John C. Moskop, Ph.D.
In the more than forty years since its introduction into case law in the United States in 1957, the concept of informed consent has become a central topic in the disciplines of health law and bioethics, with a variety of works by leading scholars devoted to its evolution and interpretation [1-4].
Despite its importance, the duty to obtain the patient’s informed consent to treatment is not absolute - several exceptions are generally recognized and accepted. One prominent exception refers directly to emergency care. According to this emergency exception, if immediate treatment is required in order to prevent death or other serious harm to a patient, that treatment may be provided without informed consent. Aware of this exception, some emergency physicians might be tempted to conclude that informed consent need not play a significant role in their professional activities. Such a conclusion would, however, be seriously mistaken, as this article will attempt to show.
In a recent multi-center study of more than 6,000 ambulatory visits to U.S. emergency departments, fully 49% of the visits were assessed as non-urgent; the emergency exception would, therefore, not apply in these situations . Because emergency physicians are less likely to have an ongoing relationship with their patients than many other physicians, the formal process of providing information about treatment alternatives and obtaining explicit consent to treatment may actually be more important in the emergency department than in other practice settings. Since emergency department patients often have not had any control over the locus of care or the provider of their treatment, obtaining their informed consent may be the only readily available way to respect their autonomy as moral agents.
This article will offer a review of the doctrine of informed consent with particular attention to its role in the emergency department. The article will discuss the moral foundations, essential features, and exceptions to the informed consent requirement. Informed consent is an important concept in both therapy and clinical research in the emergency department. At the urging of emergency and critical care physicians, federal regulations were revised in 1996 to permit clinical research on certain life-threatening emergency conditions without informed consent . This article, however, will focus on informed consent to therapy.
Moral Foundations of Informed Consent
The doctrine of informed consent has roots in both law and ethics. In the law, informed consent serves as a vehicle for establishing duties of disclosure and for financially compensating patients for injuries suffered as a result of failure to disclose information about a treatment. Ethics, in turn, has encouraged a broader vision of informed consent as a mechanism for encouraging more active participation of patients in making decisions about their health care. Informed consent is widely recognized as a significant part of the patientphysician relationship because it fosters two fundamental values, patient well-being and patient autonomy.
Patient Well-Being. Acting for the benefit of patients has been a central goal of medicine and health care since antiquity. In their efforts to restore and protect health and to eradicate, ameliorate and prevent disability, disfigurement and suffering, physicians make important contributions to the overall well being of their patients. Patients rely on the expertise of their physician to identify those treatments that have the potential to benefit them. This is often a complex process, since different treatment alternatives may differ in their expected benefits, risks, and costs. What overall effect different treatments would have on a patient’s well-being may be far from obvious, and may depend heavily on how the patient weighs his or her own goals and values. Whether amputation or attempted reconstruction will best serve the well-being of a patient with severe injury of a limb, for example, will likely depend on the patient’s own attitudes and beliefs regarding disfigurement, physical function, pain and risktaking. While the physician has expert knowledge about the likely benefits and risks of different treatments, the patient is most knowledgeable about his or her own goals and values. Primary care physicians who have had a long-term relationship with a patient may already have a good understanding of the patient’s values and goals and be able to use that understanding in formulating treatment alternatives.
Emergency physicians, in contrast, are much less likely to have a prior relationship with emergency department patients, and are thus more dependent on the patient’s own expression of his or her values and goals in discussion and the patient’s application of those values to the choice at hand. Informed consent promotes patient well-being by requiring that (a) the physician inform the patient about a range of treatment alternatives and (b) allow the patient to choose the alternative he or she prefers on the basis of the likely consequences of that treatment in light of his or her own beliefs, values and goals.
Patient autonomy. Autonomy, understood as the ability to make and to carry out important decisions about one’s life, is a second fundamental moral value underlying the doctrine of informed consent. As noted in the previous paragraphs, respecting patient autonomy in the choice of medical treatment can have an important instrumental value, that is, it can be a means toward the promotion of patient wellbeing. In addition to its instrumental value, however, autonomy is recognized as a value in itself, apart from its consequences for wellbeing. Drawing on the ethical theory of Immanuel Kant, philosophers argue that the unique abilities of human beings to engage in moral reasoning and to make moral choices command our respect for those choices. Freedom of thought and action is also enshrined as a fundamental value in American law. Informed consent respects autonomy by giving mentally competent patients the freedom to choose among alternative treatments based on the likely effects of those treatments on their future lives. As noted above, respecting autonomy by securing the patient’s informed consent may be especially important in the emergency department since many emergency patients do not choose their care setting, and most do not choose their care provider.
Essential Features of Informed Consent
An effective informed consent is traditionally said to depend on three essential features or conditions. First, the patient must possess the appropriate capacity, or competence, to make the choice at hand. Second, the patient must be given information about treatment alternaalternatives sufficient to allow him or her to make an informed choice. Third, the patient must give consent to treatment voluntarily, without coercion or duress. Let us consider each of these three essential features of informed consent in turn.
Patient Capacity. In order to take an active role in choosing their medical treatment, patients must possess certain mental abilities. These attributes have been characterized in several different ways; the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, for example, identified them as follows:
(A) possession of a set of values and goals;
(B) the ability to communicate and to understand information, and
(C) the ability to reason and deliberate about one’s choices .
Why are these attributes essential for making health care decisions? Obviously, patients must be able to understand what treatments are available and what are their likely outcomes in order to make meaningful choices among them. They must also be able to deliberate about the various treatments and their consequences, weighing them against one another in order to choose one as best. To choose among treatment alternatives, one must assess them in relation to a set of values and goals -- without values or goals, one would have no grounds for preferring one outcome to any other. One must, also, of course, be able to communicate one’s understanding and one’s decision in some intelligible way.
Assuming that these are essential elements of capacity, how well developed must each be in order to render a patient able to give informed consent to treatment? There is, unfortunately, no single or simple answer to this question; the level of capacity necessary will, for several reasons, depend on each individual situation . First, treatment choices vary significantly in their complexity: a patient may be able to understand a relatively simple treatment choice, but not a much more complicated one. Second, the consequences of a treatment choice for a patient’s well-being may also vary significantly. We may, therefore, require that a patient demonstrate a high level of understanding and reasoning in order to accept the patient’s choice of an apparently dangerous treatment.
The terms "competent" and "incompetent" are often used to describe a patient as able or unable to give informed consent. Use of those terms in this context is somewhat different from their traditional use in the law. In the law, an adult who is no longer able to manage any of his or her affairs can be adjudicated incompetent by a court and can have a formal guardian appointed to make all decisions for him or her. Although some states recognize a distinction between general and specific incompetence, legal adjudication of incompetence is often a global determination. Clearly, some patients are globally mentally incapacitated and unable to participate in any decision about treatment. Many others, however, will be able to give consent for some, but not all treatment decisions.
Physicians must, therefore, assess whether an individual patient is able to give consent for a specific treatment. In some cases, the answer will be obvious - patients who are unconscious, in early childhood, profoundly mentally handicapped, or acutely psychotic are clearly unable to participate in treatment decisions. Other patients are just as clearly able to give effective consent to treatment. For a significant number of patients who seek care in emergency departments, however, assessment of capacity for consent is more difficult.
Consider, for example, the following case: thirty-five-year-old Ted Jones is brought to an urban emergency department one afternoon by his friend and companion, James Moore. Mr. Jones was diagnosed with HIV infection six years ago and with AIDS two years ago. He has had multiple medical problems over the past two years including several opportunistic infections. His presenting symptoms today are fever, cough, chest pain, and difficulty breathing. He appears tired and severely wasted, and reports a two-week history of fatigue and weight loss of 10 pounds. Despite his fatigue and discomfort, Mr. Jones is alert and oriented. He has difficulty counting backwards from 100 by sevens, and cannot accurately copy a geometric design. Mr. Moore, his companion, reports that Mr. Jones has become increasingly tired, forgetful, and unable to concentrate over the past six months. The emergency physician strongly suspects Pneumocystis carinii pneumonia [PCP] and requests a sputum sample for testing. Mr. Jones responds, however, that he does not want specific drug treatment for his pneumonia. He maintains that he is tired of living with AIDS and wants to be allowed to die. He adds that he came to the hospital only because the pain and difficulty breathing became too great and asks that he be given only treatments to make him comfortable. Mr. Moore asks that his companion be given definitive therapy for his lung condition. If Mr. Jones has PCP, the physician believes that prompt initiation of intravenous antibiotic treatment has a 70-80% chance of success. If Mr. Jones has PCP and it is left untreated, he will have progressive respiratory symptoms leading to death in a few days.
In this case, Mr. Jones expresses a desire not to receive a potentially life-prolonging treatment. Should this refusal of treatment be honored? Like many emergency department patients, his ability to understand his condition and evaluate treatment alternatives may be compromised by several factors, including pain, anxiety, confusion or depression. Other patients’ mental abilities may be influenced by intoxicant, sedative or narcotic drugs. Any of these factors may make patient understanding and reasoning more difficult, but not necessarily impossible. In some cases, relief of acute pain by narcotics may help patients to focus their attention and to understand treatment information. When emergency treatment is not immediately required, therefore, emergency physicians should discuss treatment alternatives with these patients and attempt to assess their mental capacity. Mental status exams can provide some basic information, but more important will be the patient’s ability to understand and deliberate about his or her actual treatment alternatives. Determination of capacity to consent will remain a clinical judgment based on the patient’s actual functioning and the complexity and seriousness of the treatment decision at hand . Given the serious consequences of Mr. Jones’ refusal of treatment for his pulmonary condition, physicians may require clear evidence that he understands his treatment options and their consequences, and clear reasons for his decision, before honoring that decision.
The involvement of older children and adolescents in treatment decisions raises several additional moral and legal issues . Traditionally, children have been viewed as unable to give legally effective consent for their own treatment, though psychologists claim that older children may be able to understand and reason about treatment choices at least as well as many adults. Consent by a parent or guardian is still typically legally required for treatment of a child. Most states, however, specifically authorize treatment of minor children for particular medical conditions, such as sexually transmitted diseases and substance abuse, without parental consent. Some states also provide mechanisms for the emancipation of older minors from parental control, and some allow "mature minors" to give legally effective consent for some medical treatments.
Information. The second essential feature of informed consent is the provision of appropriate information about treatment alternatives to the patient. Without information about treatment alternatives and their likely consequences, any choice among them will be blind at best. Brock lists the following broad kinds of information to be conveyed to patients:
(A) the patient’s current medical condition, including a future prognosis if no treatment is pursued;
(B) any treatment alternatives that might improve the patient’s condition and prognosis, including an explanation of the procedures involved, the significant risks and benefits of the alternatives, with their associated probabilities, and the financial costs of the alternatives; and
(C) a recommendation as to the best alternative .
How much information in each of the above categories must be given to the patient in order to satisfy informational requirements for a genuine informed consent? Two competing standards of disclosure have emerged in the law of informed consent; each has been adopted in a number of state jurisdictions. The older standard, known as the professional standard, bases disclosure of information on prevailing practice within the profession. According to this standard, the physician must disclose to the patient what most other physicians would disclose in similar circumstances. This standard gives the physician community control over what information should be disclosed, but has been criticized for paying insufficient attention to what patients themselves may want to know about treatment alternatives.
The second disclosure standard, called the reasonable person standard, gives greater emphasis to the perspective of patients. According to this standard, the physician must convey the information a reasonable person would want to know in order to make a decision in the given situation. This reasonable person standard depends less on expert testimony about customary disclosure practice and more on a jury’s assessment of what a reasonable person would want to know. Although the reasonable person standard does focus more on the perspective of patients, it does not require physicians to tailor their disclosure to each particular patient’s specific informational desires, but rather to what a hypothetical reasonable person would want to know. Thus, the physician is not required to discover the possibly idiosyncratic interests of individual patients, a task that might be especially difficult in the hectic emergency department environment. Instead, physicians may rely on professional standards of disclosure or on common expectations regarding what kinds of information are significant in making treatment decisions.
Some hospitals and emergency departments require patients to sign "blanket" consent forms agreeing to any diagnostic tests or treatments. Such consent procedures clearly do not satisfy informational requirements, since they provide little or no information about any specific treatments. Although they may express some generic willingness to accept treatment, their value, from both a moral and a legal point of view, appears to be somewhat limited.
Voluntariness. The third essential feature of a valid informed consent is that the patient’s choice of treatment be voluntary. Forced treatment is the antithesis of treatment based on an informed consent, and a coerced consent is consent in name only, not a morally or legally effective agreement. There are typically a variety of influences on a patient’s choice of treatment; some are legitimate and some are not. Physicians must, therefore, distinguish between permissible influences on patient choice and impermissible interference with freedom of choice.
The physician’s recommendation regarding treatment typically has a strong influence on the patient’s choice. That recommendation is not considered coercive, however, but rather an expected and usually desired kind of information and guidance. Physicians, family members, and others may also seek to secure a patient’s consent to treatment by means of rational persuasion, that is, arguments in support of a particular course of action. Persuasion is also a permissible influence on choice, provided that it is not so persistent as to result in capitulation by the patient to the persuader’s treatment preference out of fear or exhaustion.
There are, however, also morally impermissible influences on patient choice short of outright physical coercion. One such morally problematic influence is called manipulation. In the context of informed consent to treatment, manipulation refers to efforts by the professional obtaining consent to elicit a specific choice from the patient by limiting the information provided to the patient, "framing" the information in a specific way, or otherwise taking advantage of a weakness of the patient. Though less blatant than overt physical force, successful manipulation leaves the patient with no real choice among alternative treatments. Consent may also be obtained under duress, if the patient is threatened with unacceptable consequences for failure to consent to treatment. A physician might, for example, threaten to discharge an anxious patient from the hospital if he or she does not accept the treatment recommended by the physician. Like manipulation, an irresistible threat effectively robs the patient of any real choice among treatment alternatives.
In an article entitled "Patients Without Choices: The Ethics of Decision-Making in Emergency Medicine," philosopher Rosalind Ladd argues that the setting of the emergency department presents special difficulties for protecting and promoting patients’ freedom of choice . Ladd points out that many emergency patients do not choose their treatment site, but are routinely transported by Emergency Medical Services [EMS] personnel to the nearest emergency department. Of those who do transport themselves to the emergency department, many may do so because they lack health insurance and so have no obvious alternative source of health care. Inside the emergency department, care is often directed by institutional protocols designed to maximize the efficient operation of the department; individual patient preferences at variance with these protocols may not be honored, and patients in need of care may have little choice but to comply with "the system." Finally, Ladd argues that although the preservation of life and the prevention of suffering are both important goals of medicine, patients’ choices to forgo life-sustaining treatment may often be ignored or overridden in the emergency department in favor of a strong institutional preference for preserving life.
Ladd’s observations show how fostering the fundamental moral value of autonomy in the emergency department may come into conflict with other values, including efficiency and patient well-being. Because these are all important values, there is no obviously or uniquely correct way to strike a balance among them. Nevertheless, claims of autonomy should be taken seriously and given due consideration in the emergency department just as they are in non-emergency settings.
Exceptions to Informed Consent
Although informed consent to treatment is generally acknowledged as one of the most important rights of patients, there is also general agreement that the right is not absolute. Instead, several types of legitimate exceptions to the right of informed consent have been described and widely defended, including exceptions for emergencies, patients unable to consent, patient waivers of consent, public health requirements, and the so-called "therapeutic privilege" [2-4]. Each of these five types of exception will be considered in turn.
Emergencies. Most important for emergency physicians, of course, is the emergency exception to informed consent. According to this exception, informed consent to treatment need not be obtained "when immediate intervention is necessary to prevent death or serious harm to the patient". The emergency exception to informed consent is sometimes defended on the grounds that patients give "implied" or "tacit" consent to emergency treatment. This language may be somewhat misleading, since there is no genuine informed consent to treatment in these circumstances. Instead, this exception is based on a presumption that the patient would consent to treatment in order to preserve life or health, if he or she were able to do so and if there were sufficient time to obtain that consent.
This rationale suggests important limits to the emergency exception. First, the physician must judge that treatment is necessary to preserve life or prevent significant harm, such as disability or severe suffering. Second, the physician must judge that treatment cannot be safely delayed in order to obtain the patient’s informed consent. Third, the presumption that the patient would consent to treatment may be defeated by clear indications to the contrary, such as explicit refusal of treatment by a patient in the absence of any evidence that the patient lacks decision-making capacity. Situations in which patients in need explicitly refuse emergency treatment pose a very difficult choice for emergency physicians between the unattractive alternatives of forgoing beneficial treatment or forcing treatment on an apparently competent, unwilling patient. In these situations, physicians who honor refusal of treatment may choose to make clear to patients that their refusal is being respected against medical advice.
Some emergency situations may allow a kind of compromise between immediate treatment and obtaining informed consent. In these situations physicians may be able to honor the patient’s interest in decision-making by communicating basic information and obtaining the patient’s consent, even though time constraints dictate that some relevant information about risks or alternatives must be omitted.
Patients Unable to Consent
Obviously, there can be no moral or legal duty to obtain a patient’s informed consent to treatment when the patient is unable to give consent. Thus, care of patients who lack decision-making capacity may be provided without the patient’s informed consent. This exception does not, however, imply that no consent is necessary; rather, informed consent is ordinarily required from a surrogate acting on behalf of the patient. This requirement of surrogate consent raises additional questions about identifying an appropriate surrogate and defining the scope of the surrogate’s authority. Some surrogate decision makers are relatively easy to identify, as, for example, the legal guardians of persons adjudicated incompetent and the parents of minor children. In other cases, the most appropriate surrogate may be much more difficult to determine, as, for example, when a patient has a large immediate family or when a patient has no known living relatives. In these latter cases, physicians have great discretion and few clear standards regarding the choice of a surrogate from whom to seek consent .
Many commentators have articulated a hierarchy of substantive moral standards intended to guide the treatment choices of surrogates [2,11]. These standards direct surrogates to rely, first of all, on any treatment preferences specifically stated, either in writing or orally, by the patient before he or she lost decisionmaking capacity. Lacking such explicitly stated preferences, surrogates are directed to exercise "substituted judgment," that is, to use their knowledge of the patient’s preferences and values to choose that alternative that they believe the patient would choose, if he or she were able to choose. In some cases, patients have never been able to express any preferences or values. Surrogates in such situations are directed to rely on an assessment of the patient’s best interests, that is, what course of action is most likely to foster the patient’s overall well-being.
These substantive decision-making standards are important for physicians as well as surrogates, because they impose limitations on surrogates’ decisionmaking authority. Surrogates are given significant latitude in applying the above criteria, but where a surrogate’s treatment choice appears clearly contrary to a patient’s previously expressed wishes or best interests, the patient’s physician has a responsibility to question that choice. The physician may not override the surrogate’s decision unilaterally, but must instead bring the issue to an appropriate legal authority, such as a court or child protection agency, for review and adjudication.
Patient Waiver of Consent. Though we recognize that informed consent to treatment is a patient’s right, we do not, in most circumstances, assert that informed consent is also a patient’s duty. In other words, we allow patients to waive their right to receive the relevant information and give informed consent to treatment [1,3]. Some patients, despite their ability to give consent, request that someone else, usually a close relative, be given the appropriate information and make the treatment decision on their behalf. Other patients request that the physician not share information about treatment alternatives with them, but rather simply choose for them. The patient waiver exception allows physicians to honor these requests, provided that the patient is making the request competently, voluntarily, and with some understanding of the fact that he or she is giving up a right. In at least some cases, however, physicians may not wish to accept the responsibility of choosing among treatment alternatives on a patient’s behalf. Physicians should not feel obligated to accept this responsibility; they may instead ask the patient to make the choice or designate another willing person to do so. Public Health Requirements. Medical interventions are sometimes desirable not only, or even primarily, for the patient’s own benefit, but for the benefit of others. Emergency physicians may, for example, encounter patients with multidrug-resistant tuberculosis or other severe, highly contagious diseases. Public health statutes may, in such cases, authorize patient detention or treatment without the patient’s consent. This exception thus overrides individual patient autonomy in specific circumstances in order to protect important public health interests. Even though consent to treatment in such circumstances is not required, physicians should ordinarily explain to these patients the nature of the mandated treatment and the reasons for it .
Therapeutic Privilege. A final exception to informed consent is known by the somewhat mysterious name of "therapeutic privilege." According to this exception, a physician may withhold certain kinds of otherwise essential information about treatment alternatives from a patient if the physician judges that the disclosure of that information would in itself cause serious harm to the patient . Note that the anticipated harm must come from the disclosure itself, not from the potential influence that the information might have on the patient’s choice of treatment.
Despite its frequent mention as an exception to informed consent, the notion of therapeutic privilege has also been sharply criticized . Critics charge that it is extremely difficult to predict accurately that imparting information will cause significant harm, or be more harmful than withholding that information from the patient. If a patient’s mental state is so precarious that the patient will be unable to cope with material information about treatment choices, that circumstance in itself should raise serious questions about the patient’s capacity to give informed consent to treatment. Thus, the value of therapeutic privilege as an independent exception to informed consent may be quite limited.
Several general conclusions can be drawn from this review of the doctrine of informed consent and its role in the emergency department. Special features of emergency medical treatment make the discharge of informed consent responsibilities more complex in the emergency department than in other settings. Many emergency department patients are limited in their ability to make treatment choices. Emergency physicians must assess whether their patients possess sufficient capacity to give informed consent to treatment, often without a great deal of time, supporting information, or any prior knowledge of the patient. Recognized exceptions to the duty to obtain informed consent frequently arise in the emergency setting. Emergency physicians must, therefore, clearly understand the scope and limitations of such exceptions. Finally, the emergency department setting itself imposes a variety of restrictions on patient’s choices about where, by whom and how they will be treated. Emergency physicians thus face special challenges in demonstrating their respect for patient autonomy. Because the right to informed consent is a fundamental expression of respect for patient autonomy, it should be recognized as an essential feature of patient care in the emergency department, no less than in other treatment settings.
(This article is based on Moskop J. Informed consent in the Emergency Department. Emergency Medicine Clinics of North America 1999; 17:327-340.)
1. Appelbaum PS, Lidz CW, Meisel A: Informed Consent: Legal Theory and Clinical Practice. New York, Oxford University Press, 1987.
2. Brock DW: Informed consent. In: VanDeVeer D, Regan T [eds.]: Health Care Ethics: An Introduction. Philadelphia, Temple University Press, 1987, pp. 98-126.
3. Faden RR, Beauchamp TL, King NMP: A History and Theory of Informed Consent. New York, Oxford University Press, 1986.
4. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: Making Health Care Decisions [Vol. 1, report]. Washington, US Government Printing Office, 1982.
5. Young GP, Wagner MB, Kellerman AL et al.: Ambulatory visits to hospital emergency departments. JAMA 276:460-465, 1996.
6. Department of Health and Human Services, Food and Drug Administration: Protection of human subjects; informed consent and waiver of informed consent in certain emergency research; final rules. Federal Register 1996; 61:51498-51533.
7. Grisso T, Appelbaum PS: Assessing Competence to Consent to Treatment. New York, Oxford University Press, 1998.
8. Holder AR: The minor’s consent to treatment. In: Legal Issues in Pediatrics and Adolescent Medicine, ed 2. New Haven, Yale University Press, 1985, pp. 123-145.
9. Ladd RE: Patients without choices: The ethics of decision-making in emergency medicine. J Emerg Med 3:149-156, 1985.
10.American College of Emergency Physicians: Code of ethics for emergency physicians. Ann Emerg Med 30:365-372, 1997.
11.Hafemeister TL, Hannaford PL: Overview of the decisionmaking process. In: Resolving Disputes Over Life Sustaining Treatment: A Health Care Provider’s Guide. Williamsburg, Virginia, National Center for State Courts, 1996, pp. 9-20.