Consent is an individualised process based on respect – it is more than a signature on a form, says medicolegal adviser Dr Gordon McDavid.
Dr U is in his first week as an F2 in ENT. A nurse asks him to consent a patient going to theatre, she cannot locate the consent form in the patient’s notes. She says that the consultant will get very cross if the patient turns up to theatre without the appropriate documentation, especially as the patient’s operation has already been cancelled once, and it would be terrible if it happened again. Dr U appears unsure, so the nurse adds that Dr U would only have to take consent for a tonsillectomy, which “isn’t rocket science”.
Dr U is in a dilemma that many foundation doctors will be familiar with. The nurse is asking Dr U to work outside his competence, as he has not taken consent from a patient for a tonsillectomy before. So how should Dr U handle this situation? MPS advice is that Dr U should seek advice from a senior colleague before obtaining consent so that the operation can go ahead as planned.
Trust, confidence and good communication are fundamental to a successful doctor–patient partnership and providing healthcare involves decisions, which should be made with your patient. Failure to obtain consent properly can lead to problems including legal or disciplinary action against you, or rarely criminal prosecution for battery (contact with an individual without consent.)
The foundation programme curriculum stipulates that you should be familiar with the GMC’s guidance document Consent: Doctors and Patients Making Decisions Together, and be able to obtain consent in line with this guidance. By the end of your FY2, you should be able to describe the principles of valid consent and demonstrate this understanding in your practice. You should also be able to undertake a capacity assessment.
What is consent?
Consent should be a discussion with your patient that assists them to reach a decision. You should facilitate this process by providing the information they need in an appropriate format.
"Consent should be a discussion with your patient that assists them to reach a decision"
Whilst consent must be obtained prior to providing healthcare, often consent may be implied, eg, when a doctor requests a blood sample, the patient holds out their arm thus implying their consent to the procedure.
In an emergency situation where a patient cannot provide consent, (eg, the patient is unconscious) a doctor may provide treatment to safeguard the patient’s life or health, acting in the patient’s best interests.
It is important to warn patients of the risks of treatment and document that you have done so. Clear documentation is necessary to provide evidence of this.
In the 2004 case of Chester v Afshar (2004), the surgeon failed to document his discussions with the patient regarding the possibility of cauda equina syndrome following discectomy for lower back pain and it could nto proot be proven that Miss Chester had been warned of all the risks.1 Miss Chester successfully argued that if she had been warned, she would have taken the time to think about it and had surgery on another day, thus avoiding the rare complication.
The GMC’s consent guidance recommends that patients should be given information in a balanced and tailored way.2 Patients should be told of any possible significant adverse outcome and of any less serious side effects or complications if they occur frequently.
Document, document, document
While many patients wish to be fully informed and involved in their healthcare, some patients may not want to know all the details about treatments and their attendant risks and benefits, making it difficult to secure their valid consent.
If a patient does not want to discuss their condition or the treatment in detail, you should respect their wishes as far as possible, but the GMC says: “You must still give them the information they need in order to give their consent”. Safeguard yourself by recording the fact that the patient had declined this information.
If patients are competent, they are entitled to refuse consent, no matter how illogical this may seem. If this happens, it is a good idea to explain to them the possible consequences of their decision. Such discussion is not with the intention of changing their mind or coercing the patient, but to clarify the situation. You should listen to patients and respect their views, even if you do not agree.
"If patients are competent, they are entitled to refuse consent, no matter how illogical this may seem"
Check their understanding of the decisions they have made and document the discussion carefully, taking into account factors such as their religious beliefs or values expressed.
Patients can withdraw consent during a procedure – but if stopping the procedure at that point would genuinely put the life of the patient at risk, the practitioner may be entitled to continue until this risk no longer applies.
"To provide consent a patient must be competent (or have capacity) to do so"
What is capacity?
To provide consent a patient must be competent (or have capacity) to do so. So what if a patient is unable to give their consent? they may be unable to understand the information, or they may be unable to retain the information to weigh up the risks/benefits, meaning a decision cannot be made.
In England and Wales, the Mental Capacity Act (MCA) (2005) exists and is based around five statutory principles:
- A person must be assumed to have capacity unless it is established otherwise.
- A person is not to be treated as unable to make a decision, unless all practicable steps to help him do so have been taken without success.
- A person is not to be treated as unable to make a decision merely because an unwise decision is made.
- An act done, or decision made, under this act or on behalf of a person who lacks capacity must be done, or made, in his best interests
- Before the act is done, or the decision is made, care must be taken to avoid restricting the person’s rights and freedom of action.
In Scotland, the Adults with Incapacity Act (2000) applies; however, this is currently under review. In Northern Ireland there is no specific legislation covering mental capacity, so decisions should be based on common law (based on previous cases) and best practice.
How do you assess capacity?
The method of formally assessing capacity is described in the MCA and its supporting Code of Practice document.3 The assessment must be decision-specific and there are two stages to the test:
- Is there an impairment of or disturbance in the functioning of the patient’s mind or brain?
- Has it made the person unable to make this particular decision?
To have capacity to make a decision a person should be able to:
- Understand the information
- Retain that information
- Use or weigh up that information
- Communicate their decision
The MCA states the following should be considered:
- The past and present wishes of the patient (especially any written statement when the patient had capacity)
- Religious beliefs or values expressed by the patient when competent
- The views of relevant others (eg, carers, relatives)
- The patient should be involved in the consent process and encouraged to give their consent to particular aspects for which they do have capacity.
A person may temporarily lose capacity in certain situations; such as if they are in extreme pain, shock, under the influence of drugs, secondary to delirium or as a consequence of their condition.
Patients who have mental health problems may have difficulty making decisions about their treatment, but this should not be assumed.
Assessing capacity can be very difficult where patients suffer from serious communication problems. All practicable steps must be taken to assist the patient in communicating their decision (and thus retaining their capacity) such as using interpreters, large print documents or sign language.
"Assessing capacity can be very difficult where patients suffer from serious communication problems"
In order to assess a patient’s understanding, it is best to try to frame questions in such a way that the patient will need to give a full response eg, “tell me what you understand by…” rather than “do you understand?”
If you are in doubt regarding a patient’s capacity it is worth seeking further advice from your senior. It is vitally important to ensure thorough documentation of a formal assessment of capacity.
Deprivation of Liberty Safeguards (DOLS)
On each occasion that treatment is required for a patient who does not have the capacity to consent, a decision should be made in the best interests of the patient.
"MCA DOLS for England and Wales provide legal protection for those who lack capacity and who may be deprived of their liberty in hospitals or care homes"
The Mental Capacity Act deprivation of Liberty Safeguards (MCA DOLS) for England and Wales provide legal protection for those who lack capacity and who may be deprived of their liberty in hospitals or care homes. They apply to anyone aged 18 or over who suffers from a mental disorder or disability of the mind, and who lacks the capacity to give informed consent to the arrangements made for their care and/or treatment. The safeguards are designed to:
- Ensure people can be given the care they need in the least restrictive regimes
- Prevent arbitrary decisions that deprive vulnerable people of their liberty.
It shouldn't be assumed that people are not able to make their own decisions, simply because of their age or frailty.4
As patients get older, there is a temptation to believe that they have decreased capacity to take decisions about their treatment. However, you should always work on the assumption that capacity to give consent for treatment exists, unless it is proven otherwise.
End of life decisions
Before people lose the capacity to consent to treatment, particularly as a result of a progressive condition, they may make an advance decision (AD) or directive (or living will). If the statement was made by a competent adult, and there is no reason to believe that they have changed their mind, it should be respected.
The MCA provides some protection for doctors dealing with advance decisions. In particular, it provides a safeguard for doctors acting on advance decisions. You will not be held liable if you:
- Are in doubt over whether there is an AD and provide treatment
- Believe a valid and applicable ad exists and withhold or withdraw treatment.
Where there is doubt, the courts will decide whether an AD exists and whether it is valid and applicable to treatment. Until the court decides, nothing should prevent the provision of life-sustaining treatment, or anything believed to be necessary to prevent a serious deterioration in the patient’s condition. ADs (or directives) are governed by common law rather than by legislation in Scotland and Northern Ireland.
Children and young people
In England and Wales, anyone aged 18 and over is assumed to be a competent adult and can give their consent. In Scotland, the legal age of capacity is 16. Young people aged 16-17 are usually treated as if they are adults in that they are usually assumed to be competent. However, if they refuse a treatment, this can be overridden either by someone with parental responsibility or the courts.
"Young people aged 16-17 are usually treated as if they are adults in that they are usually assumed to be competent"
In patients under the age of 16, it is for the doctor to decide whether a child has reached a suitable level of maturity and understanding. Children under 16 are often competent and in the case of Gillick v West Norfolk and Wisbech Area Health Authority (1985) it was found that a parent’s right to consent to treatment on behalf of a child ends when the child has sufficient intelligence and understanding to consent to the treatment themselves, ie, when the child is “Gillick competent”.
If children under 16 refuse a treatment, this can be overridden by someone with parental responsibility or the courts. However, when there is a difference of opinion between the young person and their parents, this is usually resolved within the family. If there is no need for an immediate decision, it is clearly preferable to delay a decision until this can be resolved.
The treatment of young children can be a contentious issue and it is important to seek guidance from your senior or MPS.
For young children who are not competent to give their consent, someone with parental responsibility can give consent on their behalf. The mother automatically has parental responsibility unless she lacks capacity herself. A father will have responsibility if:
- He is married to the mother of his child (or was at the time of birth)
- He has made a parental responsibility agreement with the mother
- He has obtained a court order granting him parental responsibility
- The child was born after 15 April 2002 in Northern Ireland, 1 December 2003 in England or Wales, or 4 May 2006 in Scotland and the father is named on the child’s birth certificate.
What patients should be told
- All details of the diagnosis, and prognosis, and the likely prognosis if the condition is left untreated
- Any uncertainties about the diagnosis, including options for further investigation prior to treatment
- All options for treatment or management of their condition, including the option not to treat
- The purpose of a proposed investigation or treatment; details of the procedures or therapies involved
- Explanations of the likely benefits and the probabilities of success for each option; and discussion of any serious or frequently occurring risks
- Advice about whether a proposed treatment is experimental
- How and when the patient’s condition, and any side effects, will be monitored or reassessed
- A reminder that they can change their minds about a decision at any time.
- A reminder that they have a right to seek a second opinion.
1. Chester v Afshar, UKHL 41 Pt 2 (2004)
2. GMC, Consent: Patients and Doctors Making Decisions Together (2008)
3. MCA, Code of Practice (2005)
4. DH, Seeking Consent: Working with Older People (2001)
5. Ibid 2.
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