HEALTH LAW AND BIOETHICS
Professor Helena Pereira de Melo
Informed consent and patient
autonomy
2nd CYCLE – YEAR 2013/2014
ALEXANDRA PATKOVÁ - 003889
Lisbon, 23th April 2014
Content
• 1. What is Patient Autonomy
• 2. What is informed consent
• 3. Components of Informed Consent
• 2.1 Decision making capacity
• 2.2 Disclosure
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4. Documentation of Consent
5. The right to refuse treatment
6. Clinical Trials and Research
7. Children and Consent
8. Problems with Informed Consent
9. Is the right to consent absolute right?
10. Model Case
1.What is
Patient
Autonomy?
• Medical ethics
- a system of moral principles
that apply values and judgments
to the practice of medicine (4 principles: autonomy,beneficence, nonmaleficence,justice)
• Principle of Respect for Autonomy
– autonomy - the capacity for self-determination person’s right to make choices on own values
– person should be free from coercion in
deciding to act + others are obligated to protect
confidentiality, respect privacy, and tell the truth.
• Patient Autonomy
– the right of patients to make decisions about
their medical care without their health care
provider trying to influence the decision.
– does not allow the health care provider to
make the decision for the patient.
– refers to the capability and right of patients
to control the course of their own medical
treatment + participate in the treatment
decision-making process.
– In health care - exercised through the process
of obtaining Informed Consent
• Autonomy - the patient has the right to refuse or
choose their treatment
• Justice - fairness and
equality
• Beneficence - taking actions
that serve the best interests
of patients
• Non-maleficence - "first, do no harm„ ; not absolute,
and balances against the principle of beneficence as
the effects of the two principles together often give
rise to a double effect (the use of morphine in the
dying patient – 1.beneficial effect of easing the pain –
2.maleficent effect of shortening the life)
Conflicts between autonomy and
beneficence/non-maleficence
• When the patient's interests conflict with the
patient's welfare. (western medicine - patient make
his own decisions/many other societies - prioritize
beneficence over autonomy)
• when a patient does not want a treatment because
of, for example, religious or cultural views.
• The role of surrogate medical decision makers is an
extension of the principle of autonomy.
• autonomy and beneficence/non-maleficence may
also overlap
2. What is informed consent
• Information about a particular treatment or test - to decide
whether or not you wish to undergo such treatment or test.
• Part of Universal Declaration of HR, The European Charter of
HR
• Truthfulness and honesty
• Process of understanding the risks and benefits.
• Explicit (written) consent-for more invasive tests with
significant risks or alternatives
• Exceptions:
– an emergency
– incompetence
3. Components of Informed Consent
• 4 components:
A- the capacity (or ability) to make the decision
B- disclosure of information on the by medical provide
with the expected benefits and risks
C- comprehension
D- voluntarily grant consent (no coercion/duress)
3.1 Decision making capacity
• referred to the legal term competency (=legal term used
to indicate that a person has the ability to make and be
held responsible for decisions. Person can only be declared
"incompetent" by a court of law)
• The components:
– The ability to understand the options
– The ability to understand the consequences of the options
– The ability to evaluate the personal cost and benefit of each
of the consequences
• not able to do all of the components – e.g family members
= "surrogate decision-makers„
• simply means: that you can understand + explain the
options + their implications + give a rational reason why
3.2 Disclosure
• Before giving your informed consent - health care provider
must give (disclose) to you enough information
• Not every detail - only the information that would be
expected by a reasonable person to make an intelligent
decision.
• Include the risks and probability of the risks, and the
benefits
• Questions - explained in language you understand
4. Documentation of Content
• many tests and procedures (routine blood tests) - implied
consent - no written documentation
• many invasive tests with significant risk - a written
consent
• Components in the written consent:
– An explanation of the medical condition
– An explanation of the purpose and benefits
– An explanation of the proposed test/procedure/treatment +
possible complications
– A description of alternative treatments + relative benefits
and risks
– A discussion of the consequences of not accepting
• consent form - signed and dated both by the doctor and
by patient
5. The right to refuse treatment
• patients (legally competent to make medical decisions) have the legal and moral right to refuse treatment.
• „Against Medical Advice“ (AMA) form - a provement with
the option of obtaining a recommended treatment or test
- to protect the health care provider from legal liability
for not providing treatment.
• If a health care provider decides that a patient does not
have decision-making capacity - the patient may not be
able to refuse treatment.
• Advance directives and living wills = documents that you
can complete before an emergency occurs - prevent
patient from having decision-making capacity
6. Clinical Trials and Research
• Clinical research trials = important part of health care
research
• Clinical studies = determine whether new drugs are more
effective
• Enrolment in a clinical study - opportunity to receive a new
drug or treatment before it is widely available.
– Informed consent - needed before you may be enrolled in clinical
research trials (the purpose - to allow you to learn enough about the
study to decide whether or not to participate)
– Informed consent for a research study (clinical trial) should
include:
• Why the research is being done, What the researchers hope to
accomplish, A description of what will be done during the study,
The risks, The benefits, Verification that you have the right to
leave the study at any time, ...
– Informed consent document must be signed before enrollment in a
study.
7. Children and Consent
• little direct application on children.
• Minors - do not have legal empowerment to give informed
consent – parents/other surrogate decision-makers give
informed permission (parents are assumed to act in the
best interest of their child)
- But - a conflict between what the parents and the health
care providers feel is in the best interest.
- Other disagreements in care - court orders- specify what
treatment should occur
• Most states - have laws - certain minors are emancipated
and entitled to the full rights, including in these
situations:
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–
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–
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Self-supporting and/or not living at home
Married
Pregnant or a parent
In the military
Declared emancipated by a court
8. Problems with Informed Consent
• An uninformed person is at risk of mistakenly making a
choice not reflective of his or her values or wishes
• A medical intervention without valid informed consent is a
criminal offence
• To ensure effective communication between the
researchers and the participants is necessary to cut:
1. Language barriers
2. Religious influences
3. False expactations
•
Possible improvements: demographic analysis,
professional translators, increasing explanation time,
testing for misunderstandings
9. Is the right to consent
absolute right?
• Philosopical+Ethical+Legal+Practical
consideration
• There are several restrictions – it
means that cannot be absolute
– e.g. in the UK – restrictions on minors,
patients with incapacity, patients suffering
from severe mental illness
10. Model Case
• Question 1:
A 64-year-old woman with Multiple Sclerosis is
hospitalized. The team feels she may need to be
placed on a feeding tube soon to assure adequate
nutrition. They ask the patient about this in the
morning and she agrees. However, in the evening
(before the tube has been placed), the patient
becomes disoriented and seems confused about her
decision to have the feeding tube placed. She tells
the team she doesn't want it in. They revisit the
question in the morning, when the patient is again
lucid. Unable to recall her state of mind from the
previous evening, the patient again agrees to the
procedure.
• Is this patient competent to decide? Which
preference should be honored?
• Answer 1:
This patient's underlying disease is
impairing her decision-making capacity. If
her wishes are consistent during her lucid
periods, this choice may be considered her
real preference and followed accordingly.
However, as her decision-making capacity
is questionable, getting a surrogate
decision maker involved can help determine
what her real wishes are.
• Question 2:
A 55-year-old man has a 3-month history of
chest pain and fainting spells. You feel his
symptoms merit cardiac catheterization. You
explain the risks and potential benefits to him,
and include your assessment of his likely
prognosis without the intervention. He is able
to demonstrate that he understands all of this,
but refuses the intervention.
• Can he do that, legally? Should you leave it at
that?
• Answer 2:
This patient understands what is at stake
with his treatment refusal. As he is
competent to make this decision, you have
a duty to respect his choice. However, you
should also be sure to explore his reasons
for refusing treatment and continue to
discuss your recommendations. A
treatment refusal should be honored, but
it should also not be treated as the end of
a discussion.
Thank you for your
attention