Informed Consent: V. Legal and Ethical Issues of Consent in Healthcare

views updated


This article, by Jay Katz, is reprinted from the first edition, where it carried the title "Informed Consent in the Therapeutic Relationship: II. Legal and Ethical Aspects." It is followed immediately by a "Postscript," prepared by Angela R. Holder for purposes of updating the original article.

The doctrine of informed consent, introduced into U.S. case law in 1957, represents judges' groping efforts to delineate physicians' duties to inform patients of the benefits and risks of diagnostic and treatment alternatives, including the consequences of no treatment, as well as to obtain patients' consent (Salgo v. Stanford University, 1957). The doctrine's avowed purpose was to protect patients' right to "thoroughgoing self-determination" (Natanson v. Kline, 1960). The legal implications of informed consent, however, remain unclear. The doctrine is in fact more of a slogan, which judges have been too timid or too wise to translate into law, at least as yet. It has been employed with little care but great passion to voice a dream of personal freedom and individual dignity. Though its legal impact in protecting patients' right to self-decision making has been scant, the threat of informed consent has opened profound issues for the traditional practice of medicine.

The Medical Framework

It has been insufficiently recognized, particularly by judges, that disclosure and consent, except in the most rudimentary fashion, are obligations alien to medical practice. Hippocrates' admonitions to physicians are still followed today: "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." Thus it is not surprising that the Hippocratic oath is silent on the duty of physicians to inform, or even converse with, patients. Similarly Dr. Thomas Percival, whose 1803 book Medical Ethics influenced profoundly the subsequent codifications of medical ethics in England and the United States, commented only once on the discourse between physicians and patients, restricting his remarks to "gloomy prognostications." Even in that context he advised that "friends of the patient" be primarily informed, though he added that the patient may be told "if absolutely necessary" (Percival, p. 91). The Code of Ethics of the American Medical Association, adopted in 1847, and the Principles of Medical Ethics of the American Medical Association, adopted in 1903 and 1912, repeat, in almost the same words, Percival's statement. The AMA Principles of Medical Ethics, endorsed in 1957, delete Percival's wording entirely and substitute the vague admonition that "physicians … should make available to their patients … the benefits of their professional attainments." The pertinent sections of the Opinions of the Judicial Council of the AMA, interpreting the principles, note only the surgeon's obligation to disclose "all facts relevant to the need and performance of the operation" and the experimenter's obligation, when using new drugs and procedures, to obtain "the voluntary consent of the person" (American Medical Association Judicial Council). Nine years later, the AMA House of Delegates in endorsing, with modifications, the Declaration of Helsinki, asked that investigators, when engaged "in clinical [research] primarily for treatment," make relevant disclosures to and obtain the voluntary consent of patients or their legally authorized representative.

Thus in the context of therapy no authoritative statement encouraging disclosure and consent has ever been promulgated by the medical profession. The AMA's tersely worded surgical exception was compelled by the law of malpractice. Its experimental exception represented primarily an acquiescence to the U.S. Public Health Service and the U.S. Department of Health, Education, and Welfare requirements, which in turn were formulated in response to congressional concerns about research practices. When disclosure and consent prior to the conduct of therapeutic research were endorsed by the AMA, it did not extend those requirements to all patient care but limited the exception to "clinical [research] primarily for treatment."

Two significant conclusions can be drawn: (1) Informed consent is a creature of law and not a medical prescription. A duty to inform patients has never been promulgated by the medical profession, though individual physicians have made interesting, but as a rule unsystematic, comments on this topic. Judges have been insufficiently aware of the deeply ingrained Hippocratic tradition against disclosure and, instead, seem to have assumed that individual physicians lack of disclosure was aberrant with respect to standard medical practice, and hence negligent, in the sense of forgetful or inadvertent, conduct. (2) When judges were confronted with claims of lack of informed consent, no medical precedent, no medical position papers, and no analytic medical thinking existed on this subject. Thus physicians were ill prepared to shape judges' notions on informed consent with thoughtful and systematic positions of their own.

The Legal Framework

With the historical movement from feudalism to individualism, consent, respect for the dignity of human beings, and the right of individuals to shape their own lives became important principles of English common law and, in turn, of American common law. Yet, as these principles gained greater acceptance, questions arose in many areas of law about the capacity of human beings to make their own decisions and about the need to protect them from their own "folly." The tug of war between advocates of thoroughgoing self-determination and those of paternalism has continued unabated. The informed-consent doctrine manifests this struggle. While in physician-patient interactions the legal trend during the past two decades has been to increase somewhat the right of patients to greater freedom of choice, the informed-consent doctrine has not had as far-reaching an impact on patients' self-determination as many commentators have assumed. This fact has been insufficiently appreciated and has led to confusion, further compounded by the courts' rhetoric that seemed to promise more than it delivered.

Consent to medical and surgical interventions is an ancient legal requirement. Historically an intentional touching without consent was adjudicated in battery. The law has not changed at all in this regard, and a surgeon who operates on a patient without permission is legally liable, even if the operation is successful. In such instances any inquiry into medical need or negligent conduct becomes irrelevant, for what is at issue is the disregard of the person's right to exercise control over his body. The jurisprudential basis of these claims is personal freedom:

… under a free government at least, the free citizen's first and greatest right, which underlies all others—the right to himself—is the subject of universal acquiescence, and this right necessarily forbids a physician or surgeon, however skillful or eminent … to violate without permission the bodily integrity of his patient by … operating on him without his consent.… (Pratt v. Davis, 1906)

But what does consent mean? In battery cases it means only that the physician must inform the patient what he proposes to do and that the patient must agree. Medical emergencies and patients' incompetence are the only exceptions to this requirement.

In mid-twentieth century, judges gradually confronted the question whether patients are entitled not only to know what a doctor proposes to do but also to decide whether the intervention is advisable in the light of its risks and benefits and the available alternatives, including no treatment. Such awareness of patients' informational needs is a modern phenomenon, influenced by the simultaneous growth of product liability and consumer law.

The law of fraud and deceit has always protected patients from doctors' flagrant misrepresentations, and in theory patients have always been entitled to ask whatever questions they pleased. What the doctrine of informed consent sought to add is the proposition that physicians are now under an affirmative duty to offer to acquaint patients with the important risks and plausible alternatives to the proposed procedure. The underlying rationale for that duty was stated in Natanson v. Kline:

Anglo-American law starts with the premise of thorough-going self-determination. It follows that each man is considered to be master of his own body, and he may, if he be of sound mind, expressly prohibit the performance of life-saving surgery, or other medical treatment. A doctor might well believe that an operation or form of treatment is desirable or necessary but the law does not permit him to substitute his own judgment for that of the patient by any form of artifice or deception. (Natanson v. Kline)

The language employed by the Natanson court in support of an affirmative duty to disclose derives from the language of the law of battery, which clearly makes the patient the ultimate decision maker with respect to his body. Thus the courts reasoned, with battery principles very much in mind, that significant protection of patients' right to decide their medical fate required not merely perfunctory assent but a truly informed consent, based on an adequate understanding of the medical and surgical options available to them.

Yet in the same breath judges also attempted to intrude as little as possible on traditional medical practices. In doing so their impulse to protect the right of individual self-determination collided with their equally strong desire to maintain the authority and practices of the professions. Law has always respected the arcane expertise of physicians and has never held them liable if they practiced "good medicine." The law of consent in battery represented no aberration from this principle since most physicians agree that patients at least deserve to know the nature of the proposed procedure. However, the new duty of disclosure that the law, in the name of self-determination, threatened to impose upon physicians was something quite different. For the vast majority of physicians significant disclosure is not at all part of standard medical practice. Most doctors believe that patients are neither emotionally nor intellectually equipped to be medical decision makers, that they must be guided past childish fears into rational therapy, and that disclosures of uncertainty, gloomy prognosis and dire risks often seriously undermine cure. Physicians began to wonder whether law was now asking them to practice "bad" medicine.

In the early informed-consent cases, judges simply did not resolve the conflict between self-determination and professional practices and authority. The result was distressing confusion. In obeisance to the venerable ideal of self-determination, courts purported to establish, as a matter of law, the physician's

… obligation … to disclose and explain to the patient in language as simple as necessary the nature of the ailment, the nature of the proposed treatment, the probability of success or of alternatives, and perhaps the risks of unfortunate results and unforeseen conditions within the body. (Natanson v. Kline)

The threat of such an obligation greatly disturbed the medical profession. It recognized that serious implementation of such a standard would significantly alter medical practice. Physicians argued that in order fully to serve patients' best interests, they must have the authority to exercise medical judgment in managing patients. Courts likewise bowed to this judgment. In the very sentence that introduced the ambiguous but exuberant new phrase "informed consent," the court showed its deference to medical judgment and its hesitancy to disturb traditional practice:

… in discussing the element of risk a certain amount of discretion must be employed consistent with the full disclosure of facts necessary to an informed consent. (Salgo v. Stanford University)

Thus the extent to which evolving case law, under the banner of individualism, was challenging traditional medical practice—which for millennia has treated patients paternally as children—remained confusing. In those earlier cases (Salgo v. Stanford University, Natanson v. Kline) judges were profoundly allegiant to both points of view, but the balance was soon tipped decisively in favor of protecting medical practices.

BATTERY OR NEGLIGENCE. The striking ambivalence of judges toward the doctrine of informed consent manifested itself in the competition between battery and negligence doctrines as a means of analyzing and deciding the claims of lack of informed consent. Battery offered a more rigorous protection of patients' right to self-determination. The inquiry into disclosure and consent would not be governed by professional practices but instead would rest on the question: Has the physician met his expanded informational responsibility so that the patient is able to exercise a choice among treatment options? A negative answer to this question would show that the physician's actions constitute trespass, rendering him liable for an unauthorized and offensive contact (Dow v. Kaiser Foundation).

However, in virtually every jurisdiction judges resolved the competition in favor of negligence law. In doing so, judges were able to defer to medical judgment by evaluating the adequacy of disclosure against the medical professional standard of care, asserting that this standard will govern those duties as it does other medical obligations. As a consequence, physicians remain free to exercise the wisdom of their profession and are liable only for failure to disclose what a reasonable doctor would have revealed. Furthermore, negligence theory does not redress mere dignitary injuries, irrespective of physical injuries, and requires proof that the patient, fully informed, would have refused the proposed treatment. Interferences with self-determination, standing alone, are not compensated.

In rejecting battery, judges made much of the fact that such an action required intent, while negligence involved inadvertence; it was the latter, they believed, that accounted for the lack of disclosure. They overlooked that the withholding of information on the part of physicians is generally quite intentional, dictated by the very exercise of medical judgment that the law of negligence seeks to respect. In stating that the nondisclosures were collateral to the central information about the nature of the proposed procedure and hence not required for a valid consent, judges discarded the very idea of informed consent—namely, that absence of expanded disclosure vitiates consent. They refused to extend the inquiry to the total informational needs of patients, without which patients' capacity for self-decision making remains incomplete. At bottom, the rejection of an expanded battery theory and of its proposed requirement of informed consent followed from the threat they posed to the authority of doctors and traditional medical practice.

Thus informed consent, based on patients thoroughgoing self-determination, was a misnomer from the time the phrase was born. To be sure, a new cause of action has emerged for failure to inform of the risks of, and in most jurisdictions alternatives to, treatment. Some duty to disclose risks and alternatives, the courts were willing to say, exists; the extent of that duty is defined by the disclosure practice of a reasonable physician in the circumstances of the case. The new claim is firmly rooted in the law of negligent malpractice, in that plaintiffs are still required to prove the professional standard of care by means of medical expert witnesses. In these, the majority of jurisdictions, traditional medical practice—which generally opposes disclosure—has scarcely been threatened at all in legal reality. The legal life of informed consent, except for dicta about self determination and the hybrid negligence law promulgated in a handful of jurisdictions, was almost over as soon as it began. Judges had briefly toyed with the idea of patients' self-determination and then largely cast it aside. Good medicine, as defined by doctors, remains good law almost everywhere.

MODIFICATIONS IN PROFESSIONAL STANDARD OF CARE. In a few jurisdictions, beginning in 1972 in the District of Columbia with the decision in Canterbury v. Spence, the new cause of action for failure to inform combined elements of battery with negligence, creating a legal hybrid. The court purported to abandon the professional standard of care with respect to disclosure, asserting that

… respect for the patient's right of self-determination on particular therapy demands a standard set by law for physicians rather than one which physicians may or may not impose upon themselves. (Canterbury v. Spence)

Thus the court laid down a judge-made rule of disclosure of risks and alternatives, which for all practical purposes resembled an expanded battery standard of disclosure.

The preoccupation with risk disclosure, however, continued unabated. From the very beginning, despite all the talk about informed consent, judges did not lay down any rules for a careful inquiry into the nature and quality of consent, which on its face any meaningful implementation of the doctrine required. Instead major emphasis was placed on risk disclosures. Since in the cases before courts plaintiff-patients only complained of the injurious results of treatment, this emphasis is understandable. Yet to focus solely on risks is to bypass the principal issue of self-determination— namely, whether the physician kept the patient from arriving at his own decision. The Canterbury court, too, restricted its concerns largely to risk disclosures and added the requirement that

an unrevealed risk that should have been made known must materialize for otherwise the omission, however, unpardonable, is legally without consequence. (Canterbury v. Spence)

Thus the court foreclosed legal redress for the patient who, fully informed of the potential effects of, for example, a maiming operation, would have chosen an alternative medical course, even though some of the risks did not materialize.

But to the extent these jurisdictions have abandoned the professional standard of disclosure, traditional medical practice has been challenged; "good medicine," in the eyes of the profession, may no longer be a sufficient defense. Seemingly, in these jurisdictions self-determination has begun to encroach upon the province of medical paternalism. That encroachment, however, may be substantially an illusion, for the touted abandonment of the professional standard of disclosure in Canterbury was far from complete. Medical judgment to truncate full disclosure must be "given its due," the court said, when "it enters the picture." The court left ambiguous when the plaintiff must establish the appropriate standard of disclosure by an expert witness, or when he must produce such a witness in order to rebut a defendant-physician's claim that good medical judgment was exercised.

What is clear is that the physician has a therapeutic privilege not to disclose information where such disclosure would pose a threat to the well-being of the patient. But the ambit of this privilege as well as the relationship of its invocation to a directed verdict is not clear, and this for "good" reasons: Even in these most liberal jurisdictions with respect to patients' rights, courts still cannot face squarely the question of how much they are willing to challenge the traditional medical wisdom of nondisclosure. The law remains ambiguous with respect to this, the core issue of informed consent.

TENSIONS BETWEEN SELF-DETERMINATION AND PATERNALISM. Beyond its allegiance to medical paternalism, noted above, the Canterbury court showed its preference for paternalism in another way. Under negligence law, the courts have stated that lack of disclosure cannot be said to have caused the patient's injury unless the patient, if adequately informed, would have declined the procedure; this is the crucial problem of causation in informed-consent cases. Such an approach to causation is quite appropriate where law seeks not to compensate interference with self-determination, but only physical injuries resulting from inadequate disclosure. Yet the Canterbury court, and every court that has considered the matter subsequently, held that the decision whether or not to undertake therapy must be examined not from the point of view of the patient-plaintiff but from that of a "prudent person in the patient's position," limiting the inquiry to whether a "reasonable patient" would have agreed to the procedure. This substitution of a community standard of a "reasonable" person cuts the heart out of the courts purported respect for individual self-determination. Questions of the influence of hindsight and bitterness are familiar to juries, as is the problem of self-serving testimony generally. While those are delicate problems, they do not justify abrogating the very right at issue in cases of informed consent: the right of individual choice, which may be precisely the right to be an "unreasonable" person.

EPILOGUE ON LAW. Thus law has proceeded feebly toward the objective of patients' self-determination. While a new cause of action, occasionally hybridized with battery, has emerged for the negligent failure to disclose risks and alternative treatments, it remains a far cry from the avowed purpose of the informed-consent doctrine, namely, to secure patients' autonomy and right to self-determination. In not tampering significantly with the medical wisdom of nondisclosure, yet creating a new cause of action based on traditional disclosure requirements, courts may have accomplished a different result, very much in line with other purposes of tort law—namely, to provide physically injured patients with greater opportunities for seeking compensation whenever it can be argued that disclosure might have avoided such injuries. In doing so judges may have hoped, through the anticipatory tremors of dicta, to urge doctors to consider modifying their traditional disclosure practices. But judges have been unwilling, at least as yet, to implement earnestly patients' right to self-determination.

Whither Informed Consent?

The disquiet that the doctrine of informed consent has created among physicians cannot be fully explained by the small incremental step courts have taken to assure greater patient participation in medical decision making. More likely it was aroused by the uncertainty over the scope of the doctrine and by an appreciation that medical practice, indeed all professional practice, would be radically changed if fidelity to thoroughgoing self determination were to prevail. In what follows, some of the issues raised by the idea of an informed-consent doctrine, based on a premise of self-determination, will be discussed.

PATIENTS. Traditionally patients have been viewed as ignorant about medical matters, fearful about being sick, childlike by virtual of their illness, ill-equipped to sort out what is in their best medical interest, and prone to make decisions detrimental to their welfare (Parsons). Thus physicians have asserted that it makes little sense to consult patients on treatment options: far better to interact with them as beloved children and decide for them. In the light of such deeply held convictions, many physicians are genuinely puzzled by any informed-consent requirement. Moreover, its possible detrimental impact on compassion, reassurance, and hope—ancient prescriptions for patient care—has raised grave ethical questions for the medical profession.

Those concerns should not be dismissed lightly. What may be at issue, however, is not an intrinsic incapacity of patients to participate in medical decision making. For not all patients, and probably not even most, are too uneducated, too frightened, or too regressed to understand the benefits and risks of treatment options available to them. Moreover, their capacities for decision making are affected to varying degrees, for example, by the nature of the disease process, its prognosis, acuteness, painfulness, etc., as well as by the personality of patients. The medical literature is largely silent on the question of who—under what circumstances and with what conditions—should or should not be allowed to participate fully in medical decision making.

But why has not the sorting-out process, distinguishing between those patients who do and those who do not have the capacity for decision making, been undertaken long ago? One answer suggests itself: Once those patients have been identified who, in principle, can make decisions on their own behalf, physicians would be compelled to confront the questions of whether to interact with them on a level of greater equality; whether to share with them the uncertainties and unknowns of medical diagnosis, treatment, and prognosis; and whether to communicate to them their professional limitations as well as the lack of expert consensus about treatment alternatives. Such an open dialogue would expose the uncertainties inherent in most medical interventions; and to the extent medicine's helpful and curative power depends on the faith and confidence which the physician projects, patients may be harmed by disclosure and consent.

Physicians' objections to informed consent, therefore, may have less to do with the incompetence of patients as such than with un unrecognized concern of the doctrine's impact on the dynamics of cure. Put another way, the all too sweeping traditional view of patients has misled doctors into believing that medicine's opposition to informed consent is largely based on patients' incompetence, rather than on an apprehension, however dimly perceived, that disclosure would bring into view much about the practice of medicine that physicians seek to hide from themselves and their patients; for example, the uncertainties and disagreements about the treatments employed; the curative impact of physicians' and patients' beliefs in the unquestioned effectiveness of their prescriptions rather than the prescriptions themselves; the difficulty in sorting out the contributions that vis medicatrix naturae ("the healing power of nature") makes to the healing process; the impact of patients' suggestibility to cure, etc. Thus the question: When does informed consent interfere with physicians' effectiveness and with the dynamics of cure?

Little attention has been paid to the fact that the practice of Hippocratic medicine makes patients more incompetent than they need be. Indeed patients' incompetence can become a self-fulfilling prophecy as a consequence of medical practices. That the stress of illness leads to psychological regression, to chronologically earlier modes of functioning, has been recognized for a long time. Precious little, however, is known about the contributions that physicians' attitudes toward and interactions with their patients make to the regressive pull. Also, little is known about the extent to which regression can be avoided by not keeping patients in the dark, by inviting them to participate in decision making, and by addressing and nurturing the intact, mature parts of their functioning. This uncharted territory requires exploration in order to determine what strains will be imposed on physicians and patients alike, if Anna Freud's admonition to students of the Western Reserve Medical School is heeded:

… you must not be tempted to treat [the patient] as a child. You must be tolerant toward him as you would be toward a child and as respectful as you would be towards a fellow adult because he has only gone back to childhood as far as he's ill. He also has another part of his personality which has remained intact and that part of him will resent it deeply, if you make too much use of your authority. (quoted in Katz, p. 637)

PHYSICIANS. Traditionally physicians have asserted that their integrity, training, professional dedication to patients' best medical interests, and commitment to "doing no harm" are sufficient safeguards for patients. The complexities inherent in medical decision making, physicians maintain, require that trust be patients' guiding principle. The idea of informed consent does not question the integrity, training, or dedication of doctors. Without them, informed consent would be of little value. What the idea of informed consent does question is the necessity and appropriateness of physicians' making all decisions for their patients; it calls for a careful scrutiny of which decisions belong to the doctor and which to the patient.

Physicians have preferences about treatment options that may not necessarily be shared by patients. For example, no professional consensus exists about the treatment of breast cancer. The advantages and disadvantages of lumpectomy, simple mastectomy, radical mastectomy, radiation therapy, chemotherapy, and various combinations among these are subject to much controversy. Dr. Bernard Fisher, chairman of the National Surgical Adjuvant Breast Cancer Project, has said that we simply do not know which method is best (Fisher). Thus the question must be answered: How extensive an opportunity must patients be given to select which alternative? Informed consent challenges the stereotypical notion that physicians should assume the entire burden of deciding what treatment all patients, whatever their condition, should undergo. Indeed, can the assumption of this burden be defined purely on medical grounds in the first place? Is not the decision in favor of one treatment for breast cancer over another, like many other treatment decisions, a combination of medical, emotional, aesthetic, religious, philosophical, social, inter-personal, and personal judgments? Which of these component judgments belong to the physician and which to the patient?

Much needs to be investigated in order to learn the practical human limits of any new obligations to disclose and to obtain consent:

  1. Informing patients for purposes of decision making requires learning new ways of interacting and communicating with patients. Such questions as the following will have to be answered: What background information must patients receive in order to help them formulate their questions? How should physicians respond to precipitous consents or refusals? How deeply should doctors probe for understanding? What constitutes irrelevant information that only tends to confuse? What words and explanations facilitate comprehension? Physicians have not been in the habit of posing such questions.
  2. Underlying informed consent is the assumption that physicians have considerable knowledge about their particular specialties, keep abreast of new developments, and are aware of what is happening in other fields of medicine that impinge on their area of professional interest. This is not so; indeed, it may be asking too much. Moreover, since physicians have their preferences for particular modes of treatment, can they be expected to present an unbiased picture of alternative treatments?
  3. Physicians have consistently asserted that informed consent interferes with compassion (Silk). Doctors believe that, in order to maintain hope or to avoid the imposition of unnecessary suffering, patients in the throes of a terminal illness, and other patients as well, should not be dealt with honestly. But the evidence for such allegations is lacking. When physicians are asked to support them with clinical data, they are largely unable to do so (Oken). Indeed, the few studies that have been conducted suggest that most patients do not seem to yearn for hope based on deception, but for hope based on a reassurance that they will not be abandoned, that everything possible will be done for them, and that physicians will deal truthfully with them. Moreover, evidence is accumulating that informed patients become more cooperative, more capable of dealing with discomfort and pain, and more responsible. Whether the often alleged conflict between compassionate silence and cruel disclosure is myth or reality remains to be seen. Disclosure may turn out to be a greater burden to those who have to interact with patients than to the patients themselves.
  4. Informed consent confronts the role of faith in the cure of disease and the complex problems created by the uncertainties inherent in medical practice. To some extent the two issues are intertwined. The effectiveness of a therapeutic program, it has often been said, depends on three variables: the "feeling of trust or faith the patient has in his doctor and therefore in his therapy … the faith or confidence the physician has in himself and in the line of therapy he proposes to use … and the therapy [itself]" (Hoffer, p. 124). Informed consent could interfere with the first two variables and thus undermine the effectiveness of treatment. Precisely because of the uncertainties in medical decision making, the physician, to begin with, defends himself against those uncertainties by being more certain about what he is doing than he realistically can be. There is perhaps some unconscious wisdom in what he has been doing since Hippocrates' days, for the unquestioned faith the doctor has in his own therapy is also therapeutic in its own right. Thus, to be a more effective healer, a physician may need to defend himself against his uncertainties by believing himself to be more powerful than he is. That defense will be threatened by informed consent, for it would now require him to be more aware of what he does not know, and therapeutic effectiveness in turn might suffer. Finally, patients' response to treatment also depends on faith in the physician and his medicines. Knowing of the ifs and buts may shake patients' faith and undermine the therapeutic impact of suggestibility, which contributes so much to recovery from illness.

Physicians' traditional counterphobic reaction to un-certainty, adopting a sense of conviction that what seems right to them is the only correct thing to do, has other consequences as well. Defensive reactions against uncertainty have led to overenthusiasm for particular treatments that have been applied much more widely than an unbiased evaluation would dictate. The ubiquitous tonsillectomies performed to the psychological detriment of untold children is a classical example. Moreover, by not acknowledging uncertainty to themselves, doctors cannot acknowledge it to their patients. Thus consciously and unconsciously physicians avoid the terrifying confrontation of uncertainty, particularly when associated with poor prognosis. As a result, communications with patients take the form of an evasive monologue. The dialogue that might reveal these uncertainties is discouraged (Davis).

While disclosure of information would reduce patients' ignorance, it would also diminish doctors' power within the physician-patient relationship. As Waitzkin and Stoeckle have observed, the "physician enhances his power to the extent that he can maintain the patient's uncertainty about the course of illness, efficacy of therapy, or specific future actions of the physician himself" (p. 187). Thus new questions arise: What consequences would a diminution of authority have on physicians effectiveness as healers? How would patients react to less powerful doctors? Would they accept them or turn to new faith healers?

LIMITS OF SELF-DETERMINATION. Patients' capacity for self-determination has been challenged on the grounds that neither total understanding nor total freedom of choice is possible (Ingelfinger). This of course is true. Any informed-consent doctrine, to be realistic, must take into account the biological, psychological, intellectual, and social constraints imposed upon thought and action. But those inherent constraints, which affect all human beings, do not necessarily justify treating patients as incompetents. Competence does not imply total understanding or total freedom of choice.

What needs to be explored is the extent to which medicine, like law, should presume competence rather than incompetence, in interactions with patients. Neither presumption comports fully with the psychobiology of human beings; both of them express value judgments on how best to interact with human beings. Once the value judgment is made, one can decide on the additional safeguards needed to avoid the harm that any fiction about human behavior introduces.

The idea of informed consent asks for a presumption in favor of competence. If that is accepted, it may also follow that human beings should be allowed to strike their own bargains, however improvident. The then Circuit Judge Warren E. Burger, in commenting on a judicial decision to order a blood transfusion for a Jehovah's Witness, had this to say: "Nothing in [Justice Brandeis's 'right to be let alone' philosophy, suggests that he] thought an individual possessed these rights only as to sensible beliefs, valid thought, reasonable emotions or well-founded sensations. I suggest he intended to include a great many foolish, unreasonable and even absurd ideas which do not conform such as refusing medical treatment even at great risk" (Application of President of Georgetown College). A physician may wish, and even should try, to persuade his patients to agree to what he believes would serve their medical interests best; but ultimately he may have to bow to his patients' decision, however "senseless" or "unreasonable," or withdraw from further participation. The alternatives, deception or coercion, may be worse, for either would victimize not only patients but physicians as well.


The narrow scope that courts have given to the informed-consent doctrine may reflect a deeply held belief that the exercise of self-determination by patients is often against the best interests of otherwise responsible adults and that those interests deserve greater protection than personal freedom. It may also reflect a judicial recognition of law's limited capacity to regulate effectively the physician-patient relationship. Therefore, once having suggested that patients deserve at least a little openness in communication, courts may have concluded that they had gone as far as they could. Judges, at least for the time being, have largely left it up to the medical profession to confront the question of patients' greater participation in medical decision making.

Despite their snail's pace, the courts' approach may have merit. Implementing a right of self-determination has tremendous consequences for medical practice. Many difficult problems, each with vast ethical implications, need to be considered by the medical profession. Thus introspection and education, responsive to the legal and professional problems that new patterns of physician-patient interaction will create, may ultimately provide firmer foundations for new patterns of physician-patient interactions than forced change through outside regulation. The latter, however, may increase if the profession does not rise to the challenge of addressing these long-neglected problems.

jay katz (1995)

American Medical Association. Judicial Council. 1969. "Principles of Medical Ethics." In Opinions and Reports of the Judicial Council, pp. vi-vii. Chicago: Author.

Application of President of Georgetown College. 331 F. 2d 1010 (D.C. Cir., 1964). Certiorari denied. 377 U.S. 978. 12 L. Ed. 2d 746. 84 S. Ct. 1883.

Burger, Warren E. 1968. "Reflections on Law and Experimental Medicine." UCLA Law Review 15: 436–442.

Canterbury v. Spence. 464 F.2d 772 (D.C.C.A. 1972).

Cobbs v. Grant. 104 Cal. Rptr. 505. 502 P.2d 1 (1972).

Davis, Fred. 1960. "Uncertainty in Medical Prognosis: Clinical and Functional." American Journal of Sociology 66: 41–47.

Dow v. Kaiser Foundation. 12 Cal. App.3d 488. 90 Cal. Rptr. 747 (Ct. App. 1970).

Estate of Brooks, in re. 32 Ill. 2d 361. 205 N.E.2d 435 (1965).

Fisher, Bernard. 1970. "The Surgical Dilemma in the Primary Therapy of Invasive Breast Cancer: A Critical Appraisal." Current Problems in Surgery, October, pp. 1–53.

Glass, Eleanor S. 1970. "Restructuring Informed Consent: Legal Therapy for the Doctor-Patient Relationship." Yale Law Journal 79: 1533–1576.

Henderson, L. J. 1935. "Physician and Patient as a Social System." New England Journal of Medicine 212: 819–823.

Hippocrates. 1923. "Decorum." In Hippocrates, tr. W. H. S. Jones. Loeb Classical Library. London: William Heinemann.

Hoffer, A. 1967. "A Theoretical Examination of Double-Blind Design." Canadian Medical Association Journal 97: 123–127.

Ingelfinger, F. J. 1972. "Informed (but Uneducated) Consent." New England Journal of Medicine 287: 465–466.

Katz, Jay, ed. 1972. Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process. New York: Russell Sage Foundation.

Katz, Jay, and Alexander Morgan Capron. 1975. Catastrophic Diseases: Who Decides What? A Psychosocial and Legal Analysis of the Problems Posed by Hemodialysis and Organ Transplantation. New York: Russell Sage Foundation.

McCoid, Allan H. 1957. "A Reappraisal of Liability for Unauthorized Medical Treatment." Minnesota Law Review 41: 381–434.

Mohr v. Williams. 104 N.W. 12 (Minn. 1905).

Natanson v. Kline. 186 Kan. 393. 350 P.2d 1093. 187 Kan. 186. 354 P.2d 670 (1960).

Oken, Donald. 1961. "What to Tell Cancer Patients: A Study of Medical Attitudes." Journal of the American Medical Association 175: 1120–1128.

Parsons, Talcott. 1951. The Social System. Glencoe, IL: Free Press.

Percival, Thomas. 1927. Medical Ethics, ed. Chauncey D. Leake. Baltimore: Williams & Wilkins.

Plante, Marcus L. 1968. "An Analysis of 'Informed Consent.'" Fordham Law Review 36: 639–672.

Pratt v. Davis. 118 Ill. App. 161 (1905). Aff. 224 Ill. 300. 79 N.E. 562 (1906).

Salgo v. Stanford University. 317 P.2d 170 (Cal. 1st Dist. Ct. App. 1957).

Schloendorff v. New York Hospital. 105 N.E. 92 (N.Y. 1914).

Silk, Arthur D. 1976. "A Physician's Plea: Recognize Limitations of Informed Consent." American Medical News, April 12,p. 19.

Waitzkin, H., and J. D. Stoeckle. 1972. "The Communication of Information About Illness: Clinical, Sociological, and Methodological Considerations." Advances in Psychosomatic Medicine 8: 180–215.

Wilkinson v. Vesey. 295 A.2d 676 (R.I. 1972).


Courts have broadened the doctrine of informed consent well beyond its initial construct. For example, informed consent was, in a few states, applicable only to physical touching, as courts held that a failure to obtain informed consent was a claim for battery, not for negligence (e.g., Morgan v. MacPhail, 1997; Gray v. Grunnagle, 1966). This meant, for example, that a physician who failed to warn a patient about the risks of a prescribed medication before the patient had life–threatening consequences would not have violated the patient's right to informed consent. The clear trend by the beginning of the twenty–first century, however, was to treat any claim for informed consent as one in negligence, so no touching is required (Matthies v. Mastromonaco, 1999; Hanson). Of course, if a procedure is performed without any consent (i.e., a surgeon performs a different or additional procedure from the one to which the patient had consented while the patient is under anesthesia) an action for battery is still appropriate (Montgomery v. Bazaz–Sehgal, 2002).

Several court cases broadened the doctrine of informed consent, establishing that in order to give informed consent, the patient must understand the risks of refusing the proposed therapy (Truman v. Thomas, 1980; Battenfield v. Gregory, 1991; Arato v. Avedon, 1993).

Informed consent jurisprudence at the turn of this century also explored whether the patient is entitled to some information about the physician's abilities as well as about the contemplated procedure. Does the patient have a right to know that the surgeon has never performed the procedure on anyone else? Does the patient have the right to know that the Health Maintenance Organization to which she belongs will reward her physician economically at the end of the year if he does not refer patients to specialists, even if her disease should be treated by specialists? Most cases in which disclosure of fiscal issues have arisen have imposed liability, if at all, on the HMO and not on the physician (Kurfirst; Potter; Simmons).

In one case from Illinois, the intermediate appellate court held that the physician had breached his fiduciary duty when he did not disclose to the patient that he made more money if the patient was not referred to a specialist. The Illinois Supreme Court held that since the failure to refer the patient to a cardiologist constituted malpractice, the reason the physician did not do so was irrelevant (Neade v. Portes, 2000). If a physician knows or should have known that he should refer a patient to a specialist or other more qualified physician and does not do so, if the patient's condition becomes worse, the failure constitutes malpractice even if the patient never raises the issue of informed consent (Johnson v. Kokemoor, 1996). The earliest case to this effect was decided in 1898, decades before there was any concept of informed consent (Logan v. Field, 1898).

Other informed consent cases involved a physician's failure to disclose inexperience with performing the procedure. Most courts take the position that the doctrine of informed consent applies only to the risks of the procedure or treatment itself, and not to information about the physician (Ditto v. McCurdy, 1997; Duttry v. Patterson, 2001). This was even true in one case where the surgeon failed to inform a child–patient's parents that he was an alcoholic and unlicensed (Kaskie v. Wright, 1991). A 2002 decision by the New Jersey Supreme Court, however, held that outright misrepresentation of experience or credentials (as opposed to failure to disclose) does constitute failure to obtain informed consent (Howard v. University of Medicine and Dentistry, 2002).

Special Situations

Some situations involving particular groups of patients create unusually complex problems in providing information or obtaining consent.

PREGNANT PATIENTS. During the 1980s there was a series of cases in which pregnant women were subjected to blood transfusions to which they had religious and other objections and, in some cases, court–ordered cesarean sections when they had refused the procedure. In the infamous case of A.C. (In re A.C., 1990), the woman and her premature infant both died following her court–ordered cesarean, and professional organizations began to issue statements urging that such refusals be respected (George Washington University, 1991). Since that ruling, although there has been one reported case of a court–ordered cesarean (Pemberton v. Tallahassee Memorial Regional Medical Center, 1999), there have been many more cases in which the courts rejected such requests by hospitals (In re Baby Boy Doe, 1994; Levine, 1994; Oberman, 2000). Several states have also held that a pregnant woman may not be transfused against her will, even to save her fetus (The Stamford Hospital v. Vega, 1996; Harrell v. St. Mary's Hospital, 1996).

During the 1990s, several states attempted to decrease drug abuse among pregnant women by criminalizing it as child abuse. While these statutes are still being enforced in a few states, the Supreme Court has ruled that testing women for drugs without their knowledge or consent when they come to a clinic for prenatal care is a violation of their constitutional rights against search and seizure and, of course, in violation of any concept of informed consent (Barton; Ferguson v. City of Charleston, 2001). Moreover, many medical groups issued statements that they feared that the threat of prosecution would drive away from medical care the women who needed it most (see, for example, the 1990 statement of the American Medical Association's Board of Trustees; Annas).

Women have been increasingly successful in informed consent suits alleging that they were not told during prenatal care about diagnostic tests that would have revealed serious handicaps in time to abort their fetuses (Quinn v. Blau, 1997; Kassama v. Magat, 2001). Since many states refuse to permit wrongful birth cases, an action for failure to obtain informed consent may be the patient's only recourse (Gantz). In other cases, women have successfully sued when physicians refused to respect their wishes on such matters as Cesarean sections and the newborns had handicaps as the result. All of these cases allege obstetrical malpractice as well as an absence of informed consent (Schreiber v. Physicians Insurance Co., 1998).

MINORS. Minors over age fourteen are increasingly able to make medical decisions for themselves, although many states in which a minor by herself could make decisions about major surgery or other serious interventions have abortion statutes that restrict the same young woman from deciding to have a first–trimester abortion. The standards of informed consent—the patient's capacity to understand the nature of the procedure and the risks (including foregoing treatment) and benefits—is the same for adolescent as it is for an adult (English).

Parents occasionally ask a physician not to tell their adolescent child his or her diagnosis. Although it may be negotiable in some illnesses, if an adolescent is HIV positive or has another serious communicable condition, the physician must tell him or her and make sure the patient understands safe sex and other means to keep others from contracting the infection. The physician can be found liable if the uninformed adolescent patient infects a third party (Reisner v. Regents of the University of California, 1995; Committee on Pediatric AIDS, American Academy of Pediatrics).

While minors may refuse treatment in many situations, courts rarely allow them to refuse life–saving therapies. In a few cases (In re E.G., 1989, rehearing denied, 1990 Belcher v. Charleston Area Medical Center, 1992), judges have allowed minors to refuse life–saving therapy, but most courts have ruled that minors do not have "the right to die." (In re Application of Long Island Jewish Medical Center, 1990; Novak v. Cobb County–Kennestone Hospital Authority, 1996). In no state is a minor permitted to create a valid Living Will or Durable Power of Attorney (Hawkins; McCabe). When the minor is dying, however, the fact that she or he cannot make a legally binding decision does not mean that the physician should not be the patient's advocate in arguing for that perspective if the parents wish to "try one more thing" (Leiken, 1993; Evans, 1995).

If the diagnosis and treatment of a minor is undertaken without the involvement or knowledge of the parent, the young patient is entitled to the same degree of confidentiality accorded an adult patient (Council for Scientific Affairs, American Medical Association; Sigman, Silber, English, et al.; American College of Obstetrics and Gynecology).

PSYCHIATRIC PATIENTS. Admission to a psychiatric hospital, even if a patient has been involuntarily committed, does not preclude a person's ability and right to consent to many aspects of his or her care, including agreeing to or refusing medication (Berg, Appelbaum, and Grisso; Wirshing, Wirshing, and Marder). In order to medicate a patient over his or her objections, the patient must be found incompetent to make that decision by a court (In re Qawi, 2001; Hamilton County v. Steele, 1999). Moreover, a psychiatric patient may consent to participate in research to the same extent that she or he may consent to treatment (Carpenter; Dunn and Jeste; Roberts; Capron, 1999).

Limits on Self-Determination

A patient is not always entitled to whatever care he or she wishes. A physician who does not think a therapy would be beneficial does not have to offer it to a patient, although if it is a treatment which a minority of physicians find acceptable, the physician may have the duty to refer the patient to such a practitioner. Therapies which have no adherents in mainstream medicine—for example, laetrile to treat cancer— do not impose a requirement of referral.

The physician does not have the right to discontinue a therapy he or she believes is futile over a family's objection as long as a patient is not brain dead (Jecker and Schneiderman; Blake, Maldondo, and Reinhardt; Capron, 1991; Cantor; Council on Judicial and Ethical Affairs, American Medical Association). Conversely, if an adult patient has made clear to his or her physician that he or she wishes to forego further treatment, the physician has the obligation to support the patient's decision, even if the family objects.

angela roddey holder (1995)

revised by author


A.C., In re 573 A 2d 1235, DC App. (1990).

American College of Obstetrics and Gynecology. 1998. "Confidentiality in Adolescent Health Care." International Journal of Gynecology & Obstetrics 63: 295.

Annas, George J. 2001. "Testing Poor Pregnant Women for Cocaine: Physicians as Police Investigators." New England Journal of Medicine 344(22): 1729.

Application of Long Island Jewish Medical Center, In re. 147 Misc 2nd 724, 557 NYS 2d 239 (1990).

Arato v. Avedon. 5 Cal 4th 1172, 858 P 2d 598 (1993).

Baby Boy Doe, In re. 260 Ill App 3d 392, 632 NE 2d 326 (1994).

Barton, Erin F. 2001. "What About My Right to Privacy? Where the Court Went Wrong in Ferguson v. City of Charleston." Brooklyn Law Review 67: 261.

Battenfield v. Gregory. 247 NJ Super 538, 589 A. 2d 1059 (1991).

Belcher v. Charleston Area Medical Center. 422 SE 2d 827, WV (1992).

Berg, Jessica; Appelbaum, Paul S.; and Grisso, Thomas. 1996. "Constructing Competence: Formulating Standards of Legal Competence to Make Medical Decisions." Rutgers Law Review 48: 345.

Blake, David C.; Maldonado, L.; and Meinhardt, R.A. 1993. "Bioethics and the Law: The Case of Helga Wanglie—Medically Futile Treatment v. Patient Autonomy." Whittier Law Review 14: 119.

Board of Trustees, American Medical Association (Helene M. Cole, ed.). "Legal Interventions During Pregnancy: Court-Ordered Medical Treatment and Legal Penalties for Potentially Harmful Behavior By Pregnant Women." Journal of the American Medical Association 264(20): 2663.

Cantor, Norman L. 1996. "Can Healthcare Providers Obtain Judicial Intervention Against Surrogates Who Demand 'Medically Inappropriate' Life Support for Incompetent Patients?" Critical Care Medicine 24: 883.

Capron, Alexander M. 1991. "In re Helga Wanglie." Hastings Center Report 21(5): 26.

Capron, Alexander M. 1999. "Ethical and Human Rights Issues in Research on Mental Disorders that May Affect Decision– Making Capacity." New England Journal of Medicine 340(18):1430.

Carpenter, William T., Jr.; Gold, James M.; and Lahti, Adrienne; et al. 2000. "Decisional Capacity for Informed Consent in Schizophrenia Research." Archives of General Psychiatry 57(6):533.

Committee on Pediatric AIDS, American Academy of Pediatrics. 1999. "Disclosure of Illness Status to Children and Adolescents with HIV Infection." Pediatrics 103(1): 164.

Council for Scientific Affairs, American Medical Association. 1993. "Confidential Health Services for Adolescents." Journal of the American Medical Association 269(11): 1420.

Council on Ethical and Judicial Affairs, American Medical Association. 1999. "Medical Futility in End-of-Life Care: Report of the Council on Ethical and Judicial Affairs." Journal of the American Medical Association 281(10): 937–941.

Ditto v. McCurdy. 86 Hawaii 84, 947 P 2d 952 (1997).

Dunn, Laura B., and Dilip V. Jeste. 2001. "Enhancing Informed Consent for Research and Treatment." Neuropsychopharmacology 24: 595.

Duttry v. Patterson. 565 Pa 130, 771 A 2d 1255 (2001).

E.G., In re 133 Ill 2nd 98, 549 NE 2d 322 (1989).

English, Abigail. 1990. "Treating Adolescents: Legal and Ethical Considerations." Med Clinics of North America 74: 1097.

Evans, Janet L. 1995. "Are Children Competent to Make Decisions about Their Own Deaths?" Behavioral Sciences and the Law 13: 27.

Ferguson v. City of Charleston. 532 US 67 (2001).

Gantz, Julie. 1997. "State Statutory Preclusion of Wrongful Birth Relief: A Troubling Rewriting of a Woman's Right to Choose and the Doctor–Patient Relationship." Virginia Journal of Social Policy & Law 4: 795.

George Washington University. 1991. "Policy on Decision Making With Pregnant Patients at the George Washington University Hospitals." BioLaw 2(52): S:607.

Gray v. Grunnagle. 423 Pa 144, 223 A 2d 663 (1966).

Hamilton County v. Steele. 1999 WL 632925, Ohio App (1999).

Hanson, Laurel R. 2001. "Informed Consent and the Scope of a Physician's Duty of Disclosure." North Dakota Law Review 77: 71.

Harrell v. St. Mary's Hospital. 678 So 2d 455, Fla. App (1996).

Hawkins, Lisa Ann. 1992. "Living Will Statutes: A Minor Oversight." Virginia Law Review 78: 1581.

Howard v. University of Medicine and Dentistry. 2002 WL 1333646, NJ Supreme Ct, June 18 (2002).

Jecker, Nancy S., and Schneiderman, Lawrence J. 1995. "When Families Request that 'Everything Possible' Be Done." Journal of Medicine & Philosophy 20(2): 145.

Johnson v. Kokemoor. 199 Wisc 2d 615, 545 NW 2d 495 (1996).

Kaskie v. Wright. 403 Pa Super 334, 589 A 2d 213 (1991).

Kassama v. Magat. 136 Md App 637, 767 A 2d 348 (2001).

Kurfirst, Leonard S. 2001. "The Duty to Disclose HMO Physician Incentives." Health Lawyer 13(3): 18.

Leiken, Sanford. 1993. "The Role of Adolescents in Decisions Concerning Their Cancer Therapy." Cancer 71: 3342.

Levine, Eric M. 1994. "The Constitutionality of Court-ordered Cesarean Surgery: A Threshold Question." Albany Law Journal of Science & Technology 4: 229.

Logan v. Field. 75 Mo App 594 (1898).

Matthies v. Mastromonaco. 160 NJ 26, 733 A 2d 456 (1999).

McCabe, Mary Ann, et al. 1996. "Implications of the Patient Self–Determination Act: Guidelines for Involving Adolescents in Medical Decision-Making." Journal of Adolescent Health 19:319.

Montgomery v. Bazaz-Sehgal. 2002 WL 1331774, Pa, June 18 (2002).

Morgan v. MacPhail. 550 Pa 202, 704 A 2d 617 (1997).

Neade v. Portes. 193 Ill 2d 433, 739 NE 2d 496 (2000).

Novak v. Cobb County-Kennestone Hospital Authority. 74 F 3d 1173, CCA 11 (1996).

Oberman, Michelle. 2000. "Mothers and Doctors' Orders: Unmasking the Doctor's Fiduciary Role in Maternal–Fetal Conflicts." Northwestern University Law Review 94: 451.

Pemberton v. Tallahassee Memorial Regional Medical Center. 66 F Supp 2d 1247, DC Fla (1999).

Potter, Lori. 2000. "Failure to Disclose HMO Incentives and the Breach of Fiduciary Duty: Is a New Cause of Action Against Physicians the Best Solution?" University of San Francisco Law Review 34: 733.

Qawi, In re. 109 Cal Rptr 523, 90 Cal App 4th 1192 (2001).

Quinn v. Blau. 1997 WL 781874, Conn Super (1997).

Reisner v. Regents of the University of California. 31 Cal App 4th 1195, 37 Cal Rptr 2d 518 (1995).

Roberts, Laura W. 2000. "Evidence-Based Ethics and Informed Consent in Mental Illness Research." Archives of General Psychiatry 57: 540.

Schreiber v. Physicians Insurance Co. 217 Wisc 2d 94, 579 NW 2d 730 (1998).

Sigman, Garry; Silber, Tomas J.; English, Abigail; and Epner, Jet E. Gans. 1997. "Confidential Health Care for Adolescents: Position Paper of the Society for Adolescent Medicine." Journal of Adolescent Health 21: 408.

Simmons, Jessica. 2000. "Neade v. Portes: A Physician's Fiduciary Duty to Disclose Financial Incentives." University of Toledo Law Review 31: 323.

The Stamford Hospital v. Vega. 236 Conn 646, 674 A 2d 821 (1996).

Truman v. Thomas. 165 Cal Rptr 308, 611 P 2d 902 (1980).

Wirshing, Donna A.; Wirshing, William C.; Marder, Stephen R.; et al. 1998. "Informed Consent: Assessment of Comprehension." American Journal of Psychiatry 155(11): 1508.

About this article

Informed Consent: V. Legal and Ethical Issues of Consent in Healthcare

Updated About content Print Article