Ethical/Legal Aspects of Consent to

Investigation or Treatment

March 17, 2003

ISD II – MSK
Barbara Barrowman
Andrew Latus
Outline – Consent

 General Significance
 Forms of Consent
 Elements of a Valid Consent
 Exceptions to Requirement of Consent

– Primary focus will be on legal aspects of

consent
General Considerations
 a mentally competent patient has right to refuse medical
treatment, regardless of consequences and how beneficial or
necessary treatment may be

– This is both a legal requirement as well as, to most, a moral requirement

 consent is often viewed as the single most ethically important

aspect of medical ethics

– “all of medical ethics is but a footnote to informed consent” (Mark

Kuczewski, 1996)

– But why is consent so important?

Consent: Moral Significance
 main reason: the requirement of consent reflects the
ethical principle of patient autonomy

 to some extent principles of beneficence/non-

maleficence also support importance of consent

 figuring out what is in a patient’s ‘best interests’ is

notoriously difficult in some cases.

– Distinguish medical best interest from best interests ‘all things

considered’

 often we take the view that the patient is the best judge
of what is in his own best interest ‘all things considered’
Consent: Legal Significance
 save in exceptional circumstances, medical
treatment must not be administered without
obtaining patient’s valid consent

 treatment/investigations performed without

consent constitute “battery”

 no liability results from decision to withhold or

withdraw even life-sustaining treatment at
request of competent patient
Forms of Consent - Written or
Oral
 as general rule, no legal requirement that consent be in written form

 written consent = evidence

 hospital practice to require written consent

 consent not a piece of paper, but part of a process of communication

between doctor and patient

– Beware of tendency to treat signs of consent as more important than consent

itself
Forms of Consent - Express or
Implied
 consent may often be implied by words or
conduct e.g. holding out arm for injection

 many examinations, some procedures routinely

performed with implied consent

 prudent to document for anything but the most

minor interventions
Withdrawing Consent
 right to withdraw consent at any time

 doctor must stop treatment once consent

withdrawn unless life-threatening or
immediate serious problems to health of
patient to stop

 if unclear whether consent being withdrawn,

doctor must stop to ascertain
Elements of Consent

1. Voluntary
2. Capacity
3. Specific to Treatment & Person
Administering It
4. Informed
1. Voluntary
 Some factors interfering with voluntariness

– coercion by physician, family or others

 Line between coercion & legitimate influence can be
tricky

– pre-op sedation

– misrepresentation as to nature of treatment or

procedure
2. Capacity
 presumption that adults have legal capacity

 capacity = ability to understand and appreciate nature

and purpose of treatment and consequences of giving
or refusing consent
– See notes from Psychiatry

 if patient has capacity, no one else’s consent required

 problem areas - mental disability, minors

Capacity - (a) Mental Disability
 impairment may be temporary or permanent

 assessment of capacity is functional - specific

to issue in question
– i.e., not all or nothing

 not automatically lacking capacity because of

Dx of dementia, psychosis, etc.

 refusal of treatment others see as beneficial or

necessary does not imply incompetence
Capacity - Mental Disability

 assessment - expert assistance

 documentation

 substitute consent

 Advance Health Care Directives

Capacity - (b) Minors
 legislation in some provinces

 common law - regardless of age, child

capable of consenting if able to appreciate
nature and purpose of Rx and consequences
of giving/refusing consent (“mature minor”)

 if child has capacity, parental consent not

required, nor can they override child

 common practice to get parental consent

Capacity – Minors
 if child lacks capacity, parents have (joint)
legal authority to make treatment decision

 parental refusal can be overridden by court

order if not in child’s best interests (child
protection legislation)

 many controversial areas e.g. contraception,

abortion, religious beliefs
Capacity - Minors

 Interaction between mature minor principle

& child welfare legislation is a difficult &
controversial area

 E.g., B.H. Case

 Will be discussed in pediatrics course
3. Treatment and Treating MD
 patient should only receive that treatment to which
(s)he has consented, apart from emergency

 importance of clear communication

 consent specific to doctor who will carry out care or

treatment

 presence and role of house staff should be made

clear to patient
Treatment and Treating MD
 consent should be obtained by person who
will carry out care or treatment

 role of obtaining informed consent may be

delegated (e.g. resident), but before
delegating, treating MD should be confident
delegate has knowledge and experience to
provide adequate explanations to patient

 responsibility rests with delegating MD

4. Informed Consent

Four points

(a) importance

(b) standard of disclosure

(c) research/experimental treatment

(d) documentation
(a) Importance
 gives meaning to patient’s right to medical
self-determination, profound impact on nature
of doctor-patient relationship

 focus on effective communication

 frequent basis of litigation - failure to obtain

informed consent may constitute “negligence”
or substandard care
(b) Standard of Disclosure
…in obtaining the consent of a patient for a surgical
operation, the surgeon, generally, should answer
any specific questions posed by the patient as to
the risks involved and should, without being
questioned, disclose to him the nature of the
operation, its gravity, any material risks and any
special or unusual risks…

(Reibl v. Hughes, S.C.C. 1980)

Standard of Disclosure
 professional disclosure standard vs. reasonable patient
standard

 Canadian Standard: what a reasonable person in the

patient’s position would want to know
– Reibl vs. Hughes
– compromise between reasonable person standard and subjective
standard

 material risks include common risks and risks which are

mere possibilities but have serious consequences, e.g.
death, paralysis
Standard of Disclosure
 insofar as possible, tell patient the diagnosis

 if uncertainty, explain this

 explain nature of proposed treatment, its gravity,

chances of success and risks

 give patient opportunity to ask questions

 be alert to patient’s individual concerns and

circumstances and deal with them
Standard of Disclosure
 patient should be told consequences of non-
treatment - no coercion but entitled to
information

 accepted alternative forms of treatment (no

obligation to discuss unconventional Rx)

 optimism should not allow misinterpretation of

guaranteed results
Standard of Disclosure
 although patient may waive explanations, have
no questions and be prepared to submit to
treatment, doctors must be cautious in
accepting such waivers

 “therapeutic privilege” (withholding or

generalizing information due to patient’s
emotional condition) - use very cautiously
– once much more widely accepted than today
– part of shift away from paternalism
Standard of Disclosure
 consent for cosmetic or other “medically non-
necessary” procedures - take special care re.
risks and expected results
– courts may impose higher standard of disclosure

 patients must be informed re. planned

delegation of care

 supplements to consent explanations -

pamphlets, etc.
(c) Research/Experimental Rx
 full disclosure required, “therapeutic privilege” not
applicable

 consent requirements even stronger morally than in

standard treatment situation
– less possibility of appeal to beneficence if treatment is untested, so
respecting patient autonomy is more important

 caution re. coercion if doctor-patient relationship with

researcher

 patient must understand possibility of placebo/alternative

treatment

 research and minors/incompetents

(d) Documentation
 consent form - identification,
acknowledgement of explanations,
anesthesia, added/alternative procedures,
delegation, signatures, witness

 contemporaneous note - brief summary of

informed consent discussion, risks discussed,
any special concerns/questions
Exceptions to Requirement of
Consent

 emergency situations

 legislation
1. Emergencies
 may treat without consent if:

1. injury life-threatening or imminent threat to

patient’s health,

2. patient not able to give consent, e.g.,

comatose, severe injuries, incompetent, and

3. substitute decision maker not readily available

2. Legislation
 mental health legislation - detention +/-
treatment of patients with mental disorder
who are danger to selves or others

 other examples of law providing for

compulsory treatment

 Charter of Rights issues

Controversies about Informed
Consent
 idea of the absolute centrality of informed consent is
relatively recent

 some challenge the importance of informed consent on the

grounds that it reflects an unrealistic picture of patients’
ability to understand what they are consenting to
– see studies cited in Bunch (2000)
Informed Shared Decision-
Making
 not a legal term, but in some ways a better term to
describe ideal process of medical decision-making

 emphasis on discussion, working together with

patients in deciding best way to proceed

 “meeting between experts” - MD expert in disease,

patient expert in own experience of disease and in
their preferences

– emphasis placed on consent can hide the appropriately

collaborative nature of medical treatment