Informed Consent
Philosophy 2803
Lecture IV
Feb. 5, 2003
Issues
·
Why does informed consent matter?
·
How should we understand the idea of informed consent?
·
How should the issue of consent be dealt with when a
patient is incompetent?
·
The distinction between legal and moral versions of
informed consent
Case 1
·
A 2001 study surveyed 108 4th year med
students at U of T about their experiences as clinical clerks
o
See Hicks et al, British Medical Journal
March 24, 2001
·
Several students reported being asked to perform
pelvic examinations on patients under general anesthesia without the patients’
knowledge
Case 2
§
“Once, when I was on call, there was a patient who was
palliative, in a vegetative state. The resident
I was working with decided that this would be a good opportunity for me to
learn how to do a femoral stab, even though it was not medically required. The patient was not expected to [recover]
from his current condition, and wasn’t in a position to argue … we don’t really
get a lot opportunity to practise those types of
procedures.” (Hicks et al, 2001)
The
Importance of Informed Consent
§
“every human being of adult
years and sound mind has a right to determine what shall be done with his own
body” (Justice Cardozo, p. 159)
§
“all of medical ethics is but
a footnote to informed consent” (Mark Kuczewski,
1996)
§
“Our common view of informed consent is that, when at
all relevant, it represents a minimum condition which ethics imposes upon the
physician” (p. 169)
–
But why is informed consent so important?
Resources
§
Deontology
–
Respect for persons
§
Consequentialism
–
Promoting good outcomes
§
Principilism
– Autonomy,
Beneficence, Non-maleficence, Justice
Why Value Informed
Consent?
§
Justification
#1: via The Principle of Autonomy
(self-rule)
– Control typically requires consent
– Very deontological
–
Today, thought of as the main reason for requiring
consent
– “our
capacities for personhood ought to be recognized by all – these capacities
including the capacity for rational decision” (Freedman, 170)
Why Value Informed
Consent?
§
Justification #2
– via The Principles of Beneficence and Non-maleficence
§
We're generally
thought to be the best judges of our own best interest
§
As such, obtaining
consent is an effective way of doing good and avoiding
harm.
§
Very consequentialist
§
Today, usually thought of as a secondary reason for
consent, although this might be a mistake
Potential for Conflict
§
Notice the potential for conflict between the two
justifications
–
What if we don’t think you know your best interest in
a particular case?
–
Some might say this means you’re incompetent but
best interest is a slippery notion
– Also perhaps: best
interest ¹ medical best interest
Research Subject vs. Patient
§
Generally, it is thought that requirements for consent
should be stronger in ‘pure’ research contexts than therapeutic contexts.
–
Why? Because
generally in research, the beneficence justification isn’t available to us
§
The Nuremburg
Code (1947) “The voluntary consent of the human subject is absolutely
essential.”
§
We’ll talk more about this in a future class (Lecture
6)
Elements of Informed
Consent*
§
I Information
Elements
1. Disclosure of
Information
2. Comprehension
of Information
§
II Consent Elements
3. Voluntary
Consent
4. Competence to
Consent
* follows Beauchamp & Childress, Principles of
Biomedical Ethics
4. Competence
§
No competence, no
consent
– We often talk about
parents or guardians consenting for you, but we need to remember this is
really a very different thing.
§
Competence is not
all or nothing
– Perhaps I am competent to drive a car, but not to make
complicated medical decisions about myself
What is Competence?
§
Being rational?
– i.e., using reason to pursue your own goals?
–
What about the
person who carefully figures out how to pursue his project of dismembering
himself?
§
Having the right
goals?
– A competent person reaches reasonable conclusions
based on reasonable goals?
– There’s a danger of paternalism here
Incompetence
§
What
if the patient isn’t competent?
– How can we treat the patient in such
a case?
§
We’ll
discuss this at length later on
3. Voluntariness
§
Consent must be free of corercion
or undue influence from others
§
Simple
in theory although often trickier in practice
– Pressure from family
– Health care providers
2 & 1. Disclosure & Comprehension
§
Disclosure: How
much information must be given?
–
“Full disclosure is impossible” (Freedman, p. 171)
–
Remember that how information is presented is crucial
–
An overload of information can actually hamper
informed consent
–
Patients may decide they want only limited disclosure
§
Comprehension: What must you do to ensure the patient
has consented?
Disclosure &
Comprehension
§
Disclosure
must:
–
Be specific to the intervention
–
Explain alternatives
–
Explain prognosis with and without treatment
–
Explain risks and benefits of treatment and
alternatives
–
Involve an opportunity for questions form patient
What is adequate disclosure?
§
3 Standards:
1. Medical Community: What a
typical physician/researcher would disclose
2. Subjective: What the patient
wanted to know
3. Objective: What a reasonable
person would want to know
Reibl v. Hughes (S.C.C. 1980)
§
Sets Canadian standard on disclosure
§
Reibl - 44 year old man
with a history of severe migraines
§
Dr. Hughes – removes blockage in left internal carotid
artery
–
Surgery is “competently performed” (p. 157)
§
Reibl suffers a stroke
which leaves him impotent and paralyzed on right side
§
Reibl had not been
warned about this specific risk
– Sues Hughes
claiming he had not given an informed consent
Reibl v. Hughes
§
“in obtaining consent … a 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 proposed
operation, its gravity, any material risks and any special or unusual risks
attendant upon the performance of the operation.” (p. 158)
§
“even if a certain risk is a mere possibility…, yet if
its occurrence carries serious consequences, as for example, paralysis or even
death, it should be regarded as … requiring disclosure.” (p. 158)
Reibl v. Hughes
§
Significant here is the fact that Reibl
was 1.5 years away from qualifying for a lifetime pension for Ford
§
Reibl claimed he would
at least have delayed the surgery if he had fully understood its risks
§
Are these specific facts about Reibl
relevant to whether he was fully informed about the surgery?
Reibl v. Hughes
§
Court rules that the appropriate standard of
disclosure is what a reasonable person in the patient’s position would
want to know
§
Dr. Hughes was found guilty of negligence by the
Supreme Court of Canada
§
Compromise between objective and subjective view
Ciarlariello v. Schacter (S.C.C., 1993)
§
Case involves a patient who asked to have an angiogram
stopped mid-way through and then gave verbal go ahead to start up again
(“Please go ahead”)
§
Question of the Case: How much did C’s physician have
to do to ‘re-consent’ her? Did they have to go through a process of full
disclosure?
Ciarlariello v. Schacter
§
Central element of the verdict is reminiscent of Reibl v. Hughes although perhaps more
subjective
§
“The appropriate approach is … to focus on what the
patient would like to know concerning the continuation of the process once the
consent has been withdrawn.” (p. 180)
§
“Changes may arise during the procedure
which are not at all relevant to the issue of consent. Yet, the critical question will always be
whether the patient would want to have the information…” (p. 180)
Group Work
§
S, a severely brain damaged 9 year old child has had a
series of heart surgeries since age 1 in order to save her life
§
S’s doctors say that she will die very soon unless
another heart surgery is performed
§
S is clearly not capable of consenting to the surgery
–
How should the decision about whether to carry out the
surgery be made?
–
On what basis?
–
What factors should be considered?
Results
of Group Work
- Decision should be made by
parents (most)
- Decision should be shared by
parents & doctors (some)
–
Assessment
of likely quality of life after surgery
–
Parent’s
reasons for accepting/rejecting surgery
–
Likelihood
of death without surgery
–
Impact
on health care system – time, use of resources, cost
–
Emotional
impact on family
–
Expenses
for family
What if
the Patient Isn’t Competent?
§
“a proxy consent ought to be obtained on behalf of the
incompetent subject.” (p. 169)
–
Who? Parents? Doctors? Courts?
§
Living wills
§
Newfoundland:
Advance Health Care Directives Act
Advance Health Care Directives Act
§
Sets out conditions for
setting up an advance health care directive.
§
If no directive in place, it sets out the rules for
proxy decision making
–
Spouse
–
Children
–
Parents
–
Siblings …
§
Majority rules
§
One decision maker may be designated
§
In case of a tie, the decision goes to the next place
on the list (See section 10)
On What
Basis Should Substitute Decisions Be Made?
§
3 Possibilities
–
Best Interests of the Incompetent Person
–
Substituted Judgment
–
Interests of the Substitute Decision Maker
§
Eve vs. Mrs
E. & Re. S.D. illustrate that
the Canadian legal standard is ‘best interests’
§
The NL Advance Health Care Directives Act shares this
approach
Re. S.D. (B.C.S.C., 1983)
§
B.C. Supreme Court
§
S.D. was a 7 year old boy with profound brain damage
§
“no control over his
faculties, limbs or bodily functions.” (p. 184)
§
At 5 months, had a shunt (i.e., plastic tube)
installed to draw excess cerebro-spinal fluid from
the head
§
Shunt became blocked
§
Parents at first consented to having the blockage
cleared, then withdrew consent “on the ground that the boy should be allowed to
die with dignity” (p. 184)
Verdict
in Re. S.D.
§
Family and Child Services assumed custody of S.D.
§
A B.C. provincial court judge returned custody to the
parents
§
The B.C.S.C. reversed this decision:
–
“I do not think that it lies within the prerogative of
any parent or of this court to look down upon a disadvantaged person and judge
the quality of that person’s life to be so low as not to be deserving of
continuance.” (p. 185)
Eve vs. Mrs. E. (S.C.C.
1987)
§
Eve = 24, extreme expressive aphasia
§
“at least mildly to
moderately mentally retarded”
§
Incapable of being a mother other than ‘physically’
§
Mother sought to have her daughter sterilized by tubal ligation
§
Mother feared her daughter would become pregnant and
that the child would become her responsibility
Eve vs. Mrs. E
§
Lower court (in PEI) rules Eve cannot be sterilized
for non-therapeutic reasons
§
PEI Supreme Court reversed this decision, ordered a
hysterectomy
§
Supreme Court of Canada reinstated original court’s
order
–
Very clear: no
non-therapeutic sterilization of incompetent patients
–
A controversial ruling, both legally and morally
S.C.C. Verdict
§
“The grave intrusion on a person’s rights and the
certain physical damage that ensues from non-therapeutic sterilization without
consent, when compared to the highly questionable advantages that can result
from it, have persuaded me that it can never safely be determined that such a
procedure is for the benefit of that person.” (La Forest, p. 418)
–
Clear reliance on the best interests standard
Advance
Health Care Directives Act
§
12.1c
“when the substitute decision maker has no knowledge of the maker’s wishes,
[the substitute decision maker shall act] in accordance with what … [he or
she]… reasonably believes to be in the best interests of the maker.”
A Last
Point: Moral vs. Legal Consent
§
Moral informed consent
–
patient actually having
made an informed voluntary decision with an appropriate level of disclosure
§
Legal informed consent
–
having gone through
appropriate steps so that consent will be considered legally valid (e.g.,
signing documents)
§
Remember contrast between intrinsic and instrumental
value
–
Sometimes things that are initially perceived as
instrumentally valuable come to be mistaken for having intrinsic value
Moral vs. Legal Consent
§
Legal consent requirements started out as means of
ensuring moral consent had actually been sort
§
Today, we often pay more attention to legal consent
than moral consent
–
Conversations are often about whether forms were
signed
§
Sometimes seeking legal consent actually gets in the
way of achieving moral consent
– E.g., overly
complicated consent forms