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Informed Consent and
Vulnerable Populations

MEDICAL ETHICS-SUMMER 2012
BOWLING GREEN STATE UNIV.
Lecture Goals

 Explain the connection between informed
  consent and patient autonomy

 Outline the basic requirements of informed
  consent

 Define the concept of a vulnerable population
  and explain why it’s more difficult to obtain
  informed consent from them.
Autonomy and Informed Consent

 Autonomy-the capacity to make choices
  about one’s own life, on the basis of one’s
  own values and concerns

 Protected by a right

 The requirement that physicians obtain
  informed consent ensures (or at least makes
  it more likely) that a patient’s choices are
  autonomous
Why Think Autonomy Matters?

 Mill-In most cases, individuals are the best
  judges of what is best for them. Coercion, even
  when done for the individual’s own good, is
  usually a greater harm .

 Kant-Capacity for autonomy is what makes our
  lives valuable. When we cease to have this
  capacity, we cease to count as persons in the
  morally relevant sense.

 Value Pluralism
The Conditions of Informed Consent


 Not all instances of consent count as
  informed consent

 Three Conditions
-Competence
-Understanding
-Freely Given or Withheld
Competence

 In medical practice, patients are assumed to
  be competent.

 Decisions at odds with medical advice are
  not, in themselves, evidence of
  incompetence.

 Illness, injury, or medication may lead to a
  loss of competence.
Understanding
 Diagnosis, treatment protocol, risks, benefits, side
  effects, aftercare and long-term maintenance, alternatives

 Professional standards tend to emphasize disclosure, rather
  than understanding. (Full disclosure, Medical
  Community, and Reasonable person)

 Understanding is difficult to measure.

 Difficult to give a neutral presentation of information.

 This can (perhaps) be avoided by explaining the values
  which underlie a physician’s recommendation.
Freely Given or Withheld

 No such thing as implicit consent in the
  medical field.

 Absence of coercion or
  manipulation, whether intentional or not.

 Physicians and family members most likely
  culprits.
Vulnerable Populations

 A group of individuals whose capacity to give
  informed consent is impaired or
  eliminated, in virtue of their status as
  members of that group.

 Examples: Children, disabled, people with
  psychological disorders, terminally
  ill, prisoners, people who lack a high school
  education.
Two Common Mistakes

 Race


 Elderly


 These are frequently cited as examples of
  vulnerable populations, but they are not.
  Nothing about being a member of a
  particular race, or being of a certain age, is in
  itself an impairment on informed consent.
Two Famous Cases

 Willowbrook
Parents of severely disabled children could only
  be admitted to the “hepatitis” wing of the
  school.

 Tuskegee Syphillis Study
A multi-decade study of syphillis, participants
  were all black men living in the rural South.

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Informed consent and vulnerable populations

  • 1. Informed Consent and Vulnerable Populations MEDICAL ETHICS-SUMMER 2012 BOWLING GREEN STATE UNIV.
  • 2. Lecture Goals  Explain the connection between informed consent and patient autonomy  Outline the basic requirements of informed consent  Define the concept of a vulnerable population and explain why it’s more difficult to obtain informed consent from them.
  • 3. Autonomy and Informed Consent  Autonomy-the capacity to make choices about one’s own life, on the basis of one’s own values and concerns  Protected by a right  The requirement that physicians obtain informed consent ensures (or at least makes it more likely) that a patient’s choices are autonomous
  • 4. Why Think Autonomy Matters?  Mill-In most cases, individuals are the best judges of what is best for them. Coercion, even when done for the individual’s own good, is usually a greater harm .  Kant-Capacity for autonomy is what makes our lives valuable. When we cease to have this capacity, we cease to count as persons in the morally relevant sense.  Value Pluralism
  • 5. The Conditions of Informed Consent  Not all instances of consent count as informed consent  Three Conditions -Competence -Understanding -Freely Given or Withheld
  • 6. Competence  In medical practice, patients are assumed to be competent.  Decisions at odds with medical advice are not, in themselves, evidence of incompetence.  Illness, injury, or medication may lead to a loss of competence.
  • 7. Understanding  Diagnosis, treatment protocol, risks, benefits, side effects, aftercare and long-term maintenance, alternatives  Professional standards tend to emphasize disclosure, rather than understanding. (Full disclosure, Medical Community, and Reasonable person)  Understanding is difficult to measure.  Difficult to give a neutral presentation of information.  This can (perhaps) be avoided by explaining the values which underlie a physician’s recommendation.
  • 8. Freely Given or Withheld  No such thing as implicit consent in the medical field.  Absence of coercion or manipulation, whether intentional or not.  Physicians and family members most likely culprits.
  • 9. Vulnerable Populations  A group of individuals whose capacity to give informed consent is impaired or eliminated, in virtue of their status as members of that group.  Examples: Children, disabled, people with psychological disorders, terminally ill, prisoners, people who lack a high school education.
  • 10. Two Common Mistakes  Race  Elderly  These are frequently cited as examples of vulnerable populations, but they are not. Nothing about being a member of a particular race, or being of a certain age, is in itself an impairment on informed consent.
  • 11. Two Famous Cases  Willowbrook Parents of severely disabled children could only be admitted to the “hepatitis” wing of the school.  Tuskegee Syphillis Study A multi-decade study of syphillis, participants were all black men living in the rural South.