: "Therapeutic misconception" has been misconstrued, and some of the newer, mistaken interpretations are troublesome. They exaggerate the distinction between research and treatment, revealing problems in the foundations of research ethics and possibly weakening informed consent.

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical (...) and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a ‘collective’ TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism. (shrink)

Research on doctor-patient communication has characterized such interactions as being asymmetrical. The present article tries to shift emphasis away from the different orientations individuals bring to the communicative setting and attempts to highlight the different orientations ("voices") within a given individual. We draw on an in-depth analysis of discourse between a 2 l-year-old man who can be ascribed the roles of both patient and potential research subject and an interviewer who acts in both the role of medical staff and researcher. (...) Focusing our analysis on a limited number of linguistic forms (pronouns and demonstratives), it is argued that the use of the same form for different referents signals a conflation of two voices - the voice of health care ("caring") and the voice of "research." Furthermore, we argue that the voice of research is most likely to be interpreted by the patient/research subject within the framework of curing. As such, the present article promotes a shift in emphasis from different institutional - and as such often assumed to be preexisting - orientations between the communicating parties to differing orientations within the individual that cannot help but be misconstrued in terms of the curing voice. Our conclusion focuses on the ethical and discourse analytic implications of analyzing voices in a discussion. (shrink)

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, (...) while important, might be too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically. (shrink)

Background: Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. However, little attention has been paid to its presence among individuals who participate in research while incarcerated. Methods: This study examined the extent to which 72 incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation. Results: On average, participants endorsed (...) 70% of items suggestive of therapeutic misconception. The tendency toward therapeutic misconception was significantly higher among African Americans and Latinos compared to Whites, among older and less educated participants, and among enrollment in a substance-abuse-related trial; it was also correlated with a belief that the trial was the only way to obtain needed treatment. Conclusions: Therapeutic misconception may be particularly high among select incarcerated individuals and is associated with a perceived lack of treatment options. Further examination of therapeutic misconception among incarcerated research participants is needed. (shrink)

Subjects enrolled in studies testing high risk interventions for incurable or progressive brain diseases may be vulnerable to deficiencies in informed consent, such as the therapeutic misconception. However, the definition and measurement of the therapeutic misconception is a subject of continuing debate. Our qualitative pilot study of persons enrolled in a phase I trial of gene transfer for Parkinson disease suggests potential avenues for both measuring and preventing the therapeutic misconception. Building on earlier literature (...) on the topic, we developed and tested an interview guide that focuses on how the subjects decided to participate, emphasizing the integration of subjects’ various statements that are relevant to assessing the therapeutic misconception, rather than evaluating them as isolated statements. The results indicate that a subject’s understanding of the purpose of research is best explored in juxtaposition to the subject’s motivation for participating. (shrink)

: The "therapeutic misconception," described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at (...) stake in the therapeutic misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials. (shrink)

: Responding to the paper by Miller and Joffe, we review the development of the concept of therapeutic misconception (TM). Our concerns about TM's impact on informed consent do not derive from the belief that research subjects have poorer outcomes than persons receiving ordinary clinical care. Rather, we believe that subjects with TM cannot give an adequate informed consent to research participation, which harms their dignitary interests and their abilities to make meaningful decisions. Ironically, Miller and Joffe's approach (...) ends up largely embracing the very position that they inaccurately attribute to us: the belief that, with some exceptions, it is only the prospect of poorer outcomes that should motivate efforts to dispel TM. In the absence of empirical studies on the steps required to dispel TM and the impact of such procedures on subject recruitment, it is premature to surrender to the belief that TM must be widely tolerated in clinical research. (shrink)

BackgroundStudies have shown that research participants fail to appreciate the difference between research and medical care, labeling such phenomenon as a "therapeutic misconception" (TM). Since research activity involving human participants is increasing in the Middle East, qualitative research investigating aspects of TM is warranted. Our objective was to assess for the existence of therapeutic misconception amongst Egyptians.MethodsStudy Tool: We developed a semi-structured interview guide to elicit the knowledge, attitudes, and perspectives of Egyptians regarding medical research.Setting: We (...) recruited individuals from the outpatient settings (public and private) at Ain Shams University in Cairo, Egypt.Analysis: Interviews were taped, transcribed, and translated. We analyzed the content of the transcribed text to identify the presence of a TM, defined in one of two ways: TM1 = inaccurate beliefs about how individualized care can be compromised by the procedures in the research and TM2 = inaccurate appraisal of benefit obtained from the research study.ResultsOur findings showed that a majority of participants (11/15) expressed inaccurate beliefs regarding the degree with which individualized care will be maintained in the research setting (TM1) and a smaller number of participants (5/15) manifested an unreasonable belief in the likelihood of benefits to be obtained from a research study (TM2). A total of 12 of the 15 participants were judged to have expressed a TM on either one of these bases.ConclusionThe presence of TM is not uncommon amongst Egyptian individuals. We recommend further qualitative studies investigating aspects of TM involving a larger sample size distinguished by different types of illnesses and socio-economic variables, as well as those who have and have not participated in clinical research. (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns (...) as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (shrink)

Approximately 20% of adult cancer patients are eligible to participate in a clinical trial, but only 2.5-9% do so. Accrual is even less for minority and medically underserved populations. As a result, critical life-saving treatments and quality of life services developed from research studies may not address their needs. This study questions the utility of the bioethical concern with therapeutic misconception (TM), a misconception that occurs when research subjects fail to distinguish between clinical research and ordinary treatment, (...) and therefore attribute therapeutic intent to research procedures in the safety net setting. This paper provides ethnographic insight into the ways in which research is discussed and related to standard treatment. (shrink)

Twenty-five years after the term "therapeutic misconception’ (TM) first entered the literature, most commentators agree that it remains widespread. However, the majority of scholarly attention has focused on the reasons why a patient cum human subject might confuse the goals of research with the goals of therapy. Although this paper addresses the social and cultural factors that seem to animate the TM among subjects, it also fills a niche in the literature by examining why investigators too might operate (...) under a similar confusion. In framing these issues, the paper expressly adopts a Wittgensteinian approach to evaluating the TM, suggesting that interlocutors do not need any analytic definition of the TM to use the term meaningfully in thinking about the moral implications of the TM in practice. (shrink)

Ethical research on human subjects requires that subjects, if they have the capacity to do so, give free and informed consent to participate in the trials in which they are enrolled. This requirement, which is commonly referred to as the principle of informed consent, was prominently endorsed by the authors of the Belmont Report in 1978, and it remains widely accepted today. Yet while the principle of informed consent is by now almost universally accepted, the responsibilities that it imposes on (...) those who conduct research on human subjects is a more contentious matter. New challenges to securing informed consent have emerged since the publication of the Belmont Report, and responding to these challenges requires... (shrink)

Therapeutic misconception involves the failure of subjects either to understand or to incorporate into their own expectations the distinctions in nature and purpose of personally responsive therapeutic care, and the generic relationship between subject and investigator which is constrained by research protocols. Researchers cannot disregard this phenomenon if they are to ensure that subjects engage in research on the basis of genuine informed consent. However, our presumption of patient autonomy must be sustained unless we have compelling evidence (...) of serious misunderstanding. This article argues that the mere expression of aspects of therapeutic misconception should not necessarily displace the presumption of subject autonomy or undermine ethical inclusion in research for at least three reasons. First, some interpretations of the empirical data do not suggest misunderstanding. Second, assessment of misestimation and optimism are delicate and value-laden, and turn quickly from questions of autonomy to questions of judgment. Third, incomplete understanding may yet be sufficient to allow a subject to engage in a substantially autonomous decision-making process. Our point is not to dismiss the possibility of genuine therapeutic misconception, but to question its frequency and fatality to the consent process. (shrink)

The “therapeutic misconception” describes a process whereby research volunteers misinterpret the intentions of researchers and the nature of clinical research. This misinterpretation leads research volunteers to falsely attribute a therapeutic potential to clinical research, and compromises informed decision making, therefore compromising the ethical integrity of a clinical experiment. We review recent evidence from the neurobiology of social cognition to provide a novel framework for thinking about the therapeutic misconception. We argue that the neurobiology of social (...) cognition should be considered in any ethical analysis of how people make decisions about participating in clinical trials. The neurobiology of social cognition also suggests how the complicated dynamics of the doctor-patient relationship may unavoidably interfere with the process of obtaining informed consent. Following this argument we suggest new ways to prevent or at least mitigate the therapeutic misconception. (shrink)

The term “therapeutic misconception” was coined in 1982 by Paul Appelbaum, Loren Roth, and Charles Lidz. Appelbaum and his colleagues interviewed participants in several psychiatric studies, including a drug trial with a placebo control arm. Appelbaum's group found that many people were unaware of the differences between participating in a study and receiving treatment in the clinical setting. Rather than understanding these differences, study participants tended to believe that therapy and research were governed by the same primary goal: (...) to advance the individual patient's best interests. Appelbaum's group labeled this mistaken belief the therapeutic misconception. (shrink)

(2002). Clarifying the Ethics of Clinical Research: A Path toward Avoiding the Therapeutic Misconception. The American Journal of Bioethics: Vol. 2, No. 2, pp. 22-23.

In an earlier Dissecting Bioethics contribution, Debra J. H. Mathews, Joseph J. Fins, and Eric Racine challenge standard ways of thinking about the therapeutic misconception in the context of consent for research participation. They propose that instead of demanding “rational congruence” between how researchers and participants conceive of a given protocol, we should accept a less stringent standard of “reasonable coherence.” While Mathews, Fins, and Racine (MFR) provide some important insights, their proposal needs refinement. There is room for (...) a wide but not unlimited range of participant hopes and motivations. However, their model of reasonable coherence is too weak a standard for whether participants have adequate understanding of the scientific goals of a protocol. By the time participants are recruited for medical research, the goals of the protocol, having been set and agreed to through accepted scientific processes, are no longer open for alternate interpretations. This paper discusses this and other objections to MFR’s proposal. It then suggests that a concept of “deal breakers” might be useful in this context. (shrink)

In many cases, the “therapeutic misconception” may be an unavoidable part of the imperfect process of recruitment and consent in medical researchPaul Appelbaum, Loren Roth, and Charles Lidz coined the term “therapeutic misconception” in 1982.1 They described it as the misconception that participating in research is the same as receiving individualised treatment from a physician. It referred to the research subject’s failure to appreciate that the aim of research is to obtain scientific knowledge, and that (...) any benefit to the subject is a by-product of that knowledge. More recent studies by Appelbaum and Lidz have shown that this phenomenon is just as pervasive now as it was twenty four years ago.2 The problem pertains not to any duty of care for researchers but to participants’ unfounded belief in the therapeutic potential of research.3 It is especially acute in phase I oncology trials, which aim to test the toxicity and highest tolerable dose of anticancer drugs.To remedy this situation, many have argued that both clinicians and researchers need to do more in explaining to subjects the differences between experimental research and standard care. Clinicians and researchers recruiting potential subjects for research must present information about the expected risks and benefits of participation in research in a more realistic and straightforward way.4 In one recent examination of consent forms for phase I oncology trials, Sam Horng et al found that, in the section on “benefit”, only one of 272 forms stated that the subjects were expected to benefit. They also found that 11 consent forms stated clearly that subjects would not benefit, 25 forms communicated uncertainty about benefit, and 5 forms said nothing about the chance of benefit. Interestingly, 139 forms alluded to the …. (shrink)

Subjects enrolled in studies testing high risk interventions for incurable or progressive brain diseases may be vulnerable to deficiencies in informed consent, such as the therapeutic misconception. However, the definition and measurement of the therapeutic misconception is a subject of continuing debate. Our qualitative pilot study of persons enrolled in a phase I trial of gene transfer for Parkinson disease suggests potential avenues for both measuring and preventing the therapeutic misconception. Building on earlier literature (...) on the topic, we developed and tested an interview guide that focuses on how the subjects decided to participate, emphasizing the integration of subjects’ various statements that are relevant to assessing the therapeutic misconception, rather than evaluating them as isolated statements. The results indicate that a subject’s understanding of the purpose of research is best explored in juxtaposition to the subject’s motivation for participating. (shrink)

The term 'therapeutic misconception' (TM) was introduced in 1982 to conceptualize how some psychiatry trial participants perceived and interpreted their involvement in research. TM has since been identified in many settings and is a major component in research ethics discussions. A qualitative study included a subgroup of interviews with five parents (two couples, one mother) who declined to enrol their baby in a neonatal trial. Analysis suggested the possibility of a counterpart to TM which, given the original terminology, (...) we term the 'injurious misconception' (IM). While TM is closely linked to the elision of care and research, and involves an over-stated sense of benefit and protection, IM may be a product of a particularly keen and discomforting sense of distinctions between care and research and a correspondingly over-stated sense of risk and threat. (shrink)

A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

In a recent article in The Journal of Clinical Ethics, David Wendler argues that worries about the therapeutic misconception (TM) are not only misconceived, but detract from the larger agenda of a proper informed consent for subjects involved in clinical research. By contrast, we argue that Wendler mischaracterizes those who support TM research, and that his arguments are fragmentary, often illogical, and neglect a critical difference between clinical care and clinical research. A clear explanation about the chief aim (...) of research is, in fact, what gives the other elements in a consent process their meaning. We argue that informed consent must be both trial-specific and context-sensitive, and that concern about the TM is needed now more than ever. (shrink)

Work on the therapeutic misconception suggests that investigators should ensure that potential research subjects understand the fundamental differences between clinical research and clinical care. Yet, what potential research subjects should understand depends on their circumstances and the study in question. This analysis implies that researchers and review committees should stop attempting to define, measure, and dispel the therapeutic misconception, and instead should focus on what potential subjects should understand to participate in individual studies.

The Therapeutic Misconception (TM) is a cognitive error with similarities to another cognitive error -- the Gambler's Fallacy (GF). This paper examines the similarities between TM and GF in an attempt to further illuminate the nature of TM, and to distinguish it from another cognitive error, Unrealistic Optimism (UO). Many cases of UO and mis-classified as TM.

Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey (...) of patient subjects based on this questionnaire.Results: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good , and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators. (shrink)

In a previous article, I attempted to assess the likely impact of the most prominent versions of the therapeutic misconception (TM) on research subjects’ informed consent. I concluded that the TM is not nearly as significant a concern as is commonly thought, and that focusing on it is more likely to undermine than promote research subjects’ informed consent.A recent commentary rejects these conclusions, as least as they pertain to the “consensus” definition of the TM. The authors of the (...) commentary argue that work on the TM remains central to ensuring the appropriateness of research subjects’ consent and, by implication, the ethical acceptability of clinical research.The present work evaluates the arguments offered in support of these claims. This analysis reveals that the authors offer few substantive responses to my arguments, and the responses they do offer fail to undermine my prior conclusions. Furthermore, consideration of an additional issue—the emergence of learning healthcare systems—suggests that the TM is likely to be even less significant in the future, hence, focusing on it may be even more problematic than I argued previously. (shrink)

The ethical treatment of cancer patientsparticipating in clinical trials requiresthat patients are well-informed about thepotential benefits and risks associated withparticipation. When patients enrolled in phaseI clinical trials report that their chance ofbenefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected (...) outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type can be confused with expressionsof uncertainty of the belief type. Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subservemultiple speech acts, some of which may beindirect. For example, a patient reporting ahigh expected benefit may be reporting a beliefabout the future, reassuring family members,and/or attempting to improve his or her outcome by apublic assertion of optimism. These sources oflinguistic confusion should be considered injudging whether the patient's reported expectation isgrounds for a bioethical concern that there hasbeen a failure in the informed consent process. (shrink)