her eyesight in a good eye.
Campbell J in the above case stated that:22
‘… 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 or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it.’
Department of Health guidance on consent23 advises that it is a doctor’s responsibility to inform patients on ‘material’ and ‘significant’ risks, however rare they could be, and also that doctors should document such discussions in clinical records.
Look out for a future article by the same author on consent to treatment, covering competent minors, people with mental health conditions, unconscious patients, and mentally incapacitated adults.
- Mental Health Act Code of Practice 1983 (revised 2008), para 23.31. Available at: webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_084597 (accessed 30 September 2014).
- Re T (adult: refusal of treatment)  3 WLR 782,  Fam 95 at 115 per Lord Donaldson MR.
- Re MB (medical treatment) (1997) 38 BMLR 175 at 182 per Butler-Sloss LJ.
- Jackson E. Medical law, text, cases and materials. 2nd edn. Oxford: Oxford University Press, 2010, p.221.
- Paton v BPAS  2 All ER 987.
- Paton v BPAS  2 All ER 987 at 989.
- St George’s Healthcare NHS Trust v S  3 WLR 936.
- St George’s Healthcare NHS Trust v S  3 WLR 936 at 957, cited by Jackson E. Medical law, text, cases and materials. 2nd edn. Oxford: Oxford University Press, 2010, p. 457.
- Royal College of Obstetricians and Gynaecologists guidelines (RCOG 1994, para 5.12) cited by Jackson E. Abortion, autonomy and prenatal diagnosis (2000) 9 Social and Legal Studies 467, p.473.
- General Medical Council. Good medical practice. GMC, March 2013 (updated April 2014), para 17. Available at: www.gmc-uk.org/guidance/good_medical_practice.asp (accessed 19 September 2014).
- Philip Fennell, Professor of Law, Cardiff Law School, ‘Consent to Treatment’ lecture 2011.
- Re T (adult: refusal of treatment)  Fam 95 (CA) at 102 per Lord Donaldson MR. R (on the application of Burke) v General Medical Council  EWCA Civ 1003 at paras 31 and 57 per Lord Phillips MR; Philip Fennell, Professor of Law, Cardiff Law School lecture 2011.
- Herring J. Medical law and ethics. 3rd edn. Oxford: Oxford University Press, 2010, p. 104.
- General Medical Council. Consent: patients and doctors making decisions together, guidance for doctors. London: GMC, 2008, para 49. www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_index.asp
- Jackson E. Medical law, text, cases and materials. 2nd edn. Oxford: Oxford University Press, 2010, p.217.
- General Medical Council. Consent: patients and doctors making decisions together, guidance for doctors. London: GMC, 2008, para 26. Available at: www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_index.asp (accessed 30 September 2014).
- General Medical Council. Consent: patients and doctors making decisions together, guidance for doctors. London: GMC, 2008, para 52. Available at: www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_index.asp (accessed 30 September 2014).
- Department of Health. Reference guide to consent for examination or treatment. 2nd edn. London, DOH: 2009, para 45. Available at: www.gov.uk/government/publications/reference-guide-to-consent-for-examination-or-treatment-second-edition (accessed 30 September 2014).
- General Medical Council. Consent: patients and doctors making decisions together, guidance for doctors. London: GMC, 2008, para 9. Available at: www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_index.asp (accessed 30 September 2014).
- Pearce v United Bristol Healthcare NHS Trust (1999) 48 BMLR 118.
- Chester v Afshar  UKHL 41. Available at www.publications.parliament.uk/pa/ld200304/ldjudgmt/jd041014/cheste-1.htm (accessed 19 September 2014).
- Rogers v Whitaker  175 CLR 479, 109 ALR 625, 16 BMLR 148,  4 Med LR 79. www.austlii.edu.au/cgi-bin/sinodisp/au/cases/cth/HCA/1992/58.html?query=title(Rogers%20%20and%20%20Whitaker) (accessed 30 September 2014).
- Department of Health. Reference guide to consent for examination or treatment. 2nd edn. London, DOH: 2009, para 18. Available at: www.gov.uk/government/publications/reference-guide-to-consent-for-examination-or-treatment-second-edition (accessed 30 September 2014).