Informed Consent

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Informed Consent

• Andrew Latus
• E/H/HL Course
• Oct. 28/02

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Schedule

• Today
• Informed Consent and Due Care
• Thursday, 11-1150
• Physician as Healer Some Historical
  Perspectives
• Updated Course Outline at http//www.ucs.mun.ca/a
  latus/BSM1
• Case study in mailbox soon

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Why Value Informed Consent?

• No medical intervention done for any
  purposewhether diagnostic, investigational,
  cosmetic, palliative, or therapeuticshould 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?

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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

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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
• Doing Right misses this
• Today, usually thought of as a secondary reason
  for consent

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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
• In a later session, we will focus on conflict
  cases

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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.
• WMA Helsinki Declarations (1964, 1975, 1983,
  1989, 1996, 2000)

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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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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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What if the Patient Isnt Competent?

• Substituted Judgment - Someone else can decide
  for the patient.
• Who?  Parents? Doctors? Courts?
• Living wills
• Newfoundland Advance Health Care Directives Act

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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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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?

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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 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

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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
  patients position would want to know
• Compromise between objective and subjective view

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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

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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

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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