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Informed Consent

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Patient Bill of Rights
◦ Section B #9- A patient shall receive information
necessary to give informed consent prior to the
start of any nonemergency procedure or treatment
or both the reasons for it, the reasonably
foreseeable risks and benefits involved and the
alternative for care or treatment if any as a
reasonable practitioner under similar circumstance
would disclose. Documented evidence of such
informed consent shall be included in the patients
medical record.

It is the policy of Strong Memorial Hospital that each
patient or the patient’s authorized representative will
be provided with the information they need to enable
them to make informed treatment decisions.
Informed consent may be verbal or in writing, but it
must be documented in writing prior to performance
of all invasive medical and surgical procedures,
transfusion of blood or cellular elements of blood,
and/or use of tissue in a procedure, except in cases
of emergency when informed consent cannot be
reasonably obtained. The discussion with the patient
or the patient’s authorized representative, and their
consent to the treatment or procedure, must be
documented in the patient’s medical record.


Was first referenced in World War II medical
experimentation
Introduced into American law in the 1950’s
◦ Case: Salgo V Leland Stanford Jr. Univ. Bd. of Trustees,
317 P.2d 170, 181(Cal. Dist. Ct App 1957)

Emerged from the legal idea that physicians were
from now on obligated to share decision making
authority with their patient, which was contrary to
pre-existing medical practices.

Webster Dictionary-
◦ Consent to surgery by a patient or to participation
in a medical experiment by a subject after achieving
an understanding of what is involved (No where
does it mention the practice of anesthesia or any
other non-surgical interventions)

American Medical Association:
◦ It is a process of communication between a patient
and physician that results in the patient's
authorization or agreement to undergo a specific
medical intervention

Allow for a patient to participate in his/her
own health care decisions

Involves ethical obligations

Implies legal ramifications


Having or showing knowledge of a particular
subject or situation.
A decision or judgment based on an
understanding of the facts of the situation.

Open communication between patient and
physician
◦ Specifically relating to medical diagnosis,
interventions, alternatives to intervention, and risks
of intervention

Explanation of risks and benefits
◦ Of both undergoing and not undergoing the
procedure


Opportunity for questions
Judgment regarding comprehension


Anxious adult female, presents for
lumpectomy after recently being diagnosed
with breast cancer. As you begin your
discussion of the anesthetic plan she begins
to cry and says, “ Doc, You telling me the
risks is going to make me feel worse. Please
can we skip this conversation and go to the
OR. I will be fine.”
Is this patient informed and does it matter?

Reasonable physician standard:
◦ What would a typical physician say about this
intervention?

Reasonable patient standard:
◦ What would the average patient need to know in
order to be an informed participant in the decision?

Subjective standard:
◦ What would this patient need to know and
understand in order to make an informed decision?


To give assent or approval
Permission for something to happen or
agreement to do something

Competency to make decision for ones self

Voluntariness, free of coercion

Freedom to decline

? Documentation
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Can be signed theoretically by any physician, who
partakes in that patient care.
◦ Resident or Attending from other consulting services can
sign it

In terms of anesthesia, there are only a couple of
sentences, informing the patient about there
anesthesia risk
◦ “I consent to the administration of local, regional or
general anesthesia and/or sedation as deemed most
appropriate for the procedure to be performed.( The list
of possible anesthesia providers all of whom are
credentialed to provide anesthesia at this hospital)”

The UMRC Anesthesiology Informed Consent
includes:
◦ Section for Risks from Anesthesia (You should
check only the ones you actually talk about)
◦ Section for who the Anesthetic Plan and Risk
discussion was with (ex: patient, spouse, father,
mother, etc.)
◦ Section for who the Blood Products discussed was
with
◦ Section for what medical provider your plan was
discussed with( ex CRNA, Fellow, Surgeon,
Anesthesiology Attending etc.)
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It does not require a patient signature.
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Practice a script
◦ Try to have a frame work of what you want to say to
the patient prior to your conversation

Don’t make it to scripted
◦ Try to not let the patient become a “drop down
menu”, if you can document something specific to
that patient in your consent form: (Ex I spoke to
Mrs. X and her sister who is visiting from Y)
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Document Document Document!!

Please refer back the Salgo V Leland Stanford
Jr. Univ. Bd. of Trustees, 317 P.2d 170,
181(Cal. Dist. Ct App 1957)
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Would you consider the patient informed?
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Do believe he gave proper consent?
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