Informed Consent

Question 1

Principilism

Answer 1

Perspective in medical ethics. Based on “prima facie” goods. Makes decisions based on upholding basic principles.

Question 2

Prima facia goods

Answer 2

Goods that are generally accepted by all cultures and thus do not need independent justification.

Question 3

Four components of principalism

Answer 3

• Autonomy
• Beneficience
• Nonmalefiscience
• Justice

Question 4

Deontological standard

Answer 4

We have a duty to maintain x unless other deontological principles have an overriding case.

For example, autonomy

Question 5

Beneficience is a form of ___ good.

Answer 5

Beneficience is a form of utilitarian good.

Question 6

Paternalistic model

Answer 6

In this model, the physician-patiient interaction ensures that patients receive the interventions that best promote their health and well-being. At the extreme, the physician au¬ thoritatively informs the patient when the intervention will be initiated.

The paternalistic model assumes that there are shared objective criteria for determining what is best.

Question 7

Informative model

Answer 7

In this model, the objective of the physician-patient interaction is for the physician to provide the patient with all relevant information, for the patient to select the medical interventions he or she wants, and for the physician to execute the selected interventions.

The informative model assumes a fairly clear distinction between facts and values.

Question 8

Interpretive model

Answer 8

The aim of the physician-patient interaction is to elucidate the patient’s values and what he or she actually wants, and to help the patient select the available medical interventions that realize these values.

According to the interpretive model, the patient’s values are not necessarily fixed and known to the patient. Importantly, the physician does not dictate to the patient; it is the patient who ultimately decides which values and course of action best fit who he or she is.

Question 9

Deliberative model

Answer 9

. The aim of the physician-patient interaction is to help the patient determine and choose the best health-related values that can be realized in the clinical situation.

At the extreme, the physician and patient engage in deliberation about what kind of healthrelated values the patient could and ultimately should pursue.

Question 10

Instrumental model

Answer 10

The patient’s goals are irrelevant and the physician makes decisions based on a goal independent of the patient, such as societal need.

Not an ideal, but an aberration.

Question 11

When the paternalistic model is justified

Answer 11

It is widely recognized that the paternalistic model is justified during emergencies when the time taken to obtain informed consent might irreversibly harm the patient. Beyond these limited circumstances, it is not tenable and should not be employed.

Question 12

“Preferred model” according to Emanuel and Emanuel

Answer 12

Deliberative

Question 13

Two meanings of “informed consent.”

Answer 13

1. An informed consent is an individual’s autonomous authorization of a medical intervention or of participation in research
2. Informed consent refers only to an institutionally or legally effective authorization, as determined by prevailing rules, and is not necessarily even a meaningful authorization. Consent under these circumstances is not bona fide informed consent

Question 14

“elements” of informed consent

Answer 14

The “information” element and the “consent” component are the classical ones, but some groups identify five:

(1) competence, (2) disclosure, (3) understanding, (4) voluntariness, and (5) consent

Some identify seven:

competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization

Question 15

One gives an informed consent to an intervention if (and perhaps only if) one is . . .

Answer 15

One gives an informed consent to an intervention if (and perhaps only if) one is competent to act, receives a thorough disclosure, comprehends the disclosure, acts voluntarily, and consents to the intervention.

Question 16

7 Element Model

Answer 16

Question 17

Legally, sometimes ___ is the only required element of informed consent. This does not mean it should be the ideal.

Answer 17

Legally, sometimes disclosure is the only required element of informed consent. This does not mean it should be the ideal.

Question 18

Information that physicians are required to disclose

Answer 18

(1) those facts or descriptions that patients or subjects usually consider material in deciding whether to refuse or consent to the proposed intervention or research,
(2) information the professional believes to be material,
(3) the professional’s recommendation,
(4) the purpose of seeking consent, and
(5) the nature and limits of consent as an act of authorization

Question 19

California Supreme Court decision on informed consent

Answer 19

“a physician must disclose personal interests unrelated to the patient’s health, whether research or economic, that may affect the physician’s professional judgment.”

Question 20

The professional practice standard of disclosure

Answer 20

holds that a professional community’s customary practices determine adequate disclosure. That is, professional custom establishes the amount and kinds of information to be disclosed.

As a result, only expert testimony from members of this profession could count as evidence that a physician has violated a patient’s right to information

Sometimes also called the “reasonable doctor” standard

Question 21

The reasonable person standard of disclosure

Answer 21

According to this standard, we must determine the information to be disclosed by reference to a hypothetical reasonable person. Whether information is pertinent or material is thus measured by the significance a reasonable person would attach to it in deciding whether to undergo a procedure.

Question 22

The subjective standard of disclosure

Answer 22

The subjective model judges adequacy of information by reference to the specific informational needs of the individual person, rather than the hypothetical “reasonable person.”

Preferable moral standard because it is the only one to ackowledge what the patient’s desires are

Question 23

The therapeutic privilege.

Answer 23

Legal exceptions to the rule of infonned consent allow the health professional to proceed without consent in cases of emergency, incompetency, and waiver

Question 24

Therapeutic use of placebos

Answer 24

The therapeutic use of placebos typically involves intentional deception or incomplete disclosure.

Evidence also suggests that the placebo effect-an improvement in the patient after use of a placebo–can sometimes be produced. without nondisclosure, incomplete disclosure, or deception. Nevertheless, a placebo is less likely to be effective if used with the patient’s knowledge

Question 25

Many patients do not recall that they have the right to ___ a clinical trial.

Answer 25

Many patients do not recall that they have the right to withdraw from a clinical trial.

Question 26

Information ___ has huge implications for autonomous choice.

Answer 26

Information framing has huge implications for autonomous choice.

Question 27

A ___ can invalidate a patient’s or subject’s consent even in the presence of suitable disclosure and comprehension

Answer 27

A false belief can invalidate a patient’s or subject’s consent even in the presence of suitable disclosure and comprehension

Question 28

If ___ prevents an informed choice, it may be permissible or possibly even obligatory to promote autonomy by attempting to impose unwelcome information

Answer 28

If ignorance prevents an informed choice, it may be permissible or possibly even obligatory to promote autonomy by attempting to impose unwelcome information

Question 29

Voluntariness

Answer 29

A person acts voluntarily to the degree that he or she wills the action without being under the control of another’s influence

Question 30

Forms of Influence

Answer 30

Coercion

Persuasion

Manipulation

Question 31

Coercion

Answer 31

Coercion occurs if and only if one person intentionally uses a credible and severe threat of harm or force to control another

A subjective response in which persons comply because they feel threatened (though no threat has been issued) does not by itself qualify as coercion

Question 32

Persuasion

Answer 32

Persuasion of a patient by reason is not a problem so long as it falls under the category of the physician’s arguments for recommendation and respsects the patient’s ultimate autonomy.

Persuasion by emotion is a problem.

Disclosures or approaches that might rationally persuade one patient might overwhelm another whose fear or panic would short circuit reason, complicating this model.

Question 33

Manipulation

Answer 33

A generic term for several forms of influence that are neither persuasive nor coercive.

In health care, the key form of manipulation is informational manipulation, a deliberate act of managing information that nonpersuasively alters a person’s understanding of a situation and thereby motivates him or her to do what the agent of influence intends