The Therapeutic Misconception: Informed Consent in Psychiatric Research

lnrernariona/ Journal of Law andPsychiatry. Vol. 5, pp. 319 .329 .1982 0160 .2527/62/030319- l l t03 .WIO

Printed in the U.S.A. All rights resewed. Copyright ic) 1983 Pergamon Press Ltd

The Therapeutic Misconception: Informed Consent in Psychiatric Research Paul S. Appelbaum, Loren H. Roth, and Charles Lidz*

The process by which informed consent has become an accepted part of medical and psychiatric research is reflected in the evolution of the voluminous professional literature on the subject. Early papers, focusing on the existence of ethically improper research,’ soon gave way to discussions of informed consent as a tool for satisfying ethical imperatives and protecting research subjects.2 Researchers themselves weighed in next with concerns about the impact of informed consent on the conduct of research.3 At the same time, as federal regulations firmly established informed consent as an integral part of research with human subjects, a plethora of empirical studies began to appear. Some fought a rear guard action, challenging the applicability of the doctrine on the grounds that subjects could not comprehend or utilize the information researchers were now obliged to disclose;4 others investigated a variety of approaches for improving subject comprehension.5

Conspicuous by the relative inattention it received in this process was a detailed consideration of the actual material to be disclosed to prospective research subjects. Accepting the ethical and legal importance of informed consent, what information must be communicated to achieve the desired ends? Many writers on the subject cite the items enumerated in the regulations of the U.S. Department of Health and Human Services, which govern most research with human subjects in the United States, as if they provide a satisfactory answer to this question. Yet, the requirement that prospective subjects be pro-

*Dr. Appelbaum is Assistant Professor of Psychiatry and Law, University of Pittsburgh Schools of Medi- cine and Law. Dr. Roth is Professor of Psychiatry and’Dr. Lidz is Associate Professor of Psychiatry and So- ciology, University of Pittsburgh School of Medicine. All of the authors are affiliated with the Law and Psy- chiatry Program, Western Psychiatric Institute and Clinic,,of which Dr. Roth is the program director. This work was supported by a grant from the Foundation’s Fund for Research in Psychiatry. Address all corres- pondence to Dr. Appelbaum at Western Psychiatric Institute and Clinic, 3811 O’Hara Street, Pittsburgh, PA 15213.

IBeecher, Ethics and clinical research, 274 N. ENGL. J. MED., 1354-1360 (1966). 2P.A. FREUND (ed.): EXPERIMENTATION WITH HUMAN SUBJECTS, 1970. ‘Cole, Research barriers in psychopharmacology, 134 AM. J. PSYCHIATRY, 896-898 (1977); Meyer, Sub-

jects' rights, freedom of inquiry, and the future of research in the addictions (id. 899-903); Robins, Problems in follow-up studies (id. 904-907); Lion & Monroe, Future hazards for clinical research, 158 J. NERV. MENT. DIS., 397-398 (1974).

Sarnham, Some observations on informed consent in non-therapeutic research; 1 J. MED. ETHICS, 138-145 (1975).

SMiller & Willner, The two-part consent form: (I suggestion forpromoting free and informed consent, 290 N. ENCL. J. MED., 964-965 (1974); Williams, Rieckman, Trenholme et al., The use of u test to determine thot consent is informed. MILIT. MED., 542-545 (1977); Barbour & Blumenkrantz, Videotape aids informed consent decision, 240 JAMA, 2741-2742 (1978); Morrow, How readable are subject consent forms? 244 JAMA, 56-58 (1980).

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320 P.S. APPELBAUM, L.H. ROTH, and C. LIDZ

vided with “an explanation of the purpose of the research . . . a description of the procedures to be followed, and identification of any procedures which are experimental” and “a description of any reasonably foreseeable risks or discom- forts” raises as many questions as it answers.6

Particularly inapparent from the DHHS guidelines is the disclosure required of the methodologic aspects of the study. In order to render a “fair explanation,” must subjects be informed about the double blind nature of many clinical trials? When “experimental” procedures are identified, is randomized assignment to differing treatment groups included under that rubric? Is the possibility of receiving a placebo one of the “attendant risks” to which subjects should be alerted? The intent of this paper is to focus attention on this neglected aspect of subject recruitment by demonstrating the prevalence of defective understanding of scientific methodology. In addition, we will suggest that such a lack of understanding is, in many instances, a critical handicap to the subject’s ability to engage in an accurate assessment of benefits and risks. We will also point to serious obstacles in achieving such understanding and to possible means of overcoming them.

Scientific Methodology and The Therapeutic Misconception Although relatively little attention has been given to the appropriateness of

disclosing scientific methodology in general, some commentators have ad- dressed various components of the subject. At one time or another, and for a variety of reasons, it has been suggested that disclosure of iandomized assignments,’ the use of placebos,8 the presence of control groups 9 and the use of a double blind’0 are important elements of an informed consent process.

Of these aspects of methodology, randomized assignment has received the most attention; the arguments made in connection with it, however, are generally applicable to other methodologic details, as well. Fried,” who has provided the most comprehensive and carefully reasoned discussion of the issue, notes that randomization results in

the patient’s interests . . . to some extent being sacrificed for the sake of the experimental design and thus, the wider social good. That

%J.S. Department of Health and Human Services, Final regulations amending basic HHS policy for the protection of human research subjects, 46 FEDERAL REGISTER, 8366-8392 (January 26, 1981).

‘Levine & Lebracqz. Some ethical considemtions in clinical trials, 25 CLIN. PHARMACOL. THER., 728-741 (1979); GALLANT, Commentary, in D.M. GALLANT & R. FORCE, LEGAL AND ETHICAL &UES IN HUMAN RESEARCH AND TREATMEM: PSYCHOPHARMACOLOGIC CONSIDERATIONS 132-138 (1978); F.J. INGELFINGER, Thepoor, IN EXPERIMENTS AND RESEARCH WITH HUMANS: VALUES IN CONFLKX 169 (1975); Hamilton, Role of an ethic& in the conduct of clinical triak in the United States, 1 CONTROLLED CLINICAL TRIALS 411-420 (1981).

*Bok, The ethics of giving placebas, 231 (5) SCIENTIFIC AM., 17-23 (1974); R.J. LEVINE, ETHICS AND REGULATION OF CLINICAL RESEARCH (1981).

9Veatch, Three theories of informed consent: philosophical foundations and policy implications, in NA- TIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECXX OF BIOMEDICAL AND BEHAVIORAL RESEARCH. THE BELMONT REPORT: ETHICAL GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECZTSOF RESEARCH. DHEW PUBLICATION No. (OS) 78-0012, U.S. GOVERNMENT PRINTING OFFICE (June 8, 1978). Appendix, Vol. 2, 26-l-26-56.

‘old., Levine, The nature and definition of informed consent in various research settings, Appendix, Vol. 1, 3-1-3-91.

“C. FRIED, MEDICAL EXPERIMENTATION: PERSONAL INTEGRITY AND SOCIAL POLICY (1974).

THE THERAPEUTIC MISCONCEPTION 321

sacrifice might be the overt one of exposing the patient to the risk of a treatment which in the present state of knowledge is somewhat less favored, or the less overt one of not inquiring fully into his particular circumstances (including his particular value system) in order to determine whether the balance of probabilities is in equipoise in his particular case. I2

Randomization thus deprives the patient of what Fried calls the right of “personal care,” in that “the care [participants] receive is not chosen exclusively out of a concern for their individual well-being, but with regard to the success of the experimental design.“13

Implicit in Fried’s “personal care” argument is the notion that unless otherwise informed, research subjects will assume (especially, but not exclusively, in therapeutic research) that decisions about their care are being made solely with their benefit in mind. The inappropriateness of this assumption, because of the inherent conflicts between the role of investigator and the role of physician- caretaker, has been noted by others, as we11.r4 This mind-set on the part of subjects we shall refer to as “the therapeutic misconception.”

Despite the large number of studies addressing the ability of subjects to understand or recall information presented to them about research projects, there has been little explicit, empirical investigation of subjects’ understanding of research methodology or of the prevalence of the therapeutic misconception. Gray observed, as part of a detailed study of two research projects, that 69% of the subjects in one study did not understand that a double-blind methodology was being used, largely because of an haphazard and inadequate consent process.15 The effect of this on decision-making among his subjects was noted anecdotally and exemplified by the following dialogue: Gray: “How did you think they were going to decide which drug to give

you? Did you know?” Subject: “Well, I figured they would take into consideration, you know, my

condition and what was happening to me.” Gray: “That’s what I was wondering, because several people told me they

figured they would get the best drug for them.” Subject: “Yeah. I certainly thought I was taken into consideration”16 This response demonstrates the absence of an understanding of randomization or double blind techniques and the presence of the therapeutic misconception.

Two studies explored how disclosure of randomization techniques affected subjects’ decisions to participate in research, but these are unfortunately of limited use to us. In one study, none of 104 patients who were informed about randomized assignment to treatment refused to participate in the research pro-

121d., at 54. ‘“Id., at 66. YJhurchill, Physician-investigator/patient-subject: Exploring the logic and the tension, 5 J. MED. PHILOS.

(1980). l”B.H. GRAY, HUMAN SUBJECTS IN MEDICAL EXPERIMENTATION: A SOCIOLOGICAL STUDY OF THE CONDUCT

AND REGULATION OF CLINICAL RESEARCH (197-S). 161d., at 112.

322 P.S. APPELBAUM, L.H. ROTH, and C. LID2

ject.” No effort was made, however, to ascertain if these patient-subjects ac- tually understood that randomization was going to take place. A second study, which demonstrated that actual understanding of randomized assignments did not affect the frequency of consent, involved non-therapeutic psychological research in a student population. 18 Whether this study can be generalized to medical research settings is extremely questionable.

Thus, no previous systematic attempt has been made to demonstrate in a therapeutic research setting the extent of the failure to understand scientific methodology, the relation of this failure to the prevalence of the therapeutic misconception, and the consequent effects on subjects’ decision-making powers.

Methods

The current investigation was undertaken as part of a larger study of legal and ethical problems in psychiatric research. The data reported here were ob- tained from case studies of two psychiatric research projects. After subjects gave informed consent to participate in our study, their informed consent discussions with the investigator of the research project for which they were being recruited were videotaped. Immediately thereafter, subjects were interviewed by one of the authors to ascertain their understanding of various aspects of the study to which they had just consented and their reasons for participating. The semi-structured interview ranged in length from 20 to 45 minutes, averaging approximately 30 minutes. Subjects were reinterviewed after two weeks, and again at the end of the study. Unless otherwise specified, the data presented below are from the initial interview.

An understanding of the data that follow requires some knowledge of the projects themselves.

Project A - This was a study of the effect of social skills training on chronic schizophrenics. The study took 12 weeks for each subject to complete. Subjects were assigned consecutively to one of three conditions until that group was filled. Although the investigator knew at the time of recruitment to which group the subject would be assigned, subjects were only told that they would be assigned to one of the three groups. The three conditions were: ordinary social skills training, social skills training with special training in community settings, and no social skills training. All subjects participated in a regular day-hospital program at the same time. The key methodologic issues here were the means by which assignment to the groups would be made (which, from the subject’s point of view, was random), and the existence of a control or “placebo” group that would not receive skills training.

Project B - This was a study of the comparative efficacy of two medications

“McLean, The effect of informed consent on the acceptance of random treatment assignment in a clinical population, I1 BEHAV. THERAPY, 129-133 (1980).

18Stuari, Protection of the right to informed consent to participate in research, 9 BEHAV. THERAPY, 73-82 (1978).


for the treatment of borderline personality disorders. The study took approximately 6 weeks for each subject to complete. Patient-subjects were randomly assigned to one of three conditions: anti-psychotic medication, anti-depressant medication, or placebo. The key methodologic issues here were the use of randomized assignment, the presence of a placebo group, the double-blind nature of the study, and the fact that the protocol constrained the adjustment of medication within certain limits and precluded the use of other medications during the study.

Thirteen patients were interviewed from Project A and 18 patients from Pro- ject B. These represent nearly consecutive samples, with a few patients omitted from each because of scheduling difficulties or because of refusal to participate in our study.

Results

I. Randomization

In Project A, the informed consent form did not reveal how it would be determined to which of three groups subjects would be assigned. This information was also routinely omitted from the oral consent interview. Thus, it is not surprising that six of 13 subjects reported that they did not know how they would be assigned, another five thought assignment would be individualized on the basis of their particular needs, one believed that he could request the assignment he desired, and one reported that assignments would be made alphabetically. Although this final answer was incorrect, it was the only response that reflected a clear-cut belief that therapeutic factors bore no relation to group assignments.

Of particular note were the efforts of a number of subjects, in the absence of any concrete data as to how group assignments would be made, to fabricate a therapeutic basis for the process. One subject noted that different groups existed because “each person needs different things.” Others asserted that assignment would be based on “my thinking capacity” or “how good I do in it.” In- terestingly, three patients who intially indicated partial or complete uncertainty as to how assignments would be made decided, after a period of time in the program, that a rational basis existed for allocation of subjects. One concluded assignments were made on the basis of IQ scores, a second that “I was assigned to whichever group had room for me” (an accurate approximation of the process) and a third that assignments were based on “different mental abilities.” This last respondent had, by two weeks into the study, realized that not all subjects were receiving social skills training, but justified this, too, by claiming that those who were excluded from treatment lacked the mental abilities to handle it.

In contrast to the inadequate information provided subjects in Project A, participants in Project B underwent a nearly ideal consent process. They had extended discussions with the principal investigator, often lasting several hours, during which they were told explicitly about random assignment. This was also mentioned on the written consent form. Nonetheless, only eight out of 18 subjects understood that assignment would be random, while six believed


that it would have a therapeutic basis, three did not know how they would be assigned, and one subject maintained that all patients would receive each of the study medications sequentially.

Those subjects who believed that their medications would be assigned on the basis of their needs were again willing to invent reasonable means by which that could be done. “They will look over my chart,” noted one patient, while another claimed that the doctors “decide by talking to you.” A patient who had initially described the purpose of the study as to “see which medication helps the problem I’m having,” and who thought that his medication would be “the one that helps me,” became extremely angry at the end of the study, when he discovered that he had received a placebo. He indicated that, if he had known at the beginning of the project what he now knew, he would not have agreed to participate.

II. Non-treatment Control Groups and Placebo

Subjects in Project A were told on the informed consent form, although not in the consent interview, that one of the three groups would receive the regular day-hospital program in place of social skills training. Nonetheless, ten out of 13 subjects believed that all participants would receive social skills training. This figure included three of the four subjects who were assigned to the non- treatment control group; the fourth believed that all patients who desired active treatment would receive it.

The reaction of the control subjects, particularly the tenacity with which they clung to the belief that the study would be beneficial to them, is of special in- terest. At the two-week follow-up interview, one subject thought he was receiving social skills training (confusing this with the regular day-hospital program), another had forgotten all about it, a third maintained that all subjects would receive skills training but that he “wasn’t ready for it yet,” and the final control subject said the program had not yet begun. Subjects were reinterviewed at the 1Zweek point, when the program was completed. At this point, two subjects had forgotten all about social skills training and thus had no basis to question why they had not received it; a third subject maintained that he had received it. Most interesting of all, the fourth control subject noted that he had dropped out of the program after 8 weeks, when “I was just about to enter the social skills program.” When asked if anything unexpected had happened to him during the course of the study, he replied somewhat quizzically, “I had expected it to start sooner.”

Project B presented a much different picture as far as understanding of placebo was concerned. The use of an inactive medication was explained both verbally and in writing. Thus, 16 out of 18 subjects knew that some subjects would be receiving placebo, although two of these thought it would be given only to those patients who would not need medications. Two other patients were completely unaware that placebos would be used.

III. Double Blind

Only Project B involved double-blind procedures. Subjects were again told


explicitly on the consent form and in the consent interview about the double- blind. Twelve of eighteen subjects understood that a double blind would be used. Of the remainder, three believed that both doctor and subject would know which medication was being used, two thought only the doctor would know, and one maintained that only the subject would know.

The six subjects who did not recognize the use of double-blind procedures nicely exemplified the therapeutic misconception. One of the subjects who thought both she and her doctor would know about the medication said in a matter-of-fact way, “He will be the one to decide what medication is best for me.” She received placebo. A second subject who held the same view claimed, “The doctor will decide what’s best according to what you need.” Two other subjects who lacked understanding of the double blind also were confused about randomization. They believed that all subjects would get both active medications to see which one worked best for the individual.

IV. Limitations of a Protocol

Subjects who agree to participate in research are bound in two ways by the protocol governing the study: they can receive only the treatments permitted by the protocol (even if their physician concludes that some other treatment would be helpful), and the treatment they receive must be administered in a rigid manner, with little or no allowances made for their individual needs. These issues were most apparent in Project B, in which patients could receive only the medication to which they were randomized, and in which dosages were pre- ordained (with some adjustment allowed for side effects) and adjusted according to blood levels rather than to clinical response.

All subjects in Project B were asked whether their participation limited their treatment in any way. Only two of 18 responded affirmatively in the initial interview. One noted that participation in the study meant that she would have to give up her Jungian therapist; the other recognized that only the study medications could be used. By the terminal interview, three other subjects had recognized, as a result of their experiences, constraints on their treatment inherent in the study. Two subjects said they could receive only the medications to which they had been assigned. One of these subjects had received placebo, a fact that angered him. A third subject had desired to receive sleeping medication during the study, but was told that the protocol prohibited it.

A key aspect of the protocol involved the method by which drug dosages were adjusted. Subjects were told on the consent form that “blood testing will be repeated weekly to assure a proper dose range.” The protocol called for all subjects initially to receive the same dosage, with further adjustments designed to hold blood levels within pre-defined limits. Small variations in dosage were possible in the event of side effects. This meant that adjustments would not be made on the basis of whether patients were responding or failing to respond to the medication, but rather in acccord with “objective” blood level data that might not correlate with clinical response. Yet, only five of 18 subjects recognized this method of adjusting dosages. One subject did not know how dosages were determined, and one response was ambiguous. Eleven subjects stated explicitly their belief that the medications would be raised or lowered ac-

326 P.S. APPELBAUM, L.H. ROTH, and C. LIDZ

cording to their individual needs. Typical comments included: “They give you the right amount of medicine, how much you need”; “They increase or decrease the dosage if it works or doesn’t work”; “They’ll increase the medication to where it’s comfortable for me, to where it’s helping me.”

V. Decision Making The effects on decisionmaking of a failure to understand a study’s scientific

methodology can best be demonstrated not by looking at understanding of any one methodologic element in isolation, but by examining subjects’ comprehensive understanding of the study. Two types of cases were found in which the therapeutic misconception influenced decisionmaking. In the first set of cases, subjects had an entirely therapeutic mind-set toward the study and interpreted nearly every aspect of methodology as related to their individual needs.

Case example #I - This subject, from Project A, was a 21-year-old woman with a diagnosis of chronic schizophrenia. She had 13 years of formal education and had once worked as a payroll clerk. She saw the goal of the project being to teach her “to go out into society and talk to people”; she made no mention of any research aims. Like most of her fellow subjects, she believed that they all would be receiving social skills training, and that group assignments would be decided by “how good I do in it.” The purpose of the videotaping and testing procedures, she declared, was “to see how good I am at ex- pressing myself.” Her decision to participate in the study had been motivated by a desire “to get special help and treatment.” The subject had a wholly therapeutic view of the project. Case example #2 - A 2%year-old married woman with a high school education, a subject in Project B, thought the purpose of the project was “to help people with stress vulnerability.” She was unsure how it would be decided which medication she would receive, but thought that placebo would only be given to those subjects who “might not need medication.” The subject understood that double-blind procedures would be used, but did not see any constraints placed on her treatment by the protocol. Her therapeutic misconception was stated in an interesting way. The subject said that she considered this project not to be an “experiment” because that term implied that drugs would be used whose effects were unknown. Rather, she considered this to be “research,” a process whereby doctors “were trying to find out more about you in depth.” She decided to participate because “I needed help and the doctor said that other people who had been in it had been helped.” The strength of her conviction that the project would be beneficial to her carried through to the end of the study. Although the investigators rated her as a non-responder, she was convinced that she had improved on the medication. She attributed her improvement in large part to the double-blind procedures, which she saw as a means of preventing her from persuading herself that the medication was doing no good, by keeping her in the dark as to


which medication she was receiving. She was quite pleased about having participated in the study.

These two cases exemplify the difficulties that subjects with entirely therapeutic orientations may have in evaluating the risk-benefit ratios of participation. Their reasons for joining the study are solely to receive additional help, but they are unable to identify and take into consideration those aspects of the research design that might interfere with that goal. Their underlying “trust” that the investigator will act in their best interests, often based on a positive interpersonal relationship with the investigator, hampers their ability to pursue their interests effectively. The second type of case demonstrates a more subtle influence of the therapeutic misconception on decisionmaking in subjects whose deficits in understanding methodology are quite focal.

Case example #3 - This subject was a 25year-old woman with three years of college. She was participating in Project B. At the time of the initial interview, she displayed minimal psychiatric symp- tomatology. Her understanding of the research was generally ex- cellent. She recognized that the purpose of the project was to find out which treatment worked best for the class of patients of which she was a member. She spontaneously described the three groups, including the placebo group, and indicated that assignment would be random. She understood that dosages would be adjusted according to blood levels and that a double blind would be used. When she was asked directly, however, how her medication would be selected, she said she had no idea. She then added, “I hope it isn’t by chance,” and suggested that each subject would probably receive the medication needed. Given the conflict between her earlier use of the word “random” and her current explanation, the issue was pursued. She was asked what her understanding of “random” was. Her definition was entirely appropriate: “By lottery, by chance, one patient who comes in gets one thing and the next patient gets the next thing.” She then began to wonder out loud if this procedure were being used in the current study. Ultimately, she concluded that it was not.

This patient was typical of a class of well-educated, intelligent, relatively asymptomatic patient-subjects with a good overall understanding of research methodology, whose therapeutic orientation leads them to a flawed understanding of one particular element. That interpretation then enables them to maintain the view that the study will be highly beneficial for them. In this subject’s case, despite an understanding of randomization, and a momentary recognition that random assignment would be used, the subject’s conviction that the investigators would be acting in her best interests won out. The result was a distortion of the experimental procedure and of the risk-benefit analysis.

Discussion

These data confirm that many subjects entering research projects in psychiatric settings carry strong expectations that the research, like the therapy


they have received previously, is designed and will be executed in a manner of direct benefit to them. Further, to the extent that these subjects recognize research aims, such as the production of generalizable knowledge, many of them see no conflict between research and therapeutic goals.

This therapeutic misconception manifests itself in two ways. In the absence of information concerning the means by which the project will be carried out - as in Project A - subjects tend to assume that the methodology will advance their therapeutic interests. Some subjects will invent logical, but incorrect, methdological details to support these conclusions, like the subjects in Project A who decided that group assignment was based on IQ or on their performance on tests. Subjects will sometimes go to great lengths to maintain this view - for example, the subject who dropped out after eight weeks in a control group, believing that he had been just about to receive social skills training.

Assumptions about therapeutic intent, however, may even flourish when subjects are informed about methodologic aspects of the study. Even in the face of comprehensive disclosure - as in Project B - of such methods as randomization, double blind, and placebo, subjects often appeared not to hear, to distort, or to deny what was revealed to them. This finding is consistent with the report of Park and Covilg that of 15 patients who were told they would be treated with placebo, only three were certain of this fact after one week and six believed strongly that they had received active medication. In our study, subjects’ ability to distort small aspects of the study design often had the effect of maintaining their therapeutic misconceptions, while they gave the appearance of having a good general understanding of the study. In many of these cases, only detailed inquiry into their understanding of the methodology revealed the distortion.

This finding has important implications for any effort to undo the effects of the therapeutic misconception in’ the service of enabling patient-subjects to make more accurate risk-benefit appraisals. It may be unrealistic for investigators to expect that simply explaining the use of randomization, placebos, and the like will undercut subjects’ hopes for direct personal benefit from the research. Certainly that was not the case in Project B. Rather, it may be necessary to assault the beliefs that underlie the therapeutic distortions. Sub- jects may have to be told explicitly that scientific goals will have priority over therapeutic goals, that the investigator - because of his dual role as researcher and physician - will be unable to maintain an unadulterated devotion to their well-being (or that, as Fried would say, the investigator cannot offer them personal care), and that various aspects of the study may turn out not to be in their best interests at all.

Only an empirical test would reveal whether even this drastically revised information procedure would alter either subjects’ perceptions of benefit from research or their decisions about participation. The power of the mind to hear only that which fits its preconceptions cannot be over-estimated. In addition, it is questionable whether investigators would be willing to be quite so brutal

‘Vark & Covi. Nonblindpiacebo trial: An exploration of neurotic patients’responses to placebo when its inert content is disclosed, 12 ARCH. GEN. PSYCHIATRY, 336-345 (1%5).


about shattering subjects’ therapeutic misconceptions. The perception of po- tential benefit, after all, is one of the most powerful incentives for subjects to agree to take part in research projects. That was certainly the case in the two projects examined here.

How much one can generalize from these findings remains to be determined in further research. It is possible that chronic schizophrenics, with their severe cognitive impairment, and borderlines, with their tendency for magical thinking and overvaluation of their care-takers, are particularly susceptible to the therapeutic misconception. However, the tendency of even the highest- functioning and best educated members of our sample to read therapeutic meanings into research procedures, or to ignore information that would con- tradict their misconceptions, leads us to suspect that many subjects of psychiatric research, and of medical research in general,20 are susceptible to this tendency.

The desire to protect human subjects from unwilling and potentially harmful involvement in research, which led to the introduction of informed consent, has proven to be a more complicated matter than originally anticipated. If these praiseworthy goals are to be approximated, however, some account will have, to be taken of the therapeutic misconception.

20McCollum & Schwartz, Pediatric research hospitalization: Its meaning to parents. 3 PEDIAT. RES. 199-204 (1969).

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The Therapeutic Misconception: Informed Consent in Psychiatric Research