Transcript Informed Consent

Elements of Informed
Consent
Vaughn lists 5 requirements for informed consent:
1. Competence
2. Adequate Disclosure
3. Adequate Understanding
4. Voluntary Decision
5. Consent
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: 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: 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
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
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 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
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
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
Information in Informed Consent (Garrett’s wording):
4 competing rules to guide information sharing
1. Patient preference rule
2. Professional custom rule
3. Prudent person rule
4. Subjective substantial disclosure rule
2 and 3: Disclosure and
Understanding
1.
Patient preference rule = Tell the patient whatever
the patient wants to know
Garrett dislikes this rule because it:
a) Invites wasting time answering too many
questions from certain patients
b) 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
Understanding
2. 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:
a) What is customary might be bad
b) 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
Understanding
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
Garrett likes this approach, combined with the
following …
2 and 3: Disclosure and
Understanding
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.
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
Understanding
Vaughn prefers to list some general guidelines of
what information is required for informed
consent:
1. The nature of the procedure
2. The risks of the procedure
3. The alternatives to the procedure
4. The expected benefits of the procedure
See Vaughn, p.146
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
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
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
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 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 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 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 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 …
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 NonEmergencies
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
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
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 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
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
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
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