Informed Consent

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Informed Consent

• Philosophy 2803
• Lecture IV
• Feb. 5, 2003

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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

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Case 1

• A 2001 study surveyed 108 4th year med students
  at U of T about their experiences as clinical
  clerks
• 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

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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
  wasnt in a position to argue we dont really
  get a lot opportunity to practise those types of
  procedures. (Hicks et al, 2001)

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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?

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Resources

• Deontology
• Respect for persons
• Consequentialism
• Promoting good outcomes
• Principilism
• Autonomy, Beneficence, Non-maleficence, Justice

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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)

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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

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Potential for Conflict

• Notice the potential for conflict between the two
  justifications
• What if we dont think you know your best
  interest in a particular case?
• Some might say this means youre incompetent but
  best interest is a slippery notion
• Also perhaps best interest ¹ medical best
  interest

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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 isnt available to us
• The Nuremburg Code (1947) The voluntary consent
  of the human subject is absolutely essential.
• Well talk more about this in a future class
  (Lecture 6)

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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

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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

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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?
• Theres a danger of paternalism here

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Incompetence

• What if the patient isnt competent?
• How can we treat the patient in such a case?
• Well discuss this at length later on

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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

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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?

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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
  

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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

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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

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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)

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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?

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Reibl v. Hughes

• Court rules that the appropriate standard of
  disclosure is what a reasonable person in the
  patients position would want to know
• Dr. Hughes was found guilty of negligence by the
  Supreme Court of Canada
• Compromise between objective and subjective view

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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 Cs physician
  have to do to re-consent her? Did they have to
  go through a process of full disclosure?

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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)

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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
• Ss 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?

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Results of Group Work

• Who should decide?
• Decision should be made by parents (most)
• Decision should be shared by parents doctors
  (some)
• What should be factored in?
• Assessment of likely quality of life after
  surgery
• Parents 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

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What if the Patient Isnt 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

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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)

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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

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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)

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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 persons life to be so low as
  not to be deserving of continuance. (p. 185)

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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

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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
  courts order
• Very clear no non-therapeutic sterilization of
  incompetent patients
• A controversial ruling, both legally and morally

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S.C.C. Verdict

• The grave intrusion on a persons 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

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Advance Health Care Directives Act

• 12.1c when the substitute decision maker has no
  knowledge of the makers 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.

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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

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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