Informed Consent

1
Informed Consent

• Vaughn, Chapter 5
• (144-151)

2
Elements of Informed Consent

• Vaughn lists 5 requirements for informed consent
• Competence
• Adequate Disclosure
• Adequate Understanding
• Voluntary Decision
• Consent

3
1 Competence

• Decision-making capacity is the patients
  ability to make choices that reflect an
  understanding and appreciation of the nature and
  consequences of ones actions and of alternative
  actions, and to evaluate them in relation to a
  persons preferences and priorities. A patients
  decision contrary to a physicians recommendation
  does not in itself indicate incapacity. American
  Hospital Association
• Note that the AHA is working with its own
  technical language of capacity rather than
  competency ... It will not affect this discussion

4
1 Competence

• Decision-making capacity is the patients ability
  to make choices that reflect an understanding and
  appreciation of the nature and consequences of
  ones actions and of alternative actions, and to
  evaluate them in relation to a persons
  preferences and priorities. A patients decision
  contrary to a physicians recommendation does not
  in itself indicate incapacity. American Hospital
  Association
• Note also that choices are not evaluated strictly
  in terms of consequences, but in terms of the
  nature of the choice a choice might violate a
  life-long value, it might involve lying, it might
  be the breaking of a promise.

5
1 Competence

• So, back to understanding what must a patient
  understand?
• the nature and effects of the treatment on the
  patients health, life, lifestyle, religious
  beliefs, values, family, friends, and society
  Garrett, p 32, my brackets
• This sort of understanding cannot be determined
  by classification alone.
• Some intellectually disabled persons have the
  understanding described above.
• Some children do as well.
• Some pleasantly confused people in institutions
  qualify as competent.

6
1 and 4 Competence and Voluntariness

• Competence requires not only the ability to
  understand the consequences of ones decisions,
  but freedom from coercion and such undue
  influence that would substantially diminish the
  freedom of the patient Garrett, p34
• Coercion force or drugs equivalent to force
• Undue influence blackmail, bribery, extreme
  pressure

7
1 and 4 Competence and Voluntariness

• Competence the ability to perform a certain
  task
• The task at hand is to make a decision that
  reflects your values and assessment of likely
  outcomes
• Do coercion and undue influence really eliminate
  competence?
• Do they invalidate consent?
• Is there anything important missing in the
  quotation on the previous slide?
• Can freedom (free will) be overcome by pressure?

8
Autonomy ? Informed Consent

• Autonomy is self-governance
• Part of respecting persons is respecting their
  right of self-determination the right to
  determine what their lives mean by use of their
  own judgment and decisions

9
Autonomy ? Informed Consent

• Protecting someones ability to determine who
  they are and what their life means requires
  getting their consent for medical treatment
• Meaningful consent requires that the patient be
  properly informed about treatment (unless waved
  p 146)
• Being properly informed requires patient
  competency

10
Autonomy ? Informed Consent

• Competency requires understanding
• But understanding what?
• Vaughn (p.146) and Garrett discuss the sort of
  understanding required for a patient to be judged
  competent to give consent to a medical treatment.

11
2 and 3 Disclosure and Understanding

• Information in Informed Consent (Garretts
  wording)
• 4 competing rules to guide information sharing
• Patient preference rule
• Professional custom rule
• Prudent person rule
• Subjective substantial disclosure rule

12
2 and 3 Disclosure and Understanding

• Patient preference rule Tell the patient
  whatever the patient wants to know
• Garrett dislikes this rule because it
• Invites wasting time answering too many questions
  from certain patients
• Excuses patients from their right and duty to ask
  questions and contribute to health decisions
• An exception is acknowledged in cases where
  patients are well known by their doctors, and
  can consent based on their mutual understanding

13
2 and 3 Disclosure and Understanding

• Professional custom rule (also called the
  professional community standard Vaughn calls
  this the Physician-based standard) tell the
  patient what is customarily told in similar
  circumstances
• Garrett dislikes this rule
• What is customary might be bad
• A study showed there may be no custom and the
  notion of decision based on custom reduces to
  physicians doing what they want

14
2 and 3 Disclosure and Understanding

• Prudent person rule (also called the reasonable
  patient standard) tell the patient what a
  prudent, reasonable person would need to know to
  refuse or accept treatment
• Garrett likes this approach, combined with the
  following

15
2 and 3 Disclosure and Understanding

• Subjective substantial disclosure rule tell the
  patient what is important and relevant to them
  personally (rather than an idealized prudent or
  reasonable person) to make a decision about
  treatment, where relevance is determined by
  whether it could make a difference in the
  decision.
• Garrett endorses 3 and 4 combined, first sharing
  information a prudent person would want, then
  adding anything knowledge of this particular
  patient might suggest.
• The book then complains that most hospital
  consent forms are inadequate.

16
2 and 3 Disclosure and Understanding

• Vaughn prefers to list some general guidelines of
  what information is required for informed
  consent
• The nature of the procedure
• The risks of the procedure
• The alternatives to the procedure
• The expected benefits of the procedure
• See Vaughn, p.146

17
2 and 3 Disclosure and Understanding

• Note that informing someone of a medical
  treatment requires a good explanation, which can
  be very difficult depending on the treatment and
  the condition of the patient.
• The overriding rule, though, is that the patient
  understand, not that the information is
  presented.
• No understanding no consent

18
5 Informed Consent

• Consider the In Depth box at the top of page
  147 in Vaughn.
• Which of the two conceptions of informed consent
• Shared Decision-Making
• Informed Consent
• do you find most reasonable? Why?

19
Part 2

• The following considerations are take from
  Garretts book.
• The considerations help give substance to the
  consideration of principles on the previous
  slides

20
The Consent of Adolescents, Children, and
Incompetent Patients

• Current US law is a blend of older theories that
  gave preference to the rights of parents and
  newer theories that focus on the childs welfare
  and even more recently, rights.

21
The Consent of Adolescents, Children, and
Incompetent Patients

• Incompetent patients require surrogates or
  substitutes. Problems that attend surrogacy
• There is no authoritative guide to determining
  who shall be the surrogate when surrogacy is
  not specified by the patient
• What to do when parents disagree about care?
• What to do when siblings disagree about care?
• Are uncles closer than cousins? Grandparents?

22
The Consent of Adolescents, Children, and
Incompetent Patients

• Incompetent patients require surrogates or
  substitutes. Problems that attend surrogacy
  (cont.)
• What happens when providers recognize a conflict
  between a now incompetent patients wishes and
  the decision of a surrogate?
• Garrett recommendation is twofold
• Do no harm (to the patient)
• Be ready to seek court intervention

23
The Consent of Adolescents, Children, and
Incompetent Patients

• Informed consent requires many things from
• the patient for consent, and
• the provider for information
• Which provider, though, is obliged to provide the
  information?
• The book suggests that this question may not be
  addressed well at particular hospitals and
  clinics.
• The American Hospitals Committee on Biomedical
  Ethics identifies 3 obligations borne by
  hospitals
• Ensure informed consent is obtained
• Develop educational programs for informing
  patients
• Make certain patients are aware of their right to
  reject treatments
• Note that who at hospitals is specifically
  obliged is left open

24
Emergencies

• Emergencies introduce exceptions to informed
  consent requirements.
• The authors commend following these criteria
• The patient must be incapable of giving consent
  and no lawful surrogate is available to give
  consent
• There is a danger to life or a danger of serious
  impairment of health
• Immediate treatment is necessary to avert these
  dangers
• The book amends their endorsement of the first
  criterion by requiring the patients wishes be
  unknown

25
Emergencies

• The authors give 2 reasons for their support of
  advanced directives (knowing the patients
  wishes)
• Providers need informed consent to treat patients
  (to lay hands on patients the book notes, top
  of p 45, the legal notion that unwanted touch
  constitutes battery)
• The authors agree with the New Jersey Supreme
  Courts decision, in Jobes and related cases,
  that self-determination is generally more
  important than the states countervailing
  interests.

26
Exceptions in Non-Emergencies

• Authors endorsement of the value of autonomy
  over beneficence
• When an incompetent person has no directive, no
  known wishes, no surrogate, and life and health
  are not in immediate danger, treatment cannot
  proceed. Garrett p 46 and p 47
• Note the authors claim that beneficence has been
  supplanted by autonomy generally in health care
  the priestly model supplanted by a contractual,
  collegial, or covenant model

27
Court Approval

• The book recommends help from courts in the
  absence of patient competency, proper surrogates,
  or clear legislative direction, under these
  conditions
• The incapacity is great and likely to be
  prolonged, and there is no obvious surrogate
• The capacity of the patient is questionable, and
  the decision to be made significant
• The views of the surrogate are strongly at
  variance with the medical judgment or the
  patients known views
• The choice of the individual to serve as
  surrogate is controversial, and all efforts to
  resolve the matter at the hospital level have
  failed
• Family members radically disagree about the
  course of action in the case of a patient who
  lacks adequate decision-making capacity

28
Ethics Committees

• Be aware of the books misgivings about ceding
  decision-making power to ethics committees
• Since such committees are relatively new, there
  are questions about the role they can or should
  play, i.e., if laws were crafted with only
  patients, surrogates, and physicians in mind,
  there may be dangerous loopholes

29
Ethics Committees

• The book mentions 3 main concerns
• How is the committee composed? For example, is it
  weighted in favor of physicians interests over
  patients rights?
• What rules of participation are in place?
• What rules of disclosure are in place?

30
Right to Refuse Treatment

• The American Hospital Associations Bill of
  Patient Rights includes this
• The patient has the right to refuse treatment to
  the extent permitted by law and to be informed of
  the medical consequences of his actions
• http//www.patienttalk.info/AHA-Patient_Bill_of_Ri
  ghts.htm
• Note The legal right to refuse treatment does
  not imply an ethical right to refuse

31
Problem Areas for Autonomy

• Note that autonomy is a difficult value to gauge
  at psychiatric facilities and nursing homes.
• Nursing homes will have special obligations of
• Identifying their residents wishes as early as
  possible
• Establishing relations with surrogates
• Informing residents about the living will and
  durable power of attorney
• Informing them about their rights to refuse
  treatment
• Attaching all documentation to residents medical
  records