3. Consent
• Voluntary agreement by a person who possesses
sufficient mental capacity to make an intelligent choice
to allow something proposed by another to be performed
on himself or herself.
– Express consent can take the form of
• verbal agreement
• written document authorizing medical care.
– Implied consent is determined by some act or
silence, which raises a presumption consent has been
authorized (e.g., patient in accident & in comatose
state).
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4. Informed Consent
• Legal doctrine where a patient has right to know
potential risks, benefits, & alternatives of a proposed
procedure.
• Patient has absolute right to know about & select
from available treatment options.
• Informed consent is predicated on the duty of the
physician to disclose sufficient info to enable the
patient to evaluate proposed medical or surgical
procedures before submitting to them.
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5. Assessing Decision-Making Capacity
• Includes patient's ability to:
– understand risks, benefits, & alternatives of a
proposed test or procedure
– evaluate info provided by the physician
– express his or her treatment preferences
– voluntarily make decisions regarding his or her
treatment plan
• without undue influence by family, friends, or
medical personnel
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6. Nurses & Informed Consent
A nurse generally has no duty to
– advise a patient as to a surgical procedure to be employed
• however, may confirm with patient that the physician
has explained the procedure
– advise patient as to the risks, benefits, & alternatives to a
recommended procedure
• this is the physician’s responsibility
– obtain a patient's informed consent
• P & P may provide that the nurse may witness that the
risks, benefits & alternatives have been explained.
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7. Physicians & Informed Consent - I
Physicians are expected disclose to their patients
the risks, benefits, & alternatives of
recommended procedures.
– Disclosure should include what a reasonable
person would consider material to his or her
decision of whether to or not to undergo treatment.
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8. Physicians & Informed Consent - II
• Physicians must disclose alternatives
• Physicians duty to advise: delicate medical
judgment
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9. Course of Treatment
Patient’s Decision
• Elderly woman living alone fell & fractured her hip.
An orthopedic surgeon reviewed the patient's
condition & decided that rather than utilizing a
pinning procedure for her hip =, it would be better to
adopt a conservative course of treatment, bed rest.
• Prior to her injury, plaintiff maintained an
independent style of living.
• Expert testimony at trial indicated that bed rest was
an inappropriate treatment.
– Was the patient successful for not being informed
as to alternatives courses of treatment?
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10. Yes!
Court’s Decision
• Court held that it is necessary to advise a patient
when considering alternative courses of treatment.
The physician should have explained medically
reasonable invasive & noninvasive
alternatives, including risks & likely outcomes of
those alternatives, even when the chosen course is
noninvasive.
– See text case: Matthies v. Mastromonaco
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11. Lack of Consent
Patient had multiple medical diagnoses. Her physician, Dr.
Sottiurai, ordered bilateral arteriograms to determine cause
of the patient's impaired circulation. De La Ronde Hospital
could not accommodate Sottiurai's request & patient was
transferred to Dr. Lang, a radiologist at St. Jude Hospital.
Lang performed a femoral arteriogram, not the bilateral
brachial arteriogram ordered by Sottiurai. The patient was
prepared for transfer back to De La Ronde Hospital. Shortly
after the ambulance departed, patient suffered a seizure in
the ambulance & was returned to St. Jude. Riser's condition
deteriorated & died 11 days later. Plaintiffs claimed Riser
was a poor risk for the procedure.
– What did the trial court determine?
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12. Trial Court Decision
– The district court ruled for the plaintiffs, awarding
damages in the amount of $50,000 for Riser's pain
and suffering and $100,000 to each child. Lang
appealed.
– On appeal, what did the appeals court determine?
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13. Appeals Court’s Decision
• The Court of Appeal held that Lang breached
the standard of care by subjecting the patient to
a procedure that would have no practical
benefit to the patient, that Lang failed to obtain
informed consent from the patient.
– See text case: Riser v. American Medican
Intern, Inc.
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14. Information to be Disclosed – I
• A physician should provide as much information
about treatment options as is necessary based on a
patient's personal understanding of the physician's
explanation of the risks of treatment & the probable
consequences of treatment. Needs of each patient can
vary depending on age, maturity, & mental status.
• Individual responsible for obtaining consent must
weigh importance of giving full disclosure to the
patient against likelihood such disclosure will
adversely affect the patient’s decision.
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15. Information to be Disclosed – II
• Courts generally utilize an "objective" or
"subjective" test to determine whether a patient
would have refused treatment if the physician
had provided adequate information as to the
risks, benefits, & alternatives of the procedure.
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17. Objective test
• Must show that a “reasonable person” would
not have undergone a procedure if properly
informed.
• Objective Test Preferred
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18. Consent Topics
• Hospitals and Informed Consent
– specific cases in which hospitals have a duty to
provide patients with informed consent.
• Adequacy of Consent
• Verbal Consent
– Verbal Consent to Surgery Sufficient
• Written Consent
• Consent for Routine Procedures
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19. Special Forms of Consent
• Consent for Specific Procedures
– durgery
– diagnostic tests
• Temporary Consent
– summer camp
• Implied Consent
– car accident, patient unconscious
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20. Limited Power of Attorney
Authorizes, for example, school officials,
teachers, and camp counselors to act on the
parents or legal guardians behalf when seeking
emergency care
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21. Implied Consent - I
• Presumed when immediate action is required
to prevent death or permanent injury
• Unconscious patients are presumed under the
law to approve treatment that appears
necessary
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22. Implied Consent -II
• Consent generally assumed
– Ambulance Care
• Good Samaritan Statutes
– Emergency Departments
• When patient clinically unable to give consent
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23. Statutory Consent
• Legislation adopted by states concerning
emergency care
• Emergency care in most states eliminates the need
for consent
• Occurs when a patient is clinically unable to give
consent
• Assumes that a reasonable person would consent
to life-saving medical intervention
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24. JUDICIAL CONSENT
• May be periodically necessary
• When alternatives exhausted
• 2nd opinions by consulting physicians helpful
• On-call legal advice should be sought
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25. Who May Consent
• Competent patients
• Guardianship
• Consent for minors
• Emancipated minors
• The right to choose
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26. Incompetent Patient
• Ability to consent is a question of fact
• Physicians on the best position to make that
determination
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27. Right to Refuse Treatment
• Patients have a right to refuse treatment
– Must be conscious and mentally competent
• Hospitals must honor a patient’s decisions when
treatment is refused
• Religious Beliefs
• Blood or blood products
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28. Release form
Patient's refusal to consent to treatment, for any
reason, religious or otherwise, should be noted
in the medical record, and a release form
should be executed. Completed release
provides documented evidence of a patient's
refusal to consent to a recommended
treatment.
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29. Exculpatory Agreements
• An agreement that relieves an individual from
liability when he or she has acted in good faith.
• Exculpatory agreements generally invalid in
health care setting.
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30. Proving Lack of Consent
1. Reasonably prudent person in the patient’s
position would not have undergone the treatment
if fully informed
2. Lack of informed consent is the proximate
cause of the injury for which recovery is sought
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31. Informed Consent
Claims and Defenses
• Risk not disclosed is commonly known
• Patient assured practitioner that he or she would
undergo treatment regardless of the risk
– e.g., Patient did not want to know about the risks
• Consent was not reasonably possible.
• Practitioner reasonably believed the manner & extent
of disclosure could reasonably be expected to
adversely & substantially affect patient's condition.
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32. Informed Consent and
Disclosure of Risks
• Requires physicians to disclose the risk
benefits and alternatives of a procedure
• Not merely a tool to avoid lawsuits
• The doctrine of informed consent is firmly
rooted in the notions of liberty and individual
autonomy
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33. REVIEW QUESTIONS
1. Who should be responsible for reviewing with the
patient the risks, benefits, and alternatives of a
proposed diagnostic test or treatment?
2. Describe what information a patient should be
provided prior to undergoing a risky procedure in
order for consent to be informed.
3. Why is it important to obtain consent from a patient
prior to proceeding with a risky procedure?
4. Can a patient consent to a procedure and then
withdraw it?
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34. REVIEW QUESTIONS, con’t
5. Can a parent refuse to consent to a lifesaving
procedure for his or her child? Discuss your answer.
6. Discuss how much information is sufficient in order
for informed consent to be effective (e.g., consider
your answer here from both the objective and
subjective forms of consent).
7. Discuss the implications of the following statement:
"Patients are generally persons unlearned in the
medical sciences and, therefore, except in rare
instances, the knowledge of patient and physician is
not in parity."
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