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7 Ethics and Informed Consent

Vijaya M. Vemulakonda, MD, JD

A
s clinical urologic practice continues to become more complex, Autonomy, described as respect for the “deliberated self-rule”
the ethical and legal implications of practice become more of individuals, includes an obligation to respect that patients are
profound. The purpose of this chapter is to provide a brief able to make their own choices even if the outcomes of those
history of the origins of medical ethics and legal principles of informed choices do not coincide with the physician’s calculation of maximal
consent, to define key ethical principles and their application to benefit and minimal harm (Gillon, 1994). This principle is grounded
clinical decision making, and to consider the ethical and legal in the Kantian “categorical imperative” that people be considered
requirements for informed consent in both the clinical and surgical ends in themselves rather than a means to an end. Although some
settings. have postulated that autonomy should be prioritized when in conflict
with other principles, it is also considered bound by justice or the
consideration of autonomy of others in addition to the individual
MEDICAL ETHICS patient (Gillon, 1994). Respect for autonomy provides the foundation
History of Medical Ethics for several physician obligations, including informed consent,
confidentiality, and avoidance of deceit. Importantly, communication
The origins of medical ethics are thought to be rooted in the writings is essential to providing the physician with the information about
of Hippocrates, considered to be the “father of medicine.” Fore- patient preferences and attitudes needed to guide discussions of
most among his contributions to medicine is the Hippocratic oath options and to frame medical decision making in a way that is
(Box 7.1), considered the cornerstone of ancient Greek medical ethics, respectful of the patient (Gillon, 1994).
which postulated that the primary goal of medicine is to protect Beneficence and nonmaleficence are grounded in the Hippocratic
the patient’s interests. The oath establishes the moral framework oath’s dictum to protect the patient’s best interests (Antoniou et al.,
governing the physician-patient relationship and introduces the 2010). Beneficence refers to the physician’s obligation to optimize
ethical principles of beneficence, nonmaleficence, confidentiality, benefit to the patient and should be considered through the prism
and accountability to the medical profession (Antoniou et al., 2010). of the patient’s values and preferences (autonomy). Nonmaleficence
However, in the 20th century, the traditional values embodied is grounded in the Hippocratic dictum primum non nocere (first
by the oath were challenged by prominent ethicists such as Robert do no harm) and refers to the obligation to avoid or minimize
Veatch. In this view, the oath relies on the physician to make judg- harm to the patient. These principles mean that (1) we must be
ments about diagnosis and treatment because of the patient’s inability able to provide the benefits we promise, through adequate training,
to understand the information needed for decision making. As a education, and professional standards and (2) we must be clear
result, the oath undermines the growing respect for patient autonomy about the probability and magnitude of risk and benefit associated
that emerged during the late 20th century (Veatch, 1991; Veatch, with treatment to ensure that we are able to optimize the patient’s
2009). Additionally, the oath has been criticized for not addressing understanding (Gillon, 1994). As a result, the complementary
issues surrounding justice in the allocation of medical resources, principles of beneficence and nonmaleficence can be seen as an
instead focusing on the individual outside of the social context of obligation not only to provide training to the individual clinician
his care (Veatch, 1991). but also to conduct research to ensure that the information we offer
As criticism of the Hippocratic oath grew, the interdisciplinary is as accurate as possible. Finally, the weighing of risks and benefits
field of bioethics emerged. During the 1960s, physicians first began should be considered both at the individual and at the population
to discuss the impact of technology, such as antibiotics and genetic level (justice) to ensure that risks and benefits are equally shared
testing, on medical care (Jonsen, 2001). In 1970 Van Rensselaer among patients.
Potter first coined the term bioethics to describe “the study of the Justice refers to the obligation to seek and achieve fairness in
moral relationship between humans and their social and physical the distribution of resources, benefits, and risks across patients.
world (Jonsen, 2001; Potter, 1970).” Concerns over the eugenic Although equality and justice share many traits, they are not equiva-
experiments of the Nazis during World War II strengthened the focus lent; “people may be treated unjustly even if they are treated equally”
on patient autonomy and patient rights to protect their medical and (Gillon, 1994). At the individual patient level, justice means that
genetic information (Jonsen, 2001). This focus on respect for patient the physician should try to minimize the effect of self-interest or
autonomy and informed consent was reinforced in the research personal preferences on patient decisions and should respect the
realm as information about the Tuskegee syphilis studies became patient’s right to self-determination. Additionally, the physician
public in the early 1970s (Jonsen, 2001). In 1979 the “Four Principles” should try to minimize waste of resources when possible. At the
framework for addressing ethical issues in medicine was first described societal level, determination of justice may be more difficult. Compet-
by Beauchamp and Childress. This approach remains the cornerstone ing values in justice may lead to different outcomes: does just distribu-
of modern medical ethics (Beauchamp and Childress, 1979). tion require equal access to care, provision to those who need it
most, advocacy by physicians to maximize the benefit for their
The Four-Principles Framework patients, limitation of societal costs (via taxes or insurance deduct-
ibles), or respect for patient choice? Although all of these values
The four principles delineated by Beauchamp and Childress were have merit, how do we as physicians and as a society determine
developed to help provide a common set of moral commitments which should have priority (Gillon, 1994)?
and language with which to address ethical issues (Gillon, 1994).
The principles include autonomy, beneficence, nonmaleficence, Medical Ethics in Clinical Practice
and justice. These principles are considered equal in weight and
should be considered prima facie binding unless in conflict, leading Despite the focus on these four principles in medical society codes
to ethical dilemmas in circumstances in which the physician and of ethics and in training, the translation of these principles to specific
patient must prioritize among conflicting principles (Gillon, 1994). medical care may not always be clear (Page, 2012). To address this

115
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116 PART I Clinical Decision Making

the setting of lack of adequate capacity, the physician should ensure


BOX 7.1 Translation of the Original Hippocratic Oath that the appropriate person has been identified to act as the patient’s
I swear by Apollo the physician, and Aesculapius, and Health, and surrogate and is acting in accordance with the patient’s beliefs and
wishes when possible (Schumann and Alfandre, 2008).
All-heal, and all the gods and goddesses, that, according to my
Quality of Life is the most ephemeral of the factors to be
ability and judgment, I will keep this Oath and this stipulation: to considered in practice and stems from the principles of autonomy,
reckon him who taught me this Art equally dear to me as my beneficence, and nonmaleficence (Schumann and Alfandre, 2008).
parents, to share my substance with him, and relieve his necessities As a result of the variable understanding of this term, it may be
if required; to look upon his offspring in the same footing as my difficult for the provider to intuit the impact of treatment on the
own brothers, and to teach them this Art, if they shall wish to learn patient’s perceived quality of life. As a result, the substitution of the
it, without fee or stipulation; and that by precept, lecture, and provider’s views for the patient’s raises concerns about potential bias
every other mode of instruction, I will impart a knowledge of the that should be considered in the decision-making process, and the
Art to my own sons, and those of my teachers, and to disciples provider should try to elicit from the patient his or her values and
bound by a stipulation and oath according to the law of medicine, preferences to guide assessment of quality of life (Jonsen et al., 1998).
Contextual Features allow for consideration of a patient-physician
but to none others.
partnership within the greater framework of personal, institutional,
I will follow that system of regimen which, according to my legal, and social relationships and is grounded in the ethical
ability and judgment, I consider for the benefit of my patients, and principle of justice. This may include family dynamics, patient
abstain from whatever is deleterious and mischievous. I will give socioeconomic circumstances, as well as religious beliefs (Schumann
no deadly medicine to anyone if asked, nor suggest any such and Alfandre, 2008). Additionally, this topic includes the dynamics
counsel; and in like manner I will not give to a woman a pessary of the treatment team, the need for coordination of care among
to produce abortion. With purity and with holiness will I pass my multiple providers, as well as potential physician biases or interests
life and practice my Art. that may affect treatment decisions (Jonsen et al., 1998).
I will not cut persons labouring under the stone, but will leave Although the Four-Box framework allows for a systematic approach
this to be done by men who are practitioners of this work. Into to assessing clinical conundrums by providing an easy-to use-technique
for organizing conflicting priorities in patient care and for discussing
whatever houses I enter, I will go into them for the benefit of the
areas of conflict with the patient and family, it may also lead to
sick, and will abstain from any voluntary act of mischief and cor- oversimplification of ethical issues and may not always clearly guide
ruption; and, further, from the seduction of females or males, of clinical decision making within the context of identified ethical
freemen and slaves. concerns. As a result, this framework (or any ethical model) should
Whatever, in connection with my professional practice, or not be used in conjunction with the surgeon’s assessment of reasonable
in connection with it, I see or hear, in the life of men, which ought alternatives for treatment as a vehicle to guide discussion of the
not to be spoken of abroad, I will not divulge, as reckoning that relative benefits of each alternative through the prism of the
all such should be kept secret. While I continue to keep this Oath patient’s preferences.
unviolated, may it be granted to me to enjoy life and the practice
of the Art, respected by all men, in all times! But should I trespass INFORMED CONSENT
and violate this Oath, may the reverse be my lot!
History of Informed Consent
From The Genuine Works of Hippocrates, translated from the Greek by Although now considered within the scope of negligence, the legal
Francis Adams, Surgeon, volume 2, London, 1849. concept of informed consent originated in early 20th century battery
law. From 1905 to 1914, state courts identified a right to bodily
integrity that required physicians to obtain informed consent before
performing a procedure. They found that patients have the right to
issue, Jonsen et al. recommend use of the “Four-Box” technique to decide their course of treatment, and as part of that right, they are
provide a more systematic method to consider and apply ethical entitled to be informed about the risks associated with the procedure
principles to medical cases (Table 7.1) (Jonsen et al., 1998). The and to evaluate those risks before coming to a decision (Faden and
four topics to be considered include the following: Beauchamp, 1986). Patients also may limit the consent provided.
Medical Indications include the general goals of medical treat- For example, consent for an examination under anesthesia does not
ment (prevention and care of illness) and are grounded in the extend to a consent to surgery (Schloendorff, 1914). Furthermore,
principles of beneficence and nonmaleficence (Jonsen et al., 1998). consultation for medical advice from a physician does not imply
In addition to discussion of clinical issues and potential treatment consent (Mohr vs. Williams, 1905). Although the courts did acknowl-
options, this discussion should extend to the goals of intervention. edge the potential for implied consent, this was limited to emergency
To act ethically, the physician must use his or her clinical judgment situations or to cases in which a life-threatening condition was
to evaluate the potential risks and benefits of treatment, to make a identified and the patient was not capable of consent (Faden and
recommendation based on this assessment, and to identify the Beauchamp, 1986; Luka vs. Lowrie, 1912).
patient’s preferences regarding treatment choice. The physician should In 1957 the term informed consent was coined and included that
consider and discuss with the patient potential clinical uncertainty physicians provide “any facts which are necessary to form the basis
both in terms of suspected diagnosis and outcomes. Additionally, of an intelligent consent by the patient to the proposed treatment”
when the risks and benefits of treatment appear to be equivocal, (Salgo vs. Leland, 1957). Under this new standard, physicians faced
the physician should defer to the patient’s stated preferences a heightened responsibility to provide information about the risks,
(Schumann and Alfandre, 2008). benefits, and alternatives to a procedure to facilitate an informed
Patient Preferences refer to the patient’s values and assessment decision by the patient. The Kansas Supreme Court in 1960 found
of relative benefits of treatment alternatives and are grounded in that physician liability for failure to adequately inform a patient
the ethical principle of autonomy (Schumann and Alfandre, 2008). about the risks associated with treatment fell within the scope of
To ensure adequate consideration of patient preferences, the provider negligence. As a result, the legal standard for violating informed
must ensure the patient has sufficient information and comprehension consent required both establishing that a physician’s actions fell
to weigh treatment options. Additionally, the provider should ensure outside of the scope of what a “reasonable and prudent” physician
that the patient has a clear understanding of the uncertainty in would do and that these actions were the “proximate cause” of
outcome and the potential range of treatment choices and outcomes. the subsequent harm (Katz, 1977). This standard was expanded in
Finally, it is essential to ensure the patient’s choice is voluntary. In 1972 by the DC Court of Appeals, which found that the disclosure

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Chapter 7 Ethics and Informed Consent 117

TABLE 7.1 The Four-Box Method to Application of Ethics in Clinical Practice

Medical Indications Patient Preferences


1. What is the patient’s medical problem? History? 1. What has the patient expressed about treatment preferences?
Diagnosis? Prognosis? 2. Has the patient been informed of benefits and risks, demonstrated
2. Is the problem acute? Chronic? Critical? understanding, and given consent?
Emergent? Reversible? 3. Is the patient mentally capable and legally competent? What evidence
3. What are the goals of treatment? is there of incapacity?
4. What are the probabilities of success? 4. Has the patient expressed prior preferences (e.g., advance directives)?
5. What are plans in cases of therapeutic failure? 5. If incapacitated, who is the appropriate surrogate? Is the surrogate
6. In sum, how can this patient be benefited by using appropriate standards?
medical and nursing care and how can harm be 6. Is the patient unwilling or unable to cooperate with medical treatment?
avoided? If so, why?
7. In sum, is the patient’s right to choose being respected to the extent
possible in ethics and law?

Quality of Life Contextual Features


1. What are the prospects, with or without treatment, 1. Are there family issues that might influence treatment decisions?
for a return to the patient’s normal life? 2. Are there provider issues that might influence treatment decisions?
2. Are there biases that might prejudice the 3. Are there financial and economic factors?
provider’s evaluation of the patient’s quality of life? 4. Are there religious or cultural factors?
3. What physical, mental, and social deficits is the 5. Is there any justification to breach confidentiality?
patient likely to experience if treatment succeeds? 6. Are there problems of resource allocation?
4. Is the patient’s present or future condition such 7. What are the legal implications of treatment decisions?
that continued life might be judged undesirable by 8. Is clinical research or teaching involved?
him or her? 9. Are there any provider or institutional conflicts of interest?
5. Is there a plan and rationale to forego treatment?
6. What are plans for comfort/palliative care?

Modified from Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: a practical approach to ethical decisions in clinical medicine. 4th ed.
McGraw-Hill; 1998.

should fit within what a “reasonable person” would want to know there are several limitations to patient understanding of risks. First,
rather than deferring to what a “reasonable physician” would disclose patients often use shortcuts to simplify the decision-making process,
(Canterbury vs Spence, 1972). often leading to misunderstanding of the risks posed by a treatment
(Lloyd, 2001). Second, patients may underestimate their own risks
Elements of Informed Consent compared with other people’s (Weinstein, 1989). Third, patients are
influenced by the way in which risks are presented (e.g., likelihood
Informed consent refers to the process by which a patient and medical of survival versus likelihood of death) (Lloyd, 2001). Counterintui-
provider discuss a proposed medical treatment, its anticipated con- tively, information about clinical uncertainty in the probability of
sequences, potential risks and benefits, and alternatives. This process risk improves understanding of risk and also elicits more trust in
allows for open discussion between the provider and the patient the information provided (Johnson and Slovic, 1995).
and may theoretically help reduce medical errors, improve patient Patients often idealize surgeons and accept surgical recommenda-
outcomes, and increase patient empowerment (Cordasco, 2013). tions without meaningful participation in the decision-making process
A comprehensive informed consent consists of four basic (McNeally and Martin, 2000). As a result, the surgeon has a heightened
elements: (1) description of the clinical problem, the proposed responsibility to solicit patient feedback during the consent process.
treatment, and alternatives including no treatment; (2) discussion By empowering the patient to both ask questions and to authorize
of the risks and benefits of the proposed treatment with com- surgical intervention, the surgeon also strengthens their relationship
parisons to the risks and benefits of alternatives, and discussion with the patient, opening the door to an ongoing process of com-
of medical/clinical uncertainties regarding the proposed treatment; munication before, during, and after treatment (Jones et al., 2007).
(3) assessment of the patient’s understanding of the information Substantively, the physician should ensure that the patient understands
provided by the medical provider; and (4) solicitation of the the goals of treatment, the general nature of the procedure to be
patient’s preference and consent for treatment (Cordasco, 2013). performed, as well as expected outcomes including what to expect
The extent of information to be provided is generally based on in the immediate postoperative period.
the physician’s assessment of what information may impact diagnosis The last element of the informed consent process is explicit consent
and treatment planning. Extraneous information that is unlikely to or refusal of treatment based on the information and recommenda-
impact the patient’s decision may be withheld. Additionally, to the tions provided by the surgeon. The surgeon should help the patient
extent possible, information should be provided in a way that is understand the potential future implications of his or her decisions.
understandable to the average layperson and facilitates his or her The extent to which the surgeon directs the conversation regarding
meaningful participation in treatment planning. By discussing options treatment alternatives may depend on how active the patient chooses
before making a recommendation, the surgeon may reduce undue to be in the decision-making process (Fig. 7.1). Regardless of the
influence on the patient’s decision (McCullough et al., 1986). patient’s role in the process, the surgeon should at least ensure
To ensure adequate information for consent, patients must patient understanding of the potential outcomes, risks, and benefits
understand the “material risks” and expected benefits of treatment. associated with the procedure before obtaining consent. To facilitate
However, there is no clear consensus on what constitutes a material the patient’s judgments about the relative risks and benefits of
risk. Some have proposed a 1% risk cutoff, with lower risk considered treatment, the surgeon may ask the patient about what elements of
based on the severity of harm (Adams and Smith, 2001). Additionally, treatment are most important to him or her, such as impact on job

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118 PART I Clinical Decision Making

PATERNALISTIC: Quality of Informed Consent


Information and recommendations
In assessing the quality of consent, two questions must be answered:
(1) Did the physician provide the patient with enough information
INFORMED MEDICAL DECISION MAKING: about the diagnosis and treatment and (2) Did the patient consent to
Information
treatment based on this information (Jones et al., 2007)? The standard
Clinician Patient by which to judge the adequacy of information should be based
SHARED DECISION MAKING: on what a reasonable person (patient) needs for a meaningful
Information and recommendations decision (Canterbury vs. Spence, 1972) and includes a responsibility
for the physician to respect the patient’s perspective of his or her
interests whether or not the physician agrees (Jones et al., 2007).
Values and preferences Despite the need for effective consent, most informed consent
processes are incomplete, with the most common missed element
Fig. 7.1. Models of patient decision making. (From Schrager S, Phillips G, being assessment of patient understanding of the information
Burnside E. A simple approach to shared decision making in cancer screening. provided by the physician (Cordasco, 2013). The information
Fam Pract Manag 2017;24(3):5–10.) provided in consent forms often is above the 12th-grade level,
although the majority of patients have reading levels well below
that (Hopper et al., 1998). Whether because of the difficulty of
understanding or recalling the information in informed consent
performance, sexual function, continence, or ability to pursue leisure documents, patients who report reading consent forms do not
activities. demonstrate better understanding of the procedure and its risks
than those who do not (Cassileth et al., 1980). This lack of under-
Exceptions to the Informed Consent Requirement standing is even more pronounced in patients with limited English
proficiency (Cordasco, 2013).
Emergency situations: One of the well-established exceptions to To address these limitations, several techniques have been tried
informed consent is in the emergency setting. In this setting, to improve the informed consent process. Simplifying consent forms
where there is a significant threat to patient’s well-being or life, alone has had mixed results in improving patient understanding
consent is presumed (Hartman and Liang, 1999). In unconscious (Cordasco, 2013). Supplemental written materials providing informa-
patients in need of emergent medical care, the responsibility of tion about the procedure in more simplified language than the
disclosure is waived because of the potential irreparable harm that consent form has had a more significant impact on patient recall
may result (Barnett vs. Bachrach, 1943). Similarly, in the pediatric of information (Cordasco, 2013). Similarly, decision aids with more
setting, informed consent from the parents may be waived if the detailed information about options and potential outcomes have
patient is at risk for “immediate injury or death (Hartman and improved knowledge about procedures, reduced decisional conflict,
Liang, 1999).” However, this waiver does not extend to the conscious improved patient participation in the decision, and improved risk
patient, who may refuse treatment even if to do so would be life- assessment (O’Connor et al., 2009). Finally, use of “repeat-back”
threatening (In re Quackenbush, 1978) or to children where obtaining methods in which the patient is asked to explain what he or she
parental consent does not constitute an immediate threat of harm has been told and the provider then clarifies the information provided
(Rogers vs Sells, 1936). with subsequent repeat assessments of patient knowledge has been
Patients without decision-making capacity: In patients who are found to be effective in improving comprehension but also adds
unable to participate in the decision-making process, often family significant time to the patient-provider encounter, limiting its potential
members are empowered by law to make decisions for them (Areen, feasibility (Fink et al., 2010).
1987). The goal is for the family to assess what the patient would
consider most important (“substituted judgment”) rather than for
the family to make decisions based on their own values. In cases KEY POINTS
in which the family is unable to achieve substituted judgment, they • Although the scope of medical ethics continues to evolve,
should instead act in the best interest of their loved one. When the basic ethical principles of autonomy, beneficence,
the surgeon does not believe that the surrogate decision maker is nonmaleficence, and justice remain the foundation of
adequately pursuing the patient’s wishes, he or she should then ethical medical practice.
consult with the institutional ethics board or hospital administra- • Informed consent is essential to the practice of surgery
tion to determine whether petitioning the court for a conservator with limited exceptions.
is warranted (McCullough et al., 1986). • Despite the goal of ensuring adequate understanding of
Pediatric patients: Although by law parents are considered sur- the nature, risks, benefits, and alternatives of surgery to
rogate decision makers for minor children (younger than 18 years facilitate a meaningful decision, the informed consent
of age), children should participate in the decision-making process process is often incomplete. It is therefore the
to the extent that they are able (Committee on Bioethics, American responsibility of the surgeon to make every effort to
Academy of Pediatrics, 1995). When parents and their children facilitate patient understanding and participation in the
disagree about the best treatment decision, the surgeon should offer decision-making process.
to facilitate discussion to help them reach a common decision.
Additionally, providing information about the process, including
providing families with the opportunity to visit perioperative spaces
before surgery, may help improve understanding and alleviate anxiety REFERENCES
about the process (Ziegler and Prior, 1994). The complete reference list is available online at ExpertConsult.com.

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Chapter 7 Ethics and Informed Consent 118.e1

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