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Informed Consent. Vaughn, Chapter 5. Elements of Informed Consent. Vaughn lists 5 requirements for informed consent: Competence Adequate Disclosure Adequate Understanding Voluntary Decision Consent. 1: Competence.

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informed consent

Informed Consent

Vaughn, Chapter 5

elements of informed consent
Elements of Informed Consent

Vaughn lists 5 requirements for informed consent:

  • Competence
  • Adequate Disclosure
  • Adequate Understanding
  • Voluntary Decision
  • Consent
1 competence
1: Competence

Decision-making capacity* is the patient’s ability to make choices that reflect an understanding and appreciation of the nature and consequences of one’s actions and of alternative actions, and to evaluate them in relation to a person’s preferences and priorities. A patient’s decision contrary to a physician’s 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

1 competence4
1: Competence

Decision-making capacity is the patient’s ability to make choices that reflect an understanding and appreciation of the nature and consequences of one’s actions and of alternative actions, and to evaluate them in relation to a person’s preferences and priorities. A patient’s decision contrary to a physician’s 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.

1 competence5
1: Competence

So, back to understanding … what must a patient understand?

“the [nature and] effects of the treatment on the patient’s 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.
1 and 4 competence and voluntariness
1 and 4: Competence and Voluntariness

Competence requires not only the ability to understand the consequences of one’s 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

1 and 4 competence and voluntariness7
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?

autonomy informed consent
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

autonomy informed consent9
Autonomy  Informed Consent

Protecting someone’s 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

autonomy informed consent10
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.

2 and 3 disclosure and understanding
2 and 3: Disclosure and Understanding

Information in Informed Consent (Garrett’s wording):

4 competing rules to guide information sharing

  • Patient preference rule
  • Professional custom rule
  • Prudent person rule
  • Subjective substantial disclosure rule
2 and 3 disclosure and understanding12
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 patient’s are well known by their doctors, and can consent based on their mutual understanding

2 and 3 disclosure and understanding13
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
2 and 3 disclosure and understanding14
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 …

2 and 3 disclosure and understanding15
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.

2 and 3 disclosure and understanding16
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

2 and 3 disclosure and understanding17
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

5 informed consent
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?

part 2
Part 2

The following considerations are take from Garrett’s book.

The considerations help give substance to the consideration of principles on the previous slides…

the consent of adolescents children and incompetent patients
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 child’s welfare and even more recently, rights.

the consent of adolescents children and incompetent patients21
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?

the consent of adolescents children and incompetent patients22
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 patient’s wishes and the decision of a surrogate?

Garrett recommendation is twofold:

  • Do no harm (to the patient)
  • Be ready to seek court intervention
the consent of adolescents children and incompetent patients23
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 Hospital’s 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

emergencies
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 patient’s wishes be unknown …

emergencies25
Emergencies

The authors give 2 reasons for their support of “advanced directives” (knowing the patient’s 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 Court’s decision, in Jobes and related cases, that self-determination is generally more important than the state’s countervailing interests.
exceptions in non emergencies
Exceptions in Non-Emergencies

Author’s 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 author’s claim that beneficence has been supplanted by autonomy generally in health care; the priestly model supplanted by a contractual, collegial, or covenant model

court approval
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 patient’s 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
ethics committees
Ethics Committees

Be aware of the book’s 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

ethics committees29
Ethics Committees

The book mentions 3 main concerns:

  • How is the committee composed? For example, is it weighted in favor of physicians interests over patient’s rights?
  • What rules of participation are in place?
  • What rules of disclosure are in place?
right to refuse treatment
Right to Refuse Treatment

The American Hospital Association’s 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_Rights.htm

Note: The legal right to refuse treatment does not imply an ethical right to refuse

problem areas for autonomy
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 resident’s 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 resident’s medical records