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INFORMED CONSENT questions
1. What is informed consent?
2. Who may sign /give informed consent?
NURS 110
DR CADAVID
INFORMED CONSENT questions
3. Which 4 client’s cannot provide informed consent?
4. What is the rationale for nurses engaging in informed
consent?
5. What is the nurse’s role in informed consent?
NURS 110
DR CADAVID
INFORMED CONSENT questions
6. What is the ethical significance of informed consent?
7. What is the distinction between informed consent
form and informed consent process?
NURS 110
DR CADAVID
INFORMED CONSENT questions
8. May a patient refuse to consent? Why or why not?
NURS 110
DR CADAVID
JONA’S Healthcare Law, Ethics, and Regulation / Volume 15, Number 4 / Copyright B 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins
Informed Consent
Essential Legal and Ethical Principles for Nurses
Juliet Battard Menendez, RN, MSHL, CPHRM
A B S T R A C T
Before surgery, the informed consent process is the practical application of shared decision making
between a surgeon and a patient. However, nurses, as enlightened patient advocates, also have an
entrusted interest in fully understanding the legal and ethical considerations of the informed
consent process. Some of the ethical principles impacting informed consent are existing cornerstones
of professional nursing practice. Nevertheless, surgeons bear the ultimate responsibility for the
informed consent process before surgery. The ideal completion of the informed consent process may
be achieved if surgeons and knowledgeable nurses collaborate for the patient’s good.
…………………………………………………………………………………………………………………………………………….
S
hared decision making is at
ciples of the informed consent
natives of a proposed treatment or
the foundation of a mutu-
process, autonomy, and disclo-
surgery. Therefore, the informed
ally respectful relationship
sure may come naturally to many
consent process is the (a) legal, (b)
between a health care provider
nurses and physicians. Neverthe-
ethical, and (c) moral responsibil-
and a patient. Before surgery, the
less, the actual practical application
ity of the physician.4 Nevertheless,
informed consent process serves
of these principles and implemen-
as enlightened patient advocates,
as the practical application of mu-
tation of the informed consent
hospital nurses also have an en-
tual participation and respect for
requirements are troubled with
trusted interest in fully under-
3
the patient’s autonomy. In addi-
difficulties and obstacles.
tion, the patient’s legal right to
his/her medical care is supported
Rationale for Nurses’
Engagement in Informed
Consent
by oversight regulations such as
Ultimately, physicians are respon-
the Patient Rights Condition of
sible for informing patients of the
participate in decisions about
2
Participation. The underlying prin140
(a) risks, (b) benefits, and (c) alter-
standing the legal guidelines and
…………………………………….
1
Author Affiliation: St. Lucie Medical Center,
Port St. Lucie, Florida.
The author has disclosed that she has no
significant relationships with, or financial
interest in any commercial companies
pertaining to this article.
Correspondence: Juliet Battard Menendez,
RN, MSHL, CPHRM, St. Lucie Medical Center,
1800 SE Tiffany Ave, Port St. Lucie, FL 34952
(Juliet.BattardMenendez@hcahealthcare.com).
DOI: 10.1097/NHL.0000000000000015
JONA’S Healthcare Law, Ethics, and Regulation / Volume 15, Number 4 / OctoberYDecember 2013
Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
ethical considerations of the informed consent process. With
this understanding, educated nurses possess a unique
opportunity to facilitate patient autonomy, especially in
the presence of special circumstances, such as (a) patients who refuse surgery, (b) patients with limited mental
capacity, and (c) patients with surrogate decision makers.5
Therefore, the topic of informed consent, especially when
the process involves health care surrogates, is worthy of
study for nurses.
In shared medical decision making, the physician conveys
the required information and the patient shares with the
physician all relevant personal information that might
influence the decision to consent.6 The content of the information disclosed during the informed consent process
is impacted by whether the procedure is emergent or elective and the patient’s ability to comprehend complicated
facts.1
DELIVERY METHODS
………………………………………………………………….
Review of Literature
History
Historically, the requirement that physicians involve patients in decisions has evolved from simple consent to
informed consent.5 Although the evidence of this evolution has been presented in legal cases, the basis for the shift
from simple to informed consent is actually based on longstanding ethical, not legal, principles. The historical requirement that a patient agrees to be treated, simple consent, was
based on the prevailing ethical obligation for physicians
to act with beneficence toward their patients. The current
requirement that a patient is informed of the (a) risks, (b)
benefits, and (c) alternatives to the proposed treatment is
based on the increasingly valued principle of patient autonomy.6 The paternalistic relationship between surgeons and
patients has been ethically and legally replaced by the
evolved concept of informed consent.5 Full disclosure of
information and true informed consent are actually relatively new concepts for physicians. Only in recent years
have physicians widely adopted the ethical principle of
autonomy as a basis for patient-physician discussion.3
Although nurses have never been assigned direct legal
responsible for disclosing the information necessary to
enable a patient to evaluate a proposed invasive procedure, they have been historically challenged with facilitating the documentation of the process.2 An evolving
comprehensive understanding of the informed consent
process may empower these nurses to advocate for patients and surrogates by distinguishing between a signature on an informed consent form and the important
ethical element of informed consent.5
Principles of Informed Consent
SCOPE
To meet the accepted definition of informed consent, the
patient needs to willingly accept medical intervention
after adequate disclosure of (a) the nature of the intervention, (b) its risks and benefits, and (c) its alternatives
with their risks and benefits.1 In addition, the informed
consent process represents an opportunity to move beyond physician disclosure of information to shared medical decision making between the patient and the physician.
The method of providing for informed consent for surgery
may vary among different surgeons and even among different patients of the same surgeon.7 Traditionally, the process includes an oral discussion between the surgeon and
the patient, followed by the patient signing a document
affirming his/her consent. The use of oral communication
and written documents remains common. Videos and computer software are also used to disclose important information needed to obtain a valid informed consent. Any
delivery method may be used as long as it necessitates
providing patients with the (a) indications, (b) risks, (c)
benefits, and (d) alternatives about a planned surgery.7
ETHICAL CONSIDERATIONS
The ethical significance of informed consent is based on
the opportunity that the process presents for the patient
to exert autonomy. For moral philosophers, the principle
of autonomy represents the moral right to choose and
follow one’s own plan for life and action.1 Informed consent represents a challenging dilemma for surgeons.6 To
establish effective informed consent, surgeons must balance their obligation to protect the patient’s health through
beneficence and their obligation to respect the patient’s
autonomy. The ethical principle of self-determination is a
subset of autonomy commonly associated with informed
consent. Through self-determination, a decision to consent to surgery would originate freely from an autonomous patient, who understands the facts and can engage in
practical reasoning to make that decision.6
Additional ethical tension may arise between respect
for patient autonomy and the practice of paternalism in
health care. When surgeons or nurses practice paternalism during the informed consent process, they override
or ignore patient preferences in an attempt to benefit or
enhance the patient’s welfare. Ethically, paternalism represents the health care provider’s belief that beneficence
is more important than autonomy.1 One manifestation of
paternalism may be underestimating the extent of a surgeon’s influence over the patient’s independent decision.
Although the surgeon’s recommendations have a proper
role in the informed consent process, surgeons and nurses
may alter the patient’s objective frame of reference by excessively emphasizing either the benefits or risks of a
surgery. Health care providers may also exhibit paternalism by exaggerating the gravity of a patient’s situation
or substituting descriptive terms for quantitative terms
during the informed consent process.5
JONA’S Healthcare Law, Ethics, and Regulation / Volume 15, Number 4 / OctoberYDecember 2013
141
Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Essential Concepts for Nurses
NURSE’S ROLE IN INFORMED CONSENT
Nurses may strive to ensure patient autonomy and rights
through appropriate participation in the informed consent
process. Nevertheless, compliance with legal and regulatory requirements as well as ethical and patient family
concerns can make the concept of informed consent baffling and challenging. Furthermore, confusion exists concerning the important distinction between a signature on
the surgical consent/authorization form and the patient’s
informed consent. The misconception that informed consent is the same as a signature on a consent form can be
problematic for nurses who are frequently charged with
facilitating the legal documentation form.5 As patient advocates and direct care providers, nurses have a unique
opportunity to meaningfully advocate for mutual decision
making, a process that promotes (a) patient autonomy, (b)
comprehension, and (c) self-determination.6 Empowered
by a comprehensive understanding of the informed consent process, nurses can serve in that advocacy role without running the risk of practicing outside their professional
scope by assuming the responsibly for ‘‘consenting’’ the
patient.
PATIENT EDUCATION
Consent forms are potential meaningful education tools
that nurses may use as springboards into important discussions about what to expect before and after surgery.8
Health care professionals may, within the scope of the informed consent process, move beyond simply informing
a patient of risks to actually educating a patient. Approaching the informed consent process for surgery using
an educational model may result in liability reduction by
serving to develop an alliance between the patient and the
surgeon.8 Using this educational approach, the informed
consent form evolves from a waiver of liability to an educational tool. In the end, the consent form, frequently
completed by nurses, is essentially evidence that the appropriate discussion between the surgeon and patient occurred; it is not a substitute for that important discussion
and patient education.8
PATIENT COMPREHENSION
Comprehension of the information provided is a precondition for obtaining a valid informed consent.3 Ideally, a
patient would demonstrate full comprehension, but the
practical application of that ideal can be problematic in
implementation. Even highly intelligent patients have difficulty in fully comprehending complicated information
and potential hazardous outcomes.3 Important factors such
as (a) the disease itself, (b) anxiety, (c) pain, and (d) various
therapeutic interventions can hinder a patient’s ability to
participate in shared decision making. To maximize comprehension, information should be carefully provided in
a manner that increases patient understanding of what is
being explained.3
142
In the context of elective surgery, the surgeon is responsible for ensuring patient comprehension to the extent
possible. Nurses could contribute toward maximizing comprehension by using a repeat-back process on comprehension after informed consent discussions.9 Nurses may be
more familiar with and skilled in the repeat-back method,
which could be used by asking patients to recount what
they had learned in the informed consent discussion. The
repeat-back methodology has been shown to have an effect on patient comprehension of information disclosed during informed consent for surgery.9
EFFECT ON PATIENT ANXIETY
Surgeons may occasionally circumvent satisfactory consent negotiations because they do not want to alarm the
patient or increase the patient’s anxiety. Therefore, in an
attempt to avoid undesirable patient anxiety, a surgeon
may fail to completely disclose adequate information needed
for shared decision making.1 A surgeon may be concerned
that providing comprehensive information about all of the
risks of a planned surgery may have an adverse effect on
patient anxiety.7 In addition, patients overcome by anxiety
have limited ability to comprehend information provided.1
The nurse-to-patient relationship facilitates nurses’ ability to identify and address patient anxiety that may both
impact comprehension and be influenced by disclosure
of information during informed consent. The format in
which the informed consent is provided (oral, written, or
video) has no significant effect on patient anxiety.7 Therefore, nurses could skillfully recommend a preferred format
identified through a patients’ individual learning methods
assessment.
DISTINCTION BETWEEN FORM AND PROCESS
The informed consent form may be regarded by some hospitals or surgeons as offering legal protection. This perception can overshadow the ethical goal of providing for
patient autonomy. Actually, the signing of the form itself
may be more of a formality than the actual conclusion of
a mutual decision-making process.1 The distinction between the form and the process can be best conceptualized
if surgeons and nurses recognize that informed consent is
a continuing process, not a static event. Therefore, it is not
simply the patient’s signature on a form. The form is legal
documentation but does not equate to the ethical obligation of respect for patients’ rights.5 Frequently, patients
make decisions about elective surgery well before viewing
the form but after consulting with (a) family, (b) friends,
and (c) their health care providers. Therefore, the attention
given to the consent form signing may be misdirected.10
Surrogate Decision Making
DECISIONAL CAPACITY
For informed consent to be valid, the patient must have
capacity to process information received and communicate a meaningful response. This determination of capacity
JONA’S Healthcare Law, Ethics, and Regulation / Volume 15, Number 4 / OctoberYDecember 2013
Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
is different from determination of competence, which is a
legal matter.4 Decisional capacity or incapacity is a clinical
situation and must be established as part of the informed
consent process. For patients who lack decisional capacity,
such as the unconscious or extremely disoriented and delusional, a surrogate decision maker assumes authority to
provide informed consent for treatment.1
SURROGATES AND PROXIES
State statutes frequently provide guidance for hospital
policies and procedures delineating who can provide informed consent for treatment for a patient when the patient lacks capacity. For example, according to the Florida
Health Care Advance Directive Statute, a health care surrogate is an adult expressly designated by a patient to
make health care decisions on behalf of the patient in the
event the patient’s incapacity.11 The statute also provides
guidance on documentation of the selection of a health
care surrogate. The designation of a health care surrogate
does not expire and remains in effect until revoked by
the patient. In addition, state statutes such as the Florida
Health Care Surrogate Act may provide guidance on the
extent of authority entrusted to surrogates. The surrogate
has the legal authority to make all health care decisions for
the patient during the patient’s incapacity.12 The surrogate
has the responsibility to provide informed consent, which
he/she believes the patient would have made under the
circumstances.
In the event a patient lacks capacity but has not designated a health care surrogate, the Florida Advance
Directives Statute provides for the designation of a proxy
to make health care decisions for that patient.11 The statute
provides a list of individuals, in order of priority, who are
to be designated to provide informed consent on the patient’s behalf. If no individual at the top of the list, such as
a judicially appointed guardian or patient’s spouse, is reasonably (a) available, (b) willing, or (c) competent to act,
then the designation goes to a subsequent individual on
the list, such as an adult child or parent of the patient. Like
the health care surrogate, the proxy has the responsibility to provide informed consent based on the decision the
proxy reasonably believes the patient would have made
under the circumstances.11
Both proxies and predetermined health care surrogates
have an obligation to exercise substituted judgment.1 Therefore, when the incapacitated patient’s preferences are known,
for example, expressed by the patient before incapacity,
the surrogate must use that knowledge in making medical
decisions. This principle of substituted judgment is applicable whether the patient expressed those preferences
in writing or verbally.1
Refusal of Consent
A competent patient’s right to refuse a recommended treatment is an important principle in the informed consent process. Respect for patient autonomy and self-determination
requires that decisions to consent to or refuse treatment
originate freely from the patient as an autonomous agent.6
Not only must consent be freely given, but it may also be
freely withdrawn at any time. With some exceptions, even
patients with mental illness are usually considered competent to refuse treatment at any point in the informed
consent process.4 The granting of autonomy to refuse consent to a recommended treatment requires health care providers to accept the free choice of each person even if that
choice seems inappropriate, foolish, or hazardous.3
Refusal of surgical intervention is possible after an appropriate informed consent discussion.5 It does not mean
the surgeon did not provide adequate information during
the process. The patient may find alternatives to surgery
equally attractive to having an operation. In addition, refusal to consent is not itself evidence of the patient’s incapacity to make health care decisions.5
………………………………………………………………….
Discussion, Conclusions, and
Implications
Discussion
The practice of informed consent is multifaceted and presents complex legal and ethical challenges. The informed
consent process has even been accused of being (a) culturally biased, (b) legalistic, (c) ritualistic, and (d) unevenly
enforced.10 Surgeons and nurses facilitating the informed
consent process could benefit from remembering that the
seemingly complex process is simply the practical application …
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