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Informed consent is one of the great puzzles of modern medical research and practice. As Professor Henderson has argued in her article, there is ample reason to be concerned that many, and maybe all, of the goals announced for informed consent law and ethics have not been reached. In this article, I will review the goals that theorists and judges have assigned to the doctrine and discuss some of the evidence concerning the difficulties of meeting those goals. Finally, I will suggest some of the reasons that might account for our continued commitment to informed consent despite its difficulties.

Informed consent often fails to meet the intended goals that a prospective subject should understand fully and choose autonomously to participate in research. The current study is an attempt to understand such failures by applying linguistic methods of discourse analysis to the transcripts of informed consent interviews. Elements of conversation and of the frame of discourse were analyzed to understand how the participants shaped their spoken interaction during the interview. We looked at the degree to which the subject appeared to be fully informed, at the problem of therapeutic misconception, and at the degree to which the subject was helped to explore concerns relevant to the choice at hand. We found that lapses or miscommunications could be understood specifically in terms of conversational elements and framing. This kind of detailed, language-based analysis is an alternative to approaches that are more abstract and inferential, such as those that are based upon the attitudes or the cognitive performance of speakers. We discuss possible educational and research implications of this approach.

A good deal of policy and practice in human subjects research aims to ensure that when subjects consent to research, they do so voluntarily. To date, however, voluntariness and its impairment have been poorly conceptualized and studied. The legal doctrine of informed consent could provide a useful model.

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.

The doctrine of informed consent rests on empirical claims. This is true particularly of what commentators have characterized as the "strong" model of informed consent. This model assumes that if adequate information is given to a competent individual, understanding will result and, permitted to make a voluntary decision, the individual will make a rational decision. However, the "therapeutic misconception" posits that individuals may confuse the goals of research with those of treatment and may make decisions that do not rest on adequate understanding. This article reviews research suggesting that this may in fact be true, and concludes that, as a result, traditional notions of informed consent may not yield results consistent with the assumptions on which the doctrine of informed consent rests., (Copyright (c) 2006 John Wiley & Sons, Ltd.)

Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the "therapeutic misconception". Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA. Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified and coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks or disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages and risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks or disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols. The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation.

Background: The therapeutic misconception occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures. The therapeutic misconception is a serious problem for informed consent in clinical research., Objectives: This paper analyzes the nature and origins of the therapeutic misconception and suggests some ways in which researchers can overcome this problem when obtaining a subject's consent to participation in research., Research Design: A conceptual analysis of informed consent to research and a review of the empirical literature are undertaken., Results: Research and clinical care involve different standards for how the patient/subject is to be treated. The confusion of the two often leads to profound misunderstandings on the part of the patient/subject., Discussion: A method for describing to patients/subjects the differences between research and treatment is proposed as a potential solution to the therapeutic misconception. Research is needed to determine whether this or any other change in the nature of the disclosure is effective in reducing the therapeutic misconception.

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. [ABSTRACT FROM PUBLISHER]

Therapeutic misconception (TM)—when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care—has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants’ incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers’ frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial. [ABSTRACT FROM PUBLISHER]

In the past 30 years, the incarcerated population in the United States has more than quadrupled to 2.3 million adults. With an alarmingly high prevalence of mental illness, substance use, and other serious health conditions compounding their curtailed autonomy, prisoners constitute perhaps the nation's most disadvantaged group. Scientifically rigorous research involving prisoners holds the potential to inform and enlighten correctional policy and to improve their treatment. At the same time, prisoner research presents significant ethical challenges to investigators and institutional review boards (IRBs) alike, by subjecting participants to conditions that potentially undermine the validity of their informed consent. In 2006, the Institute of Medicine Committee on Ethical Considerations for Revisions to the Department of Health and Human Services (DHHS) Regulations for Protection of Prisoners Involved in Research recommended both further protections and a more permissive approach to research review that would allow inmates greater access to potentially beneficial research. These recommendations have sparked renewed debate about the ethical trade-offs inherent to prisoner research. In this article, the authors review the major justifications for research with prisoner subjects and the associated ethical concerns, and argue that the field of empirical ethics has much to offer to the debate. They then propose a framework for prioritizing future empirical ethics inquiry on this understudied topic. [ABSTRACT FROM PUBLISHER]

Greater attention is being focused on the willingness and motivations of potential subjects who are recruited for research protocols. Given the importance of subjects' abilities to choose freely and reason through their decisions about entering psychiatric research, empirical researchers have been developing assessment and education tools that address the potential vulnerabilities of research subjects. In this study subjects' responses and reasons for or against participation were elicited as part of an assessment of their research decision making. Fifty-two persons diagnosed with a thought disorder were asked to consider a hypothetical research study using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Their responses were documented, coded for content, and correlated with demographic characteristics and scores on scales rating psychosis, cognition, and health-related quality of life. Subjects expressed common considerations that have been identified by other psychiatric investigators, as well as by those studying nonpsychiatric protocols. In general, reasons were both appropriate to the study being considered and appropriately linked to common considerations that flowed logically from the study. However, elements of the therapeutic misconception were evident as well. Willingness to participate was correlated with higher MacCAT-CR scores on certain scales, better education, and lower levels of psychosis and cognitive impairment. These findings highlight both the strengths and weaknesses of the decision making of research subjects with thought disorder. Research protections and assessments may consequently be appropriately targeted to specific vulnerabilities. Because of differences in severity of illness, cognition, and reasoning among subjects who decline to participate in research, greater attention to this population appears warranted. [ABSTRACT FROM PUBLISHER]

Abstract: To characterize predictors of impairment in research decision-making capacity, we undertook a direct comparison of schizophrenia/schizoaffective (n =52), medically ill (diabetic; n =51), and non-ill (n =57) subjects. Scores on the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) were correlated with demographic variables and scores on the Positive and Negative Syndrome Scale (PANSS), Mini-Mental State Examination (MMSE), and Short-Form-36 (SF-36). Across diagnoses, cognitive capacity, physical functioning, and a diagnosis of mental illness had the greatest impact on decision-making capacity, with level of education also having an impact. 69–89% of schizophrenia/schizoaffective subjects attained MacCAT-CR subscale scores achieved by almost all comparison (98–100%) and medically ill (94–100%) subjects. Positive, negative, and general psychotic symptoms correlated with poorer scores. Prior research experience, number of queries used during interview, and emotional functioning also predicted MacCAT-CR scores. These data suggest that investigators and IRBs should consider a number of variables, many of which reach across diagnoses, as they decide which populations and individual subjects may require more intensive screening for decisional impairment or educational interventions to improve their abilities to make capable decisions about research participation. [Copyright &y& Elsevier]