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Review Articles Ethical Aspects of Informed Consent in Obstetric Anesthesia—New Challenges and Solutions Paul J. Hoehner, MD, MA, FAHA* Department of Anesthesiology, University of Virginial Health System and the Department of Religious Studies, University of Virginia School of Arts and Sciences, Charlottesville, VA, 22908-0710

Informed consent is a cornerstone and routine component of the ethical practice of modern medicine. Its full theoretical application to specific clinical situations, however, presents a number of ethical dilemmas for health care providers. Obstetric anesthesia, in particular, presents many unique challenges to the process of informed consent. In this review, the ethical background to the doctrine of informed consent within the context of “principlism” is explored and critiqued. The application of principlism to actual clinical situations, the limitations of principlism in the peculiarities of the patient-physician encounter, as well as possible alternative models of ethical discourse is discussed. The process of informed consent can be broken down into seven elements: Threshold elements or preconditions, which include 1) decision-making capacity or competency of the patient, 2) freedom or voluntariness in decision-making, including absence of over-riding legal or state interests; informational elements, including 3) adequate disclosure of material information, 4) recommendation, and 5) an understanding of the above; consent elements, which include 6) decision by the patient in favor of a plan and 7) authorization of that plan. Each of these elements is discussed in turn, and their implications, especially for the anesthesiologist and the obstetric patient, are addressed. © 2003 by Elsevier Science Inc.

Introduction

*Associate Professor Address correspondence and reprint requests to Dr. Hoehner at the Department of Anesthesiology, University of Virginia Health System, P.O. Box 800710, Charlottesville, VA 22908-0710, USA. Received for publication June 17, 2002; revised manuscript accepted for publication July 16, 2002. Journal of Clinical Anesthesia 15:587– 600, 2003 © 2003 Elsevier Science Inc. All rights reserved. 360 Park Avenue, South, New York, NY 10010

Informed consent is a cornerstone and routine component of the ethical practice of modern medicine. Its full theoretical application to specific clinical situations, however, presents a number of ethical dilemmas for health care providers. Obstetric anesthesia, in particular, presents many unique challenges to the process of informed consent. This review will look at and critique the ethical background to the doctrine of informed consent, break down the current understanding of the process of informed consent into its specific components, and examine the clinical application of each of these components, specifically as they apply to the practice of obstetric anesthesia

Ethical Principles The classic paradigm of modern medical ethics is that of “principlism,” in which the concepts of respect for autonomy, beneficence, nonmaleficence, and justice 0952-8180/03/$–see front matter doi:10.1016/S0952-8180(03)00505-6

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are the central and organizing principles of ethical discussion.1 Autonomy (derived from the Greek autos, meaning “self,” and nomos, meaning “law,” “rule,” or “governance”) is a term rooted in the respect for the freedom of self-determination of those individuals directly affected by a decision, and it the most important principle in discussions of informed consent. Beneficence refers to those beneficial actions that contribute to the welfare of the patient. It is the moral obligation to act for the benefit of others. The principle of nonmaleficence refers to the moral obligation to avoid inflicting intentional harm and is associated with the maxim Primum non nocere (“Above all, do no harm”). Both principles are expressed in the Hippocratic Oath: “I will use treatment to help the sick according to my ability and judgment, but I will never use it to injure or wrong them.”2 The two principles are intimately related. Because there are few instances in which medical intervention is without harm (e.g., inserting an epidural or spinal needle into the back) or risk of harm (e.g., infection, hematoma, etc.), the admonition “do no harm” must be seen within the context of an overriding intent to benefit patients (e.g., relieve the pain of labor). Doing harm is not absolutely forbidden, only unnecessary and intentional harm not balanced by any greater good. Justice is a problematic term in that its definition is elusive, especially in its application to the distribution of scarce or costly resources. Justice differs from the first three principles in that it raises our eyes from the individual patient to the needs of other individuals and/or society. Issues such as discrimination, the high cost of medical care, and limited supply of resources fall under the influence of this principle. Philosophers and ethicists attempt to explain the meaning of justice by using such terms as fairness, desert, entitlement, and equality (these may not be the same thing). Distributive justice may either refer to 1) equal access to health care or 2) to equal entitlement based on some form of desert or utilitarian goal. These two forms of distributive justice may not result in the same outcome. There are many other principles that go by familiar terms such as sanctity of life, veracity (truthtelling), stewardship, mercy, and hope that may be seen as subheadings under the “big four.” Although the above principles may appear on the surface to be self-evident for the clinical practitioner trained within Western cultural norms, they are not without difficulty in application to the real-world dilemmas of modern clinical practice. The concept of “principlism” was developed as a means to avoid incommensurable conflicts over particular moral theories and moral rules in dealing with ethical problems that arise in medical practice. The “self-evidential” nature of these four principles was meant to provide a unified basis for discussion and a universal guide to action. Isolated from this context, however, these principles can become both misleading theoretically and unusable practically, especially when they are seen to be in apparent conflict with one another. The “principles” become in reality merely names for a collection of sometimes superficially related matters for consideration when dealing with a moral problem.3 “Principles” can never be seen as isolated concepts, but are always embedded within 588

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and derived from larger metaethical frameworks (utilitarian, deontological, teleological, etc.), which are in turn interpreted by an outworking of an even larger, overarching metaphysical framework or presuppositional world view (humanistic or anthropocentric, theocentric, etc.). One of the difficulties in the process of ethical decisionmaking is that most physicians and health care workers focus on specific treatment options in specific, isolated cases. “May we turn off the ventilator in this patient?” “Should we perform this procedure on this mentally incompetent patient who is resisting therapy?” The usual approach is to attack the issue head on. The difficulty is that well-intentioned attempts are made to solve a specific dilemma without an appropriate appreciation for the different levels of thinking in medical ethics. We want to focus on the process of ethical decision-making, and to try and base our decision-making process on certain ethical principles. But these principles do not appear in isolation but are derived from and are necessary consequences of specific methods of moral reasoning. All moral reasoning, furthermore, is done in the immediate context of specific metaphysical frameworks or world views. Confusion can exist when people argue at different levels or assume common higher levels. This becomes particularly evident and troublesome when there is a conflict of cultures and/or religious traditions.4 – 6 Further discussion along these lines is beyond the scope of this review, other than to point out that recent work in medical ethics has focused on alternative frameworks based on such concepts as “the narrative life”7 and “virtue ethics.”8,9 These concepts may overcome some of the philosophic limitations of the traditional approach and provide a more firm theoretical grounding which can proceed to the level of principles, policies, and rules. In the context of the specific topic under review, that of informed consent in obstetric anesthesia, it is important nonetheless to appreciate how principlism has been applied, its limitations, as well as possible alternative models of ethical discourse.

Autonomy and the Development of Informed Consent The concept of informed consent is a hallmark of modern medical ethics and is firmly grounded in the principle of respect for autonomy. Autonomy is the capacity for selfgovernment, originally derived from the Greek terms referring to self-governance in the ancient city-states. Modern concepts of autonomy are rooted in 17th-century political philosophy and involve the essential conditions of liberty (freedom from controlling influences or coercion), rationality (capacity for understanding), and self-sufficiency (ability for intentional action). Agents are autonomous if their actions are truly their own. Both Jean-Jacques Rousseau (1712–1778) and Immanuel Kant (1724 –1804) wrote of the necessity of this moral liberty in their respective ethical theories, in which possessing autonomy of the will is a necessary condition of moral agency.10 True or

Informed consent in obstetric anesthesia: Hoehner

“radical” autonomy is elusive if not mythical in that our desires, choices, and actions are all partly under the control of factors not of our own choosing or control. Nevertheless, autonomy has remained an important ethical concept. The argument that only agents acting autonomously are responsible for their actions is very powerful. Yet, centering ethical deliberation on such a concept of autonomy rapidly leads to forms of subjectivism in which our believing and desiring are ultimately due to what we do, not what the world does to and through us.11 This leads to a conundrum when autonomy is contrasted, as is often the case, with the state of being “enslaved” to one’s “bad” desires. If only the autonomous can be held responsible for their actions, it follows that nobody is responsible for “bad” actions. Subjectivism also can lead to the eschewal of the role of reflection or deliberation, assuming that wants and desires are, like taste, indisputable and basic, a path that leads to extreme forms of relativism. Proposals for defending the concept of autonomy in ethical reflection include describing agents as truly autonomous only when they are “reasoning” correctly, a concept much too weak to be of practical use.12 It is also important to keep in mind that Western values and concepts of autonomy often clash with other worldviews that may place greater emphasis on spirituality, family and community, or authority and social hierarchy. Despite this, the role of autonomy has become the focal point of the legacy of Western ethical theory, especially as it is applied in the setting of the patient-physician relationship. It is important to note that the ideal of personal autonomy is neither a presupposition nor an implication of the principle of respect for personal autonomy, which obligates us to respect the autonomous choices and actions of other.13 Even though the concept of autonomy was so central to the development of Western ethical and political theory, its role in the physician-patient relationship did not mature until the early 20th-century. Part of the reason lies in the balance between paternalism and autonomy that exists in every physician-patient encounter (which was much more pronounced before the 20th century) as well as the role of disease and suffering, which was often perceived as an uncontrollable outside force. In previous eras, physicians made decisions for patients based on the physicians’ perception of the patients’ best interests, often with little involvement from the patients themselves other than their assent. Physicians did not regard this behavior as unethical, however, and indeed felt that it was unethical to place too much burden on the patient and family with regards to medical decisions. Physicians at times felt it was their ethical duty to “protect” patients and their families from unfavorable diagnoses and prognoses. This, ironically, can be traced back to the Hippocratic tradition: Perform [these duties] calmly and adroitly, concealing most things from the patient while you are attending to him. Give necessary orders with cheerfulness and serenity, turning his attention away from what is being done to him; sometimes reprove sharply and emphatically and sometimes comfort with solicitude and attention, revealing nothing of the patient’s future or present condition.14

The Hippocratic Oath is likewise silent on the duty of physicians to inform, or even converse with, patients. The AMA’s first code of medical ethics in 1847 did not include any discussion of informed consent or physician-patient interaction. Hence, the nature of “informed consent” was destined to originate within the sphere of law and not within historic medical practice. The role of the patient in the consent process, however, began to be recognized by the courts as early as the 18th century in the case of Slater v. Baker and Stapleton in which it was recognized that “ . . . a patient should be told what is about to be done to him, that he may take courage and put himself in such a situation as to enable him to undergo the operation.”15 However, the concept of “informed” consent was not appreciated fully until the 1957 landmark case of Salgo v. Trustees of Leland Stanford Hospital.16 The plaintiff in this case became paraplegic following translumbar aortography. He did not file for medical malpractice, but maintained that he had not been informed of the risks of the procedure. The court subsequently introduced the concept of “informed consent” by requiring the physician to explain the “risks, benefits and alternatives” of the procedure to the patient. Katz points out that the entire informed consent paragraph in this landmark 1957 California case was adopted verbatim, and without attribution, from the amicus curiae brief submitted by the American College of Surgeons. Furthermore, it was without legal antecedent and appeared to surface “seemingly out of nowhere.”17 Meisel and Kuczewski note that, “it is an ironic twist of history that informed consent was dreamed up by lawyers in the employ of physicians.”18 The principle of respect for personal autonomy, in which the patient is viewed as an independent decisionmaker in his/her medical care, began to dominate medical ethics in the 1960s with a general rebellion from authority and greater emphasis on rights and freedoms of the individual. This movement coincided with the birth of bioethics as a field in itself in the wake of the development of kidney dialysis and the controversies around the “God Committee,” as well as with the new consumer-rights mentality.19 Ethical issues arose from the perceived conflict between physician paternalism (the old model) and patient autonomy (the new model). This distinction between physician paternalism and patient autonomy has not been useful because of the complex nature of the physician-patient relationship. No patient is completely autonomous in the decision-making process, and no clinical encounter is completely devoid of some degree of caretaker paternalism. Indeed, neither complete autonomy nor complete lack of paternalism is necessarily desirable. Many ethical conundrums in medical ethics are the result of specific principles coming into conflict in specific cases. The principle of respect for autonomy is sometimes taken to be the overriding principle in modern medical ethical deliberation. However, respect for personal autonomy does not, and should not, exhaust moral deliberation. Other principles are important and not only when autonomy reaches its limits. Childress notes that focusing on the principle of personal autonomy can foster indifference J. Clin. Anesth., vol. 15, December 2003

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and that the principles of care and beneficence are important even in discussions of informed consent. The role played by the principle of respect for autonomy is one of setting limits, such that, “without the limits set by the principle of respect for autonomy, these principles (beneficence, nonmaleficence, and justice) may support arrogant enforcement of ‘the good’ for others.”13 Yet, the principle of respect for autonomy is not absolutely binding and does not outweigh all other principles at all times. Two different approaches have been used by ethicists to resolve conflicts or apparent contradictions between competing principles. First is to construct an a priori serial ranking of the principles, such that some take absolute priority over others. Second, principles can be viewed as prima facie binding, competing equally with other prima facie principles in particular circumstances. This view requires one to view more closely the complexities and particularities of individual cases and is more situational in context. The prima facie principle of respect for autonomy can be overridden or justifiably infringed when the following conditions are satisfied: 1) when there are stronger competing principles (proportionality); 2) when infringing on the principle of respect for autonomy would probably protect the competing principles (effectiveness); 3) when infringing the principle of respect for autonomy is necessary to protect the competing principle(s) (last resort); and when the infringement of the principle of respect for autonomy is the least intrusive or restrictive in the circumstances, consistent with protecting the competing principle(s) (least infringement).13 Aside from legal requirements and the specter of malpractice, recent discussions of “informed consent” have focused on the concept of “shared decision-making” and the clinical-therapeutic role of the informed consent process in improving patient care. These discussions recognize that there should be a collaborative effort between physicians and patients to arrive at appropriate treatment decisions. The physician brings his knowledge and trained judgment to the process, while the patient brings his/her individual and unique priorities, needs, concerns, beliefs, and fears. Focusing on the “process” of informed consent, as opposed to bare legal requirements, increases a patient’s participation in his/her own care, which may result in increased patient compliance and self-monitoring. Informed consent as “teaching” (the origin of the word “Doctor” is from “teacher”) further diminishes a patient’s misconceptions or inaccurate fears about their situation and prospects, and may improve patient recovery or comfort with a better understanding of the care that is being provided. No good data are available regarding these “therapeutic” effects of informed consent, and further studies seem warranted. Despite these theoretical positive aspects, issues surrounding informed consent remain vexing for physicians in a number of clinical situations from both legal and ethical perspectives. Even the ideal model of “shared decision-making” does not address many of the realities of medical practice, including emergency situations, conflicts of interest, and questions of futility. 590


Table 1. The Process of Informed Consent Threshold Elements (Preconditions) Decision-making capacity or competency Freedom or voluntariness and absence of overriding state or legal interests Informational Elements Adequate disclosure of material information Recommendation Understanding Consent Elements Decision Authorization

By emphasizing informed consent as a temporal “process,” one can avoid the pitfalls of viewing informed consent as a single event. Informed consent can never be reduced to a signature on a consent form. “Perhaps the most fundamental and pervasive myth about informed consent is that informed consent has been obtained when a patient signs a consent form. Nothing could be further from the truth, as many courts have pointed out to physicians who were only too willing to believe this myth.”18 Although a matter of routine in many institutions because they are seen as providing protection against liability, informed consent forms actually provide very little. The informed consent form does have value in that it provides an opportunity for the patient to read the information on the form and to create a locus for the appropriate patient-physician discussion that is the key element. An informed consent form merely documents that the “process” of informed consent has taken place. Traditionally, consent to anesthesia in the past was usually subsumed under the consent to the surgical procedure and included within the surgery consent form. The anesthesiologist was one step removed from the formal consent process. Today, separate specific consent for anesthesia is required in most states. It is imperative that the anesthesiologist make a concerted effort to adequately complete this process with the patient and, when appropriate, the patient’s family regarding the anesthetic procedure and adequately document in a note the patient’s consent on the chart or anesthetic record (above and beyond any signature on a standard form issued by a ward clerk). Beauchamp and Childress1 have broken down the process of informed consent into seven elements (see Table 1): Threshold elements or preconditions, which include 1) decision-making capacity or competency of the patient, 2) freedom or voluntariness in decision-making, including absence of over-riding legal or state interests; informational elements including 3) adequate disclosure of material information, 4) recommendation, and 5) an understanding of the above; consent elements, which include 6) decision by the patient in favor of a plan and 7) authorization of that plan. Each of these elements will be discussed in turn, and its implications especially for the anesthesiologist and the obstetric patient will be addressed.


Decision-Making Capacity Decision-making capacity requires: 1) a capacity to understand and communicate; 2) a capacity to reason and deliberate; and 3) possession of a set of values and goals.20 –22 Although there is general agreement regarding these three requirements, there is no single, universally accepted standard of decision-making capacity. This is because decision-making capacity is not an all-or-nothing concept. Decision-making is a task-related concept and the requisite skills and abilities vary according to the specific decision or task. Basically, one must ask the following questions: Does the patient understand his or her medical condition? Does the patient understand the options and the consequences of his or her decision? Is the patient capable of reasonable deliberation? Is the patient able to communicate his or her decision? Does the patient possess a coherent set of values and/or goals? A frequent objection to the concept of informed consent is the patient’s lack of medical knowledge and the question as to what extent must a patient “understand” his or her condition, treatment options, and risks.23 In this regard, truly “informed” consent may be seen as an impossible standard. Even disclosing the facts of a procedure in an understandable manner may not be sufficient to produce a truly educated consent. For example, merely disclosing the fact or probability of having an “allergic reaction” to an anesthetic drug does not make clear the wide range of meanings and phenomenon associated with the word “allergic.” Nor does it address the therapeutic options, risks and possible outcomes of treating an allergic reaction. One can carry this example ad infinitum such that “informed” consent becomes a meaningless term. This will always be the case if fully “informed” is meant to mean fully “educated.”24 One must keep in mind, however, that the primary object of information is to facilitate the patient’s care rather than avoid a lawsuit. Factual knowledge is used, not as an end in itself, but as a means to extend the patient’s own understanding in such a way as to meet his or her own unique priorities, needs, concerns, beliefs, and fears so that they may come to a decision about their care in the manner they normally make similar choices. This will vary from patient to patient and with the risks of the procedure involved. It is a mistake to assume that a patient must understand information to the same extent and in the same manner as a physician. This may indeed be seen just as paternalistic as not permitting patients to participate in decision-making at all.18 Many obstetric patients present with a significant amount of prior knowledge regarding labor, epidurals, and other pain-relief options that is gleamed from textbooks, popular literature, web sites, and/or antenatal classes. Others may have little or no understanding of the nature of labor and delivery and pain relief options. Both may have unique perspectives on the information given or not have completely accurate factual understanding of the information. The nature of the informed consent process will be different for both. In neither case is the patient disqualified as a decision-maker.

One must also be careful to avoid the mistake of equating recall, a standard endpoint in many studies on the adequacy of informed consent, with understanding and comprehension. Meisel and Kuczewski note that, “While it may be true that someone who cannot retain information for a few seconds might not be said to understand it, people often make reasonable decisions but cannot later recall the premises that supported the reasoning or the process that led to the conclusion.”18 Distant recall of the informed consent process may be an indicator of the adequacy of a patient’s understanding, but its absence says little about the patient’s understanding at the time of consent. Another question arises with regard to the patient in pain, especially labor pains. Is a patient in severe pain capable of providing consent? Many physicians are concerned that the pain and stress of labor invalidates the process of informed consent. This concern is unfounded. A study by Grice et al.25 strongly suggests that the majority of laboring women are at least as mentally and physically competent to give consent as preoperative cardiac patients. Their study may be limited in that the endpoint, i.e., recall of certain topics, is not necessarily equivalent to understanding and comprehension of the topics. Pattee et al.26 showed that patient satisfaction with the consent process for labor epidural anesthesia in laboring parturients did not correlate with either anxiety score (r ⫽ 0.048) or pain score (r ⫽ 0.013). They noted, “The distress they (parturients) experienced during labor was great; but this discomfort did not interfere with their ability to hear and comprehend the information associated with the consent process.” A brief review of the Lexis database of legal cases addressing the issue of adequacy of anesthetic consent given during labor showed that in no case did the degree of stress and pain in a laboring parturient call into question the adequacy of informed consent obtained during that labor.27 Scott goes so far as to argue that, “the only time when consent to a pain-relieving procedure is valid is when the person concerned knows what the pain is like...There is clearly a case for saying that the only time when consent to an epidural to relieve the pain of labor is truly informed is in labor itself.”28 Furthermore, Post et al.29 argue convincingly that the duty of beneficence, which provides a moral imperative to relieve pain, may place the patient in pain in a special class with regards to the informed consent process. Hence, according to these authors, the caregiver may have a duty to relieve pain even in the absence of informed consent until evidence of patient refusal is forthcoming. The duty of beneficence, they argue, can be seen to transcend boundaries of culture and even autonomy-based self-determination. Their discussion is in the context of the patient incapacitated by their pain and suffering, but may also apply to the laboring patient in whom all the formalities of the informed consent process are not feasible due to the patient’s extreme reactions to their labor pains and/or the requirements of expediency in placing an epidural catheter.30 What about the patient who is heavily medicated with opioids for pain-relief or sedated with benzodiazepines? This is seen quite frequently in laboring women who often J. Clin. Anesth., vol. 15, December 2003

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received parenteral opioids before requesting labor epidural analgesia. Do they still possess decision-making capacity? The mere presence of opioids or sedatives does not in and of itself invalidate the process of informed consent. In a recent study of informed consent during labor epidural anesthesia, 37/66 (64%) of surveyed patients received opioids for pain relief before the administration of the epidural. There was no difference between the two groups studied, those receiving opioids and those not receiving opioids, with respect to patient satisfaction with the consent process.31 While patient satisfaction may not be the best measure of the adequacy of the informed consent process, it does show that, from the patients’ point-of-view, premedication does not necessarily interfere with the informed consent process. It is important, however, to distinguish between the appropriate use of sedatives or opioids in an overly anxious patient by which they will become even more capable of providing informed consent and the inappropriate use of sedation to manipulate a patient’s decision-making or eliminate their decision-making capacity altogether. Drugs with amnestic properties may be particularly problematic in that the patient may not remember the informed consent process at a later time. But, again, recall is not to be equated with what is really important, i.e., adequate understanding and comprehension at the time of the informed consent process. There are no legal precedents addressing informed consent in patients already sedated or receiving pain medication. The mere presence of sedative or pain medication seems not to have a bearing on the legal requirements for informed consent as long as the physical effects of pain or medication are not so great “as to diminish the patient’s mental abilities to apprehend the consent process.”32 In general minors (a person under the age of 18 in all but four states) are not considered to have decisionmaking capacity on the presumption that they lack the experience and judgment to make fully informed decisions. States have traditionally recognized the right of parents to make health care decisions on their children’s behalf. There are exceptions to this rule, however, such as medical emergencies when the parents cannot be contacted in a reasonable amount of time and there is a serious risk to the life or limb of the patient, and in cases where the minor is “emancipated.” Emancipation is defined as the renunciation of parental rights to a minor and the parents can no longer make decisions for the minor. In these instances the minor is entitled to some, but not all, adult rights and privileges. A minor is typically considered emancipated if he or she is married, in the armed services, has established a home and is economically independent, or his or her parent has failed to fulfill parental support obligations and the minor seeks emancipation by court order. Pregnant minors may also give valid consent to confidential medical, dental, health, and hospital services relating to prenatal care under most state statutes. Table 2 shows individual state policies or case laws as they relate to the pregnant minors ability to provide informed consent for prenatal care, including anesthetic procedures (this information is current as of June 1, 2002 592


and is updated periodically on the Guttmacher Report website, www.guttmacher.com).33 Arguable, most medical treatment that a pregnant minor may receive can be regarded as “relating to prenatal care.” For this reason, a pregnant minor can consent to all or almost all health care decisions for herself and her children.

Freedom or Voluntariness in Decision-Making A second threshold element is one of freedom or voluntariness. Here one asks the question of whether the patient’s decision is free from external constraints. These constraints can consist of a myriad of social, familial, and even financial factors that can be difficult, if not impossible, to sort out. However, it is not true that the principle of respect for autonomy is at odds with all forms of heteronomy, authority, tradition, etc. Competent individuals may autonomously choose to yield first-order decisions (i.e., their decisions about the rightness and wrongness of particular modes of conduct) to a professional, family, spouse, or to a religious institution. In these instances, the person is exercising second-order autonomy in selecting the professional, person, or institution to which they choose to be subordinate. In these cases, second-order autonomy becomes central.34 The distinguishing feature becomes whether the second-order decision was free and voluntary. Of particular concern are instances in which a patient has decided on having or not having an epidural and the patient’s partner (or mother in some instances) refuses one or demands one on the patient’s behalf, overriding the patient’s decision. The patient may have even instructed her partner before labor, “Don’t let me change my mind.” In these special cases it may be important, if possible, to separate the patient for a small amount of time from their partner or family to assess what the patient really wants. It is important to note that when a partner or parent of a pregnant minor disagrees with the stated desire of the patient, the patient has the ultimate say in the decision (with some exceptions by state, see Table 2). Occasionally, an irate partner may position himself or herself physically to prevent the care being requested. In these difficult situations, Wendy Scott offers the following advice: “Often practicality has to take precedence over ethics and the anesthetist must beat a retreat. The prospect of talking it through rationally is no longer an option at this stage.”35 Most often patience, good nonconfrontational bedside manner, assistance from an empathetic nurse, or involvement of third parties can resolve even the most difficult of situations. One must also not forget the role of the physician in limiting a patient’s freedom. A physician, in the course of the informed consent process, may provide misleading information, censor information, or “play down” certain risks. All these issues underscore the elusive nature of autonomy in all the complexities of real-world application.


Table 2. Minors and the Right to Consent to Prenatal Care by State MINORS MAY CONSENT to confidential prenatal care, including regular medical visits and routine services for labor and delivery Alabama Idaho§,㛳 Montana* Pennsylvania Alaska Kansas Nevada§,** South Carolina§,§,‡ Arkansas Kentucky* New Hampshire§,† Tennessee California Maryland* New Jersey* Texas* Delaware*,† Massachusetts New Mexico Utah District of Columbia Michigan* New York Virginia Florida Minnesota* North Carolina Washington*† Georgia Mississippi Oklahoma* Hawaii*,‡ Missouri* Oregon*,§,† SOME MINORS MAY CONSENT to confidential prenatal care, including regular medical visits and routine services for labor and delivery llinois (when a physician believes there is a probable health hazard, when a minor is a parent, or when a minor has been referred by a specified professional, such as a physician or clergyman) NO EXPLICIT POLICY related to minors’ access to prenatal care Arizona Iowa North Dakota Colorado Louisiana Ohio Connecticut Maine Rhode Island Indiana Nebraska South Dakota

Vermont West Virginia Wisconsin Wyoming

Data as of June 1, 2002. Source: Boonstra H and Nash E. Minors and the right to consent to health care. The Guttmacher Report on Public Policy 2000;3:4 – 8 and www.guttmacher.org. *Physician may but is not required to inform the parents. †Minor must be at least 12. ‡Minor must be at least 14; excludes surgery. §State policy does not specifically address prenatal care but applies to medical care in general. 㛳

The attorney general’s office “frequently” interprets state law as authorizing consent.

**State policy allows a minor to consent if the minor is mature enough to understand the nature and consequences of the treatment. †Minor must be at least 15. ‡Minor must be at least 16; however, health services may be rendered to minors of any age without parental consent when the provider believes the services are necessary. 㛳㛳 To provide confidential prenatal care to minors, providers rely on a state supreme court decision that held that minors have the same constitutional rights as adults.

Overriding Legal Interests and Maternal-Fetal Conflicts The advent of intrauterine imaging, increased understanding of maternal-fetal physiology, and the prospect of intrauterine therapeutic intervention has made the obstetrician and obstetrical anesthesiologist acutely aware of the unique challenge of being responsible and caring for two patients, the pregnant patient and her fetus.36 In these situations, ethical dilemmas arise when the physician perceives that he or she is caught between the principles of beneficence/nonmaleficence as directed toward the mother, her fetus, and respect for the mother’s autonomy. Due to these complicated issues, the courts have been frequently called on to assist in providing, and even coercing, medical care. In the past three decades, the pendulum of legal judgment has swung from the one extreme of the unborn fetus’s rights clearly taking precedence over those of the mother to the other extreme, whereby the autonomous informed decision of the pregnant patient takes precedence over concerns of fetal health and safety.

There are a number of specific situations in which state interests may override the patient’s autonomy, such as involvement of minors, public safety, etc. In the case of the pregnant patient, this was seen most clearly in the 1980s when courts, legislatures, and state prosecutors increasingly sought to compel the behavior of women that would promote the birth of healthy babies. Clearly favoring the fetal status over the mother in late gestation (when the fetus is viable), women faced pregnancy-related restrictions and penalties, including civil suit, criminal prosecution, and court-ordered surgery.37–39 Roe v. Wade (1973), in fact, cites the State’s interest in protecting the life of the unborn fetus once it has reached a viable age.40 In the celebrated case of Jefferson v. Griffin Spalding County Hospital Authority (1981), the Supreme Court of Georgia refused to lift a court-order authorizing physicians to perform a caesarian section, and blood transfusion if necessary, on a Jehovah’s Witness patient with placenta previa at term who refused these interventions. The court reasoned that the woman could be forced to undergo the procedure against her objections where the examining physician found a J. Clin. Anesth., vol. 15, December 2003

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“99% certainty” that the child would not survive a vaginal delivery and a 50% chance the woman would die.41 (A caesarean section was not performed and the woman gave birth to a healthy baby without adverse sequelae.) The courts decision was heavily criticized. In 1986, the District of Columbia Civil Division in re Madyun ruled that a competent adult’s refusal of treatment on religious grounds must be respected unless the state can demonstrate a compelling interest to justify overriding the individual’s choice.42 On the basis of the case in question, the court ruled parents may not make a martyr of their unborn infant and ordered the hospital to take any steps medically indicated, including cesarean section, to preserve the life of the fetus. Subsequently both appellate courts have considered the constitutionality of a coerced caesarean section (and other interventions) and declared it unconstitutional.43,44 Both decisions embraced the principle that a pregnant woman, as a capable decision maker, has a very sacred right to be fully informed about the options available to her and that her decision to accept or refuse treatment or intervention, even on religious grounds alone, must be honored in virtually all cases, even when the choice may be harmful to the fetus. The ethics committees of the American College of Obstetricians and Gynecologists (ACOG) in October 198745 and the American Academy of Pediatricians (AAP) in June 198846 published statements regarding the ethical implications of managing conflict over the use of invasive fetal therapies. The ACOG statement reflected the view that the rights of the pregnant woman and respect for her personal autonomy in the decision-making process are nearly absolute. The AAP took the view that respect for the autonomy of the pregnant woman should be limited or prima facie in character. According to the AAP courtordered treatment is sometimes justifiable, provided that 1) maternal risk posed by the forced treatment is low, 2) there is substantial likelihood that the fetus will sustain irrevocable harm without the intervention, and 3) the intervention is clearly appropriate and will likely be effective. The American Medical Association (AMA) has endorsed respect for a woman’s constitutional right to bodily integrity, even in the face of harm to her fetus: “Decisions that would result in health risks are properly made only by the individual who must bear the risk. Considerable uncertainty can surround medical evaluations of the risks and benefits of obstetrical interventions. Through a courtordered intervention, a physician deprives a pregnant woman of her right to reject personal risk and replaces it with the physician’s evaluation of the amount of risk that is properly acceptable.”37 The AMA has also noted that the practice of seeking court orders is counter productive to the goal of promoting healthy pregnancies and births because it causes women to distrust physicians, stating that, “women may withhold information from the physician . . . Or they may reject medical or prenatal care altogether.”37 The AMA did recognize that under certain conditions ethically justifiable court-ordered intervention on the pregnant woman may be allowed. The intervention must 1) post insignificant or no health risks for the 594


woman, 2) involve minimal invasion of the woman’s bodily integrity, and 3) clearly prevent substantial and irreversible fetal harm. It is not at all clear what clinical scenario would meet all these criteria. These statements have been criticized for their failure to recognize certain ethical distinctions.47-49 Chervenak and McCullough49 have argued that while the ACOG statement failed to understand that there may well be justified limits on respect for autonomy as the basis of the pregnant woman’s negative right to refuse interventions on behalf of her fetus, the AAP statement discounted nearly altogether the pregnant woman’s negative rights. They proposed an alternative approach to that of accepting absolute maternal autonomy. According to these authors, fetal therapy should be offered and recommended for a fetus when certain criteria are met: 1) invasive therapy is reliably judged to have a high probability of being life-saving or of preventing serious and irreversible disease, injury, or disability for the viable fetus and for the child it can become, 2) such therapy is reliably judged to involve low mortality risk and low or manageable risk of serious disease, injury, or disability to the viable fetus and the child it can become, and 3) the mortality risk and the risk of disease, injury, or disability to the pregnant woman are reliably judged to be low or manageable. Jehovah’s Witness patients can present unique challenges to the obstetrical anesthesiologist. The ethical issues surrounding the anesthetic care of Jehovah’s Witness patients are complex and there are good recent reviews.50 –52 In general, there are no legal precedents for a physician being held liable for the death of a patient due to lack of a blood transfusion who refused to consent to such. However, there is clear legal precedence prohibiting the giving of blood to a Jehovah’s Witness patient if that person, after careful explanation of the medical implications, still refuses to receive blood on the grounds of their religious belief. But, is there an overriding interest when the life of an unborn fetus is at stake? Before 1997, there have been several cases wherein the courts have, with disparate justification, allowed the transfusion of pregnant women against their wishes.53,54 Since 1997, the courts have established that pregnant women have the right to refuse blood transfusions even when the life of the fetus is endangered.55 In fact, there are few cases in which it is medically necessary to transfuse a mother to save her life and subsequently preserve the viability of the fetus.52 In most cases, surgical delivery of a term fetus at risk is usually life-saving and can be initiated before a transfusion is required. In summary, when the obstetric anesthesiologist is faced with a conflict of maternal-fetal rights the negative rights of the pregnant patient (the right to make an informed decision to refuse intervention) should prevail, patients should not be physically forced or mentally coerced to the operating room or to receive anesthesia, and court orders should be avoided in these circumstances. However, should the pregnant patient choose to exert her positive right to request or demand a treatment or procedure that is not in accord with accepted medical practice and may be harmful to her or her fetus, then that right can


be denied in respect for the caregiver’s autonomy. When seemingly irresolvable conflicts arise every effort must be made to educate and respectfully persuade (not coerce) the patient regarding her options according to the best medical judgment available. The assistance of the hospital ethics committee may be useful in mediating and helping to resolve these situations. Appropriate hospital policies and guidelines, involving input from all members of the health care team including obstetricians, pediatricians, anesthesiologists, family practitioners, nursing, the hospital ethics committee and hospital counsel, should be in place for the anticipated management of dilemmas involving real or perceived maternal-fetal conflicts.47

Adequate Disclosure The first of the informational elements of informed consent is adequate disclosure. This is the process of properly informing the patient of his or her diagnosis, prognosis, treatment options, risks and possible outcomes. The anesthesiologist should reveal the specific risks and benefits of each anesthetic option, the complications of instrumentation of the airway, the risks and benefits of invasive monitoring, the presence and use of a fallback plan, and basis for the anesthesiologist’s recommendations.56 “Transparency” is a useful term describing the openness by which the anesthesiologist discusses the treatment plans with a patient. By “thinking out loud” regarding the options and plans, the anesthesiologist communicates the thought processes that he is making that is going into his or her recommendation thus allowing the patient to understand and participate in this process. Most patients and parents of patients want assurance and explanation regarding anesthesia, not necessarily detailed and exhaustive information. The discussion of risks and hazards of the diagnostic or therapeutic options, as well as information about anticipated pain or suffering, are, in theory and practice, the most troublesome aspects of informed consent. According to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, “Adequate informed consent requires effort on the part of the physician to ensure comprehension; it involves far more than just a signature on the bottom of a list of possible complications. Such complications can be so overwhelming that patients are unable to appreciate the truly significant information and to make sound decisions.”22 The law does not require one to give a list of every possible complication of a planned procedure (which may inflict an undue amount of emotional distress), but only a “reasonable” amount of information. Negligence is not failure to achieve a good outcome, nor failure to disclose all remote risks.57 But just how does one define “reasonable?” The courts have had difficulty as well assessing what a “reasonable” standard of disclosure may be. The most cited standard is the professional practice standard.58 This standard defines reasonable disclosure as what a capable and reasonable medical practitioner in the same field would reveal to a patient under the same or similar circumstances. This language flows out of the landmark

1960 Kansas court case of Natanson v. Kline. The details of the case are unimportant, but the decision notes that, “The duty of the physician to disclose . . . is limited to those disclosures which a reasonable practitioner would make under same or similar circumstances. How the physician may best discharge his obligation to the patient ...involves primarily a question of medical judgment. The physician’s choice of plausible courses should not be called into question if it appears...that the physician was motivated only by the patient’s best therapeutic interest.”59 This case occurred in a climate that still held a high esteem of the professional medical community. Subsequently, some courts have ignored this prevailing standard of disclosure and shifted the focus from the professional community as forming the standard to the patients themselves. It focuses on the “new consumerism” in health care, an extension of the patient’s right of self-determination, in which the patient is viewed as consumer of health care and the physician as provider.60 The “reasonable patient standard” asks what a reasonable patient would consider reasonable and material to the decision of whether to consent to a procedure offered. The burden, however, is still on the physician to ascertain just what is reasonable and material for a hypothetical “reasonable patient.” “On the basis of his medical training and experience the physician can sense how the average, reasonable patient expectedly would react . . . A risk is material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk in deciding whether or not to forgo the proposed therapy.”61 This recognizes a significant shift in consent law. As legal standards continue to evolve, the reasonable patient standard may become more commonly accepted and eventually displaced the professional practice standard as the majority opinion in American informed consent law. A further extension of this line of thinking is the “subjective person standard.” This standard recognizes that all patients are different, there is no hypothetical “reasonable person,” and, hence, the standard of disclosure must recognize not only the local standard of care but individual patient needs and idiosyncrasies as well. One important factor in all the above is the notion of “causality,” i.e., would additional information have affected this particular patient’s decision? What specific, individual concerns did the patient have that would have most affected his or her decision whether or not they are part of the local standard of care for disclosure? The risk of vocal cord damage from a routine intubation may be so small as to not require mentioning in the normal situation (although this is debatable). It may, however, be very important for a professional singer in opting between regional or general anesthesia. One exemplary Australian case involved a plaintiff who was blind in the right eye following a 1946 accident.62 In 1984, the patient underwent a procedure to provide possible functional and cosmetic benefit for the blind eye. Although the preoperative questioning concerning damage to her good eye was quite extensive, the remote complication of sympathetic ophthalmia was not mentioned. Postoperatively the patient J. Clin. Anesth., vol. 15, December 2003

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suffered this rare complication and became completely blind. The court ruled that the physician defendant failed in his duty to warn the patient of a material and causal risk. Patients also have many different reasons for wanting certain information, either for making decisions about their management, to feel more knowledgeable, to allay fears, or to become more involved and in control. Multicultural issues are also very important in this regard and should be taken into consideration. There are several studies in the literature addressing the specifics of risk disclosure in the setting of obstetric anesthesia. Lanigan and Reynolds63 used a postal questionnaire of 523 British and Irish anesthesiologists to study their current practice of risk disclosure. The questionnaire involved a fictitious case history of an elective cesarean section and a list of sample statements to ascertain the level of consensus among anesthesiologists regarding treatment options and risk information. For regional anesthesia there was reasonable agreement on disclosing perioperative discomfort, hypotension, conversion to general anesthesia, partial blockade, weak legs, and accidental dural puncture. The majority of the anesthesiologists surveyed would not have discussed paraplegia as a complication. Discussion of backache and urinary retention with regional anesthesia was optional. For general anesthesia, there was a consensus on discussion of postoperative pain, but a mixed opinion regarding disclosure of the risks of deep vein thrombosis, awareness, aspiration, and hypoxia. The majority of the anesthesiologists surveyed would recommend regional anesthesia to the patient as the safer option over general anesthesia. The limitations of this study include its hypothetical case discussion removed from the actualities of the actual physician-patient encounter and its focus on the physician’s opinion alone, reflecting only a professional practice standard. Dornette has suggested that a formula for a “reasonable” presentation of risks and involves defining a significant risk as one that poses a high (10% or greater) incidence of transient complications or a low (0.5% to 1%) incidence of permanent sequelae.64 It is not clear as of yet whether these quantitative definitions of significant risk will be recognized by the courts. Pattee el al.26 conducted a subsequent study to focus more on patient expectations. They interviewed sixty patients during the first 2 months after vaginal delivery. They were asked, among other things, to rate the adequacy of the risk information they received as part of the initial informed consent process. In contrast to the physician-focused study of Lanigan and Reynolds, all epiduralrelated complications were considered important to disclose, regardless of severity of risk. These risks included headache, backache, infection, hypotension, urinary retention, inadvertent spinal anesthetic, side effects of local anesthetic, convulsions, death/paralysis, effects on the baby, effect on the course of labor, and inability to walk during labor. Particularly important were complications associated with the highest morbidity and mortality, including convulsions, death/paralysis and effects on the baby. The complication considered to be least important, and different from the others, was “inability to walk once 596


they have the epidural.” Sixty percent (36/60) of patients said they would choose labor epidural anesthesia, even if the risks were high, if the complication was minor (backache, urinary retention). Sixty-six percent, however, would not choose labor epidural anesthesia when the complication was serious (death/paralysis) and had a higher risk (⬎1:10,000). The limitation of this study is in its retrospective nature, not taking into account the setting of the laboring patient requesting analgesia. While attempting to formulate an ideal standard list of general risk disclosures universally applicable to every situation, this may not be possible. Clark and Jacka30 have commented “Informed consent, fully respecting patient autonomy, may not be possible during labor . . . Respect for patient autonomy, while ideal in informed consent, may conflict with beneficence and nonmaleficence, if effective therapy is withheld unnecessarily.” Informed consent needs to take into account the complete set of ethical principles (not merely autonomy to the exclusion of beneficence and nonmaleficence), be tailored to the individual situation and patients at hand, and not be limited to a mere recitation of risks. “Appropriately imparting real anesthetic options, setting risk information in context, and allaying anxiety are all central to the art of medicine.”57 From a practical and legal point of view, Knapp has commended that the courts have generally favored the anesthesiologist when it comes to questions regarding the adequacy of information given during the informed consent process. “They have not looked exclusively at the opinion of the patient, nor have they sought a specific kind of documentation. Instead, they have looked for evidence that reasonable information was given. For the two courts that discussed this issue explicitly, reasonable information would be a brief description of the anesthetic and its effects, a general acknowledgement of serious risks with an approximate probability of occurrence, and an opportunity for the patient to ask questions.”27 Finally, some patients for various reasons may elect not to be told about any of the risks of anesthesia. This is perfectly acceptable from both ethical and legal perspectives and should be documented in the medical record,65 although it is not unreasonable to gently probe the patient for reasons or fears responsible for their decision not to be adequately informed. One obvious solution to many of the problems involved with informed consent in obstetric anesthesia is adequate antenatal education. Pattee et al.26 provide evidence in a retrospective questionnaire that patients perceived both the doctor who administered the epidural or a prenatal education course equally with regards to the usefulness of the information obtained regarding epidural anesthesia. Swan and Borshoff66 have shown that recall of information pertaining to informed consent for epidural insertion was significantly better in patients who had attended antenatal epidural education classes. The limitation of their study is twofold. First, they again make the mistake of equating recall of information with understanding and comprehension of the information at the time of presentation. Second, their groups were not randomized, and other factors may have contributed to the results. For instance,


they note that working-class women were less likely to attend antenatal classes67 and other studies have shown that patients with more formal education have significantly greater recall of information pertaining to informed consent.68 Although the value of antenatal education cannot be denied and is an appropriate goal, it may not necessarily lead to a truly “informed” decision. Clark and Jacka again comment that, “ . . . previous personal experience of the parturient with labor would serve as the only appropriate benchmark for comparison (impossible in the primiparous!).”30 Women may come with advanced care plans or “Birth Plans” (these are not equivalent to “advance directives”) that stipulate they do not want an epidural, yet later change their mind in the midst of extreme labor pain. It is unethical to withhold pain relief at this point solely because of a previously written statement. The only time a patient can truly understand the nature of labor pains is during labor itself, and only then, many argue, can they truly assess their desire for analgesia and provide truly “informed” consent.28

Recommendation and Understanding Providing a recommendation and patient understanding are the other two informational elements in the informed consent process. The principle of patient autonomy does not require the physician to present the information in a totally neutral manner, if this were even possible. Indeed, part of the informed consent process is to present information to the patient in a way that buttresses a physician’s recommendations. Persuasion is a justifiable way for educating patients. This is different from manipulation, which is defined as inappropriately causing a certain behavior, and coercion, which is actually threatening a patient with a plausible punishment so the patient will act in a certain way. Assessing patient understanding of the information presented can be a difficult issue, especially if “standard” consent forms are relied on. In one study, 27% of postoperative surgical patients signing consent forms did not know which organ had been operated on, and 44% did not know the nature of the procedure.69 Cassileth et al. showed that 55% of cancer patients could list one of the major complications for chemotherapy within one day of signing consent forms.70 Other studies have shown that risk-specific consent forms do not aid retention71 and that decision-makers often sign consent forms that they do not understand.72 Attempts must be made to educate patients according to their individual needs and, as has been stated previously, not to assume a patient must have complete understanding, but only that necessary given their own particular situation to come to a reasonable decision. This will vary from patient to patient and from situation to situation and consent forms cannot be relied on to provide this information, no matter how detailed.

Decision and Autonomous Authorization Finally, there are the two consent elements: decision and autonomous authorization. The patient must be able to

reach a decision and authorize the physician to provide the care decided on. The physician must document the consented to technique as well as the invasive monitoring to be used. The patient may consent either verbally or in writing, both are ethically and legally just as valid. It may be more difficult to provide proof or evidence of verbal consent after the fact, however, making it all the more important to document adequately the patient’s response in the chart. Although lack of an objection is not equivalent to an authorization, cooperation of patients during performance of a procedure in the absence of overt verbal authorization has usually been deemed equivalent to implied consent and sufficient in cases specifically addressing these issues.27 What if the patient’s decision is counter to the recommendations of the anesthesiologist or amounts to something the anesthesiologist regards as dangerous? Must the physician necessarily do whatever a patient wants? In short, no. In nonemergent circumstances, physicians are not obligated to provide care that they feel is not in their patients’ best interest. “First, do no harm” is the operative principle in these situations. It is important again to distinguish in these cases the negative and positive rights based on or related to the principle of respect for autonomy, and to recognize that the limits on positive rights may be greater than the limits on negative rights. For example, the positive right to request a particular treatment may be severely limited by appropriate clinical standards of care, physician judgment, or just allocation schemes. Clinicians should, however, be very cautious when making this claim and should only do so if absolutely convinced that no other options are available. This right to refuse to provide care is ripe for abuse because physicians can easily use this virtuous claim as a pretense not to provide care. Anesthesiologists should give additional information regarding the ramifications of the patient’s choice and inquire about reasons for the decision to see if they are based on fact or if goals can be achieved in another mutually satisfactory way. In nonemergency situations, and no mutually satisfactory answer is forthcoming, it is ethically reasonable to transfer care to another provider. The decision to consent to or refuse a procedure or treatment must also be contemporaneous with the current situation. This was discussed previously in terms of antenatal care plans and actually experiencing the pains of labor. The need for a contemporaneous decision was brought out in a 1991 Michigan case involving a patient who was a Jehovah’s Witness.73 This case focused on the issue of the timing of the consent process. Approximately two months before the patient was to deliver twins, she registered at her local hospital. In accord with the tenants of the Jehovah’s Witness faith, she signed a “refusal to permit blood transfusion” form. Her husband signed a second refusal form when she was admitted to the hospital to deliver the twins. After the delivery, the patient suffered extensive bleeding, and underwent a dilation and curettage procedure. When the bleeding still did not stop, the anesthesiologist ordered that the transfusion be administered, although he knew of the patient’s religious beliefs. J. Clin. Anesth., vol. 15, December 2003

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The patient and her husband subsequently sued the anesthesiologist for battery. The Trial Court in this case sided with the defendant, finding that the plaintiff had signed forms indicating her refusal to accept transfusions at a time when she was contemplating routine elective surgery, rather than at the time her condition was lifethreatening. An Appeals Court ruling sided with the Trial Court, finding that the plaintiff never stated that she did not want transfusions if they were necessary to save her life. The court held that, without contemporaneous refusal of treatment by a fully informed, competent adult patient, no action lies for battery. Although interesting in itself, this case illustrates the need for informed consent to be given at a time contemporaneous with the actual situation, illness, procedure, or treatment plan being faced. This may call into question the adequacy of some parts of the informed consent process during antenatal classes.

Emergency Situations and the Limits of Informed Consent One obvious situation in which the process of informed consent necessarily breaks down and is irrelevant is during true emergencies. Physicians and hospitals must act on the assumption that all reasonable patients want life-sustaining therapy. When treatment is necessary to save a patient’s life, a physician has a legally recognized duty to proceed. In these situations, the anesthesiologist needs to provide as much information as is practical, obviously prioritizing the information based on the expediency of the moment. The patient may or may not be capable or given a chance to enter fully into the consent process, ask questions, or even be able to signal consent or otherwise when prompt action is required, such as during an emergent caesarean section for fetal distress. Assessment of patient capacity to enter into the process of informed consent or competency to make rational medical decisions is a complicated issue. Much has been written on the criteria for determining individual capacity and the legally defined characteristic of “competency.”22,74 –77 Competency, unlike the decision-making capacity, is a legal term and an all-or-nothing concept specific to a given task. In the absence of a clear medical diagnosis such as delirium or unconsciousness, decisions regarding competency must be made with assistance from psychiatric services, ethics consult services, and/or legal counsel. In general, decisions must be made in these situations on the patient’s behalf, either by “substituted judgment” (a decision based on what the patient would have wanted, assuming some knowledge of what the patient’s wishes would have been) with or without the help of proxy consent or by a decision made according to the “best interests” of the patient on the basis of a balancing of a “benefit versus burdens” ratio. The appropriate hierarchy for surrogate decision makers is delineated in a provision of the Virginia Health Care Decisions Act. It must be remembered that the caregiver has an ethical obligation to evaluate the competency of the surrogate’s decisions 598


with regards to 1) lack of conflict of interest, 2) reliability of the evidence of the patient’s desires on which the surrogate is relying, 3) the surrogate’s knowledge of the patient’s own value system, and 4) the surrogate’s responsible commitment to the decision-making process.47 All these situations involve complex issues and, again, may require the assistance of hospital ethics committees or consult services.

Summary The principle of respect for autonomy, while probably lacking an adequate philosophical basis, has come to dominate medical ethics in America today and forms the basis for much of the thinking about informed consent. As thinking about medical ethics, and ethical theory in general, evolves we may encounter different paradigms for understanding the special and unique relationship that exists between patients and physicians that will further clarify the role of informed consent. The trend in modern medicine toward a business-like, consumer-oriented approach to medical care may, on the other hand, relegate the role of informed consent to a bare legal standard of care rather than an enhancement of the patient-physician encounter.78 Medical, philosophical, ethical, and legal issues are all intertwined in the informed consent process and can lead to conflicting viewpoints. Many practitioners view “true” informed consent as an impossible standard, an ethical “myth,” or something akin to the speed of light, i.e., you can approach it but never attain it. Yet, in its proper place, and aside from adversarial issues such as malpractice protection, informed consent can be the locus for providing a closer patient-physician relationship and greater involvement of the patient in his or her own care.

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