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115 Ethics and Informed Consent Vijaya M. Vemulakonda, MD, JD 7 A s clinical urologic practice continues to become more complex, the ethical and legal implications of practice become more profound. The purpose of this chapter is to provide a brief history of the origins of medical ethics and legal principles of informed consent, to define key ethical principles and their application to clinical decision making, and to consider the ethical and legal requirements for informed consent in both the clinical and surgical settings. MEDICAL ETHICS History of Medical Ethics The origins of medical ethics are thought to be rooted in the writings of Hippocrates, considered to be the “father of medicine.” Foremost among his contributions to medicine is the Hippocratic oath (Box 7.1), considered the cornerstone of ancient Greek medical ethics, which postulated that the primary goal of medicine is to protect the patient’s interests. The oath establishes the moral framework governing the physician-patient relationship and introduces the ethical principles of beneficence, nonmaleficence, confidentiality, and accountability to the medical profession (Antoniou et al., 2010). However, in the 20th century, the traditional values embodied by the oath were challenged by prominent ethicists such as Robert Veatch. In this view, the oath relies on the physician to make judgments about diagnosis and treatment because of the patient’s inability to understand the information needed for decision making. As a result, the oath undermines the growing respect for patient autonomy that emerged during the late 20th century (Veatch, 1991; Veatch, 2009). Additionally, the oath has been criticized for not addressing issues surrounding justice in the allocation of medical resources, instead focusing on the individual outside of the social context of his care (Veatch, 1991). As criticism of the Hippocratic oath grew, the interdisciplinary field of bioethics emerged. During the 1960s, physicians first began to discuss the impact of technology, such as antibiotics and genetic testing, on medical care (Jonsen, 2001). In 1970 Van Rensselaer Potter first coined the term bioethics to describe “the study of the moral relationship between humans and their social and physical world (Jonsen, 2001; Potter, 1970).” Concerns over the eugenic experiments of the Nazis during World War II strengthened the focus on patient autonomy and patient rights to protect their medical and genetic information (Jonsen, 2001). This focus on respect for patient autonomy and informed consent was reinforced in the research realm as information about the Tuskegee syphilis studies became public in the early 1970s (Jonsen, 2001). In 1979 the “Four Principles” framework for addressing ethical issues in medicine was first described by Beauchamp and Childress. This approach remains the cornerstone of modern medical ethics (Beauchamp and Childress, 1979). The Four-Principles Framework The four principles delineated by Beauchamp and Childress were developed to help provide a common set of moral commitments and language with which to address ethical issues (Gillon, 1994). The principles include autonomy, beneficence, nonmaleficence, and justice. These principles are considered equal in weight and should be considered prima facie binding unless in conflict, leading to ethical dilemmas in circumstances in which the physician and patient must prioritize among conflicting principles (Gillon, 1994). Autonomy, described as respect for the “deliberated self-rule” of individuals, includes an obligation to respect that patients are able to make their own choices even if the outcomes of those choices do not coincide with the physician’s calculation of maximal benefit and minimal harm (Gillon, 1994). This principle is grounded in the Kantian “categorical imperative” that people be considered ends in themselves rather than a means to an end. Although some 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 patient (Gillon, 1994). Respect for autonomy provides the foundation for several physician obligations, including informed consent, confidentiality, and avoidance of deceit. Importantly, communication is essential to providing the physician with the information about patient preferences and attitudes needed to guide discussions of options and to frame medical decision making in a way that is respectful of the patient (Gillon, 1994). Beneficence and nonmaleficence are grounded in the Hippocratic oath’s dictum to protect the patient’s best interests (Antoniou et al., 2010). Beneficence refers to the physician’s obligation to optimize benefit to the patient and should be considered through the prism of the patient’s values and preferences (autonomy). Nonmaleficence is grounded in the Hippocratic dictum primum non nocere (first do no harm) and refers to the obligation to avoid or minimize harm to the patient. These principles mean that (1) we must be able to provide the benefits we promise, through adequate training, education, and professional standards and (2) we must be clear about the probability and magnitude of risk and benefit associated with treatment to ensure that we are able to optimize the patient’s understanding (Gillon, 1994). As a result, the complementary principles of beneficence and nonmaleficence can be seen as an obligation not only to provide training to the individual clinician but also to conduct research to ensure that the information we offer is as accurate as possible. Finally, the weighing of risks and benefits should be considered both at the individual and at the population level (justice) to ensure that risks and benefits are equally shared among patients. Justice refers to the obligation to seek and achieve fairness in the distribution of resources, benefits, and risks across patients. Although equality and justice share many traits, they are not equivalent; “people may be treated unjustly even if they are treated equally” (Gillon, 1994). At the individual patient level, justice means that the physician should try to minimize the effect of self-interest or personal preferences on patient decisions and should respect the patient’s right to self-determination. Additionally, the physician should try to minimize waste of resources when possible. At the societal level, determination of justice may be more difficult. Competing values in justice may lead to different outcomes: does just distribution require equal access to care, provision to those who need it most, advocacy by physicians to maximize the benefit for their patients, limitation of societal costs (via taxes or insurance deductibles), or respect for patient choice? Although all of these values have merit, how do we as physicians and as a society determine which should have priority (Gillon, 1994)? Medical Ethics in Clinical Practice Despite the focus on these four principles in medical society codes of ethics and in training, the translation of these principles to specific medical care may not always be clear (Page, 2012). To address this
116 PART I Clinical Decision Making the setting of lack of adequate capacity, the physician should ensure that the appropriate person has been identified to act as the patient’s surrogate and is acting in accordance with the patient’s beliefs and wishes when possible (Schumann and Alfandre, 2008). Quality of Life is the most ephemeral of the factors to be considered in practice and stems from the principles of autonomy, beneficence, and nonmaleficence (Schumann and Alfandre, 2008). As a result of the variable understanding of this term, it may be difficult for the provider to intuit the impact of treatment on the patient’s perceived quality of life. As a result, the substitution of the provider’s views for the patient’s raises concerns about potential bias that should be considered in the decision-making process, and the provider should try to elicit from the patient his or her values and preferences to guide assessment of quality of life (Jonsen et al., 1998). Contextual Features allow for consideration of a patient-physician partnership within the greater framework of personal, institutional, legal, and social relationships and is grounded in the ethical principle of justice. This may include family dynamics, patient socioeconomic circumstances, as well as religious beliefs (Schumann and Alfandre, 2008). Additionally, this topic includes the dynamics of the treatment team, the need for coordination of care among multiple providers, as well as potential physician biases or interests that may affect treatment decisions (Jonsen et al., 1998). Although the Four-Box framework allows for a systematic approach to assessing clinical conundrums by providing an easy-to use-technique for organizing conflicting priorities in patient care and for discussing areas of conflict with the patient and family, it may also lead to oversimplification of ethical issues and may not always clearly guide clinical decision making within the context of identified ethical concerns. As a result, this framework (or any ethical model) should be used in conjunction with the surgeon’s assessment of reasonable alternatives for treatment as a vehicle to guide discussion of the relative benefits of each alternative through the prism of the patient’s preferences. INFORMED CONSENT History of Informed Consent Although now considered within the scope of negligence, the legal 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 decide their course of treatment, and as part of that right, they are entitled to be informed about the risks associated with the procedure and to evaluate those risks before coming to a decision (Faden and Beauchamp, 1986). Patients also may limit the consent provided. For example, consent for an examination under anesthesia does not extend to a consent to surgery (Schloendorff, 1914). Furthermore, consultation for medical advice from a physician does not imply consent (Mohr vs. Williams, 1905). Although the courts did acknowledge the potential for implied consent, this was limited to emergency situations or to cases in which a life-threatening condition was identified and the patient was not capable of consent (Faden and Beauchamp, 1986; Luka vs. Lowrie, 1912). In 1957 the term informed consent was coined and included that physicians provide “any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment” (Salgo vs. Leland, 1957). Under this new standard, physicians faced a heightened responsibility to provide information about the risks, benefits, and alternatives to a procedure to facilitate an informed decision by the patient. The Kansas Supreme Court in 1960 found that physician liability for failure to adequately inform a patient about the risks associated with treatment fell within the scope of negligence. As a result, the legal standard for violating informed consent required both establishing that a physician’s actions fell outside of the scope of what a “reasonable and prudent” physician would do and that these actions were the “proximate cause” of the subsequent harm (Katz, 1977). This standard was expanded in 1972 by the DC Court of Appeals, which found that the disclosure issue, Jonsen et al. recommend use of the “Four-Box” technique to provide a more systematic method to consider and apply ethical principles to medical cases (Table 7.1) (Jonsen et al., 1998). The four topics to be considered include the following: Medical Indications include the general goals of medical treatment (prevention and care of illness) and are grounded in the principles of beneficence and nonmaleficence (Jonsen et al., 1998). In addition to discussion of clinical issues and potential treatment options, this discussion should extend to the goals of intervention. To act ethically, the physician must use his or her clinical judgment to evaluate the potential risks and benefits of treatment, to make a recommendation based on this assessment, and to identify the patient’s preferences regarding treatment choice. The physician should consider and discuss with the patient potential clinical uncertainty both in terms of suspected diagnosis and outcomes. Additionally, when the risks and benefits of treatment appear to be equivocal, the physician should defer to the patient’s stated preferences (Schumann and Alfandre, 2008). Patient Preferences refer to the patient’s values and assessment of relative benefits of treatment alternatives and are grounded in the ethical principle of autonomy (Schumann and Alfandre, 2008). To ensure adequate consideration of patient preferences, the provider must ensure the patient has sufficient information and comprehension to weigh treatment options. Additionally, the provider should ensure that the patient has a clear understanding of the uncertainty in outcome and the potential range of treatment choices and outcomes. Finally, it is essential to ensure the patient’s choice is voluntary. In From The Genuine Works of Hippocrates, translated from the Greek by Francis Adams, Surgeon, volume 2, London, 1849. I swear by Apollo the physician, and Aesculapius, and Health, and All-heal, and all the gods and goddesses, that, according to my ability and judgment, I will keep this Oath and this stipulation: to reckon him who taught me this Art equally dear to me as my parents, to share my substance with him, and relieve his necessities if required; to look upon his offspring in the same footing as my own brothers, and to teach them this Art, if they shall wish to learn it, without fee or stipulation; and that by precept, lecture, and every other mode of instruction, I will impart a knowledge of the Art to my own sons, and those of my teachers, and to disciples bound by a stipulation and oath according to the law of medicine, but to none others. I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous. I will give no deadly medicine to anyone if asked, nor suggest any such counsel; and in like manner I will not give to a woman a pessary to produce abortion. With purity and with holiness will I pass my life and practice my Art. I will not cut persons labouring under the stone, but will leave this to be done by men who are practitioners of this work. Into whatever houses I enter, I will go into them for the benefit of the sick, and will abstain from any voluntary act of mischief and corruption; and, further, from the seduction of females or males, of freemen and slaves. Whatever, in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret. While I continue to keep this Oath 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 and violate this Oath, may the reverse be my lot! BOX 7.1 Translation of the Original Hippocratic Oath
Chapter 7 Ethics and Informed Consent 117 there are several limitations to patient understanding of risks. First, patients often use shortcuts to simplify the decision-making process, often leading to misunderstanding of the risks posed by a treatment (Lloyd, 2001). Second, patients may underestimate their own risks compared with other people’s (Weinstein, 1989). Third, patients are influenced by the way in which risks are presented (e.g., likelihood of survival versus likelihood of death) (Lloyd, 2001). Counterintuitively, information about clinical uncertainty in the probability of risk improves understanding of risk and also elicits more trust in the information provided (Johnson and Slovic, 1995). Patients often idealize surgeons and accept surgical recommendations without meaningful participation in the decision-making process (McNeally and Martin, 2000). As a result, the surgeon has a heightened responsibility to solicit patient feedback during the consent process. By empowering the patient to both ask questions and to authorize surgical intervention, the surgeon also strengthens their relationship with the patient, opening the door to an ongoing process of communication before, during, and after treatment (Jones et al., 2007). Substantively, the physician should ensure that the patient understands the goals of treatment, the general nature of the procedure to be performed, as well as expected outcomes including what to expect in the immediate postoperative period. The last element of the informed consent process is explicit consent or refusal of treatment based on the information and recommendations provided by the surgeon. The surgeon should help the patient understand the potential future implications of his or her decisions. The extent to which the surgeon directs the conversation regarding treatment alternatives may depend on how active the patient chooses to be in the decision-making process (Fig. 7.1). Regardless of the patient’s role in the process, the surgeon should at least ensure patient understanding of the potential outcomes, risks, and benefits associated with the procedure before obtaining consent. To facilitate the patient’s judgments about the relative risks and benefits of treatment, the surgeon may ask the patient about what elements of treatment are most important to him or her, such as impact on job should fit within what a “reasonable person” would want to know rather than deferring to what a “reasonable physician” would disclose (Canterbury vs Spence, 1972). Elements of Informed Consent Informed consent refers to the process by which a patient and medical provider discuss a proposed medical treatment, its anticipated consequences, potential risks and benefits, and alternatives. This process allows for open discussion between the provider and the patient and may theoretically help reduce medical errors, improve patient outcomes, and increase patient empowerment (Cordasco, 2013). A comprehensive informed consent consists of four basic elements: (1) description of the clinical problem, the proposed treatment, and alternatives including no treatment; (2) discussion of the risks and benefits of the proposed treatment with comparisons to the risks and benefits of alternatives, and discussion of medical/clinical uncertainties regarding the proposed treatment; (3) assessment of the patient’s understanding of the information provided by the medical provider; and (4) solicitation of the patient’s preference and consent for treatment (Cordasco, 2013). The extent of information to be provided is generally based on the physician’s assessment of what information may impact diagnosis and treatment planning. Extraneous information that is unlikely to impact the patient’s decision may be withheld. Additionally, to the extent possible, information should be provided in a way that is understandable to the average layperson and facilitates his or her meaningful participation in treatment planning. By discussing options before making a recommendation, the surgeon may reduce undue influence on the patient’s decision (McCullough et al., 1986). To ensure adequate information for consent, patients must understand the “material risks” and expected benefits of treatment. However, there is no clear consensus on what constitutes a material risk. Some have proposed a 1% risk cutoff, with lower risk considered based on the severity of harm (Adams and Smith, 2001). Additionally, TABLE 7.1 The Four-Box Method to Application of Ethics in Clinical Practice Medical Indications 1. What is the patient’s medical problem? History? Diagnosis? Prognosis? 2. Is the problem acute? Chronic? Critical? Emergent? Reversible? 3. What are the goals of treatment? 4. What are the probabilities of success? 5. What are plans in cases of therapeutic failure? 6. In sum, how can this patient be benefited by medical and nursing care and how can harm be avoided? Patient Preferences 1. What has the patient expressed about treatment preferences? 2. Has the patient been informed of benefits and risks, demonstrated understanding, and given consent? 3. Is the patient mentally capable and legally competent? What evidence is there of incapacity? 4. Has the patient expressed prior preferences (e.g., advance directives)? 5. If incapacitated, who is the appropriate surrogate? Is the surrogate using appropriate standards? 6. Is the patient unwilling or unable to cooperate with medical treatment? 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 1. What are the prospects, with or without treatment, for a return to the patient’s normal life? 2. Are there biases that might prejudice the provider’s evaluation of the patient’s quality of life? 3. What physical, mental, and social deficits is the patient likely to experience if treatment succeeds? 4. Is the patient’s present or future condition such that continued life might be judged undesirable by him or her? 5. Is there a plan and rationale to forego treatment? 6. What are plans for comfort/palliative care? Contextual Features 1. Are there family issues that might influence treatment decisions? 2. Are there provider issues that might influence treatment decisions? 3. Are there financial and economic factors? 4. Are there religious or cultural factors? 5. Is there any justification to breach confidentiality? 6. Are there problems of resource allocation? 7. What are the legal implications of treatment decisions? 8. Is clinical research or teaching involved? 9. Are there any provider or institutional conflicts of interest? Modified from Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: a practical approach to ethical decisions in clinical medicine. 4th ed. McGraw-Hill; 1998.
118 PART I Clinical Decision Making Quality of Informed Consent In assessing the quality of consent, two questions must be answered: (1) Did the physician provide the patient with enough information about the diagnosis and treatment and (2) Did the patient consent to treatment based on this information (Jones et al., 2007)? The standard by which to judge the adequacy of information should be based on what a reasonable person (patient) needs for a meaningful 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). Despite the need for effective consent, most informed consent processes are incomplete, with the most common missed element being assessment of patient understanding of the information provided by the physician (Cordasco, 2013). The information 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 documents, patients who report reading consent forms do not demonstrate better understanding of the procedure and its risks than those who do not (Cassileth et al., 1980). This lack of understanding is even more pronounced in patients with limited English proficiency (Cordasco, 2013). To address these limitations, several techniques have been tried to improve the informed consent process. Simplifying consent forms alone has had mixed results in improving patient understanding (Cordasco, 2013). Supplemental written materials providing information about the procedure in more simplified language than the consent form has had a more significant impact on patient recall of information (Cordasco, 2013). Similarly, decision aids with more detailed information about options and potential outcomes have improved knowledge about procedures, reduced decisional conflict, improved patient participation in the decision, and improved risk assessment (O’Connor et al., 2009). Finally, use of “repeat-back” methods in which the patient is asked to explain what he or she has been told and the provider then clarifies the information provided with subsequent repeat assessments of patient knowledge has been found to be effective in improving comprehension but also adds significant time to the patient-provider encounter, limiting its potential feasibility (Fink et al., 2010). performance, sexual function, continence, or ability to pursue leisure activities. Exceptions to the Informed Consent Requirement Emergency situations: One of the well-established exceptions to informed consent is in the emergency setting. In this setting, where there is a significant threat to patient’s well-being or life, consent is presumed (Hartman and Liang, 1999). In unconscious patients in need of emergent medical care, the responsibility of disclosure is waived because of the potential irreparable harm that may result (Barnett vs. Bachrach, 1943). Similarly, in the pediatric setting, informed consent from the parents may be waived if the patient is at risk for “immediate injury or death (Hartman and Liang, 1999).” However, this waiver does not extend to the conscious patient, who may refuse treatment even if to do so would be lifethreatening (In re Quackenbush, 1978) or to children where obtaining parental consent does not constitute an immediate threat of harm (Rogers vs Sells, 1936). Patients without decision-making capacity: In patients who are unable to participate in the decision-making process, often family members are empowered by law to make decisions for them (Areen, 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 in which the family is unable to achieve substituted judgment, they should instead act in the best interest of their loved one. When the surgeon does not believe that the surrogate decision maker is adequately pursuing the patient’s wishes, he or she should then consult with the institutional ethics board or hospital administration to determine whether petitioning the court for a conservator is warranted (McCullough et al., 1986). Pediatric patients: Although by law parents are considered surrogate decision makers for minor children (younger than 18 years of age), children should participate in the decision-making process to the extent that they are able (Committee on Bioethics, American Academy of Pediatrics, 1995). When parents and their children disagree about the best treatment decision, the surgeon should offer 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 about the process (Ziegler and Prior, 1994). Clinician Patient PATERNALISTIC: Information and recommendations INFORMED MEDICAL DECISION MAKING: Information SHARED DECISION MAKING: Information and recommendations Values and preferences Fig. 7.1. Models of patient decision making. (From Schrager S, Phillips G, Burnside E. A simple approach to shared decision making in cancer screening. Fam Pract Manag 2017;24(3):5–10.) • Although the scope of medical ethics continues to evolve, the basic ethical principles of autonomy, beneficence, nonmaleficence, and justice remain the foundation of ethical medical practice. • Informed consent is essential to the practice of surgery with limited exceptions. • Despite the goal of ensuring adequate understanding of the nature, risks, benefits, and alternatives of surgery to facilitate a meaningful decision, the informed consent process is often incomplete. It is therefore the responsibility of the surgeon to make every effort to facilitate patient understanding and participation in the decision-making process. KEY POINTS REFERENCES The complete reference list is available online at ExpertConsult.com.
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