Transcript Consent

Session 7
Key Concepts (1)
Consent and refusal of treatment
Intended Outcomes
 describe the requirements for a person’s valid
consent or refusal of treatment
 consider issues relating to elements of the
consent process
 Basic ethical principles
autonomy vs beneficence (paternalism)
self-determination vs best interests
 Ethics and law
Schloendorff v Society of New York Hospital (1914) 105 NE
92 : classic legal statement: “Every human being of adult
years and sound mind has right to determine what shall be
done with his own body; and a surgeon who performs an
operation without his patient’s consent, commits an
i.e.* battery
 Function of consent
 moral function
 clinical function – foster patient’s trust, cooperation,
confidence, etc.
 legal function – provide justification for care; protect
healthcare professionals from criminal/civil claims
“It is trite law that in general a doctor is not entitled to treat a
patient without the consent of someone who is authorised to
give that consent. If he does so, he will be liable in damages
for trespass to the person and may be guilty of a criminal
assault.” Lord Donaldson
Re R (A Minor) (Wardship: Medical Treatment) (1991)
Consent: guidelines
 General Medical Council (GMC) guidance
doctors should do their best to find out about
patients’ individual needs and priorities when
providing information about treatment options
if the patient asks specific questions about the
procedure and associated risks these should
be answered truthfully
an individual’s personal preferences should
also be taken into account when identifying his
or her needs in the provision of care.
Absence of consent: trespass to the
 to avoid trespass to the person healthcare professionals
need to have a legal justification to avoid the risk of being
sued for battery or assault (tort of battery; OAP Act 1861
s18 s20, criminal assault etc.)
 no battery where patient understands the broad nature of
the treatment i.e. information threshold for battery very
 if valid consent has not been given, patient typically has an
action in negligence Chatterton v Gerson [1981] QB 432
“ …once the patient is informed in broad terms of the
nature of the procedure which is intended and gives her
consent, the consent is real and the cause of the action on
which to base a claim for failure to go into risks and
implications is negligence, not trespass.” Bristow J
Absence of consent: trespass to the
 advantages of action in battery:
intentional tort – no need to prove physical injury
or that had patient been adequately informed,
s/he would have rejected the treatment
Bristow J, "I think justice requires that in order to vitiate the reality
of consent [in battery] there must be a greater failure of
communication between doctor and patient than that involved in
a breach of duty if the claim is based on negligence. When the
claim is based on negligence the plaintiff must prove not only
the breach of duty to inform but that had the duty not been
broken she would not have chosen to have the operation.
Where the claim is based on trespass to the person, once it is
shown that the consent is unreal, then what the plaintiff would
have decided if she had been given the information which would
have prevented the vitiation of the reality of her consent is
Absence of consent: trespass to the
 Sidaway v Board of Governors of the Bethlem Royal Hospital
[1984] 1 All ER 1018
“…it would be deplorable to base the law in medical cases of this
kind on the torts of assault and battery.” Lord Scarman
 attempts to bring actions for battery claiming invalid consent to
medical treatment rarely succeed – why?
 limited case law explained by:
tendency of claimants to pursue claim in negligence
declaratory procedure in medical cases – declaration by High Court
as to legality of proposed treatment (sought by healthcare
professionals/organisations to protect themselves against
subsequent litigation)
Absence of consent: trespass to the
 low information threshold means that action in battery only likely
in situations such as:
 no information at all
 treatment against patient’s will
 different treatment administered
 consent obtained by fraud
Appleton & Others v Garrett [1997] 8 Med LR 75
gross overtreatment of patients by a dental surgeon
action in battery
Bartley v Studd (1995) Medical Law Monitor 2(8) 1
removal of ovaries by surgeon when patient had consented
to a hysterectomy constituted battery
Absence of consent: trespass to the
person: information and negligence
 sufficiency of information defined by the Bolam principle
 Sidaway v Board of Governors of the Bethlem Royal Hospital
[1984] 1 All ER 1018
doctor could withhold information on ground of ‘therapeutic
privilege’ – if s/he considered information would be detrimental to
health of the patient
House of Lords rejected the argument that different tests should be
applied to different aspects of doctor/patient care
all but one Law Lord applied Bolam test – a doctor need
only disclose such information as would be disclosed by
a reasonable body of medical opinion
Lord Scarman – thought ‘patient’s rights should be prime
concern – ‘prudent-patient’ test
Note also:
Bolitho v City of Hackney HA [1997] AC 232
Pearce v United Bristol Healthcare NHS Trust [1999] P.I.Q.R 53
Sidaway v Bethlehem Royal Hospital
per Lord Diplock:
“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. To decide
what risks the existence of which a patient should be voluntarily
warned and the terms in which such warning, if any, should be
given, having regard to the effect that the warning may have, is as
much an exercise of professional skill and judgment as any other
part of the doctor’s comprehensive duty of care to the individual
patient, and expert medical evidence in this matter should be
treated in just the same way. The Bolam test should be applied”.
Sidaway v Bethlehem Royal Hospital Governors[1985] 1 AC 871 643 - applied
Bolam v Friern Hospital Management Committee [1985] 1 WLR 582.
Absence of consent: trespass to the
person: information and negligence
 Pearce v United Bristol Healthcare NHS Trust [1999]
P.I.Q.R 53
“…if there is a significant risk which would affect the judgement
of a reasonable patient, then in the normal course, it is the
responsibility of the doctor to inform the patient of that significant
risk...” Lord Woolf
 what is a significant risk?
 see also:
 Australia (Rogers v Whitaker [1992] 175 CLR 479
 Canada (Reibl v Hughes [1980] 114 DLR (3d) 1
Principle applied in Rogers v
“Except in the case of an emergency or where disclosure would
prove damaging to the patient, a medical practitioner has a duty to
warn the patient of a material risk inherent in proposed treatment. A
risk is material if, 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. The fact that a body of reputable medical practitioners would have
given the same advice as the medical practitioner gave does not
preclude a finding of negligence. Generally speaking, whether the
patient has been given all the relevant information to choose
between undergoing and not undergoing the proposed treatment is
not a question the answer to which depends upon medical standards
or practice.”
Summary so far
 two main areas of law concerned with consent
 battery
 negligence
 patient requires information about the nature of the
treatment otherwise battery
 patient requires information about risks common/serious side-effects; benefits; reasonable
alternatives, etc. (moving towards ‘prudent patient’
standard) otherwise negligence
 i.e. failure to inform amounts to negligence; may also
amount to battery.
Absence of consent: trespass to the
person: burden of proof
 The tort of battery is ‘the unconsented to intrusion of
another’s bodily integrity…[and] the burden of proving
absence of consent is on the claimant.” McCowen J
Freeman v Home Office [1984] QB 524 – upheld by Court of
Defences to an action for trespass of
the person
 Consent
 Statutory justification (e.g. Children Act 1989, Mental
Health Act 1983)
 Common law powers to act out of necessity in the
best interests of the person – doctrine of necessity
Exceptions to principle of consent
 principle of necessity
 unconscious adult patients
 requirements:
 must be a necessity to act in a situation
 unable to communicate with patient
 action taken must be what a reasonable person would do
in the best interests of the patient
 ‘best interests’ test
 incompetent adult patients
 Bolam test applies regarding best interests
 see new Mental Capacity Act 2005
 ReF (Mental Patient: Sterilisation) [1990] 2 AC 1
Ethical aspects
 tension between beneficence and/or non-maleficence
and respect for autonomy:
“the desire to do what is considered to be in the best
interests of the patient and a desire to do what the
patient says he wants” – Raanan Gillon
“ Whether respect for the autonomy of patients should
have priority over professional beneficence directed at
those patients is a central problem in biomedical ethics
… “Beneficence provides the primary goal and
rationale of medicine and health care, whereas respect
for autonomy . . . and justice sets moral limits on the
professional's actions in pursuit of this goal.” Beauchamp and Childress
How can consent be given?
 law does not require or explicit verbal agreement
 consent is a process (ongoing) – a ‘state of mind’
 signed consent form – no more than ‘evidence of consent’
 Express consent
in writing
 by word of mouth
 by conduct equivalent to words of agreement – e.g nodding
 Implicit consent/Implied consent
 conduct signalling consent in the context in question – e.g.
offering one’s arm for an injection in a surgery
 where patient consents to one activity and some other is
necessary to fulfil the purpose of the express consent - e.g in
healthcare team working
Legal principles and consent
 law distinguishes between competent and incompetent patients
competence - ability to give or withhold consent - legal term is capacity
 competent adults (in English law a person becomes adult on
18th birthday)
 legal right to refuse treatment
 demand withdrawal of treatment
incompetent adults must be treated in their ‘best interests’
no proxy consent for adults, whether competent or not
those aged 16 – 17 years can consent to treatment (but not
necessarily refuse beneficial treatment)
children aged less than 16 may, if competent, consent to
a parent or guardian can give proxy consent on behalf of a
minor – and are under a legal obligation to act in child’s best
Valid consent
 Essential elements to a valid consent :
patient must have sufficient understanding
(capacity/competence) to make the decision
patient must consent to (or refuse) treatment of his/her own
free will – no duress/undue influence/ coercion
patient must have sufficient information about the proposed
The right to consent or refuse
 just as a person has a right to consent to treatment or
intervention they also have the right to refuse the treatment or
intervention being offered
 both refusal and consent of treatment or intervention are
absolute rights if the person making the decision is competent
informed and un-coerced
 adults with capacity can refuse even life saving treatment “"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", ” Dame Butler –Schloss in
Ms B v An NHS Hospital Trust (2002) 2 All ER 449
Valid consent
 Essential elements to a valid consent :
competent – see Re T [1992]
voluntary – see Re C [1994]
informed – see Sidaway
 competence to take decisions requires ability
to understand information given
to retain and believe it
to use it to reach a reasoned decision
and communicate choice!
per Thorpe J - Re C ( Adult)( Refusal of Medical Treatment)[1994] 1 All ER 819
see Mental Capacity Act 2005
Valid consent
 “For consent to be valid, it must be given voluntarily by
an appropriately informed person (the patient or where
relevant someone with parental responsibility for a
patient under the age of 18*) who has the capacity to
consent to the intervention in question. Acquiescence
where the person does not know what the intervention
entails is not “consent”.
DoH (2001) Reference Guide to Consent for Examination or
* N.B. relevant issues for children and young people
Capacity or competence
 ability to comprehend and retain information material
to the decision and must be able to use this in the
decision-making process
 capacity should not be confused with a health
professional’s assessment of the reasonableness of
a patient’s decision
Capacity (cont)
 need to differentiate between reasonableness and
a patient who refuses an amputation for a gangrenous foot
and is aware of the consequences of his refusal is making a
competent decision based on his own value system
a patient who refuses help denying his foot is gangrenous
when it is clearly obvious may not be able to comprehend
and make use of the information and hence may lack
Capacity (cont)
 A person’s ability to understand may be temporarily affected:
 N.B. does not mean they are incapable of consenting
 requires communication of decision
do not underestimate the ability of a patient to
need to take all reasonable steps to facilitate
communication aids
What information do people need?
 enough information in broad terms to make a balanced decision
 information such as:
the benefits and the risks of the proposed treatment
in particular those that are ‘material’ or ‘significant’ risks
what the treatment will involve
what the implications of not having the treatment are
what alternatives may be available
the practical effects on their lives of having, or not having,
the treatment
 patients who ask direct questions?
“ is clear that if a patient asks a doctor about a risk, then the
doctor is required to give an honest answer.” Lord Woolf Pearce v
United Bristol Healthcare NHS Trust [1999]
 is the consent given voluntarily?
consider who or what may exert undue influence or
pressure on the patient during the consenting
coercion should be distinguished from providing
the patient with appropriate reassurance or
pointing out the potential benefits of treatment
 different types of influence:
 coercion: use of force or threats
 manipulation: non-coercive but uses non-rational
methods to achieve control e.g. deliberately
withholding information
 rational persuasion: use of reasons to influence
Re T (Adult: refusal of treatment) [1992] 4 All ER 649
Consent and vulnerable groups
 minors
 mentally incapacitated
 anorexics
 person with learning disabilities
 dementia
 prisoners
 research/teaching
 Adults without capacity
no-one can give consent on behalf of adults who are not capable of
giving consent themselves
unless a valid advance refusal of treatment is applicable to
the situation, the law permits interventions to be made where
necessary and no more than is reasonably required in the
patient’s best interests until capacity has returned
 What is best interests?
“to preserve the life, health or well-being” of a patient will be
in their best interests
best interests goes beyond a patient’s best medical
interests, to include much wider welfare considerations
not necessary for others to sign consent but strongly
recommend good practice of documenting reasons for
 Why are family members consulted?
not for consent
to gain insight into a patient’s previous competent
beliefs and values
to determine possible preferences of patient
good practice
Consent by 16 and 17 year old
The Family Law Reform Act 1969 (section 8)
the consent of a minor who has attained the age
of 16 years to any surgical, medical or dental
treatment which, in the absence of consent, would
constitute a trespass to his person shall be as
effective as it would be if he were of full age: and
where a minor has by virtue of this section given
an effective consent it shall not be necessary to
obtain any consent from his parent or guardian
See Mental Capacity Act 2005
Refusal by 16 and 17 year old
 the refusal of a 16 or 17 year old patient may in
certain circumstances be over-ridden either by
someone with parental responsibility or by a court
 the principle of best interests must be considered
 no definitive guidance exists but it has been
suggested that over-ruling the decision of a
competent young person’s refusal should be
restricted to situations where they are at risk of
suffering “grave and irreversible mental or
physical harm”
Children under the age of 16
 Gillick v West Norfolk and Wisbech AHA [1986] AC 112:
subsequnetly courts have held that children who have
sufficient understanding and intelligence to enable them to
understand fully what is involved in a proposed intervention
will also have the capacity to consent to that intervention.
 so-called ‘Gillick’ (or Fraser ) Competence’ will be affected by
maturity of child, experience and the health care circumstances
Child or young person without
 Who has parental responsibility under the Children Act
a mother has automatic parental responsibility for her child
where both parents were married at the time of the child’s
birth both parents have parental responsibility
where more than one person has parental responsibility
each of them may act alone, this means that consent for
treatment is only required from one parent
after divorce, both parents retain parental responsibility for
their child in equal measures
a person with a residence order
Parental responsibility under
the Adoption and Children Act 2002
 parental responsibility was broadened for any child born after
unmarried fathers who register the birth with the mother now
have parental responsibility for the child
English law is not retrospective
children born under the 1989 regulations can be re-registered if
the mother and father both request it
this gives parental responsibility to both parents
Children: Consent by Others
 Consent treated differently to refusal
 parents, guardian or court able to over-rule refusal by a ‘Gillick
competent’ adolescent to receive treatment which is in her best
 Re R (A minor) (1992); Re W (A Minor) (Medical
Treatment: Court’s Jurisdiction) (1992)
 ‘Gillick competence’ depends on seriousness of the decision
taken as well as cognitive powers and maturity
 Re L(Medical Treatment: Gillick Competence) (1998)
 Courts adopt paternalistic approach when adolescents are
afflicted with life-threatening situations
 Re M (Medical Treatment: Consent) (1999) 2 FLR 1027;
Re E (A Minor) (Wardship: Medical Treatment) (1993)
Children: Consent by Others
 Rationale for distinguishing between consent and
 consent – accepting greater knowledge of medical
 refusal – decision asks more of the child
 Courts reluctant to empower children to refuse
treatment against medical opinion; best interest
test applied
Hierachy for decisions:
 a person has a right to consent to or refuse treatment
 law assumes adults to be competent unless proved otherwise
 legally no one is able to give or refuse consent on behalf of another
adult i.e. over 18 (not even the courts) This applies to adults with or
without capacity!
 healthcare professionals must respect a valid decision
 3 requirements for valid decision
each requirement needs careful consideration because of the individual
circumstances and situation of the person receiving care and the
knowledge and skills of the healthcare professional
 consent/refusal is not a one off decision
 capacity can fluctuate
 a patient’s capacity may be temporarily affected by factors such as
confusion, shock, pain, etc.
 capacity should not be confused with unreasonable, eccentric or
unwise decisions, nevertheless, irrationality may be evidence of
 need to document adequately discussions around consent and risks etc