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					Consent
The philosophical basis of informed consent rests on the principle of patient autonomy.
Lidz (1984) analysed valid consent into three principal components and two secondary
components. These three principal components are incorporated into English law.
    1. Informed
    2. competent
    3. voluntary (not coerced)

The two subsidiary components are
   a. understanding
   b. deciding
The two subsidiary components can be seen as elements of competence.


The law of consent

There are two main areas of the law that are concerned with consent.
     Battery
     Negligence
Both are part of civil and common law.
In addition, there is statute law covering
         children's act 1989 (consent with regards to children)
         family Law reform act 1969 (consent with regards to children aged 16 to 17)
         mental health act

The law distinguishes competent (the legal term is called capacity) and incompetent patients.
There is a fundamental difference between competent and incompetent.
     a. A competent adult is aged over 18 years, and may refuse any, even lifesaving,
        treatment. Patients should be given information about the nature of the procedure
        (otherwise battery) and information about common or rare serious side-effects and
        benefits and reasonable alternatives (otherwise negligence)
     b. An incompetent adult should be treated in whatever way serves their best interests.
        This is the doctor's professional judgment. Relatives and friends may be sources of
        information but cannot give or withhold consent.
Battery
If one person touches another with out consent, this is battery and it involves both the civil
court (claiming the damages) and the criminal court (criminal act). Without true consent, the
patient could successfully sue the doctor for battery.
Negligence
In order to choose whether or not to accept a treatment or to undergo a diagnostic test, the
patient needs information (benefits, risks, alternatives). Without this information, the patient
could sue for negligence. Up until recently, the Bolam test, based on the concept that a
doctor acts in accordance with the practice accepted as proper by a reasonable body of
medical men skilled in that particular art, has been the guiding principle. A more recent case
(Sidaway 1984) has changed this review, the law lords suggested that the court could find that
normal medical practice falls below acceptable standards.

The case of Sidaway involved a female patient suffering recurrent pain in her neck. Following
operation, the patient suffered considerable disability and partial paralysis. She subsequently
sued the hospital, lost the claim however took the case to the Court of Appeal, which also
dismissed the case, and then went on to further appeal to the House of Lords. The central
legal argument was whether the Bolam test should be applied with regard to giving
information. Based on this argument, the neurosurgeon was not negligent. However in this
case it was felt that if there was a significant risk which could affect the judgment of a



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reasonable and prudent patient, then in the normal course it is the responsibility of the doctor
to inform the patient of that significant risk. Although there has never been any figure with
regards to the level of risk that could be expressed to a patient, doctors are now normally
expected to disclose much lower probabilities of serious side-effects. For example in Australia
1992, a doctor was found negligent in not warning of the risk of blindness following an eye
operation were that risk was put at 1: 14,000.

The guidelines from the General medical Council state that doctors must respond honestly to
any question from the patient and as far as possible, answer as fully as the patient wishes. The
issue of a consent form is an interesting one. That failure to sign a consent form make it illegal
to perform surgery on a competent patient?. The answer is no. From the legal point of view,
the key thing is that the patient has given valid consent. That consent can be given verbally.
The purpose of a written consent form is twofold. First of all it provides a mechanism to
ensure that consent is obtained and secondly to provide evidence that the patient has given
consent. One important implication is that a patient may withdraw consent after signing the
consent form.

Because touching without consent can constitute battery, the patient's consent is needed even
when taking the pulse. Does this mean that patients could successfully sue doctors much of
the time. The answer is no because the court recognized the concept of implied consent.
However the mere fact that a person voluntarily comes to see a doctor does not imply consent
to any examination investigation or treatment.

Competency (Capacity)
The process by which a person comes to a particular decision in the eyes of the law is a
functional approach. The Mental Capacity Act 2005 separates the assessment of capacity into
four aspects. If the person fails one or more parts of the test, then they do not have the
capacity to make the decision.
    1. Understanding the information. This requires intellectual abilities and understanding
        to be able to appreciate the nature and meaning of potential alternatives.
    2. To retain the information and be able to deliberate the information This requires
        sufficient short-term memory to retain the relevant information and allow the process
        of decision-making to take place. Severe memory impairment, even in the absence of
        other intellectual deficits, may render someone incompetent for a specific task.
    3. Weighing up the information in coming to a decision. The person must have a ‘set of
        values or conception of the good’. These values should be their own and they should be
        at least stable and consistent. This is needed to be able to balance outcomes such as
        benefit or harm, good or evil, and to assign different relative weight or importance to
        each of them.
    4. To communicate the information (by any means). Just because a patient may not be
        able to talk clearly, for example the patient may have severe motor neurone disease,
        does not mean they lack capacity. All efforts should be made to allow a patient to
        express themselves however badly.

With regards to capacity the following should be borne in mind:
            Just because a patient makes an unwise decision, this does not necessarily
                indicate a lack of capacity. The decision itself does not indicate in capacity if
                the reasoning to it was sound in the patient's mind.
            A person is not globally competent or incompetent. A patient may be
                competent to make a will, but incompetent to consent or refuse consent.
            The usual standard of proof is "balance of probabilities" as opposed to "beyond
                reasonable doubt"
            An adult is presumed to be competent until contrary evidence is provided. In
                other words the onus of proof lies with showing that someone does not have
                the capacity.



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             Once in capacity has been established, it is presumed to continue until contrary
              is proved by acceptable evidence.
             Ultimately capacity is a legal and not a medical decision. In practice however
              courts usually take considerable notice of doctors assessments of capacity.

An example of this could be the situation where a patient suffering from schizophrenia refuses
amputation for a gangrenous leg. The fact that the patient suffers from schizophrenia does not
necessarily mean that he lacks capacity to make the decision about his leg. In this case the
patient refused to have a leg amputated even though without the procedure he could die.
(Adult refusing treatment 1994).

In order to assess the competence or capacity, three assessment steps are necessary.
    1. Identify the information relevant to the decision. This means that a decision needs to
        be made, what the variable decisions are, and the pros and cons of each decision.
        There needs to be an understanding what the medical treatment is, in broad terms the
        nature of the proposed treatment, to understand the benefits and risks of treatment
        and the consequences of not receiving the treatment.
    2. Assess cognitive ability. This means the patient is able to carry out all four functional
        elements of the decision-making process as outlined above (to understand the
        information, to be able to reason and deliberate, to be able to weigh up the
        information in order to come to a decision and finally to be able to communicate their
        opinion).
                 Consider the following conditions that can interfere with such ability:
                        acute confusional state (delirium)
                        dementia
                        learning disability
                        stroke
                        Korsakoff's psychosis
                        brain tumour
    3. Assess other factors that may interfere with decision-making.
                      Mental illness such as delusion, hallucination, and affective disorders
                         such as depression or manic illness.
                      Lack of maturity considering both emotional and cognitive maturity.
                         With children the assessment of competence may involve also an
                         assessment of coercion. For example a child who is in securely
                         attached to their parents may be unable to muster sufficient autonomy
                         to be free to make a decision, instead they may feel bound to comply
                         with parental wishes.

Assessing competency is not like a school exam. The doctor may need to treat any mental
disorder that affects capacity, the capacity is likely to improve, then he should wait. To be
aware that medication could adversely affect capacity, and that it capacity fluctuates for
example depending on the time of day, to assess capacity when the patient is at their best. To
choose a suitable environment to maximise the patient's capacity, and to consider whether the
person might be helpful if the relative or friend is with them. To allow time to process the
information and perhaps by using aides mémoire.




Incompetency

Buchanan and Brock (1989) identified four theoretical approaches to making decisions about
health care of incompetent patients.




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   1. Best interests. This is the approach supported by English law. In other words the
      Bolam test will apply should any question arises as to a doctor's judgement concerning
      an incompetent patient's best interests. However there in mind the previous discussion
      regarding Sidaway.
   2. Proxy. In English law, no one can act as proxy on the hearth of an incompetent adult
      although the situation is under review. In Scotland there is some provision for proxy
      consent for incompetent adults.
   3. Substituted judgement. This asks a hypothetical question, suppose the patient were
      (magically) able to become competent, what treatment would they choose. To answer
      this question, the doctor would use evidence such as the report of what the patient has
      said about this situation in the past, the kind of general values the patient holds, and
      experience with other patients.
   4. Advance directives. An advance directive is a statement made by a person at a time
      when there are competent about how they wish to be treated in the future when they
      become ill and at the same time incompetent to decide what is best themselves.
      Types of advance directive include:
           a. Instruction directive: a statement expressing a preference for, or refusal of,
              specific treatments in certain specific future circumstances.
           b. General values/preferences statement. A statement of a person's general
              value or preference relevant to medical treatment
           c. Proxy directive. Authorising another specific person to take the patient's part
              in making healthcare decisions
           d. Formal: written and witnessed in the same way that they "last will and
              testament" is created. This contrasts with an informal directive which could
              arise, for example, from a conversation with a relative.
           e. Living will: a term sometimes used synonymously with advanced directives
           f. Advanced statement of health care: synonymous with advance directive.
      There are many reasons to encourage advanced directives. These include respecting,
      and extending patient autonomy, however reasons against include whether or not
      people can imagine future situations sufficiently vividly for the present views to be a
      good guide to the future wishes, or whether a person may change their mind without
      altering the directive. Currently there is no statute authorising advanced directives;
      however there is common law relevant to instruction directives. Lord Donaldson (1992)
      in the court of appeal stated "there seems to be a view in the medical profession that
      in emergency circumstances the next of kin should be asked to consent on behalf of the
      patient. This is a misconception because the next of kin has no legal right either to
      consent or refuse consent. This is not to say that it is undesirable practice because it
      may reveal that the patient has made anticipatory choice which if clearly established
      and applicable in the circumstance, would bind the practitioner." Case law has
      established that the court will accept advanced directives refusing specific treatment
      provided the patient was competent at the time the decision was made, and that the
      patient was free from undue influence, sufficiently informed, and intended to apply to
      the circumstance that subsequently arose. From a legal point of view, advanced
      directives are essentially advance refusals of treatment (or investigations) as they do
      not allow patients to demand a treatment that would otherwise not be offered. Proxy
      directives are not legally valid in English law because no one can give or withhold
      consent on a half of another adult. That is, even if a person when competent says that
      they wished their spouse to act as proxy for consent to medical treatment, this will
      have no legal force.


The Tony Bland case : House of Lords. Airedale NHS Trust v Bland 1992

The Tony Bland case is a landmark case. Tony Bland was in a persistent vegetative state and
had been in hospital in this state for some time. He was breathing spontaneously, requiring



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nutritional support. The Doctors were worried that if they withdrew nutritional support and
Tony Bland died, they (the doctors) would be guilty of murder.

The conclusion from the review was that withdrawal of medical treatment from a hopeless
case was not unlawful

However, medical practitioners should apply to the court for a declaration in each case as to
the legality of any proposed discontinuance of life support where there was no valid consent on
the part of the patient.

The fundamental principle of law was the sanctity of human life. But that principle was not
absolute. There was no absolute rule that a patient's life had to be prolonged by medical
treatment regardless of the circumstances.

It was crucial for the understanding of the question that the question itself should be correctly
formulated. The question was not whether the doctor should take a course which would kill his
patient, or even take a course which had the effect of accelerating his death. The question was
whether the doctor should or should not continue to provide his patient with medical
treatment which, if continued, would prolong his patient's life.

Anthony was not merely incapable of feeding himself. He was incapable of swallowing and
therefore of eating and drinking in the normal sense of those words. There was overwhelming
evidence that, in the medical profession, artificial feeding was regarded as a form of medical
treatment; and even if it was not strictly medical treatment, it must form part of the medical
care of the patient.


The Mental Capacity Act 2005

In 2005 the government introduced the new mental capacity act. This is due to come into
force in October 2007. The Act applies to England and Wales. Scotland has its own legislation,
the Adults with Incapacity (Scotland) Act 2000. For the first time, this provides a statutory
framework to empower and protect vulnerable people who may not be able to make their own
decisions. It makes clear who can take decisions, in which situations, and how they should go
about this.

The assessment of capacity is ‘task-specific’, that is to it say focuses on the specific decision
that needs to be made at the specific time the decision is required. It does not matter
therefore if the incapacity is temporary, or the person retains the capacity to make other
decisions, or if the person’s capacity fluctuates


The key areas of the act affecting GPs are:
    The introduction of an independent mental capacity advocate (IMCA’s)
    The ability for adult patients to make a lasting power of attorney (LPA)
    The establishment of a new Court of Protection
    The introduction of Court appointed Deputy’s

There are five key principles to the act, and have been guided by current best practice and
common law principles concerning people who lack mental capacity.
   1. The presumption of Capacity: A person must be assumed to have capacity unless it is
       established that they lack capacity.
   2. Maximising decision-making capacity: A person cannot be treated as unable to make a
       decision unless all practical steps to help them to do so have been taken without
       success.



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    3. The freedom to make unwise decisions: A person cannot be treated as unable to
       make a decision merely because they make an unwise decision.
    4. Best interests. You must act or make decisions on behalf of a person who lacks
       capacity in their best interests. Relevant factors are likely to include:
             The person’s past and present wishes and feelings, including any relevant
                 written statement made when she or he had capacity – this would include
                 general statements of wishes or ‘living wills’
             His or her beliefs or values where they would have an impact on the decision.
            A crucial part of any best interests judgement will involve a discussion with those
            close to the individual, including family, friends or carers, where it is practical or
            appropriate to do so. It could also include anyone nominated to act under a LPA or
            any deputy appointed to make decisions by the Court of Protection.
    5. Least restrictive intervention. Before you act or make a decision, you must consider
       whether the purpose for which it is needed can be as effectively achieved in a way that
       is less restrictive of the person's rights and freedom of action.

The act will apply to people aged 16 or over who lack capacity and will cover all decisions
made on their behalf, from minor matters about everyday living, to complex issues such as
health, property and financial affairs. The key principle of the act is based on the individual's
fundamental right to autonomy. A person must be assumed to have capacity unless it is proved
otherwise.

Determining capacity for a particular decision is a two-stage process.
   A. Determine whether or not there is an impairment or disturbance of the functioning of
       the mind or brain. If so, does it make the person unable to make a particular decision.
       No one can be labeled in ‘capable’ as a result of a medical condition or diagnosis. For
       example, just because someone has schizophrenia, does not make them incapable.
       Neither can the appearance or behaviour indicate incapability.
   B. Can the person make a decision for themselves? They must be able to understand the
       information relevant to the decision, retain it, use it as part of the deciding process
       and finally communicate the decision. Failure in any of these means the person lacks
       capacity.

The act has a checklist of factors to consider including the patient's past and present wishes,
feelings, beliefs and values. The views of relevant people, such as close relatives or carers,
should also be considered if it is practical or appropriate. All the relevant factors, not just
medical issues should be considered and weighed against each other to make sure the outcome
is the best one for the individual.

The use of restraint or deprivation of liberty is defined and can only be used in situations
where it is believed that it is necessary to prevent harm to the incapacitated person.

The Act clarifies this aspect of common law by giving legal protection to decision makers in
these circumstances. An action or intervention will be lawful – ie health professionals will enjoy
protection from liability – where the decision maker has a reasonable belief both that the
individual lacks capacity, and that the action or decision is in his or her best interests. It
applies to anyone making a decision on behalf of another, irrespective of whether they have a
professional relationship with the incapacitated individual. It could include, for example,
taking an incapacitated stranger by the arm to assist them cross a road. In relation to medical
treatment, it is applicable not only to an episode of treatment itself, but also to those
necessary ancillary procedures such as conveying a person to hospital



Advance Directives and Independent Mental Capacity Advocates (IMCA)



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The 2005 Act also provides welcome strategy clarification on advance refusals of treatment.
The status has now been spelt out.

The Act’s powers are restricted explicitly to “advance decisions to refuse treatment” and NOT
advance decisions covering other areas such as those often included in Living Wills. Although
broader general advance statements or ‘living wills’ which indicate treatment preferences may
well be relevant to a broader ‘best interests’ assessment, they are not legally binding.


An advance refusal to refuse specified medical treatment at a point in the future will only be
valid if:
     the person making the decision is 18 years or older and has capacity
     the treatment to be refused and the circumstances in which the refusal is to apply
          specified. i.e. it must be specific about the treatment that is to be refused and the
          circumstances in which the refusal will apply
     the person has not subsequently appointed an attorney to make the decision
     the person has not done anything clearly inconsistent with the directive
     the individual does not have the capacity at the time the decision needs to be enforced
     they cannot require doctors to provide a treatment that they (doctors) consider
          clinically unnecessary futile or appropriate.

Advanced decisions to refuse specified medical treatment must be in writing, signed and
witnessed, and with a statement that it is to apply even where life may be at risk.

Advanced decisions cannot be used to refuse basic care, which includes warmth, shelter and
hygiene measures to maintain body cleanliness. This also includes the offer of oral food and
water, but not artificial nutrition and hydration.

In an emergency or where there is doubt about the existence or validity of an advance
directive, doctors can provide treatment that is immediately necessary to stabilise or to
prevent a deterioration in the patient until the existence or applicability of the advance
directive can be established.

The Act also created specific safeguards for incapacitated adults who do not have anyone other
than paid carers close to them to consult about decisions. This is relevant for a person who
lacks capacity and has no family or friends who doctors could appropriately consult, nor do
they have an appointed attorney under a Lasting Power of Attorney (LPA). In these
circumstances, where health workers are proposing either serious medical treatment or a
change of accommodation, the Independent Mental Capacity Advocate (IMCA) must be
instructed. The IMCA does not have decision-making responsibilities -- these will rest with the
doctor or health work in making the decision -- but the views of the IMCA must be taken into
account

Where it is clear that a decision needs to be made on behalf of an incapacitated adult in
relation to either serious medical treatment or place of residence and there is no one close to
the adult to provide advice or guidance, including an attorney or deputy, then the services of
an independent advocate will be engaged. Serious medical treatment is defined as treatment
which involves providing, withdrawing or withholding treatment in circumstances where:
     In the case of a single treatment being proposed, there is a fine balance between its
        benefits to the patient and the burdens and risks it is likely to entail for him or her
     In a case where there is a choice of treatments, a decision as to which one to use is
        finely balanced, or
     What is proposed would be likely to involve serious consequences for the patient




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Lasting Power of Attorney
One of the Act’s main innovations is the introduction of a procedure by which adults while they
have capacity, can nominate another person to make decisions on their behalf if they lose
capacity at some point in the future. In order to do this, the act created a new Lasting Power
of Attorney (LPA), replacing the older Enduring Powers of Attorney. (EPA). As well as covering
property and affairs like an EPA, the LPA can also be extended to include health and welfare
decisions such as consent to medical treatment.
There are two types of LPA.
     1. the LPA who deals with property and affairs
     2. the LPA who deals with personal welfare
The personal welfare attorney can make decisions about the continuation or withdrawal of life-
sustaining treatment ONLY if expressly documented by the patient before losing capacity. The
Attorney cannot consent to or refuse treatment when the person has capacity to make the
decision themselves. The patient can also add restrictions or conditions on areas where they
do not wish the attorney to act. The attorney is not able to overrule advanced directives, or
insist on treatment that a doctor does not believe is in the patient’s best interest.
If as a GP, you aware that a patient has such an advocate, you will need to check whether it
covers financial or personal welfare matters that it applies to the situation in question. This
situation where the property and affairs attorney requests disclosure of patient records,, the
GP must check whether or not a personal welfare LPA is in force, the details of its provision,
and confirmed that the patient lacks capacity before complying. These documents must be set
out in a statutory form.and be registered at the Office of the Public Guardian

Court of Protection
The Court is the final arbiter in relation to the legality of decisions made under the Act,
including decisions in relation to an individual’s capacity. This could deal with complex
decisions such as disputes between doctors and family members. Court authorisation will be
required to withdraw artificial nutrition and hydration from patients in a persistent vegetative
state and to perform a hysterectomy for contraceptive purposes.

The Act’s Code of Practice advises that the following cases should continue to go before the
Court:

       Proposals to withdraw or withhold artificial nutrition and hydration from patients in a
        persistent vegetative state
       Cases involving organ or bone marrow donation by a person lacking the capacity to
        consent
       Proposals for non-therapeutic sterilisation
       Some termination of pregnancy cases
       Cases where there is a doubt or dispute about whether a particular treatment will be in
        a person’s best interests
       Cases involving ethical dilemmas in untested areas




Case studies involving the new Act:
   1. An elderly female patient has bowel cancer but surgery is deemed risky because of her
        medical conditions. She has mild dementia, and although she is able to communicate
        with doctors, she is found to be unable to retain information about the proposed
        treatment, and is considered to lack capacity. She has no known relatives and has only
        recently been admitted to a nursing home, where the carers do not yet know her very
        well. The hospital staff request an independent mental capacity advocate to support



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   and represent the patient and to speak for her when they are deciding whether or not
   to operate.
2. A female patient with advanced multiple sclerosis who lacks capacity to make decisions
   for herself is admitted to hospital acutely unwell with pneumonia. Her husband has a
   lasting power of attorney, and refuses consent to treat the pneumonia, stating that this
   would have been his wife's wish. The doctors feel it is in the patient's best interests to
   treat her acute illness, and are unable to resolve the position with the husband. While
   waiting for a decision from the Court of Protection, the doctors are only able to
   provide treatment that is necessary to prevent a serious deterioration in her condition.
3. An elderly man in a nursing home requires a blood test to monitor his warfarin
   treatment. Despite the efforts of the GP, the patient is unable to understand the
   information and so lacks capacity to consent. He resists each time the nurse attempts
   to take blood. The GP discusses the matter with the patient's wife, who tells her that
   before the onset of his dementia, her husband was always compliant with monitoring.
   The GP decides the test is in the patient's best interests and advises the nursing home
   staff that it is reasonable and proportionate to hold him still just long enough to have
   the blood taken.
4. A GP carries out a home visit on a patient with metastatic breast cancer who is
   receiving palliative care and has developed signs of a chest infection. The patient has
   made a lasting power of attorney giving her husband authority to make decisions about
   her personal welfare, including decisions about life-sustaining treatment. She is
   intermittently drowsy because of her medication and her husband wants to make the
   decision about treatment for the chest infection. However, the GP feels the patient
   still has capacity to make decisions for herself, so the LPA cannot be used.




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