Describe the professional guidance surrounding shared decision-making and consent in anaesthesia and critical care.
Explain the ethical principles underpinning capacity and consent, and the legal framework applicable to the UK jurisdiction in which you practise.
Demonstrate an awareness of situations where determining capacity and the validity of consent may be less clear.
The standard for determination of medical negligence with regards to consent is now based on what a reasonable patient would want to know in the circumstances rather than what a body of clinicians would deem reasonable practice.
Assessment of capacity is integral to the consent process.The law surrounding treating patients without consent and treating 16- and 17-yr-old patients differs across the three jurisdictions of the UK.
Treating a patient who has capacity without consent could lead to conviction for battery or assault.Medicine is becoming less paternalistic; increasing importance is being given to autonomy and self-determination in medical decision-making. The belief that patients cannot understand information or make decisions in their own best interests is no longer accepted. Public expectation of doctors to support a patient's decision-making by providing information tailored to the needs of the individual is increasingly reflected in law. The evolving legal situation prompted the Association of Anaesthetists of Great Britain and Ireland (AAGBI) to update guidance on consent in January 2017, 1 supplementing existing guidance from the General Medical Council. 2 This article summarises the professional and legal consensus on consent in anaesthesia, critical care and pain medicine, illustrated with case examples. Capacity is integral to the consent process and statutory legislation and case law surrounding capacity for medical decision making in the three legal jurisdictions of the UK is discussed. Consent and capacity in children has been covered previously in BJA Education.
Hanley was injured when the needle used to administer an injection by Dr Hunter broke in situ. She alleged negligence as the needle used was not appropriate for the purpose. The Scottish courts found that to prove negligence, it must be established that no professional of ordinary skill would have taken that course of action if acting with ordinary skill and care. 3 This is the precursor to the Bolam principle, and remains the standard for medical negligence in Scots Law.
Bolam voluntarily underwent electroconvulsive therapy. Neuromuscular blockers and restraints were not used and he sustained an acetabular fracture. He alleged negligence. The House of Lords determined that ‘a medical professional is not guilty of negligence if he acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art’. 4
Sidaway alleged negligence after paralysis arising from spinal cord compression as a complication of spinal surgery. The surgeon obtained consent for surgery including the possibility of cord compression but did not explain that this may cause paralysis. The House of Lords ruled that ‘the only effect that mention of risks can have on the patient's mind, if it has any at all, can be in the direction of deterring the patient from undergoing the treatment which in the expert opinion of the doctor it is in the patient's interest to undergo’. Lord Scarman dissented, arguing that doctors should have a duty to inform the patient of the inherent and material risk of the treatment proposed. However, the final judgement confirmed that the Bolam principle did apply to consent, and thus the test of reasonable disclosure of risk lay with the physician, not the patient. 5
A patient underwent spinal surgery for back pain and developed cauda equina syndrome. This is a recognised complication of spinal surgery but was not mentioned during the consent process. The patient successfully alleged negligence, arguing that although she would probably still have had surgery had she known of the potential complication, she would have explored other options first and therefore not had the operation at that time. 6 As a result of this ruling, whether being informed of a particular risk during the consent process would have altered the patient's decision is not relevant in determining negligence.
Montgomery's son sustained a brachial plexus injury and cerebral palsy from a period of fetal hypoxia during a vaginal birth complicated by shoulder dystocia. She was recognised as being at high risk for shoulder dystocia but this was not discussed with her during the antenatal period and she was not offered an elective caesarean section. Her obstetrician argued that although the risk of shoulder dystocia was significant, it is normally managed effectively with simple manoeuvres and the risk of fetal morbidity is minimal. The obstetrician continued to argue that if all women were counselled on the small risk of such a serious complication then they would invariably opt for a caesarean section, which would be contrary to their interests. The lower courts found in favour of the obstetrician based on Hunter vs Hanley but this was overturned by the Supreme Court. They found that:
The Montgomery case fundamentally changes the medical profession's duty regarding disclosure of risk to patients during the consent process from what the ordinary, responsible physician may feel is appropriate, as laid out in Hunter vs Hanley and Bolam, to that which the reasonable patient would wish to know. There is now a clear duty placed on the physician to communicate any material risks to the patient during the consent process.
Respect for autonomy is a key principle of medical ethics. Patients have the right to be involved in decisions about their care and therefore a duty is placed on the treating physician to gain consent. This includes the right to make a decision that is considered contrary to their best interests. All cases to date have been based on an allegation of negligence. However, treating a patient without consent could lead to conviction for battery or assault. Assessment of capacity is crucial to the consent process. A patient may lack capacity to make decisions about some aspects of their care but retain the capacity to make decisions about more straightforward aspects.
The General Medical Council published guidance on consent in 2008, which lays down the values the regulator expects from the profession. Case law now reflects these values, making them legal and professional obligations. Medical professionals must:
The AAGBI released guidance in January 2017 ( Table 1 ). There are no specific guidelines for intensive care medicine or pain medicine.
Summary of AAGBI guidance on consent for anaesthesia. 1
Valid consent requires capacity and the provision of adequate information. Capacity is the ability, without coercion, to understand and weigh up information and communicate a decision. Determining whether a patient has capacity is the responsibility of the clinician obtaining consent. Where time permits and a patient's capacity is in doubt, the Court of Protection should determine whether or not to treat without consent.
C had paranoid schizophrenia and was detained under the Mental Health Act in Broadmoor Hospital. He developed gangrene in his leg but refused amputation, which doctors considered necessary to save his life. The Court upheld C's decision, and determined he had capacity to refuse consent, regardless of the risks this may incur. 8
MB required a caesarean section but withdrew consent because of needle phobia. The hospital obtained a judicial declaration that it would be lawful to undertake the procedure. The Court of Appeal upheld the view that MB's capacity had been impaired as her phobia prevented her from understanding and weighing the information she was given about her condition and the proposed treatment. 9 This decision confirms that capacity is time- and decision-specific and can fluctuate.
The Mental Health Act 1985 (MHA) permits the detention of an individual and treatment of a mental illness without consent including the physical manifestations of that illness. The MHA does not permit the treatment of conditions unrelated to the patient's mental illness. Detention under the Act does not mean a patient lacks capacity to make any decisions about their healthcare.
The Mental Capacity Act (MCA) applies to all individuals older than 16 yr in England and Wales and sets out the law with regards to assessing capacity and the action required where a patient lacks capacity. 10 The key principles are provided in Table 2 . Guidance on assessing capacity is provided in the accompanying code of practice. 11 To lack capacity, a patient must have a ‘disturbance of the functioning of the mind or brain’. In a patient with capacity, it is not relevant how unwise or ill-considered a decision may appear, even if it may result in their death.
Principles underlying the MCA 2005. 10
| A person must be assumed to have capacity unless proved otherwise. |
| A person must be given all practicable help to make their own decision before being treated as lacking capacity. |
| A person must not be treated as lacking capacity merely because they make an unwise decision. |
| An intervention or decision made on behalf of a person lacking capacity must be in their best interests. |
| The intervention or decision made on behalf of a person lacking capacity must cause the least restriction of their rights and freedom of action to achieve the stated purpose. |
If a patient is unable to consent, treatment is carried out in their best interests. Assessment of best interests must include social, psychological, and medical factors and should be informed by the patient's attitudes and opinions. If time permits, family or close friends must be consulted. If this is not possible, and the course of action proposed may have serious consequences or the risks and benefits are finely balanced, an Independent Mental Capacity Advocate should be consulted.
A patient may have an advanced decision, lasting power of attorney for health and welfare (LPA) or a court-appointed deputy. An advanced decision to refuse life-saving treatment must be written, witnessed and specifically document that it applies in the event of risk to life. It is legally binding unless there is evidence that the patient lacked capacity or was acting under coercion when they made it, or have since changed their mind. An LPA must be registered with the Office of the Public Guardian and can only refuse life-saving treatment if the provision is specifically included. A court-appointed deputy can never refuse life-saving treatment. None of these methods can compel the administration of treatment that is not in the patient's best interests or where the primary intention is to hasten death. Individuals aged 16 or 17 yr can consent to treatment and parental consent is not required. Consent of a parent or guardian can overrule refusal of consent by 16- and 17-yr-olds and emergency life-saving treatment can be given without consent from the patient or those with parental responsibility. 10 Overruling the wishes of the 16- or 17-yr-old patient is fraught with difficulty and where practicable, an application to the Court of Protection is advisable.
Deprivation of Liberty Safeguards (DoLS) are an amendment to the MCA applicable to the hospital and care home setting. They are intended to uphold Article 5 of the Human Rights Act (‘everyone has the right to liberty and security of person’) and apply in England and Wales. A person is deprived of their liberty if they lack the capacity to consent and:
is subject to continuous supervision and control and; is not free to leave (regardless of whether they are trying to or want to leave).A patient with capacity can consent to deprivation of liberty in advance if it is a foreseeable part of their treatment and DoLS would not apply. DoLS requires an application to a supervisory body (usually the local authority) to ensure care meets DoLS safeguards. 12
DoLS in relation to critical care was clarified by the Court of Appeal in January 2017; ‘any deprivation of liberty resulting from the administration of life-saving treatment to a person falls outside Article 5 so long as [it is] rendered unavoidable as a result of circumstances beyond the control of the authorities and is necessary to avert a real risk of serious injury or damage, and [is] kept to the minimum required for that purpose’. ‘The treatment must be materially the same treatment as would be given to a person of sound mind with the same physical illness’. As long as the root cause of any loss of liberty is the patient's physical condition, rather than restrictions imposed by the hospital, DoLS will not apply. In cases where the application of DoLS is unclear legal advice should be obtained. 13
The legal framework surrounding consent and capacity in Scotland is based on the Adults with Incapacity Act. It is similar to the MCA but without specific provisions for 16- or 17-yr-olds who are treated the same as those aged >17 yr in England and Wales. Emergency treatment can be given to patients lacking capacity under common law rather than the provisions of the act. 14
In Northern Ireland, the MCA 2016 is not yet in force and capacity is currently based on common law. The provisions are similar to the MCA but proxy decisions under an LPA are valid from the age of 16 yr rather than 18 yr. 15
A 17-yr-old Jehovah's Witness with placenta previa required an emergency caesarean section for antepartum haemorrhage with fetal compromise. She had been counselled antenatally regarding blood products and had completed a consent form specifically detailing her decision to refuse primary blood components even if her life was at risk. This was reaffirmed at subsequent antenatal consultations and again verbally as part of the consent process for her emergency surgery. She underwent caesarean section under general anaesthesia complicated by major haemorrhage. Her father refused assent to blood products. However, her mother wished her daughter to receive a blood transfusion.
In England and Wales under the MCA and in Northern Ireland, a 16- or 17-yr-old can consent to but not refuse life-saving treatment. Failure to address this antenatally represents poor practice. Parents can overrule a lack of consent on their behalf. It would be legal to administer a lifesaving blood transfusion in these circumstances against the consistently expressed wishes of the patient regardless as parents cannot refuse emergency life-saving treatment on behalf of their child. 10
In Scotland, there is no specific provision for 16- and 17-yr-olds, so administering a blood transfusion against the wishes of the patient without good reason to believe she had changed her mind would be unlawful irrespective of parental assent. 14
A 16-yr-old was listed for cosmetic pinnaplasty. She and her parents were happy with the explanation they received at the preoperative visit and both the patient and her parents signed the consent form for the procedure. In the anaesthetic room she became distressed and refused induction of anaesthesia as she was needle-phobic. The parents were keen to proceed.
It could be argued that the patient is incapacitated by their phobia and an attempt to defend a decision to proceed could be made on this basis across all three jurisdictions. In England, Wales, and Northern Ireland, the parents can legally consent on behalf of 16- and 17-yr-olds against their wishes. However this is elective, cosmetic surgery and no significant patient harm would arise from delaying the operation. Proceeding against the patient's wishes may result in psychological harm. Delaying would be the least restrictive option, provide an opportunity to explore the patient's concerns and develop a strategy to manage the situation in the future.
A consultant anaesthetist supervised a student performing laryngoscopy as part of tracheal intubation for elective surgery. The patient sustained dental damage.
Dental damage is a recognised complication of endotracheal intubation and should form part of the routine discussion in the preoperative anaesthetic visit and consent process. An explanation, apology, and follow-up should be arranged by the responsible consultant. Professional and legal guidance does not advocate obtaining consent specifically relating to training less experienced individuals in practical procedures. However, it does state that risks to the patient from training should be minimised through methods such as teaching and simulation before undertaking the procedure in patients under adequate supervision. 1
An anaesthetist is asked to perform a diagnostic lumbar puncture to exclude subarachnoid haemorrhage in a patient who has presented with a ‘thunderclap’ headache and has had a normal head computed tomography scan. The medical team looking after the patient has been unsuccessful in performing a lumbar puncture.
In this situation, the lumbar puncture is not part of anaesthesia or facilitating a separate procedure. A full discussion of the procedure and its risks and benefits should be undertaken and, in this situation, it would be good practice to obtain full written consent.
A patient presents for wound exploration and tendon repair for a hand laceration. The anaesthetist is not confident in performing regional nerve blocks and there is no other anaesthetist available so they consent the patient for a general anaesthesia with systemic opioid analgesia. The patient later complains as they have since learnt they could have had a regional technique and avoided a general anaesthetic, and that this was not discussed with them.
The consent process should involve a discussion of the proposed procedure and the alternatives available. If it is not possible to offer the option of regional anaesthesia, this should be explained to the patient and they should have the opportunity to attend on another date when it would be available or seek treatment elsewhere. By not mentioning the option of regional anaesthesia, the patient has been denied the opportunity to make their own decision.
Patients have increasing expectations, and a legal and moral right, to be informed about the risks, benefits, and alternatives to proposed treatments. The legal framework underpinning this is evolving, reinforcing the responsibility on clinicians to ensure patients are at the centre of decision-making about their healthcare.
The associated MCQs (to support CME/CPD activity) will be accessible at www.bjaed.org/cme/home by subscribers to BJA Education.
Tim Orr MRCP FRCA is a specialty trainee in anaesthesia in South Yorkshire whose interests include medical law.
Rosaleen Baruah FRCP FRCA FFICM LLM is a consultant in critical care in NHS Lothian. She has a masters degree in Medical Law and Ethics, and is a member of the Legal and Ethical Policy Unit, a Joint Standards Committee of the Faculty of Intensive Care Medicine and the Intensive Care Society. She has taught regionally on consent and capacity in anaesthesia and critical care in children and adults.
Matrix codes: 1E03, 2C06, 3J00
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