1. The doctrine of informed consent embodies the general principle that a person has a right to determine whether or not to undergo any medical therapy. The classic statement of the common law premise is that of Judge Cardozo in Schloendorff v. Society of N.Y. Hosp., 211 N.Y. 125, 129, 105 N.E. 93, 93 (1914): “every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages.” In its most prevalent form, the doctrine offers a cause of action in negligence for a physician's failure to disclose information concerning a person's medical condition and the risks and benefits of possible therapies where an undisclosed risk materialized to the injury of the patient. See, e.g., Canterbury v. Spence, 464 F.2d 772(D.C. Cir. 1972); Cobbs v. Grant, 8 Cal. 3d 229, 104 Cal. Rptr, 505, 502 P.2d 1(1972). A cause of action in battery is available in cases in which no consent at all has been obtained or consent was obtained by misrepresentation or under duress. See, e.g., Logan v. Greenwich Hosp. Ass'n, 191 Conn. 282, 465 A.2d 294 (1983).Google Scholar

2. Slater v. Baker & Stapleton, 95 Eng. Rep. 860(K.B. 1767).Google Scholar

3. Of physicians surveyed in 1961, 90% preferred not to tell patients with cancer of their diagnosis. Diane Oken, What to Tell Cancer Patients: A Study of Medical Attitudes, 175 J. A.M.A. 1120(1961). In a more recent survey conducted for the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 98% of the physicians said they usually or always discuss diagnosis and prognosis, although only 13% would give a statistical prognosis for advanced lung cancer. 1 President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavior Research, Making Health Care Decisions, 74-76(Washington, D.C.: Government Printing Office,1982) (“President's Commission, Making Health Care Decisions”).Google Scholar

4. In a study observing informed consent practices in a psychiatric institution, Charles W. Lidz et al. found that informed consent “did not often exist,” and staff's attempts at engaging in any discussion were often perfunctory at best. Informed Consent: A Study of Decision-Making in Psychiatry 322(New York: Guilford Press, 1984).Google Scholar

5. The Supreme Court of California made the following finding: “The patient, being unlearned in medical sciences, has an abject dependence upon and trust in his physician for the information upon which he relies doing the decisional process, thus raising an obligation in the physician that transcends arms-length transactions.” Cobbs v. Grant, 502 P.2d at 7.Google Scholar

6. The scope of the physician's disclosure has been measured by two different standards. The traditional professional standard, modeled after the standard of care for medical malpractice, merely requires disclosure of whatever information a competent physician would disclose in similar circumstances. Expert medical testimony is required to prove what must be disclosed. See, e.g., Woolley v. Henderson, 418 A.2d 1123 (Me. 1980); Beattie v. Thomas, 668 P.2d 268 (Nev. 1983). The modern trend measures the scope of disclosure by what is material to the patient. Canterbury v. Spence, 464 F.2d 772. This patient-oriented standard recognizes that while a patient needs medical information to understand her options, the choice of what is best for her is a personal, not a medical, decision. Unlike the traditional standard, expert testimony is not required to prove what is material. While the materiality standard is applied in a minority of states, and a number of states have enacted legislation to narrow it or to retain the professional standard, most recent judicial decisions have adopted the materiality standard. See, e.g., Harnish v. Children's Hospital Medical Center, 387 Mass. 152(1982).Google Scholar

7. Mariner, Wendy K. & McArdle, Patricia J., Consent Forms, Readability and Comprehension: The Need for New Assessment Tools, 13 Law, Med. & Health Care 68–74(1985).Google ScholarPubMed

8. See, e.g., Ingelfinger, F. J., Informed(But Uneducated)Consent, 287 New Eng. J. Med. 465–66(1972).Google ScholarPubMed

9. See, e.g., Katz, Jay, Informed Consent-A Fairy Tale? Law's Vision, 39 U. Pitts. L. Rev. 137–74(1977).Google Scholar

10. Their section on the history of informed consent is a rich synthesis of materials from different fields. Separate chapters are devoted to the tradition(or its absence)of seeking consent in medical practice, the development of the legal doctrine, consent requirements in research ethics, and federal policy governing research with human subjects. The authors' familiarity with clinical and social science research and with the development of moral philosophy enables them to consolidate disparate bits of history into an incisive description of when and how informed consent developed.Google Scholar

11. Martin S. Pernick, The Patient's Role in Medical Decisionmaking: A Social History of Informed Consent in Medical Therapy, in 3 President's Commission, Making Health Care Decisions, at 3 (cited in note 3).Google Scholar

12. Ancient Egyptian priest-physicians appear to have followed particular rules for diagnosis and treatment in order to avoid being held responsible if the patient died. The existence of codes of conduct, such as that of the Babylonian King Hammurabi, written around 2000 B.c., may have led to the belief that physicians should not deviate from the rules, possibly on penalty of death.Google Scholar

13. But opinion on truthtelling was not monolithic. Among their examples of dissidence, Faden and Beauchamp cite Worthington Hooker's criticism of the AMA's limitation of truthtelling to communications between physicians, which he developed into an attack against medical secrecy(at 70-72). Not only did he counsel against deceiving patients by withholding information, he argued that physicians may sometimes deceive themselves by their uncritical acceptance of “medical delusions” as fact.Google Scholar

14. Paul Starr, The Social Transformation of American Medicine 9(New York: Free Press, 1982).Google Scholar

15. In the mid-19th century, American medical practitioners who disagreed on causes and cures for illness divided into sects. The more orthodox or regular physicians, supported by the AMA, sought to exclude homeopaths from medical schools and societies largely because the homeopaths claimed a more scientific basis for their treatment. Homeopathy was a tightly formulated philosophy developed by Samuel Hahnemann of cures by medicines producing disease-like symptoms. Other sectarians dubbed the regular physicians “allopaths” on the theory that they practiced cure by opposites. Id. at 93-100.Google Scholar

16. Abraham Flexner's 1910 proposal to the Carnegie Foundation that medical education be restructured to provide scientific learning and clinical experience as was being done in European schools is considered by many historians to have been the catalyst for the shaping of modern American medical education.Google Scholar

17. His purpose is not to set the record straight but to document that “disclosure and consent… are obligations alien to medical thinking and practice”(at 1). Where Faden and Beauchamp describe the historical record and its varying interpretations, Katz asks “why physicians have been so insistent in their demand that all authority be vested in one party- the doctor”(at xvii). Katz's historical account is less analytic than that of Faden and Beauchamp but richer for its thematic coherence. Even if he sometimes fits his examples to his theory, his conclusions nonecheless merit serious attention.Google Scholar

18. Charles E. Rosenberg, The Care of Strangers: The Rise of America's Hospital System(New York: Basic Books, 1987).Google Scholar

19. Pratt v. Davis, 118 Ill. App. 161, 79 N.E. 562(1905)(physician seeking to treat woman with epilepsy removed uterus and ovaries without advising patient, deliberately telling her instead that he intended only to repair superficial cervical and rectal tears). Judge Cardozo characterized the Schloendorff case as a trespass, since the physician removed a fi-broid tumor during an examination under ether, even though the patient had insisted that “there must be no operation.” See also 1 F. Harper & F. James, The Law of Torts §§ 3.1–3.3 at 211–20(Boston: Little, Brown & Co., 1956); Mohr v. Williams, 95 Minn. 261, 104 N.W. 12(1905).Google Scholar

20. Salgo v. Leland Stanford Jr. Univ. BM. of Trustees, 317 P.2d 170(Cal. Dist. Ct. App. 1957).Google Scholar

21. Id. Katz notes(at 61)that, ironically, the quoted language appeared the amicus curiae brief submitted by the American College of Surgeons.Google Scholar

22. See, e.g., US., Dept of Health & Human Services, Protection of Human Subjects of Research, 45 C.F.R. pt. 46 (governing federally funded research).Google Scholar

23. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research produced 17 reports on issues in research involving special procedures or groups such as children, prisoners, and other institutionalized persons. Its summary of general principles can be found in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research(Apr.1979). Its successor covered a wider range of subjects, but focused special attention on informed consent. See President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Implementing Human Research Regulations.Google Scholar

24. The authors disclaim any intent to argue that informed consent ought to take any particular form. Instead they seek to provide a theory of informed consent in answer to “What is informed consent?” In the last chapter in the historical section of the book, the authors state their intention to “provide a philosophical argument in defense of a particular analysis of both autonomy and informed consent that we believe is needed to rid these concepts of the pervasive vagueness that always has and to this day still does surround them and their connection”(at 225). This is a much stronger statement than any made in the “argument” itself, and yet it, too, does not indicate that the authors believe their analysis ought to prevail.Google Scholar

25. They claim that this is one of two different conceptions of informed consent that have emerged from history. They describe the second conception as “legally or institutionally eflective… authorization from a patient”(at 280). Under this rubric, they lump common law requirements, federal regulations, and hospital policies for obtaining consent. This is unfortunate in several respects. First, they fail to distinguish what is practical and therefore effective for institutions from what is valid in law. Hospitals apparently find it convenient and useful to have patients sign standard written consent documents as a matter of hospital policy. Such documents are almost never required by any law and may or may not provide adequate evidence of legally binding consent. Federal regulations, such as those promulgated by the Department of Health and Human Services requiring researchers to obtain written consent from prospective human subjects as a condition of receiving federal funds for research, lay out procedures for specific circumstances. It is misleading to conflate hospital policies with federal regulatory requirements and either with common law doctrinal requirements. Second, offering a second sense seems inconsistent with the authors' stated objective of analyzing the logical conditions of informed consent. It might have been better to note that specific institutional, political, or legal entities have used the term to mean different things and that compliance with any of their procedures does not necessarily result in the kind of autonomous authorization the authors prefer.Google Scholar

26. The authors also make a useful distinction between autonomous persons and autonomous actions, acknowledging that one may exist without the other(at 235-37).Google Scholar

27. The authors state that intentionality is dichotomous-actions are either intentional or not intentional(at 238). Their explanation of “intentional” includes toleration of expected(even if undesired)consequences of wanted actions, such that a person who deliberately undergoes surgery knowing that it may produce a scar intentionally consents to being scarred as a result of surgery(at 246).Google Scholar

28. While acknowledging that influence is a continuous variable ranging from “controlling” to “uncontrolling,” they classify influences into three major categories: coercion, manipulation, and persuasion. Ultimately, they condemn only coercion as incompatible with substantial autonomy. Yet they define coercion quite narrowly, as occurring “if one party intentionally and successfully influences another by presenting a credible threat of unwanted and avoidable harm so severe that the person is unable to resist acting to avoid it”(at 261, emphasis added). This definition excludes the possibility of coercive situations and intentional actions that sway a decision maker from his intended course. Someone must actually intend to control a patient's choice, and a patient must actually find the threat irresistible and therefore comply(at 341). The authors devote an entire chapter to the concepts of control and coercion. In practice, however, there are few gray areas of control in the informed consent process itself. A full delineation of the subject is unnecessary to this discussion, which focuses on the most problematic component-that of knowledge and understanding.Google Scholar

29. In a pilot study of parents bringing their infants to a pediatrician for a well-baby checkup that included polio immunization, none of the parents had a clear idea that they were actually authorizing a physician to give the child a vaccine, regardless of how well they understood or recalled the risks and benefits of vaccination they had heard or read at the time. Mariner & McArdle, 13 Law, Med. & Health Care (cited in note 7). Of course, there are instances, such as ordinary blood tests, that are so routine that a detailed consent is unnecessary. Authorization, even if unconscious, may be implied from the common knowledge of the procedure, as for the simple and well-known therapies of the past century.Google Scholar

30. Meisel, Alan & Roth, Loren H., Toward an Informed Discussion on Informed Consent: A Review and Critique of the Empirical Studies, 25 Ariz. L. Rev. 265–346(1983).Google ScholarPubMed

31. Mariner & McArdle, 13 Law, Med. & Health Care(cited in note 7).Google Scholar

32. Given the importance of understanding to their theory and its centrality to the principle of autonomy underlying legal doctrine, it is disappointing that Faden and Beauchamp expressly disavow proposing legal reforms or social policies for consent (at 298). While the authors offer several suggestions for effective communication between physicians and patients, their primary purpose is only to provide a clearer view of the process of soliciting consent to medical care or research. What conclusions is the reader to draw from this explicated picture? Faden and Beauchamp don't really say. The book simply stops after the chapters analyzing understanding and control, without any summation or conclusion. Although they warn that their analysis of understanding has demanding implications for professional conduct, it falls to the rest of us to determine what those implications are and how, if at all, they should be incorporated into social policy and law.Google Scholar

33. Canterbury v. Spence, 464 F.2d 772.Google Scholar

34. In Cobbs v. Grant, 104 Cal. Rptr. 505(1972), e.g., the court simply noted that the explanation should be in lay terms. It did not think a “mini-course in medical science” was necessary. The opinion seems to assume that the patient will necessarily understand whatever he or she is told because the patient is depicted as properly weighing the information to make a choice. Nevertheless, there is no mention of any requirement that the information be comprehensible or comprehended in fact.Google Scholar

35. Katz says that the purpose of his book is “to initiate a more enlightened debate about the respective rights, duties, and needs of physicians and patients in their intimate, anxiety-producing, and fateful encounters with one another”(at xiii). His characterization of these encounters as “intimate, anxiety-producing, and fateful” suggests that he views the physician-patient relationship as having more importance than it typically does. This may be attributable to his own perspective as a physician. His weakest argument against physicians' failure to communicate with their patients is that physician silence constitutes psychological abandonment of the patient. He notes that many patients are uncomfortable with the feeling that illness has deprived them of control of their bodies(or minds), and may want the physician to help them regain control over themselves; others may feel a childlike need to be taken care of. Yet while they may be grateful for a physician's parental solicitude, they may also resent being treated like a child. The patient may love the doctor but hate his evasion, and feel abandoned. Katz suggests that such tension may lead patients to act even more passively to forestall complete abandonment. This description, which rings true for some patients, is not the best argument against silence, but will probably be the most persuasive to physicians because it appeals to their sense of fiduciary responsibility, keeping them psychologically in charge. Patient autonomy makes the physician merely an equal-or worse, an adviser-in the physician-patient relationship. Charging physicians to disclose their own uncertainties deprives them of a large measure of their perceived authority. Calling upon them not to abandon their patients leaves them in control, like parents, and relies on traditional feelings of altruism or even noblesse oblige to protect the helpless patient.Google Scholar

36. Katz does not claim that all irrational and unconscious influences are bad or even undercut autonomy. Rather, he urges that patients try to identify the unconscious factors that may influence their reactions and choices so that they can consciously determine whether they will accept them. Thus, decisions that may appear irrational to outside observers can be nonetheless autonomous. A person achieves psychological autonomy, however, only if he becomes aware of at least most of what is influencing him.Google Scholar

37. Not only should patients have a duty to be informed, they must be active participants in the conversation. For an even stronger argument against waiving any right to be informed, see Ost, David E., The “Right” Not to Know, 9 J. Med. & Philosophy 310–12(1984), and id., Information Waivers: Reply to Strasser, 11 J. Med. & Philosophy 279–84 (1986).CrossRefGoogle ScholarPubMed

38. Other psychiatrists may be ready to explore how the process of informed consent may be used to express uncertainty so that the patient enters into a therapeutic alliance with the physician. See Gutheil, Thomas G., Harold Bursztajn, & Archie Brodsky, Malpractice Prevention Through the Sharing of Uncertainty: Informed Consent and the Therapeutic Alliance, 311 New Eng. J. Med. 49–51 (1984).Google Scholar

39. See text accompanying notes 14-17 supra.Google Scholar

40. Many in the medical profession continue to advance rather worn arguments that patients are incapable of understanding the subtleties of medical uncertainty and expect their physicians to be decisive, confident, and perhaps infallible. As Katz notes, there is little evidence, other than anecdotes, for the validity of this argument. Patients who expect miracles may be the profession's own creation.Google Scholar

41. See, e.g., Fay A. Rozovsky, Consent to Treatment: A Practical Guide (Boston: Little, Brown & Co., 1984).Google Scholar

42. See, e.g., Katz, 39 U. Pitt. L. Rev.(cited in note 9); Meisel, Alan, The Expansion of Liability for Medical Accidents: From Negligence to Strict Liability by Way of Informed Consent, 56 Neb. L. Rev. 51–152(1977);Meisel, Alan, Roth, Loren H., & Lidz, Charles W., Toward a Model of the Legal Doctrine of Informed Consent, 134 Am. J. Psychiatry 285–89 (1977);Plant, M. L., An Analysis of “Informed Consent”, 36 Fordham L. Rev. 639–72(1968).Google ScholarPubMed

43. See, e.g., Charles W. Lidz et al., Informed Consent: A Study of Decision Making in Psychiatry(New York: Guilford Press, 1984); Faden, Ruth R. & Beauchamp, Tom L., Decisionmaking and Informed Consent: A Study of the Impact of Disclosed Information, 7 Soc. Indicators Research 313–36(1980);Grundner, T. M., On the Readability of Surgical Consent Forms, 87 Am. J. Ophthalmology 620–23(1979);Robinson, G. & Merav, A., Informed Consent: Recall by Patients Tested Postoperative, 22 Ann. Thoracic Surgery 209–12(1976);Alfidi, R. J., Informed Consent-A Study of Patient Reaction, 216 J. A.M.A. 1325–29(1971). The quality of empirical studies has shown a much needed improvement since 1980.Google ScholarPubMed

44. See, e.g., Joel Feinberg, Autonomy, Sovereignty, and Privacy: Moral Ideals in the Constitution 58 Notre Dame Law. 445(1983).Google Scholar

45. It may be that, today, the nature of disease itself supports patient autonomy over physician beneficence. Dr. Engelhardt has argued that because we are not likely to be able to define disease except in a culture-relative way, it is necessary to allow individuals to shape their own roles and make their own choices. Engelhardt, H. Tristram Jr., Clinical Complaints and the Ens Morbi, 11 J. Med. & Philosophy 207–14, 211(1986).Google ScholarPubMed

46. The locus of decision-making authority is certainly a proper subject of law, as is the definition of what constitutes “coercion” sufficient to deprive a person of the capacity to intentionally exercise that power. Competence, the legal shorthand for identifying those with lawful decision-making authority, also seems a necessary, if more complex, element. Faden and Beauchamp and Katz give short shrift to the concept of competence, arguing that their notions of understanding or autonomy better describe the attributes of a person whose decisions ought to be respected. For purposes of constructing a workable legal doctrine, however, it is unlikely that competence can be discarded, since it serves to define the persons who are presumed to be autonomous. This is not to suggest that the concept could not be clarified; only that it retains a useful function in the absence of complete knowledge of our decision-making capacities.Google Scholar

47. Faden and Beauchamp suggest that, as a practical matter, in view of the difficulty of knowing what kind of information is desired by each patient, “core disclosures” be made to all patients. This differs little from existing law, except that the scope of information would be at least as broad as that required by the materiality standard.Google Scholar

48. In her discussion of Truman v. Thomas, 165 Cal. Rptr. 308(1980), she points to “the need for a theory of informed consent that is independent of the constraints of the battery/negligence distinction”(at 39).Google Scholar

49. Recent codes of ethics have begun to include the concept of patient autonomy as a necessary part of the relationship, even when retaining traditional ideas of the need for trusting a physician. The 1984 American College of Physicians Ethics Manual, for example, describes the patient as a free agent entitled to full explanation and full decision-making authority with regard to his medical care. American College of Physicians, Ad Hoc Committee on Medical Ethics, American College of Physicians Ethics Manual, pt. 2, 101 Annals Internal Med. 263–74, 264(1984). The typical physician-patient relationship is described as one in which the physician attempts to “discern… what the patient wishes to accomplish” before presenting a course of action: “If agreeable to both parties, the patient then empowers the physician to treat him for the disorder in question, and the physician accepts the responsibility. Through effective communication the relationship is sealed by understanding and acceptance of one another and by mutual trust and respect.” American College of Physicians, Ad Hoc Committee on Medical Ethics, American College of Physicians Ethics Manual, Part I, 100 Annals Internal Med. 129–37, 131(1984). The document also accepts the older premise that faith in the physician enhances recovery: “belief and confidence in the physician, essential ingredients of healing, come easier when the choice is free.” Id.Google Scholar

50. Too often, physicians perceive the legal theory of informed consent as a means for patients to obtain damages for injuries that did not result from medical malpractice. In fact, attorneys may press informed consent claims in cases in which they are unable to muster sufficient evidence to prove malpractice. It is not surprising that physicians do not view the doctrine of informed consent as protecting disclosure for its own sake. Few court decisions have held physicians liable for failing to disclose alternatives to treatment or failing to satisfy any of the more esoteric elements of the doctrine beyond risk disclosure. Indeed, while many judicial opinions are eloquent in describing a patient's right of self-determination, most of the rhetoric remains dictum. Faden and Beauchamp's chapter on the law of informed consent provides an excellent synthesis of the underlying philosophy, but fails to point out that the law has rarely translated its ideals into holdings.Google Scholar

51. See, e.g., LeBlang, Theodore R., Informed Consent-Duty and Causation: A Survey of Current Developments, 18 Forum 280–89(1983); Meisel, 56 Neb. L. Rev. (cited in note 41); White, W. D., Informed Consent: Ambiguity in Theory and Practice, 8 J. Health Politics, Pol'y & L. 99(1983); James Ludlam, Informed Consent(Chicago: American Hospital Association, 1978); Rosovsky, Consent to Treatment (cited in note 40).Google Scholar