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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
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Chapter 7 Ethics and Informed Consent 117
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
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Chapter 7 Ethics and Informed Consent 118.e1
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