Informed Consent
Andrew Latus
E/H/HL Course
Oct. 28/02
Schedule

Today
– Informed Consent and Due Care

Thursday, 11-11:50
– Physician as Healer – Some Historical
Perspectives

Updated Course Outline at
http://www.ucs.mun.ca/~alatus/BSM1

Case study in mailbox soon
Why Value Informed Consent?

“No medical intervention done for any purpose—
whether diagnostic, investigational, cosmetic,
palliative, or therapeutic—should take place
unless the patient has consented to it.” (Doing
Good, 84)
– Note the emphatic tone
– Later qualified: “in the case of an incompetent patient,
someone else who is authorized to do so has agreed to
do it.” (84)
– Emergencies

Why is informed consent 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
Why Value Informed Consent?

Justification #2
– via The Principles of Beneficence and Nonmaleficence
 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
 Doing Right misses this
 Today, usually thought of as a secondary reason for
consent
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 medical best interest

In a later session, we will focus on conflict cases
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.”
WMA Helsinki Declarations (1964, 1975, 1983,
1989, 1996, 2000)
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
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
What if the Patient Isn’t
Competent?

Substituted Judgment - Someone else can
decide for the patient.
– Who? Parents? Doctors? Courts?


Living wills
Newfoundland: Advance Health Care
Directives Act
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
Disclosure & Comprehension

Disclosure: How much information must
be given?
– Remember that how information is presented
is crucial
– An overload of information can actually
hamper informed consent

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 vs. Hughes
Case 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
 Reibl is left impotent and profoundly
paralyzed on right side
 Reibl had not been warned about this
specific risk

Reibl vs. Hughes



Dr. Hughes was found guilty of negligence
by the Supreme Court of Canada
Court rules that the appropriate standard
of disclosure is what a reasonable person
in the patient’s position would want to
know
Compromise between objective and
subjective view
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

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
A Common Consent Issue for
Students
 Examinations
on patients who have
not consented to them
A
number of U of T students reported
encountering this (BMJ March, 2001)
– Utilitarianism vs. Deontology