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)

In lieu of an abstract, here is a brief excerpt of the content:Ought We to Require Emotional Capacity as Part of Decisional Competence?Paul S. Appelbaum* (bio)AbstractThe preceding commentary by Louis Charland suggests that traditional cognitive views of decision-making competence err in not taking into account patients’ emotional capacities. Examined closely, however, Charland’s argument fails to escape the cognitive bias that he condemns. However, there may be stronger arguments for broadening the focus of competence assessment to include emotional capacities, centering on (...) the ways in which emotions aid humans in processing information. Before emotional capacities are added to the list of functions essential for decisional competence, though, the feasibility and utility of such a reorientation must be demonstrated.To what extent ought persons’ capacities to experience emotion be taken into account when determining whether they should be deemed competent to make their own decisions? In the previous article, Louis Charland (1998) argues that traditional models of decision-making competence—of which the MacArthur Competence Treatment Study is a typical example—are mistaken in focusing narrowly on persons’ cognitive abilities to the neglect of emotional factors. In contrast, he suggests, constructs of competence ought explicitly to require a capacity to experience emotions, which he believes is central to meaningful decision making, before deeming persons competent.Charland, as he acknowledges, is not the first to suggest that the presence of some degree of emotional capacity is a necessary element of competence, but his argument is among the most elaborate to date and is certainly worth closer examination. Looked at carefully, however, Charland’s argument does not make quite the case for the determination of emotional capacity in competence assessment that he claims for it. Indeed, as I demonstrate below, Charland may share the same “pernicious [End Page 377] cognitive bias” that he ascribes to more traditional approaches. However, despite what I identify as the problems in Charland’s argument, others have raised more disturbing questions about the lack of attention to emotional issues in competence assessment. Thus, I am not ready to reject entirely the possibility that determinations of decisional competence ought to consider emotional factors. I conclude by outlining the questions that remain to be answered to identify more clearly the potential benefits of such an approach.The Construct of Decision-Making CompetenceSome preliminary comments about the nature of the dominant construct of decision-making competence may provide a useful frame for my response to Charland’s paper. Contemporary ideas of competence are tied inextricably to the ideal of self-determination in modern Western societies. Such societies are committed to respect for individual choice, both as a good in its own right and on the grounds that each person knows best what choices will maximize his or her own welfare. In general, therefore, states will not intervene to prevent persons from acting on their decisions, even when the choices they make—like the decision to smoke or to refuse potentially life-saving medical care—may objectively be thought to be detrimental to them.In some cases, however, the presumption that people will act in their own interests, as well as the notion that there is something intrinsically valuable in respecting their choices, fails (Buchanan and Brock 1989). When people’s minds are so disordered that they cannot be said to be making meaningful choices, other values come into play. Such people are called “incompetent.” When persons reach that point, the state’s interest in protecting its citizens becomes primary and someone else must make decisions on their behalf. Note that the size of this group must be sharply limited, lest a liberal society’s commitment to self-determination be undermined: There is no more profound infringement of the rights of citizens than the determination that they are incompetent. Thus, the criteria for incompetence must be selected in a deliberately narrow fashion—alternately, one might say that the standards for competence are made intentionally broad—so that all but a tiny percentage of citizens will be permitted to make decisions on their own.In the Anglo-American world, the process of formulating criteria of competence by and large has been left to the common law courts. Over the course of centuries they have identified the capacities that are, in... (shrink)

When emotions are mentioned in the literature on mental competence, it is generally because they are thought to influence competence negatively; that is, they are thought to impede or compromise the cognitive capacities that are taken to underlie competence. The purpose of the present discussion is to explore the possibility that emotions might play a more positive role in the determination of competence. Using the MacArthur Treatment Competence Study as an example, it is argued that appreciation, a central theoretical concept (...) in many contemporary approaches to competence, has important emotive components that are seldom sufficiently recognized or acknowledged. If true, this means that some leading contemporary accounts of competence need to be revised in order to make more adequate provision for the positive contribution of emotion. (shrink)

This article gives a brief introduction to the MacArthur Competence Assessment Tool-Treatment (MacCAT-T) and critically examines its theoretical presuppositions. On the basis of empirical, methodological and ethical critique it is emphasised that the cognitive bias that underlies the MacCAT-T assessment needs to be modified. On the one hand it has to be admitted that the operationalisation of competence in terms of value-free categories, e.g. rational decision abilities, guarantees objectivity to a great extent; but on the other hand it bears severe (...) problems. Firstly, the cognitive focus is in itself a normative convention in the process of anthropological value-attribution. Secondly, it misses the complexity of the decision process in real life. It is therefore suggested that values, emotions and other biographic and context specific aspects should be considered when interpreting the cognitive standards according to the MacArthur model. To fill the gap between cognitive and non-cognitive approaches the phenomenological theory of personal constructs is briefly introduced. In conclusion some main demands for further research to develop a multi-step model of competence assessment are outlined. (shrink)