Autonomy and Informed Consent

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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

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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

Being properly informed requires patient competency

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Competency requires understanding

But understanding what?

On p 32 the book begins its discussion of the sort of understanding required for a patient to be judged competent to give consent to a medical treatment.

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From the bottom of p 32 (only in 4th ed.):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

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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.

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Finally, note that the book fails to mention the nature of the action and focuses instead on its consequences: Pages 34-5 (32-3 4th ed.) Under…

Competence and Understanding:

2nd sentence, 1st sentence of paragraph 2

Classifying the Incompetent 1st sentence of paragraph 2 3rd sentence of paragraph 3

Read carefully7

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…” –Ethics, p 34 (4th ed. 32), my brackets

P 35 (33 4th ed.) is an effort to show this sort of understanding cannot be determined by classification alone. o Some intellectually disabled people have the understanding

described above. o Some children do as well. o Some “pleasantly confused” people in institutions qualify as

competent.

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Competency and FreedomCompetence 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 – p36 (4th ed. 34)

Coercion = force or drugs equivalent to forceUndue influence = blackmail, bribery, extreme

pressure

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Competency and Freedom (cont.)Recall: Competence = the ability to

perform a certain taskThe 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?

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Who is the Utilitarian in this clip?

Information in Informed Consent:4 competing rules to guide information sharing1. Patient preference rule2. Professional custom rule3. Prudent person rule4. Subjective substantial disclosure rule

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1. Patient preference rule = Tell the patient whatever the patient wants to know

The book dislikes this rule because it:a) Invites wasting time answering too many questions

from certain patientsb) Excuses patients from their right and duty to ask

questions and contribute to health decisionsAn exception is acknowledged in cases where patient’s

are well known by their doctors, and can consent based on their mutual understanding

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2. Professional custom rule (also called the professional community standard) = tell the patient what is customarily told in similar circumstances

The book dislikes this rule:a) What is customary might be badb) A study showed there may be no custom and

the notion of decision based on custom reduces to physicians doing what they want

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3. 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

Read the 7 pieces of information a prudent person will need at the bottom of p 38 (4th ed. 39)

The book likes this approach, combined with the following …

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4. 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.

The book 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.

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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

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The term paternalism comes from Latin, pater, meaning father.

‘Paternal’ suggests benevolent action irrespective of or even contrary to the wishes of the beneficiary.

As such, Paternalism is always a violation of patient autonomy, though it may be justified, depending on circumstances.*

*Text is not clear if Paternalism is always a medical benefit violating consent requirements … see slide 21, text pp. 41-2 (4th ed. 40-1)

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What paternalism is not: Stopping someone from harming others (the

book calls this “delegated police authority”) Overriding a patient’s wishes in order to

benefit the hospital, doctor, nurse, etc. Overriding the patient’s wishes when they

conflict with the health care provider’s values

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Strong Paternalism (sometimes called extended paternalism) = overriding of a competent patient’s wishes for their own good

Weak Paternalism (sometimes called cooperative paternalism) = overriding of an incompetent or doubtfully competent patient’s wishes for their own good

*Red text my additions to Garrett

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Strong Paternalism = overriding of a competent patient’s wishes for their own good

Is Strong Paternalism ever justified?For government: To protect the rights of others To protect an overriding state

interest (is this the basis for prohibiting suicide?)

*Note that both of those reasons are for the good of others, not the patient’s good, and so are not paternalistic actions.

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P 43 paragraph 1 (4th ed. 41, para 2):The government, however, has not authorized health care

providers to use strong paternalism …

The next 2 paragraphs give inability to know another’s values and the possibility of multiple acceptable choices as reasons to reject strong paternalism.

P 42 (4th ed. 40), third paragraph: Discussion of suicide and any legal obligation to prevent it are put off.

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Weak Paternalism = overriding an incompetent or doubtfully competent patient’s wishes:

Courts have accepted weak paternalist excuses when overriding the patient’s wishes is required to relieve serious pain or suffering

Weak paternalism is also mitigated if exercised to gain informed consent. The book calls such treatment “in the service of autonomy.”

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Restraints: restraints are justified on weak paternalistic grounds when patients are confused or disoriented, posing a danger to themselves. Their use should include safeguards:

Periodic patient visits Approval of supervisors and or

physicians “Written justification”

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The book’s trepidation regarding paternalism is found on p 44 (4th ed. 42):

“…we insist that there is no general authorization for even weak paternalism. Each case needs to be studied, and exceptions should be made carefully.”

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The law has recognized paternalism under the name Therapeutic Privilege.

Therapeutic Privilege = the privilege of withholding information from the patient when the physician believes that the disclosure will have an adverse effect on the patient’s condition or health.

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3 conditions guide the use of therapeutic privilege:1. Its use must not be based on generalities, but

on the actual circumstances of the particular patient

2. The physician must have a founded belief, based on intimate knowledge of the patient, that full disclosure will have a significant adverse effect on the patient

3. Reasonable discretion must be used in the manner and extent of the disclosure

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The book dislikes this legal device; it notes 2 problems with it:

Research fails to confirm full disclosure adversely effects patient condition or health

It is a denial of patient autonomy

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P 45 (4th ed. 43), in the introductory paragraph of the section on children and adolescents the book tells us there is some problem with consent regarding them, but does not specify what it is.

The book mentions the law being 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.

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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?

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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?

The books recommendation is twofold: Do no harm (to the patient) Be ready to seek court intervention

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Which provider is obliged to provide the information?

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

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Emergencies introduce exceptions to informed consent requirements.

The authors commend following these criteria from Rosoff (see references):

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 …

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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 47 (4th ed. 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.

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Author’s endorsement of the value of autonomy over beneficence in section Exceptions in Nonemergencies:

When an incompetent person has no directive, no known wishes, no surrogate, and life and health are not in immediate danger, treatment cannot proceed. – paraphrase of section

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

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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

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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

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The book mentions 3 main concerns: How is the committee composed?

For example, is it weighted in favor of physician’s interests over patient’s rights?

What rules of participation are in place?

What rules of disclosure are in place?

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The American Hospital Association’s Bill of Patient Rights includes this:

4. 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

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

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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

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