The Limits of Informed Consent

It will come as no surprise to anyone who has read this far to know that we are enthusiastic supporters of informed consent. We believe that entitlement to adequate information and the right to make choices about one’s medical treatment are fundamental ethical rights that are every bit as important in the healthcare arena as, for example, free speech and due process of law are in the wider society. Moreover, informed consent does not merely have deontological value. We have argued that, if done correctly, informed consent can often lead to better doctor-patient relationships, better patient adherence to treatment plans, and a fuller understanding of the disease process on the part of the healthcare provider. Yet it is also important to understand the limits of informed consent so we do not try to make it do what it cannot do. For example, although informed consent may help in managing treatment, by itself it does not cure illness. The claims that have been made for informed consent, however, are sometimes almost that extravagant. Informed consent has been suggested as the means to protect patients from poor care (1-3), including involuntary care (4), and as a means to improve the outcomes of care (5,6). It has been proposed as the solution to the problems of nursing homes (7) and as a device for compensating patients who are harmed by poor medical treatment (8). None of these are entirely specious ideas. Several of them, indeed, may be correct in part, but it is important for us to understand what informed consent cannot do as well as what it can. Just as free speech does not guarantee good government and due process of law does not guarantee justice, so too informed consent cannot solve all of the problems of the healthcare system. In this chapter we explore some of the limitations of informed consent. Specifically, we want to suggest four propositions. First, informed consent is a mechanism for improving communication and decision making among healthcare providers and patients.

Fulfilling the Underlying Purpose of Informed Consent to Research

To a great extent the underlying purposes of informed consent in research settings resemble those in the treatment situation. Informed consent promotes individuals’ autonomy by allowing subjects to make meaningful decisions about participation in research projects. Informed consent is also a means of reducing inequalities of knowledge and power in the researcher-subject relationship and thus increases the cooperation and compliance of subjects. Increased knowledge also enhances patients’ abilities to make decisions that will protect them from unwanted and undesirable intrusions on bodily integrity, perhaps of even greater importance here than in treatment settings, because of the sorry history of abuses inflicted on research subjects. As great as the similarities are between consent to treatment and consent to research, the differences are equally great. In treatment settings, as already noted, clinicians and patients are presumed to share the same goal: promoting patients’ health. They may disagree over the means, but a general coincidence of interests is ordinarily the rule. Charles Fried calls this confluence of interests the principle of personal care. “The traditional concept of the physician’s relation to his patient is one of unqualified fidelity to that patient’s health. He may certainly not do anything that would impair the patient’s health and he must do everything in his ability to further it”. The essence of this principle is that physicians will not allow any other considerations to impinge on their decisions as to what measures are in their patients’ best interests. Since the goal of scientific investigation is the production of generalizable knowledge, not primarily the promotion of individual health, the interests of subjects and researchers are not identical. Clinician-researchers who are providing treatment to subjects in their research studies may feel this clash of interests most acutely as steps taken to protect the generalizability of the data may conflict with the maximization of benefit to individual subjects (2). The need to take this conflict into account in the decisionmaking process is largely responsible for the differences between consent to research and consent to treatment.

Patients Who Refuse Treatment

From its inception, the law of informed consent has been based on two premises: first, that a patient has the right to receive sufficient information to make an informed choice about the treatment recommended; and second, that the patient may choose to accept or to decline the physician’s recommendation. The legitimacy of this second premise should be underscored because it is too often belied by the everyday language of medical practice. Getting a consent is medical jargon that implies that patient agreement is the only acceptable outcome. Indeed, the term informed consent itself suggests that patients are expected to agree to be treated rather than to decline treatment. Unless patients are viewed as having the right to say no, as well as yes, and even yes with conditions, much of the rationale for informed consent evaporates. Nonetheless, the medical profession’s reaction to patients who refuse treatment often has been less than optimal. The right to refuse treatment is frequently ignored in practice because it is inconsistent with the history and ethos of medicine (1,2). Physicians are trained to treat illness and to prolong life; situations in which they cannot do either—not because of limitations of knowledge or technology, but because patients or third parties reject their recommendations for care—evoke profound feelings of frustration and even anger. It would not be too much to suggest that these confrontations challenge an essential element of the medical identity. Physicians’ reactions to these situations are varied. Some will contend with patients over their refusal, while others, having assimilated a distorted version of patients’ right to refuse treatment, may too quickly abandon their patients to the consequences of their choices, thereby depriving them of the guidance for which patients traditionally have turned to their physicians. Regardless of the quality of care offered to patients or the degree of concern of those who treat them, some patients will have reasons of their own to decline treatment. Before considering how clinicians might respond to these situations, this chapter reviews the status of the law regarding treatment refusal, surveying a legal landscape that has seen dramatic changes in the last decade.

Managed Care and Informed Consent

In the last decade, American medicine has been transformed by a series of changes in the economic arrangements governing clinical practice that have come to be known genetically as “managed care.” Since the nature of these changes is complex and the process of evolution incomplete, managed care evades efforts at easy definition. However, it is probably fair to say, as Iglehart has, that “[a]ll forms of managed care represent attempts to control costs by modifying the behavior of doctors, although they do so in different ways”. Managed care’s alteration of some of the basic premises of the physicianpatient relationship, has raised serious questions about its effect on the doctrine of informed consent. To take but one example, if the physician is now subject to incentives from a managed care organization to decrease the amount and cost of care provided, would this information be material to the decision making of a reasonable patient? Should the law therefore require that such information be disclosed? If so, who should disclose this information, and when should the disclosure be made? At this stage, most of the questions that can be framed are, like this one, not susceptible to definitive answers from a legal or ethical perspective. But the potential impact of these new means of authorizing and paying for medical treatment is so substantial that there is value in laying out the issues to which jurists and legislators will have to respond, and in providing some initial guidance to clinicians and administrators. These are the goals of this chapter. To understand the changes wrought by managed care in the practice of medicine— and their possible relevance for informed consent law—one needs to begin by recalling the economic framework of medical care during the development of the doctrine of informed consent. With the growth of employer-provided health insurance following World War II, most middle-class Americans and their families were freed of the spectre of bankruptcy attending serious medical illness (2).

The Role of Informed Consent in Medical Decision Making

How can informed consent be integrated into the physician-patient relationship in a manner that is respectful of both the idea of informed consent and the imperatives of clinical care? A realistic answer to that question could, we believe, remove much of the resistance of many healthcare professionals to the idea of informed consent. This chapter’s goal is to offer a practical procedural framework within which clinicians can operate to facilitate patients’ decision making in a manner that meets both these desiderata. The interactions of physicians and patients in making decisions about medical treatment can be conceptualized in two ways. Decision making can be approached as an event that occurs at a single point in time (an “event model”), or it can be viewed as a continuous element of the relationship between patients and their caregivers (a “process model”). The implications of these different ways of conceptualizing decisions about treatment are quite profound, rooted as they are in distinct visions of the relationship between physicians and patients. The event model of informed consent is predicated on a relatively simple paradigm. A patient seeking medical care approaches a physician for assistance. After assessing the patient’s condition, the physician reaches a diagnosis and formulates a recommended plan of treatment. The physician’s conclusions and recommendations are presented to the patient, along with information concerning the risks and potential benefits of the proposed treatment, and possible alternatives and their risks and potential benefits. Weighing the available data, the patient reflects on the relative risks and benefits of each course of action and then selects the medically acceptable alternative that most closely fits the patient’s particular values. On the surface at least, the event model conforms well to the legal requirements for informed consent. The event model emphasizes the provision of full and accurate information to patients at the time of decision making. Consent forms are often used for this purpose; indeed, the consent form can be said to be the central symbol of the event model (see Chapter 9). Patients’ understanding, although desirable in the abstract, is less crucial to this model than is the provision of information.

Legal Rules for Recovery

This chapter deals with the legal theory and procedural framework under which patients can obtain redress for their injuries resulting from treatment administered in the absence of informed consent. The evolution of the legal doctrine was driven by the demands of patients for redress for injuries, and more attention has been given by courts and legislatures to the questions of when and how compensation might be obtained than to providing guidance for clinicians. In some important respects, the distinction between the law as it applies to the physician engaged in medical decision making with a patient and the law as it applies to that same patient who later seeks compensation in the courts is an artificial one. Insofar as the spirit of informed consent is not embraced voluntarily by the medical profession, but is adhered to in large part to avoid the likely consequences of failure to observe the legal rules, physician behavior will be shaped not only by the rules themselves but also by the way they are enforced. If, for example, the rules governing the means of redress were complex, time-consuming, and unlikely to yield the desired compensation, few injured patients would pursue a judicial remedy. As a result, physicians would eventually realize that adverse consequences were unlikely to follow from a failure to observe the relevant rules and, except to the extent that they had accepted the ethical theory of informed consent, their adherence to the doctrine would crumble. Some critics of the present system contend that this has already happened (see Chapter 7). On the other hand, rules that make recovery easier and more certain would be likely to encourage compliance with the requirements for informed consent. Differential emphasis by the courts on particular kinds of lapses by clinicians might also shape their actions accordingly. For example, the courts’ focus on risk information has led many physicians to tailor disclosure to emphasize risks. Thus, the issues addressed in this chapter, although framed in legal terminology, are important (some would argue crucial) determinants of the ultimate impact of informed consent.

The Concept and Ethical Justification of Informed Consent

The values underlying informed consent—autonomy and concern for individual well-being—are deeply embedded in American culture, in our religious traditions, and in Western moral philosophy. It is not surprising that informed consent is a cornerstone doctrine of contemporary medical ethics and health law in the United States. There is widespread agreement about the importance of the concept, goals, and practice of informed consent. Even when there are differences of opinion about the best way to implement informed consent in clinical practice, or when there is debate about the core meaning of the concept, the attention paid to these controversies only reinforces recognition of the importance of informed consent in contemporary health care and medical research. The concept of informed consent has multiple meanings and draws its ethical justification from several sources. Some consider informed consent to be synonymous with the ideal of shared decision making between physician and patient, or at least to embody this ideal (1). Others emphasize that informed consent is a particular sort of decision made by a particular sort of decision maker (2). Still others focus on informed consent as a norm-governed social practice that is embedded in social institutions, specifically law and medicine. This chapter discusses these different but often overlapping conceptions of informed consent. From a patient’s perspective, informed consent appears to be a right, while from the physician’s viewpoint, it is a duty or obligation. In fact, informed consent imposes responsibilities on both patient and physician. The relationship between ethical rights and duties, as well as the possibility of conflict between them, form another topic of this chapter. In this chapter we also discuss the ethical values and goals that underlie informed consent. Informed consent is grounded in some of the ethical values most prized in American society and Western ethical thought, especially autonomy— auto from the Greek word for self, and nomos from the Greek for rule—literally “self-rule.” It is interesting to observe how the fundamental goals of informed consent usually coincide, but sometimes conflict, both in theory and as manifest in particular cases.

Informed Consent: Framing the Questions

What is informed consent? The answer may seem self-evident only to those who have yet to explore the many meanings of the term. Informed consent refers to legal rules that prescribe behaviors for physicians and other healthcare professionals in their interactions with patients and provide for penalties, under given circumstances, if physicians deviate from those expectations; to an ethical doctrine, rooted in our society’s cherished value of autonomy, that promotes patients’ right of self-determination regarding medical treatment; and to an interpersonal process whereby these parties interact with each other to select an appropriate course of medical care. Informed consent is each of these things, yet none of them alone. As a theory based on ethical principles, given effect by legal rulings and implemented by clinicians, it has been haunted by its complex lineage. When legal principles and ethical values conflict, which should take precedence? When clinical interests appear to be served by neither legal nor ethical concerns, which interests should be compromised and to what degree? The vast literature on informed consent, found in journals and books of medicine, law, bioethics, philosophy, and public policy, has been stimulated by the need to create a workable doctrine that can accommodate values that to many observers are in an irremediable state of conflict. The conflicts in theory and the need to resolve them in practice are the subjects of this book. Theory is the focus of the first half of the volume; practice is the topic of the second. Seeking to understand the fascinating theoretical problems requires us to grapple with some of the most difficult ethical and policy issues facing our society today. But let us state at the outset our belief that the clinician on the front lines need not be paralyzed by differences of opinion among legal and ethical theorists. Through the vaguely translucent wall of expertise behind which the discussion about the proper shape of the informed consent doctrine has taken place, a reasonable approach to informed consent in the clinician-patient relationship can be discerned. Our most important and challenging task in this book is to make that approach evident.

Exceptions to the Legal Requirements: Incompetence

It might seem strange to locate discussion of incompetence under the heading of “exceptions.” Although patient competence serves as a prerequisite for informed consent, surely patient incompetence cannot serve to relieve physicians of all obligations, either ethical or legal, under the doctrine of informed consent. The goals of informed consent—safeguarding patient welfare and autonomy—apply no less to incompetent patients, although they must be pursued differently. The goals of informed consent are pursued on behalf of an incompetent patient by a process of surrogate decision making. A surrogate or proxy participates in the informed consent process on behalf of the incompetent patient. Yet, from the perspective of the physician, the patient’s incompetence constitutes an exception to the usual process of informed consent. A determination of incompetence alters the legal requirements for physician disclosure and for patient consent and thus it is properly regarded as an exception in this sense. This chapter, like the previous two, focuses on the legal doctrine of informed consent and addresses the variation in the legal requirements occasioned by a patient’s incompetence. We leave to others to examine in greater detail the ethical justifications for the legal framework surrounding treatment of incompetent patients (3). It has been recognized since the earliest legal cases dealing with consent that certain individuals are incompetent to consent to treatment and that they may be treated without their consent (4,5). One alternative to treatment without the patient’s consent would be no treatment at all (6), a result that would make a fetish of consent, for it would mean that those lacking the ability to make medical decisions would be required to forgo medical care. The exception for incompetent patients is closely related to the emergency exception. In fact, many situations involve an overlap of the two exceptions, since a number of cases of genuine emergency treatment involve unconscious (and thus incompetent) patients. However, the class of incompetent patients includes more than just those who are unconscious, and situations arise involving the treatment of incompetent patients that are not emergencies.

Exceptions to the Legal Requirements: Emergency, Waiver, Therapeutic Privilege, and Compulsory Treatment

In the preceding chapter we spoke of the requirement for informed consent in absolute terms, as something that was an invariable component of medical decision making. Over the years, courts have come to recognize that there are a number of situations in which physicians are permitted to render treatment without patients’ informed consent. Even under the earlier simple consent requirement, consent to treatment was not required in all situations. There are different kinds of situations in which requiring disclosure and obtaining consent could be detrimental to the patient, such as in an emergency or when the disclosure itself would harm the patient, and therefore in these situations informed consent is not required. Patients may also waive, or give up, the right to be informed and/or to consent. Here the concern is not with promoting health values but with promoting autonomy. Informed consent may also be dispensed with in a fourth set of cases, those of legally required treatment, in which the harm from requiring informed consent is not necessarily to the patient (or the patient alone) but to other important societal interests (e.g., civil commitment of the dangerous mentally ill—see Chapter 11—or forced treatment of patients with infectious disease). In addition, informed consent requirements are modified when a patient is incompetent (see Chapter 5). Each of these exceptions contains the potential for undermining the values sought to be implemented by the informed consent doctrine: self-determination and informed decision making. Exceptions that are too broadly defined and applied are a threat to these values. On the other hand, these exceptions are an important vehicle for the interjection into the decisionmaking process of another set of values, society’s interest in promoting the health of individuals. When judiciously defined and applied, the exceptions accord health-related values their due. However, the exceptions can be, and sometimes have been, defined so broadly as to dilute, if not dissolve, the fundamental duties imposed by the doctrine and to undermine its essential purpose of assuring patient participation in medical decision making (1).