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EDITORIAL
INFORMED CONSENT ALAN MEISEL
Ask a physician what informed consent is, and the not-infrequent response is "a myth," "a fiction," "a legal or bureaucratic obstacle to treating patients," or "a signature on a consent form." In fact, informed consent might be a little of all these things, but it also is and ought to be something quite different. The goal of informed consent is to foster selfdetermination in the medical sphere of an individual's life. The requirement that patients not be treated without first obtaining their informed consent allows people to express their own values, goals, preferences, and tolerance for pain and suffering when deciding what treatments they wish to undergo or forgo. Thus, law requires doctors to provide patients with information about the risks and benefits of, and alternatives to, the treatment the doctor proposes to administer, and then to obtain the patient's consent for that treatment. But more important, informed consent is not merely a legal requirement. It is increasingly taken for granted that informed consent is a fundamental ethical precept of the doctor-patient relationship. It is the form in which the physician's respect for the fact that the patient is a person is made manifest. But, for the physician to be truly respectful of the patient's status as a person, there must be more than form. Literally, there must be more than a patient's signature on a form, and figuratively, there must be more than the patient's consent, however exhibited. Foremost, there must be a recognition by the physician that the patient From the Center for Medical Ethics and School of Law, University of Pittsburgh, Pittsburgh, Pennsylvania. Alan Meisel, JD. Address reprint requests to Alan Meisel, JD, Professor of Law, Center for Medical Ethics, 3400 Forbes Avenue, Pittsburgh, PA 15213. Arthritis and Rheumatism, Vol. 35, No. II (November 1992)
is his or her moral equal. This is ordinarily made manifest by the physician's initiating a conversation with the patient. But this should not merely be the pro forma conversation that any physician might initiate, such as a greeting, an introduction, and an inquiry about how the patient is doing. Rather, the ethical ideal of informed consent envisions that decisions about the medical care a person will receive, if any, are to be made between patient and physician in a collaborative manner and that the physician will initiate a conversation with the patient about the patient's condition and the options for its amelioration (1). The law of informed consent focuses on whether the doctor has given the patient adequate information about the risks of the treatment the doctor proposes to administer and for which consent is being sought, so that the patient may weigh these risks against the anticipated benefits of the proposed treatment (which the doctor must also tell the patient) and decide whether to give or withhold consent. The ethical ideal of informed consent further envisions that the physician will initiate a discussion of the options available to the patient, so that the patient may weigh each option-including the option of no treatment-against the others. Of course, in order to compare options, the patient will also need to know the risks and benefits associated with each of the options. The important point is that the focus of the discussion is on options, rather than on a single option and its risks, benefits, and alternatives. This does not mean that physicians may not make recommendations to patients; indeed, it is likely that even the most staunchly independent patients want advice as well as
EDITORIAL
information, though whether they choose to follow or reject it is up to them. Regardless of whether there are fundamental differences, or merely differences of emphasis, between the legal requirement of informed consent and the ethical ideal of informed consent, it is a given that it is the responsibility of the physician to open the channels for communication by providing the patient with information; it is not the patient's responsibility to ask for information. A patient who does not want to hear the information is free to cut off the doctor's patter, but there are far too many social, psychological, and structural barriers in the doctor-patient relationship to make it realistic to impose the responsibility on patients to ask for information. The report by Katz and colleagues, published elsewhere in this issue of Arthritis and Rheumatism (2), sheds light on physicians' practices and reveals the great gulf between these practices on the one hand and the legal requirements and the loftier ethical ideal on the other. Although the authors acknowledge that there are limitations on their study (what study does not have some?), the findings are consistent with those of the few previous studies on what doctors tell patients (3,4). The findings are also, unfortunately, consistent with the common plaint that doctors do not talk to patients enough. The fact that Katz et al undertook this study is itself a matter for congratulations. As they acknowledge, there have been a multitude of studies of informed consent and related issues in doctor-patient communications, but (as I noted more than a decade ago [5,6]), there has been exceptionally little attention paid to the fundamental issue of what doctors tell patients about their therapeutic (or diagnostic) options. This repeated oversight has rendered insignificant the many studies of what patients understand, because it is impossible to meaningfully determine what patients understand without first knowing what they were told. (It is unfortunate that, in avoiding this fundamental pitfall, Katz and co-workers stopped short of trying to determine what the patients they studied did understand of what they were told.) There is yet another reason that this is an important study. My experience is-and I have no reason to suspect that it is unrepresentative, though it might be-that institutional review boards are loathe to approve studies the results of which might paint physicians in an unflattering light, and they often impose a variety of obstacles to approval of such studies. One way of killing such a study is to require
1265
that the investigators tell the subjects (in these studies, not only patients, but physicians as well) precisely what the study is about: namely in this case, to determine how much information doctors give patients. Ifthe investigators were required to do this, it is likely that the physician-subjects' behavior would be strongly influenced toward providing more information than would be provided otherwise. One of the interesting points made by this study (though it is an assumption of the study rather than a finding) is that informed consent is required for the prescription of medications. It will probably come as a great surprise to many physicians that informed consent has a role in treatments other than "procedures." Although the older requirement of consent to treatment and the more modern requirement of informed consent to treatment have been shaped largely in the context of surgical procedures, with the explicit exception of Pennsylvania (which recognizes lawsuits for lack of informed consent except when the treatment is a drug [7]) and the implicit exception of Georgia (which is the only state to require only consent, but not informed consent [8]), appellate courts have upheld claims brought by patients against doctors for lack of informed consent when the patients were injured by a prescription medication. One unfortunate limitation of the study by Katz et al is that it is cross-sectional. Longitudinal studies are needed to determine not merely what doctors tell patients when they first meet with them, but what additional information they provide over time. An unarticulated assumption of this study (though I am certain that the authors are aware of its inappropriateness) is that decision-making occurs at one point in time. In fact, decision-making about important (and sometimes about trivial) matters is frequently a process that takes place over time, like the learning on which it is based. While some people do make impulse decisions about important matters, many, including those sometimes-impulsive people, frequently take a lot of time to gather information (read Consumer Reports, talk to friends), tryout various possibilities (test-drive different models), and vacillate for long periods of time before making a decision (to repair the existing one rather than buy a new one), and then sometimes change their minds anyway. Why should a decision about treatment be any different? Some patients will ask questions of a doctor who is not particularly communicative, but others will
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not; some patients will not process information given by a doctor who is communicative, but will ask questions on a followup visit, perhaps prompted by side effects from the medication or by questions asked the patient by family members about the medication, which the patient is unable to answer. There are infinite variations which cannot be captured in a cross-sectional study, though in fairness, they are extraordinarily difficult, for logistical reasons, to capture even in a longitudinal study. The fact that the investigators found that younger physicians tend to give patients more information is important. I find it a hopeful sign that while perhaps you can't teach an old dog new tricks, at least new dogs can learn them. The legal requirement to obtain informed consent celebrates its thirty-fifth birthday this year, but its widespread legal acceptance has existed for less than half that time. Indeed, Massachusetts, where the study by Katz et al took place, was one of the later states to recognize the legal duty to obtain informed consent, and the findings-which I find otherwise to be rather gloomy-must be viewed in this light.
REFERENCES 1. Katz J: The Silent World of Doctor and Patient. New York, Free Press, 1984 2. Katz IN, Daltroy LH, Brennan TA, Liang MH: Informed consent and the prescription of nonsteroidal antiinflammatory drugs. Arthritis Rheum 35:1257-1263, 1992 3. Lidz CW, Meisel A, Zerubavel E, Carter M, Sestak RM, Roth LH: Informed Consent: A Study of Decisionmaking in Psychiatry. New York, Guilford Press, 1984 4. Lidz CW, Meisel A: Informed consent and the structure of medical care, Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Edited by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Vol. 2. Washington, DC, Government Printing Office, 1982 5. Meisel A, Roth LH: Toward an informed discussion of informed consent: a review of the empirical studies. Arizona Law Review 25:265-345, 1983 (reprinted in Bioethics Reporter 3:361-442, 1983) 6. Meisel A, Roth LH: What we do and do not know about informed consent. JAMA 246:2473-2477, 1981 7. Wu v Spence, 605 A2d 395 (Pa Super Ct May 5, 1992) 8. Young v Yarn, 222 SE2d 113 (Ga 1975)
EDITORIAL
INFORMED CONSENT ALAN MEISEL
Ask a physician what informed consent is, and the not-infrequent response is "a myth," "a fiction," "a legal or bureaucratic obstacle to treating patients," or "a signature on a consent form." In fact, informed consent might be a little of all these things, but it also is and ought to be something quite different. The goal of informed consent is to foster selfdetermination in the medical sphere of an individual's life. The requirement that patients not be treated without first obtaining their informed consent allows people to express their own values, goals, preferences, and tolerance for pain and suffering when deciding what treatments they wish to undergo or forgo. Thus, law requires doctors to provide patients with information about the risks and benefits of, and alternatives to, the treatment the doctor proposes to administer, and then to obtain the patient's consent for that treatment. But more important, informed consent is not merely a legal requirement. It is increasingly taken for granted that informed consent is a fundamental ethical precept of the doctor-patient relationship. It is the form in which the physician's respect for the fact that the patient is a person is made manifest. But, for the physician to be truly respectful of the patient's status as a person, there must be more than form. Literally, there must be more than a patient's signature on a form, and figuratively, there must be more than the patient's consent, however exhibited. Foremost, there must be a recognition by the physician that the patient From the Center for Medical Ethics and School of Law, University of Pittsburgh, Pittsburgh, Pennsylvania. Alan Meisel, JD. Address reprint requests to Alan Meisel, JD, Professor of Law, Center for Medical Ethics, 3400 Forbes Avenue, Pittsburgh, PA 15213. Arthritis and Rheumatism, Vol. 35, No. II (November 1992)
is his or her moral equal. This is ordinarily made manifest by the physician's initiating a conversation with the patient. But this should not merely be the pro forma conversation that any physician might initiate, such as a greeting, an introduction, and an inquiry about how the patient is doing. Rather, the ethical ideal of informed consent envisions that decisions about the medical care a person will receive, if any, are to be made between patient and physician in a collaborative manner and that the physician will initiate a conversation with the patient about the patient's condition and the options for its amelioration (1). The law of informed consent focuses on whether the doctor has given the patient adequate information about the risks of the treatment the doctor proposes to administer and for which consent is being sought, so that the patient may weigh these risks against the anticipated benefits of the proposed treatment (which the doctor must also tell the patient) and decide whether to give or withhold consent. The ethical ideal of informed consent further envisions that the physician will initiate a discussion of the options available to the patient, so that the patient may weigh each option-including the option of no treatment-against the others. Of course, in order to compare options, the patient will also need to know the risks and benefits associated with each of the options. The important point is that the focus of the discussion is on options, rather than on a single option and its risks, benefits, and alternatives. This does not mean that physicians may not make recommendations to patients; indeed, it is likely that even the most staunchly independent patients want advice as well as
EDITORIAL
information, though whether they choose to follow or reject it is up to them. Regardless of whether there are fundamental differences, or merely differences of emphasis, between the legal requirement of informed consent and the ethical ideal of informed consent, it is a given that it is the responsibility of the physician to open the channels for communication by providing the patient with information; it is not the patient's responsibility to ask for information. A patient who does not want to hear the information is free to cut off the doctor's patter, but there are far too many social, psychological, and structural barriers in the doctor-patient relationship to make it realistic to impose the responsibility on patients to ask for information. The report by Katz and colleagues, published elsewhere in this issue of Arthritis and Rheumatism (2), sheds light on physicians' practices and reveals the great gulf between these practices on the one hand and the legal requirements and the loftier ethical ideal on the other. Although the authors acknowledge that there are limitations on their study (what study does not have some?), the findings are consistent with those of the few previous studies on what doctors tell patients (3,4). The findings are also, unfortunately, consistent with the common plaint that doctors do not talk to patients enough. The fact that Katz et al undertook this study is itself a matter for congratulations. As they acknowledge, there have been a multitude of studies of informed consent and related issues in doctor-patient communications, but (as I noted more than a decade ago [5,6]), there has been exceptionally little attention paid to the fundamental issue of what doctors tell patients about their therapeutic (or diagnostic) options. This repeated oversight has rendered insignificant the many studies of what patients understand, because it is impossible to meaningfully determine what patients understand without first knowing what they were told. (It is unfortunate that, in avoiding this fundamental pitfall, Katz and co-workers stopped short of trying to determine what the patients they studied did understand of what they were told.) There is yet another reason that this is an important study. My experience is-and I have no reason to suspect that it is unrepresentative, though it might be-that institutional review boards are loathe to approve studies the results of which might paint physicians in an unflattering light, and they often impose a variety of obstacles to approval of such studies. One way of killing such a study is to require
1265
that the investigators tell the subjects (in these studies, not only patients, but physicians as well) precisely what the study is about: namely in this case, to determine how much information doctors give patients. Ifthe investigators were required to do this, it is likely that the physician-subjects' behavior would be strongly influenced toward providing more information than would be provided otherwise. One of the interesting points made by this study (though it is an assumption of the study rather than a finding) is that informed consent is required for the prescription of medications. It will probably come as a great surprise to many physicians that informed consent has a role in treatments other than "procedures." Although the older requirement of consent to treatment and the more modern requirement of informed consent to treatment have been shaped largely in the context of surgical procedures, with the explicit exception of Pennsylvania (which recognizes lawsuits for lack of informed consent except when the treatment is a drug [7]) and the implicit exception of Georgia (which is the only state to require only consent, but not informed consent [8]), appellate courts have upheld claims brought by patients against doctors for lack of informed consent when the patients were injured by a prescription medication. One unfortunate limitation of the study by Katz et al is that it is cross-sectional. Longitudinal studies are needed to determine not merely what doctors tell patients when they first meet with them, but what additional information they provide over time. An unarticulated assumption of this study (though I am certain that the authors are aware of its inappropriateness) is that decision-making occurs at one point in time. In fact, decision-making about important (and sometimes about trivial) matters is frequently a process that takes place over time, like the learning on which it is based. While some people do make impulse decisions about important matters, many, including those sometimes-impulsive people, frequently take a lot of time to gather information (read Consumer Reports, talk to friends), tryout various possibilities (test-drive different models), and vacillate for long periods of time before making a decision (to repair the existing one rather than buy a new one), and then sometimes change their minds anyway. Why should a decision about treatment be any different? Some patients will ask questions of a doctor who is not particularly communicative, but others will
MEISEL
1266
not; some patients will not process information given by a doctor who is communicative, but will ask questions on a followup visit, perhaps prompted by side effects from the medication or by questions asked the patient by family members about the medication, which the patient is unable to answer. There are infinite variations which cannot be captured in a cross-sectional study, though in fairness, they are extraordinarily difficult, for logistical reasons, to capture even in a longitudinal study. The fact that the investigators found that younger physicians tend to give patients more information is important. I find it a hopeful sign that while perhaps you can't teach an old dog new tricks, at least new dogs can learn them. The legal requirement to obtain informed consent celebrates its thirty-fifth birthday this year, but its widespread legal acceptance has existed for less than half that time. Indeed, Massachusetts, where the study by Katz et al took place, was one of the later states to recognize the legal duty to obtain informed consent, and the findings-which I find otherwise to be rather gloomy-must be viewed in this light.
REFERENCES 1. Katz J: The Silent World of Doctor and Patient. New York, Free Press, 1984 2. Katz IN, Daltroy LH, Brennan TA, Liang MH: Informed consent and the prescription of nonsteroidal antiinflammatory drugs. Arthritis Rheum 35:1257-1263, 1992 3. Lidz CW, Meisel A, Zerubavel E, Carter M, Sestak RM, Roth LH: Informed Consent: A Study of Decisionmaking in Psychiatry. New York, Guilford Press, 1984 4. Lidz CW, Meisel A: Informed consent and the structure of medical care, Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Edited by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Vol. 2. Washington, DC, Government Printing Office, 1982 5. Meisel A, Roth LH: Toward an informed discussion of informed consent: a review of the empirical studies. Arizona Law Review 25:265-345, 1983 (reprinted in Bioethics Reporter 3:361-442, 1983) 6. Meisel A, Roth LH: What we do and do not know about informed consent. JAMA 246:2473-2477, 1981 7. Wu v Spence, 605 A2d 395 (Pa Super Ct May 5, 1992) 8. Young v Yarn, 222 SE2d 113 (Ga 1975)
