Informed Consent Flashcards
Principilism
Perspective in medical ethics. Based on “prima facie” goods. Makes decisions based on upholding basic principles.
Prima facia goods
Goods that are generally accepted by all cultures and thus do not need independent justification.
Four components of principalism
- Autonomy
- Beneficience
- Nonmalefiscience
- Justice
Deontological standard
We have a duty to maintain x unless other deontological principles have an overriding case.
For example, autonomy
Beneficience is a form of ___ good.
Beneficience is a form of utilitarian good.
Paternalistic model
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.
Informative model
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.
Interpretive model
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.
Deliberative model
. 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.
Instrumental model
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.
When the paternalistic model is justified
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.
“Preferred model” according to Emanuel and Emanuel
Deliberative
Two meanings of “informed consent.”
- An informed consent is an individual’s autonomous authorization of a medical intervention or of participation in research
- 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
“elements” of informed consent
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
One gives an informed consent to an intervention if (and perhaps only if) one is . . .
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.
7 Element Model
Legally, sometimes ___ is the only required element of informed consent. This does not mean it should be the ideal.
Legally, sometimes disclosure is the only required element of informed consent. This does not mean it should be the ideal.
Information that physicians are required to disclose
(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
California Supreme Court decision on informed consent
“a physician must disclose personal interests unrelated to the patient’s health, whether research or economic, that may affect the physician’s professional judgment.”
The professional practice standard of disclosure
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
The reasonable person standard of disclosure
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.
The subjective standard of disclosure
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
The therapeutic privilege.
Legal exceptions to the rule of infonned consent allow the health professional to proceed without consent in cases of emergency, incompetency, and waiver
Therapeutic use of placebos
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
Many patients do not recall that they have the right to ___ a clinical trial.
Many patients do not recall that they have the right to withdraw from a clinical trial.
Information ___ has huge implications for autonomous choice.
Information framing has huge implications for autonomous choice.
A ___ can invalidate a patient’s or subject’s consent even in the presence of suitable disclosure and comprehension
A false belief can invalidate a patient’s or subject’s consent even in the presence of suitable disclosure and comprehension
If ___ prevents an informed choice, it may be permissible or possibly even obligatory to promote autonomy by attempting to impose unwelcome information
If ignorance prevents an informed choice, it may be permissible or possibly even obligatory to promote autonomy by attempting to impose unwelcome information
Voluntariness
A person acts voluntarily to the degree that he or she wills the action without being under the control of another’s influence
Forms of Influence
Coercion
Persuasion
Manipulation
Coercion
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
Persuasion
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.
Manipulation
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
