Transcript Informed Consent - Publish Web Server

Informed Choice
Overview
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Brief introduction to cases (ours, yours)
Elements of informed choice
Capacity
Informed choice for research
Return to cases
Cases
1. Informed choice for chemotherapy for
breast cancer (primary and adjuvunct)
2. Informed choice for retreatment
radiotherapy
3. Informed choice for BRCA testing
4. Informed choice for clinical trials
Elements of Informed Choice
Informed consent/informed choice
• Consent/refusal of recommended therapy –
informed consent requires that a patient (1)
has sufficient information and (2) makes a
voluntary choice
• Increasing emphasis on patient
involvement, shared decision-making has
prompted a shift to discussion of “informed
choice”
What does it mean to be
informed?
“The claim has been made…that ‘fully
informed consent’ is a goal which we can
never achieve, but towards which we must
strive”
• only graduate/medical students as research
subjects?
Freedman on “fully informed”
consent
• “Fully informed” consent would require
consent forms to be infinitely long….
– e.g. to insert a catheter, must a doctor inform a
patient by showing him an anatomy text?
Ensuring that he understands the text? Must he
tell the patient the chemical formula of the
catheter? Its melting point?
One possible response
“…it is not surprising to find doctors who
claim that since they cannot fully inform
patients, they will tell them nothing, but
instead will personally assume the
responsibility for assuring the subject’s
safety”
Freedman’s response
• It is a mistake to talk about “information” in
the abstract, without reference to human
purpose
– relevant “information” about clouds is different
for an artist, a meteorologist, a sooth-sayer
• Depending on what we want to use it for,
different sorts of information about a topic
are relevant
Freedman’s response
• The first thing we need to do, then, in deciding
what information is required for informed consent
is to determine why the patient must be informed
(i.e. what is the purpose of getting consent?)
• The answer to this question: the patient must be
informed so that he can make a decision about
whether to undergo the procedure
Freedman’s response
• So, the patient will need to know:
– what to expect from the procedure/treatment
– possible outcomes (good and bad) and their
likelihood of occurring
– alternatives to the procedure/treatment (and
their possible outcomes)
• Informed consent/informed choice
Freedman’s response
• “The proper test of whether a given piece of
information needs to be given, then, is
whether the physician, knowing what he
does about the patient/subject, feels that the
patient/subject would want to know this
before making up his mind.”
• We must know “what is necessary to make
meaningful the power to decide”
Capacity
Consent and Capacity
• We must know “what is necessary to make
meaningful the power to decide”
• What matters is that “the consent [is] the
expression of a responsible choice”
What is a responsible choice?
• Some choices are clearly not responsible
– E.g. small children
• can make choices
• but cannot make what we would generally consider
to be responsible choices
• would we hold them responsible for the outcome of
their choice?
What is a responsible choice?
• Distinction between a responsible choice
and a “good” choice
• We also know that people who are generally
responsible can make bad choices
• At what point do we say that a choice is not
responsible?
What is a responsible choice?
• Trying to determine when a choice is
responsible leads to a dilemma
– A dilemma is a situation or question that leads
to a choice between two undesirable
alternatives
The dilemma of informed consent
1)
2)
We must require that a choice is
responsible for consent to be valid
But if we require that a choice is
responsible, this presupposes a set of
standards by which the responsibility of
a choice is to be judged
– So, who sets the standards?
Between the horns of the dilemma
• The “responsibility” required should not be
taken to mean that the choice is responsible,
but that the person doing the choosing is
responsible
Responsibility: a dispositional
characteristic
• Someone is responsible when she
– makes choices on the basis of reasons,
arguments
– remains open to the claims of reason
– is capable of making and carrying out a lifeplan
– can live with/take responsibility for the
outcomes of her choices
Capacity
• Shifting the focus from responsible choice to
responsible persons means that giving valid
consent means that a person must be competent to
give informed consent
- The test for capacity is described in legislation at
Section 4(1) of the Health Care Consent Act (HCCA).
Capacity
s.4.(1) Capacity:
A person is capable with respect to a treatment,
admission to a care facility or a personal
assistance service if the person is able to
understand the information that is relevant to
making a decision about the treatment, admission
or personal assistance service as the case may be
and able to appreciate the reasonable
foreseeable consequences of a decision or lack of
a decision as the case may be.
Capacity
• A patient is assumed to be capable unless proven
otherwise.
Sec. 4(2) Presumption of Capacity:
A person is presumed to be capable with respect to treatment, admission
to a care facility and personal assistance services
What Does This Imply?
The onus is on the doctor to prove that the patient is not capable.
He/She must prove this using the criteria of Sec.4(1), and provide clear
and cogent evidence to demonstrate that this criteria is not fulfilled.
Consent and Capacity
• Presumption of capacity: addresses our
general belief that adults are responsible
individuals (who may occasionally make
bad choices)
• Capacity as decision-specific: addresses our
belief that making a responsible decision
requires understanding the information
relevant to that decision
Informed Choice for Research
Informed choice for research
• Considerations are similar to those in
informed choice for treatment, but we may
“set the bar higher” for capacity to consent
to research
– in a therapeutic setting, the physician is more
likely to know what the outcome(s) will be
– the goals of therapy and of research are
different
Challenging the difference
between research and therapy
• Some settings are partly therapeutic and
partly experimental (e.g. when no
traditional therapy is available, or when
adding an experimental therapy to an
established treatment regimen)
• Patients/subjects sometimes do benefit from
participating in research
What is different about research?
• Goals are different (benefit to participants is
incidental)
• But it is true that some research protocols
involve interventions that would also occur
during therapy. They may also involve nonexperimental procedures that serve the
purpose of research, not of clinical care.
Choice must also be voluntary
• Consent given under duress or coercion is
not voluntary
– E.g. threat (but a threat need not be overt)
– Power imbalance
• Even without coercion, consent may be
“unfree”  motivated by reward
Freedman: 2 distinctions
1. Acts of God vs. acts of human beings
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Response to “natural contingencies” does not
make us unfree
2. Reward that brings us up to a minimum
standard of living vs. reward that supplies
“luxuries” above this standard
Summary of problems
• Distinction between research and treatment
may appear to be blurred
• Possibility that patients may view their
treatment as depending on acquiescence to
research participation
Weijer’s solution
• Make clear what parts of a protocol are (1)
established therapies vs. experimental
interventions and (2) required by the
protocol but not part of standard care
– This approach fits neatly into Freedman’s
discussion of what is required for informed
consent
– Also, specifying alternatives helps to address
problems raised by power differential
Cases
1. Informed choice for chemotherapy for
breast cancer (primary and adjuvunct)
2. Informed choice for retreatment
radiotherapy
3. Informed choice for BRCA testing
4. Informed choice for clinical trials