Informed Consent: I. History of Informed Consent

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Informed consent is not an ancient concept with a rich medical tradition. The term informed consent first appeared in 1957, and serious discussion of the concept began only around 1972. As the idea of informed consent evolved, discussion of appropriate guidelines moved increasingly from a narrow focus on the physician's or researcher's obligation to disclose information to the quality of a patient's or subject's understanding of information and right to authorize or refuse a biomedical intervention.

Early History of Associated Ideas

Prior to the late 1950s, there was no firm ground in which a commitment to informed consent could take root. This is not to say, however, that there is no relevant history of the physician's or researcher's management of information in the encounter with patients and subjects. The major writings of prominent figures in ancient, medieval, and modern medicine contain a storehouse of information about commitments to disclosure and discussion in medical practice. But it is a disappointing history from the perspective of informed consent. Beginning with the classic text of ancient medicine, the Hippocratic Corpus, the primary focus of medical ethics became the obligation of physicians to provide medical benefits to patients and to protect them from harm. The purpose of medicine as expressed in the Hippocratic oath was to benefit the sick and keep them from harm and injustice. Managing information in interactions with patients was portrayed as a matter of prudence and discretion. The Hippocratic writings did not hint even at obligations of veracity.

Throughout the ancient, medieval, and early modern periods, medical ethics developed predominantly within the profession of medicine. With few exceptions, no serious consideration was given to issues of either consent or self-determination by patients and research subjects. The proper principles, practices, and virtues of truthfulness in disclosure were occasionally discussed, but the perspective was largely one of maximizing medical benefits through the careful management of medical information. The central concern was how to make disclosures without harming patients by revealing their condition too abruptly and starkly. Withholding information and even outright deception were regularly justified as morally appropriate means of avoiding such harm. The emphasis on the principle "First, do no harm" even promoted the idea that a healthcare professional is obligated not to make disclosures because to do so would be to risk a harmful outcome.

Eighteenth and Nineteenth Centuries

Benjamin Rush and John Gregory are sometimes cited for their enlightened views about disclosure and public education in the eighteenth century. However, neither was advocating informed consent; they wanted patients to be sufficiently educated so that they could understand physicians' recommendations and therefore be motivated to comply. They were not even optimistic that patients would form their own opinions and make appropriate medical choices. For example, Rush advised physicians to "yield to [patients] in matters of little consequence, but maintain an inflexible authority over them in matters that are essential to life" (p.323). Gregory (1772) was quick to underscore that the physician must be keenly aware of the harm that untimely revelations might cause. There is no assertion of the importance of respecting rights of self-determination for patients or of obtaining consent for any purpose other than a medically good outcome. Gregory and Rush appreciated the value of information and dialogue from the patient's point of view, but the idea of informed consent was not foreshadowed in their writings.

Thomas Percival's historic Medical Ethics (1803) continues in this same tradition. It makes no more mention of consent solicitation and respect for decision making by patients than had previous codes and treatises. Percival did, however, struggle with the issue of truth-telling. He held that the patient's right to the truth must yield to the obligation to benefit the patient in cases of conflict, thereby recommending benevolent deception. Percival maintained that

[T]o a patient … who makes inquiries which, if faithfully answered, might prove fatal to him, it would be a gross and unfeeling wrong to reveal the truth. His right to it is suspended, and even annihilated; because its beneficial nature being reversed, it would be deeply injurious to himself, to his family, and to the public. And he has the strongest claim, from the trust reposed in his physician, as well as from the common principles of humanity, to be guarded against whatever would be detrimental to him …. The only point at issue is, whether the practitioner shall sacrifice that delicate sense of veracity, which is so ornamental to, and indeed forms a characteristic excellence of the virtuous man, to this claim of professional justice and social duty. (pp. 165–166)

Percival was struggling against the arguments of his friend, the Rev. Thomas Gisborne, who opposed practices of giving false assertions intended to raise patients' hopes and lying for the patient's benefit: "The physician … is invariably bound never to represent the uncertainty or danger as less than he actually believes it to be" (Gisborne, p.401). From Percival's perspective, the physician does not lie or act improperly in beneficent acts of deception and falsehood, as long as the objective is to give hope to the dejected or sick patient.

The American Medical Association (American Medical Association) accepted virtually without modification the Percival paradigm in its 1847 "Code of Medical Ethics." Many of the above passages appear almost verbatim in this code as the AMA position on the obligations of physicians in regard to truth-telling (American Medical Association, 1847). This code and most codes of medical ethics before and since do not include rules of veracity although many codes today do contain rules for obtaining an informed consent. For more than a century thereafter, American and British medical ethics developed under Percival's vision.

There was, however, a notable nineteenth-century exception to the consensus that surrounded Percival's recommendations. Connecticut physician Worthington Hooker was the first champion of the rights of patients to information, in opposition to the model of benevolent deception that had reigned from Hippocrates to the AMA (Hooker). He and Harvard professor of medicine Richard Clarke Cabot were the best known among physicians who championed this model prior to the second half of the twentieth century. Moreover, there may never have been a figure who, in regard to truth-telling, swam so much against the stream of indigenous medical tradition as Hooker.

Hooker's arguments are novel and ingenious but do not amount to a recommendation of informed consent. Hooker was concerned with "the general effect of deception" on society and on medical institutions. He thought the effect disastrous. But in Hooker no more than in the AMA Code is there a recommendation to obtain the permission of patients or to respect autonomy for the sake of autonomy. Hooker's concerns were with expediency in disclosure and truth-telling rather than with the promotion of autonomous decision making or informed consent. The idea that patients should be enabled to understand their situation so that they are able to participate with physicians in decisions about medical treatment was an idea whose time was yet to come.

Although the nineteenth century saw no hint of a rule or practice of informed consent in clinical medicine, consent practices were not entirely absent. Evidence exists in surgery records of consent-seeking practices and rudimentary rules for obtaining consent since at least the middle of the nineteenth century (Pernick). However, the consents thus obtained do not appear to have been meaningful informed consents, because they had little to do with the patient's right to decide after being appropriately informed. Practices of obtaining consent in surgery prior to the 1950s were pragmatic responses to a combination of concerns about medical reputation, malpractice suits, and practicality in medical institutions. It is at best physically difficult and interpersonally awkward to perform surgery on a patient without obtaining the patient's permission. Such practices of obtaining permission, however, do not constitute practices of obtaining informed consent, although they did provide a modest nineteenth-century grounding for this twentieth-century concept.

The situation is similar in research involving human subjects. Little evidence exists that, until recently, requirements of informed consent had a significant hold on the practice of investigators. In the nineteenth century, for example, it was common for research to be conducted on slaves and servants without acquiescence or consent on the part of the subject. By contrast, at the turn of the century, American army surgeon Walter Reed's yellow-fever experiments involved formal procedures for obtaining the consent of potential subjects. Although deficient by contemporary standards of disclosure and consent, these procedures recognized the right of the individual to refuse or authorize participation in the research. The extent to which this principle became ingrained in the ethics of research by the mid-twentieth century is a matter of historical controversy. Although it has often been reported that the obtaining of informed and voluntary consent was essential to the ethics of research and was commonplace in biomedical investigation, it is unclear that consent seeking on the part of investigators was standard practice. Anecdotal evidence suggests that biomedical research often proceeded without adequate consent at least into the 1960s.

Early Twentieth-Century Legal History

The legal history of disclosure obligations and rights of self-determination for patients evolved gradually. It is the nature of legal precedent that each decision, relying on earlier court opinions, joins a chain of authority that incorporates the relevant language and reasoning from the cited cases. In this way, a few early consent cases built on each other to eventuate in a legal doctrine. The best known and ultimately the most influential of these early cases is Schloendorff v. New York Hospital (1914). Schloendorff used rights of self-determination to justify imposing an obligation to obtain a patient's consent. Subsequent cases that followed and relied upon Schloendorff implicitly adopted its justifactory rationale. In this way, self-determination came to be the primary rationale or justification for legal requirements that consent be obtained from patients.

In the early twentieth century, the behavior of physicians was often egregious, and courts did not shrink from using ringing language and sweeping principles to denounce it. The same language was then applied as precedent in later cases in which physicians' behavior was less outrageous. As the informed-consent doctrine developed and problems grew more subtle, the law could have turned away from the language of self-determination but instead increasingly relied on this rationale as its fundamental premise. The language in the early cases suggests that rights of freedom from bodily invasion contain rights of medical decision making by patients.

The 1950s and 1960s: Law and Medicine

The emerging legal doctrine of informed consent first brought the concept of informed consent to the attention of the medical community. "The doctrine of informed consent" is a legal doctrine; and informed consent has often been treated as synonymous with this legal doctrine. A remarkable series of cases in the second half of the twentieth century brought informed consent to the attention of lawyers and physicians alike.

During the 1950s and 1960s, the traditional duty to obtain consent evolved into a new, explicit duty to disclose certain types of information and then to obtain consent. This development needed a new term; and so informed was added onto consent, creating the expression informed consent, in the landmark decision in Salgo v. Leland Stanford, Jr. University Board of Trustees (1957). The Salgo court suggested, without accompanying analysis, that the duty to disclose the risks and alternatives of treatment was not a new duty but a logical extension of the already established duty to disclose the treatment's nature and consequences. Nonetheless, Salgo clearly introduced new elements into the law. The Salgo court was not interested merely in whether a recognizable consent had been given to the proposed procedures. Instead, Salgo focused strongly on the problem of whether the consent had been adequately informed. The court thus created not only the language but the substance of informed consent by invoking the same right of self-determination that had heretofore applied only to a less robust consent requirement.

Shortly thereafter, two opinions by the Kansas Supreme Court in the case of Natanson v. Kline (1960) pioneered the use of the legal charge of negligence in informed-consent cases, rather than that of battery. The court established the duty of disclosure as the 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, 1960). Thus, the Natanson court required essentially the same extensive disclosure—of the nature, consequences, risks, and alternatives of a proposed procedure—as had Salgo. After Natanson, battery and negligence appeared virtually identical in their disclosure requirements for informed consent.

Not surprisingly, the number of articles in the medical literature on issues of consent increased substantially following these and other legal cases. Typically written by lawyers, these reports functioned to alert physicians both to informed consent as a new legal development and to potential malpractice risk. How physicians reacted to these legal developments in the 1950s and 1960s is not well documented, but a handful of empirical studies of informed consent in clinical medicine provides some insights. A study done in the early to mid-1960s indicates that a preoperative consent form was not yet a ubiquitous feature of the practice of surgery. Surgeons at several hospitals refused to participate in this study precisely because they were not using a consent form for surgery.

This indifference to consent procedures seems to have changed by the late 1960s, when most physicians appear to have come to recognize both a moral and a legal duty to obtain consent for certain procedures and to provide some kind of disclosure. There is also evidence, however, that physicians' views about proper consent practices even in the late 1960s differed markedly from the consensus of opinion and convention today. For example, in one study, half of the physicians surveyed thought it medically proper, and 30 percent ethically proper, for a physician to perform a mastectomy with no authorization from the patient other than her signature on the blanket consent form required for hospital admission; more than half the physicians thought that it was ethically appropriate for a physician not to tell a cancer patient that she had been enrolled in a double-blind clinical trial of an experimental anti-cancer drug.

On the basis of the volume of commentary in the medical literature, many physicians before the 1970s were at least dimly aware of informed consent. Empirical studies conducted at the time suggest that there was at least enough documentable consent seeking in such areas as surgery, organ donation, and angiography to warrant empirical investigation. Also during this period, the procedure-specific consent form was gaining acceptance, although it was not yet universally in use. Whether in the 1960s physicians generally regarded informed consent as a legal nuisance or as an important moral problem is unclear, but an explosion of commentary on informed consent emerged in the medical literature in the early 1970s. Much of this commentary was negative: Physicians saw the demands of informed consent as impossible to fulfill and—at least in some cases—inconsis-tent with good patient care. In tone the articles ranged from serious critique to caustic parody. Predictions were voiced that fearful patients would refuse needed surgery after disclosure. In much of this literature, only the legal, not the moral dimensions of informed-consent requirements were recognized. This began to change in the 1970s, with the ascendancy of an interdisciplinary approach to medical ethics. Gradually, informed consent became a moral as well as a legal issue.

The 1950s and 1960s: Biomedical Research

The histories of informed consent in research and in clinical medicine have developed largely as separate pieces in a larger mosaic of biomedical ethics, and these pieces have never been well integrated even when they developed side by side. Research ethics prior to World War II was no more influential on research practices than the parallel history of clinical-medicine ethics was on clinical practices. But one event that unquestionably influenced thought about informed consent was the Nuremberg trials. The Nuremberg military tribunals unambiguously condemned the sinister political motivation of Nazi experiments in their review of "crimes against humanity." A list of ten principles constituted the Nuremberg Code. Principle One of the code states, without qualification, that the primary consideration in research is the subject's voluntary consent, which is "absolutely essential" (Germany [Territory Under Allied Occupation], 1947).

The Nuremberg Code served as a model for many professional and governmental codes formulated in the 1950s and 1960s, but several other incidents involving consent violations subsequently moved the discussion of post-Nuremberg problems into the public arena. Thus began a rich and complex interplay of influences on research ethics: scholarly publications, journalism, public outrage, legislation, and case law. In the United States, one of the first incidents to achieve notoriety in research ethics involved a study conducted at the Jewish Chronic Disease Hospital (JCDH) in Brooklyn, New York. In July 1963, Dr. Chester Southam of the Sloan-Kettering Institute for Cancer Research persuaded the hospital's medical director, Emmanuel E. Mandel, to permit research involving injection of a suspension of foreign, live cancer cells into twenty-two patients at the JCDH. The objective was to discover whether a decline in the body's capacity to reject cancer transplants was caused by the cancer or by debilitation. Patients without cancer were needed to supply the answer. Southam had convinced Mandel that although the research was nontherapeutic, such research was routinely done without consent. Some patients were informed orally that they were involved in an experiment, but it was not disclosed that they were being given injections of cancer cells. No written consent was attempted, and some subjects were incompetent to give informed consent. The Board of Regents of the State University of New York later censured Southam and Mandel for their role in the research. They were found guilty of fraud, deceit, and unprofessional conduct (Hyman v. Jewish Chronic Disease Hospital, 1964).

Another major controversy about the ethics of research in the United States developed at Willowbrook State School, an institution for "mentally defective" children in Staten Island, New York. Beginning in 1956, Saul Krugman and his associates began a series of experiments to develop an effective prophylactic agent for infectious hepatitis. They deliberately infected newly admitted patients with isolated strains of the virus based on parental consents obtained under controversial circumstances that may have been manipulative. The issues in the Willowbrook case are more complex than those in the Jewish Chronic Disease Hospital case, and today there are those who still defend, at least in part, the ethics of these experiments. Krugman's research unit was eventually closed, but closure on the debate about the ethics of the studies conducted in the unit was never achieved (New York University).

The most notorious case of prolonged and knowing violation of subjects' rights in the United States was a Public Health Service (PHS) study initiated in the early 1930s. Originally designed as one of the first syphilis-control demonstrations in the United States, the stated purpose of the Tuskegee syphilis study, as it is now called, was to compare the health and longevity of an untreated syphilitic population with a nonsyphilitic but otherwise similar population. These subjects, all African-American males, knew neither the name nor the nature of their disease. That they were participants in a nontherapeutic experiment also went undisclosed. They were informed only that they were receiving free treatment for "bad blood," a term local African-Americans associated with a host of unrelated ailments, but which the white physicians allegedly assumed was a local euphemism for syphilis (Jones).

Perhaps the most remarkable thing about Tuskegee was that, although the study was reviewed several times between 1932 and 1970 by PHS officials and medical societies as well as reported in thirteen articles in prestigious medical and public-health journals, it continued uninterrupted and without serious challenge. It was not until 1972 that the U.S. Department of Health, Education and Welfare (DHEW) appointed an ad hoc advisory panel to review the study and the department's policies and procedures for the protection of human subjects. The panel found that neither DHEW nor any other government agency had a uniform or adequate policy for reviewing experimental procedures or securing subjects' consents.

The 1970s and 1980s

Although the Jewish Chronic Disease Hospital case, the Willowbrook study, and the Tuskegee study had a profound effect on public consciousness with respect to the ethics of research and medicine, these events are insufficient to explain why informed consent became the focus of so much attention in both case law and biomedical ethics between the late 1960s and the late 1980s. Many hypotheses can be invoked to explain this phenomenon. Perhaps the most accurate explanation is that law and ethics, as well as medicine itself, were all affected by issues and concerns in the wider society about individual liberties and social equality, made dramatic by an increasingly technological, powerful, and impersonal medical-care system. It seems likely that increased legal interest in the right of self-determination and increased philosophical interest in the principle of respect for autonomy and individualism were instances of the new rights orientation that various social movements had introduced. The issues raised by civil rights, women's rights, the consumer movement, and the rights of prisoners and the mentally ill often included healthcare components and helped reinforce public acceptance of rights applied to healthcare. Informed consent was swept along with this body of social concerns, which propelled the new bioethics throughout the 1970s.

Three 1972 court decisions are widely recognized as informed consent landmarks: Canterbury v. Spence, Cobbs v. Grant, and Wilkinson v. Vesey. Canterbury had a massive influence. In its most significant and dramatic finding, the Canterbury court moved in the direction of a more patient-oriented standard of disclosure:

The patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The patient should make his own determination on treatment. Informed consent is a basic social policy for which exceptions are permitted (1) where the patient is unconscious or otherwise incapable of consenting, and harm from failure to treat is imminent; or (2) when risk-disclosure poses such a serious psychological threat of detriment to the patient as to be medically contraindicated. Social policy does not accept the paternalistic view that the physician may remain silent because divulgence might prompt the patient to forego needed therapy. Rational, informed patients should not be expected to act uniformly, even under similar circumstances, in agreeing to or refusing treatment. (Canterbury v. Spence, 1972)

As the impact of Canterbury filtered down to medical practice, the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research began in 1974 what would be a four-year struggle with a variety of concerns about informed consent in research involving human subjects. The commission developed an abstract schema of basic ethical principles for research ethics that gave informed consent a major role (U.S. National Commission, 1978):

Principle ofapplies toGuidelines for
Respect for PersonsInformed Consent
BeneficenceRisk/Benefit Assessment
JusticeSelection of Subjects

Under this schema, the purpose of consent provisions is not protection from risk, as some earlier federal policies had implied, but rather the protection of autonomy and personal dignity, including the personal dignity of incompetent persons incapable of acting autonomously (for whose involvement a third party must consent). This conclusion develops an explicit philosophical position on informed consent for the first time in a government-sponsored document.

Among the most important publications in the medical literature to appear during this period was a statement by the Judicial Council of the American Medical Association in 1981. For the first time, the AMA recognized informed consent as "a basic social policy" necessary to enable patients to make their own choices even if the physician disagrees. The AMA's statement is a testament to the impact of the law of informed consent on medical ethics: The AMA's position closely followed the language of Canterbury v. Spence (Judicial Council, 1981).

The U.S. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research provides further evidence regarding the status informed consent had achieved by the 1980s. The commission was first convened in January 1980, with informed consent as a main item on its agenda. In 1982 it produced a three-volume report that dealt directly with informed consent: Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. The commission argued that although informed consent has emerged primarily from a history in law, its requirements are essentially moral and policy-oriented. It held that informed consent is ultimately based on the principle that competent persons are entitled to make their own decisions from their own values and goals, but that the context of informed consent and any claim of "valid consent" must derive from active, shared decision making. The principle of self-determination was described as the "bed-rock" of the commission's viewpoint.

In addition to the efforts of the U.S. President's Commission and the statement of the AMA, the 1980s saw the publication of several books devoted to the subject of informed consent, as well as hundreds of journal articles, and the passage of procedure-specific informed-consent laws and regulations. These events provide powerful testimony of the importance of informed consent in moral and legal thinking about medicine in the United States. By themselves, however, they tell us little about physicians' or researchers' actual consent practices or opinions or about how informed consent was viewed or experienced by patients and subjects.

As might be expected, the empirical evidence on this subject is mixed, although it is clear that procedures of informed consent have taken a firm hold in some parts of medical practice. For example, routine practice encourages the obtaining of signatures on consent forms and the disclosing of information about alternative treatments, risks, and benefits. The best data on this subject are the findings of a national survey conducted for the U.S. President's Commission by Louis Harris and Associates in 1982. Almost all of the physicians surveyed indicated that they obtained written consent from their patients before in-patient surgery or the administration of general anesthesia. At least 85 percent said they usually obtained some kind of consent— written or oral—for minor office surgery, setting of fractures, local anesthesia, invasive diagnostic procedures, and radiation therapy. Only blood tests and prescriptions appear to have proceeded frequently without patient consent, although about half of the physicians reported obtaining oral consent (1982).

The overall impression conveyed by this survey is that the explosion of interest in informed consent in the 1970s had a powerful impact on medical practice. However, evidence from the Harris survey and other sources questions the meaningfulness of the increase in consent-related activity. The overwhelming impression from the empirical literature and from reported clinical experience is that the actual process of soliciting informed consent often falls short of a serious show of respect for the decisional authority of patients. As the authors of one empirical study of physician-patient interactions put it, "despite the doctrine of informed consent, it is the physician, and not the patient, who, in effect, makes the treatment decision" (Siminoff and Fetting, p. 817).

The history of informed consent, then, indicates that medicine has undergone widespread changes under the influence of legal and moral requirements of informed consent, but it also remind us that informed consent is an evolving process, not a set of events whose history has passed.

tom l. beauchamp

ruth r. faden (1995)

SEE ALSO: Autonomy; Competence; Information Disclosure, Ethical Issues of;Professional-Patient Relationship; and other Informed Consent subentries


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American Medical Association. Judical Council. 1981. Current Opinions of the Judicial Council of the American Medical Association. Chicago: Author.

Canterbury v. Spence. 464 F.2d 772 (D.C. Cir. 1972), cert. denied 409 U.S. 1064.

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

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Germany (Territory Under Allied Occupation, 1945–1955: U.S. Zone) Military Tribunals. 1947 "Permissible Military Experiments." In vol. 2 of Trials of War Criminals Before Nuremberg Tribunals Under Control Law No. 10, pp. 181–184. Washington, D.C.: U.S. Government Printing Office.

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Rush, Benjamin. 1786. An Oration … Containing an Enquiry into the Influence of Physical Causes upon the Moral Faculty. Philadelphia: Charles Cist.

Salgo v. Leland Stanford, Jr. University Board of Trustees. 317 P.2d 170 (Cal. 1957).

Schloendorff v. Society of New York Hospital. 211 N.Y. 125, 129, 105 N.E. 92 (1914).

Siminoff, L. A. and Fetting, J. H. 1991. "Factors Affecting Treatment Decisions for a Life-Threatening Illness: The Case of Medical Treatment of Breast Cancer." Social Science and Medicine 32(7): 813–818.

U.S. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1982. Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. 3 vols. Washington, D.C.: Author.

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

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