The following is the first 21 points on how consent must be established to be valid from the Department for Health dated 2004. I believe new guidelines have come after this, but it's an interesting read on principles because it raises some questions. I will let others comment. Some are pretty glaring in terms of 'sex change' operations especially involving vulnerable children and adults (notably with autism)
Valid consent
- 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 (this will
be the patient or someone with parental responsibility for a patient under the age of 18, someone authorised to do so under a Lasting Power of Attorney (LPA) or someone who has the authority to make treatment decisions as a court appointed deputy). Acquiescence where the person does not know what the intervention entails is not ‘consent’.
Does the person have capacity?
2. The Mental Capacity Act 2005 defines a person who lacks capacity as a person who
is unable to make a decision for themselves because of an impairment or disturbance
in the functioning of their mind or brain. It does not matter if the impairment or
disturbance is permanent or temporary. A person lacks capacity if:
• they have an impairment or disturbance (for example a disability, condition or
trauma or the effect of drugs or alcohol) that affects the way their mind or brain works, and
• that impairment or disturbance means that they are unable to make a specific
decision at the time it needs to be made.
- An assessment of a person’s capacity must be based on their ability to make a specific
decision at the time it needs to be made, and not their ability to make decisions in
general. A person is unable to make a decision if they cannot do one or more of the following things:
• understand the information given to them that is relevant to the decision
• retain that information long enough to be able to make the decision
• use or weigh up the information as part of the decision-making process
• communicate their decision – this could be by talking or using sign language and
includes simple muscle movements such as blinking an eye or squeezing a hand.
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People may have capacity to consent to some interventions but not to others, or may have capacity at some times but not others. Under the Mental Capacity Act, a person must be assumed to have capacity unless it is established that they lack capacity. If there is any doubt, then the healthcare professional should assess the capacity of the patient to take the decision in question. This assessment and the conclusions drawn from it should be recorded in the patient’s notes. Guidance on assessing capacity is given in chapter 4 of the Mental Capacity Act (2005) Code of Practice.
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A person’s capacity to consent may be temporarily affected by factors such as confusion, panic, shock, fatigue, pain or medication. However, the existence of such
factors should not lead to an automatic assumption that the person does not have the capacity to consent.
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Capacity should not be confused with a healthcare professional’s assessment of the reasonableness of the person’s decision. Under the Mental Capacity Act and the common law, a person is not to be treated as unable to make a decision merely because they make an unwise decision. A person is entitled to make a decision
which may be perceived by others to be unwise or irrational, as long as they have the capacity to do so.
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However, if the decision that appears irrational is based on a misperception of reality,
as opposed to a different value system to that of the health practitioner – for example a patient who, despite the obvious evidence, denies that his foot is gangrenous, or a patient with anorexia nervosa who is unable to comprehend their failing physical condition – then the patient may not be able to comprehend, weigh or make use of the relevant information and hence may lack the capacity to make the decision in question.
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The Mental Capacity Act also requires that all practical and appropriate steps are
taken to enable a person to make the decision themselves. These steps include the
following:
• Providing relevant information. For example, if there is a choice, has information
been given on the alternatives?
• Communicating in an appropriate way. For example, could the information be
explained or presented in a way that is easier for the person to understand?
• Making the person feel at ease. For example, are there particular times of the day
when a person’s understanding is better?
• Supporting the person. For example, can anyone else help or support the person
to understand information and to make a choice?
- Guidance on how people should be helped to make their own decisions is given in
chapter 3 of the Mental Capacity Act (2005) Code of Practice.
Is the consent given voluntarily?
10. To be valid, consent must be given voluntarily and freely, without pressure or
undue influence being exerted on the person either to accept or refuse treatment.
Such pressure can come from partners or family members, as well as health or care
practitioners. Practitioners should be alert to this possibility and where appropriate should arrange to see the person on their own in order to establish that the decision is truly their own.
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The test of capacity is set out in the Mental Capacity Act (see paragraph 2 above).
Once it has been determined that a person has the capacity to make a particular
decision at a particular time, a further requirement (under the common law) for that
consent to be valid is that it must be given voluntarily and freely, without pressure
or undue influence being exerted upon them.
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When people are seen and treated in environments where involuntary detention may
be an issue, such as prisons and mental hospitals, there is a potential for treatment
offers to be perceived coercively, whether or not this is the case. Coercion invalidates
consent, and care must be taken to ensure that the person makes decisions freely.
Coercion should be distinguished from providing the person with appropriate
reassurance concerning their treatment, or pointing out the potential benefits of treatment for the person’s health. However, threats such as withdrawal of any privileges, loss of remission of sentence for refusing consent or using such matters to
induce consent may well invalidate the consent given, and are not acceptable.
Has the person received sufficient information?
13. To give valid consent, the person needs to understand the nature and purpose of
the procedure. Any misrepresentation of these elements will invalidate consent.
Where relevant, information about anaesthesia should be given alongside information
about the procedure itself.
- It is particularly important that a person is aware of the situation when students or
trainees carry out procedures to further their own education. Where the procedure
will further the person’s care – for example taking a blood sample for testing – then, assuming the student is appropriately trained in the procedure, the fact that it is carried out by a student does not alter the nature and purpose of the procedure.
It is therefore not a legal requirement to tell the person that the clinician is a student,
although it would always be good practice to do so. In contrast, where a student proposes to conduct a physical examination that is not part of the person’s care then it is essential to explain that the purpose of the examination is to further the student’s training, and to seek consent for that to take place.
- Although informing people of the nature and purpose of procedures enables valid
consent to be given as far as any claim of battery is concerned, this is not sufficient
to fulfil the legal duty of care to the person.
Failure to provide other relevant
information may render the practitioner liable to an action for negligence if a
person subsequently suffers harm as a result of the treatment received.
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The requirements of the legal duty to inform patients continues to develop in
case law. In 1985, the House of Lords decided in the Sidaway case that the legal standard to be used when deciding whether adequate information had been given to a patient should be the same as that used when judging whether a doctor had been
negligent in their treatment or care of a patient: a doctor would not be considered negligent if their practice conformed to that of a responsible body of medical opinion held by practitioners skilled in the field in question. This is known as the
'Bolam test’. Whether the duty of care had been satisfied was therefore primarily a matter of medical opinion. However, Sidaway also stated that it was open to the courts to decide that information about a particular risk was so obviously necessary that it would be negligent not to provide it, even if a ‘responsible body’ of medical opinion would not have done so.
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Since Sidaway, judgments in a number of negligence cases (relating both to the
provision of information and to the standard of treatment given) have shown that
courts are willing to be critical of a ‘responsible body’ of medical opinion. It is now clear that the courts will be the final arbiter of what constitutes responsible practice, although the standards set by the healthcare professions for their members will still be influential. In Chester v Afshar, a majority of the House of Lords held that a neurosurgeon who failed to warn a patient of the small risk of injury inherent in surgery, even if properly performed, was liable to the patient when that risk materialised, even though the risk was not increased by the failure to warn and thepatient had not shown that she would never have had an operation carrying the same
risk.The Lords departed from the traditional ‘but for’ test of causation on the basis that, exceptionally, policy and justice required a modification to causation principles.
The fundamental principle underlying the decision was the right of a patient to make
an informed choice as to whether – and if so, when and by whom – to be operated on.
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In considering what information to provide, the health practitioner should try
to ensure that the person is able to make an informed judgement on whether to give or withhold consent. Case law on this issue is evolving. It is therefore advisable to inform the person of any ‘material’ or ‘significant’ risks or unavoidable risks, even if small, in the proposed treatment; any alternatives to it; and the risks incurred by doing nothing. A Court of Appeal judgment stated that it will normally be the responsibility of the doctor to inform a patient of ‘a significant risk which would affect the judgment of a reasonable patient’. Following Chester v Afshar, it is advisable that healthcare professionals give information about all significant possible
adverse outcomes and make a record of the information given.
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The GMC provides guidance on the type of information that patients may need to
know before making a decision, and recommends that doctors should do their best to find out about patients’ individual needs and priorities when providing information about treatment options. It advises that discussions should focus on the patient’s ‘individual situation and risk to them’ and sets out the importance of providing the
information about the procedure and associated risks in a balanced way and checking
that patients have understood the information given. BMA guidance advises that if in doubt about the amount of information to give a patient, doctors ‘should contact their hospital lawyers or their medical defence organisation’.
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In the very rare event that the healthcare professional believes that to follow the
guidance in paragraphs 18 and 19 in full will cause the patient serious harm, the
GMC guidance states that this view, and the reasons for it, should be recorded in the patient’s notes. When such concerns arise it is advisable to discuss the issue within the team caring for the patient. In individual cases the courts may accept such a justification but would examine it with great care. The mere fact that the patient might become upset by hearing the information, or might refuse treatment, is not sufficient to act as a justification.
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Some people may wish to know very little about the treatment that is being proposed.
If information is offered and declined, it is good practice to record this fact in the
notes. However, it is possible that individuals’ wishes may change over time, and it is important to provide opportunities for them to express this. GMC and BMA guidance encourages doctors to explain to patients the importance of knowing the options open to them while respecting a person’s wish not to know, and states that basic information should always be provided about what the treatment aims to achieve and what it will involve.