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.
Vaughn, Chapter 5
Vaughn lists 5 requirements for informed consent:
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
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.
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.
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
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 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
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
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.
Information in Informed Consent (Garrett’s wording):
4 competing rules to guide information sharing
Garrett dislikes this rule because it:
An exception is acknowledged in cases where patient’s are well known by their doctors, and can consent based on their mutual understanding
Garrett dislikes this rule:
Garrett likes this approach, combined with the following …
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.
Vaughn prefers to list some general guidelines of what information is required for informed consent:
See Vaughn, p.146
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
Consider the “In Depth” box at the top of page 147 in Vaughn.
Which of the two conceptions of informed consent
do you find most reasonable? Why?
The following considerations are take from Garrett’s book.
The considerations help give substance to the consideration of principles on the previous slides…
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.
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?
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:
Informed consent requires many things from
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:
Note that who at hospitals is specifically obliged is left open
Emergencies introduce exceptions to informed consent requirements.
The authors commend following these criteria:
The book amends their endorsement of the first criterion by requiring the patient’s wishes be unknown …
The authors give 2 reasons for their support of “advanced directives” (knowing the patient’s wishes):
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
The book recommends help from courts in the absence of patient competency, proper surrogates, or clear legislative direction, under these conditions:
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
The book mentions 3 main concerns:
The American Hospital Association’s Bill of Patient Rights includes this:
Note: The legal right to refuse treatment does not imply an ethical right to refuse
Note that autonomy is a difficult value to gauge at psychiatric facilities and nursing homes.
Nursing homes will have special obligations of