Abstract: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 ascientific reframingof participation in a clinical trial. (shrink)

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that (...) acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved. (shrink)

Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection.

The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of (...) time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects. (shrink)

Issues associated with consent to clinical trials have attracted considerable attention recently, spurred in part by controversies over alleged inadequacies in the consent process. Professor Jansen's interesting essay is unusual in two ways. First, it raises issues about the conceptualization of one set of problems in informed consent (which Jansen subsumes under the term “therapeutic error”) and, more critically, about the methods and the data used to assess them. Second, she is unique in using the findings of academic experimental psychology (...) to critique the empirical findings. This produces a thoughtful and original critique of the process of informed consent to research that, nonetheless, we believe, yields a model that does not reflect the reality of clinical research. (shrink)

Institutional review boards are almost universally considered to be overworked and understaffed. They also require substantial commitments of time and resources from their members. Although some surveys report average IRB memberships of 15 people or more, federal regulations require only five. We present data on IRB meetings at eight of the top 25 academic medical centers in the United States funded by the National Institutes of Health. These data indicate substantial contributions from primary reviewers and chairs during protocol discussions but (...) little from other members, which implies that it may be possible for smaller IRBs to accomplish the same tasks with no reduction in the quality of review. (shrink)

Voluntariness of consent to research has not been sufficiently explored through empirical research. The aims of this study were to develop a more comprehensive approach to assessing voluntariness and to generate preliminary data on the extent and correlates of limitations on voluntariness. We developed a questionnaire to evaluate subjects’ reported motivations and constraints on voluntariness. 88 subjects in five different areas of clinical research—substance abuse, cancer, HIV, interventional cardiology, and depression—were assessed. Subjects reported a variety of motivations for participation. Offers (...) of financial incentives were common but not influential, pressures from others were rare, and no threats were reported. However, certain financial incentives and—paradoxically—altruistic motivations led some subjects to feel more constrained. Consistent with previous studies, no one pattern of motivation was common to all research subjects. There was little evidence of constrained voluntariness, but some suggestion of areas of concern. Voluntariness appears to be susceptible to systematic empirical investigation. (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)

Depression is often diagnosed in patients nearing the end of their lives and medication or psychotherapy is prescribed. In many cases this is appropriate. However, it is widely agreed that a health care professional should treat sick persons so as to improve their condition as they define improvement. This raises questions about the contexts in which treatment of depression in late life is appropriate. This article reviews a problematic case concerning the appropriateness of treatment in light of the literature in (...) bioethics. Specific attention is paid to the concept of authenticity and the role of suffering. Suffering is often the result of a situation in which one's self is damaged. In some circumstances, this suffering should not be seen as a symptom of illness but as a reflection, in a difficult life context, of the individual's authentic nature. Assessment of depression in the elderly must go beyond a symptom list and must consider both the context of the individual's situation and his or her authentic self. When the symptoms reflect the individual's assessment of the situation in the context of the authentic self, they may be "appropriate." However, even when the symptoms are appropriate, if they interfere with life assessment and adjustment, treatment should be considered. (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)

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB (...) process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials. (shrink)

As a 2006 Institute of Medicine report highlights, surprisingly little empirical attention has been paid to how prisoners arrive at decisions to participate in modern research. With our study, we aimed to fill this gap by identifying a more comprehensive range of factors as reported by prisoners themselves during semistructured interviews. Our participants described a diverse range of motives, both favoring and opposing their eventual decision to join. Many are well-recognized considerations among nonincarcerated clinical research participants, including a desire for (...) various forms of personal benefit, altruism, and concern about study risks and inconveniences. However, a number of influences seem unique to prisoners. Participants did not report that they were not coerced into enrolling, and they have even been under pressure not to enroll. However, many sought to enroll in order to obtain access to better health care, raising a concern about whether they were unfairly exploited. (shrink)

The present edition provides a detailed and accessible discussion ofhis theories and adds an account of the immediate responses to the book on publication.

Charles Darwin's On the Origin of Species is unquestionably one of the chief landmarks in biology. The Origin (as it is widely known) was literally only an abstract of the manuscript Darwin had originally intended to complete and publish as the formal presentation of his views on evolution. Compared with the Origin, his original long manuscript work on Natural Selection, which is presented here and made available for the first time in printed form, has more abundant examples and illustrations (...) of Darwin's argument, plus an extensive citation of sources. (shrink)

At the very beginning of L’Homme-Machine, La Mettrie claims that Leibnizians with their monads have “rather spiritualized matter than materialized the soul”; a few years later Pierre-Louis Moreau de Maupertuis, President of the Berlin Academy of Sciences and natural philosopher with a strong interest in the modes of transmission of ‘genetic’ information, conceived of living minima which he termed molecules, “endowed with desire, memory and intelligence,” in his Système de la nature ou Essai sur les corps organisés. This text first (...) appeared in Latin in 1751 under the title Dissertatio inauguralis metaphysica de universali naturae systemate, with the pseudonym Dr Baumann; it was translated by Maupertuis in 1754 as Essai sur la formation des corps organisés and was later included in his 1756 Œuvres under the title Système de la nature. Now, it is clear that Maupertuis was a kind of Leibnizian; and that his molecule possessed higher-level, ‘mental’ properties. In that sense he falls under the first category described by La Mettrie. But he was also involved in a debate on this issue with Diderot, who put forth a sustained critique of Maupertuis’ theory of the molecule in the additions to his 1753 Pensées sur l’interprétation de la nature. Where Maupertuis attributes higher-level properties to his living minima, Diderot argues that these properties are ‘organizational’, i.e., they can only be properties of the whole. At issue here is the degree of commitment to a form of materialism. (shrink)

In his Philosophical Inquiry concerning Human Liberty (1717), the English deist Anthony Collins proposed a complete determinist account of the human mind and action, partly inspired by his mentor Locke, but also by elements from Bayle, Leibniz and other Continental sources. It is a determinism which does not neglect the question of the specific status of the mind but rather seeks to provide a causal account of mental activity and volition in particular; it is a ‘volitional determinism’. Some decades later, (...) Diderot articulates a very similar determinism, which seeks to recognize the existence of “causes proper to man” (as he says in the Réfutation d’Helvétius). The difference with Collins is that now biological factors are being taken into account. Obviously both the ‘volitional’ and the ‘biological’ forms of determinism are noteworthy inasmuch as they change our picture of the nature of determinism itself, but my interest here is to compare these two determinist arguments, both of which are broadly Spinozist in nature – and as such belong to what Jonathan Israel called in his recent book “the radical Enlightenment,” i.e. a kind of underground Enlightenment constituted by Spinozism – and to see how Collins’ specifically psychological vision and Diderot’s specifically biological vision correspond to their two separate national contexts: determinism in France in the mid-1750s was a much more medico-biological affair than English determinism, which appears to be on a ‘path’ leading to Mill and associationist psychology. (shrink)

The meaning of 'most' can be described in many ways. We offer a framework for distinguishing semantic descriptions, interpreted as psychological hypotheses that go beyond claims about sentential truth conditions, and an experiment that tells against an attractive idea: 'most' is understood in terms of one-to-one correspondence. Adults evaluated 'Most of the dots are yellow', as true or false, on many trials in which yellow dots and blue dots were displayed for 200 ms. Displays manipulated the ease of using a (...) 'one-to-one with remainder' strategy, and a strategy of using the Approximate Number System to compare of (approximations of) cardinalities. Interpreting such data requires care in thinking about how meaning is related to verification. But the results suggest that 'most' is understood in terms of cardinality comparison, even when counting is impossible. (shrink)

Kierkegaard’s ideal supports a radical form of “deep diversity,” to use Charles Taylor’s expression. It is radical because it embraces not only irreducible conceptions of the good but also incompatible ones. This is due to its paradoxical nature, which arises from its affirmation of both monism and pluralism, the One and the Many, together. It does so in at least three ways. First, in terms of the structure of the self, Kierkegaard describes his ideal as both unified (the “positive (...) third”) and plural (a “negative unity”). Second, he affirms a process which brings together unity, as implied by the linear notion of “stages”, with plurality, in the form of “spheres of existence” (aesthetic, ethical, and religious). And third, the culmination of the process implies that we should embrace both a unified dialectic (“Religiousness A”) alongside the plural remnants of the ethical/aesthetic, that is, both the infinity of the former and the finitudes of the latter. Unsurprisingly, while Kierkegaard describes those who are able to exemplify his ideal in practice as “always joyful,” he also considers the ideal to be “extremely hard, the hardest task of all.” This is why those such as Hubert L. Dreyfus are wrong to claim that it provides an experience of bliss; on the contrary, those who realize it “are always in danger.” As I shall show, one form this danger takes is that it threatens to dirty the hands of those who manage to uphold Kierkegaard’s ideal. Moreover, it does so in ways that, I claim, tend to be missed by Kierkegaard himself. Nevertheless, the danger is also essential to the creativity of his approach, and I conclude by pointing out how this creativity makes it capable of tackling one of the profoundest challenges in contemporary ethics: that arising from what just war theorists call a “supreme emergency.” . (shrink)

This book provides a novel interpretation of the ideas about language in Ludwig Wittgenstein's Philosophical Investigations. Travis places the "private language argument" in the context of wider themes in the Investigations, and thereby develops a picture of what it is for words to bear the meaning they do. He elaborates two versions of a private language argument, and shows the consequences of these for current trends in the philosophical theory of meaning.

This book is an examination of the inattention of business schools to moral education, addressing lessons learned from the most recent business corruption scandals and financial crises, and also questioning what we're teaching now and what should be considering in educating future business leaders to cope with the challenges of leading with integrity in the global environment"--Provided by publisher.

Quantifiers are a test case for an interface between psychological questions, which attempt to specify the numerical content that supports the semantics of quantifiers, and linguistic questions, which uncover the range of possible quantifier meanings allowable within the constraints of the syntax. Here we explore the development of comprehension of most in English, of particular interest as it calls on precise numerical content that, in adults, requires an understanding of large exact numerosities (e.g., 23 blue dots and 17 yellow is (...) an instance of “most of the dots are blue”). In a sample of 100 children 2 to 5 years of age we find that (a) successful most comprehension in cases with two salient subsets is achieved at 3 years, 7 months of age, and (b) most comprehension is independent of knowledge of large exact number words; that is, knowledge of large exact number words is neither necessary, as evidenced by children who understand “most” but not “four,” nor sufficient, as evidenced by children who understand “nine” but not “most.”. (shrink)

I will begin by considering how the social world appears to the scientific observer and ask the question of whether the world of scientific research, with all its categories of meaning interpretation and with all its conceptual schemes of action, is identical with the world in which the observed actor acts. Anticipating the result, I may state immediately that with the shift from one level to the other, all the conceptual schemes and all the terms of interpretation must be modified.Proceeding (...) in this direction, I encounter several problems overlapping with the problem of rational action and the “rational act unit” in Professor ParsonsParsons, Talcott’ sense. First: The conceptual scheme of rational action presupposes a more or less definite knowledge of, or orientation within, the world in which this action is performed. In this sense the term, “rationality”, is not specific to the conceptual scheme of action; it embraces the conceptual scheme of the world in general and is only one element in it. Therefore, we also must examine the problem of orientation in this world. Second: We ought to keep in mind that all interpretation of the social world has to start from the actor’s subjective point of view. Therefore, we cannot accept the term, “unit act”, as such, without trying to reduce it to its subjective meaning. Here I have to discuss in general terms why I insist on the subjective point of view. This is more than the whim of a few social scientists; social science cannot be built up except by taking cognizance of the subjective meaning the actor connects with his acting. Finally, I have to discuss the fact that there are social sciences operating on high theoretical levels that, like economics, apparently prefer to deal with statistical curves and mathematical formulae rather than with actions of human beings in the social world, yet they use the term, “rational action”, as an indispensable element of their systems. I will have to show what modification this term undergoes in these types of social sciences..). (shrink)

Ce livre étudie, à travers une série d'épisodes allant de la philosophie des Lumières à notre époque, le problème du matérialisme dans l'histoire de la philosophie et l’histoire des sciences. Comment comprendre les spécificités de l’histoire du matérialisme, des Lumières à nos jours, au sein de la grande histoire de la philosophie et de l’histoire des sciences ? Quelle est l’actualité de l’opposition classique entre le corps et l’esprit ? Qu’est-ce que le rire ou le rêve peuvent nous apprendre du (...) matérialisme ? En traversant l’histoire de ce concept jusqu’à l’émergence d’un « nouveau matérialisme » contemporain, l’ouvrage vise à revitaliser le matérialisme et sa lecture. -/- . (shrink)

I argue that Kant thought his Transcendental Deduction of the Pure Concepts could reach skeptical empiricists like Hume by providing an overlooked explanation of the mind's a priori relation to the objects of experience. And he thought empiricists may be motivated to listen to this explanation because of an instability and dissatisfaction inherent to empiricism.

This paper proposes an Interface Transparency Thesis concerning how linguistic meanings are related to the cognitive systems that are used to evaluate sentences for truth/falsity: a declarative sentence S is semantically associated with a canonical procedure for determining whether S is true; while this procedure need not be used as a verification strategy, competent speakers are biased towards strategies that directly reflect canonical specifications of truth conditions. Evidence in favor of this hypothesis comes from a psycholinguistic experiment examining adult judgments (...) concerning ‘Most of the dots are blue’. This sentence is true if and only if the number of blue dots exceeds the number of nonblue dots. But this leaves unsettled, e.g., how the second cardinality is specified for purposes of understanding and/or verification: via the nonblue things, given a restriction to the dots, as in ‘|{x: Dot(x) & ~Blue(x)}|’; via the blue things, given the same restriction, and subtraction from the number of dots, as in ‘|{x: Dot(x)}| – |{x: Dot(x) & Blue(x)}|’; or in some other way. Psycholinguistic evidence and psychophysical modeling support the second hypothesis. (shrink)

El libro que estableció la teoría de la separación de poderes -afirmando la independencia del poder judicial con respecto al ejecutivo y el legislativo, para asegurar la libertad del pueblo- es una de las obras clave del pensamiento político, jurídico, sociológico e histórico de todos los tiempos.Aquella teoría enunciada por Charles-Louis de Secondat, barón de La Brède y de Montesquieu -"No hay libertad si el poder judicial no está separado del legislativo y executivo"- es tan sólo uno de los (...) momentos cumbres de este libro{ probablemente, el más importante de todo el siglo XVIII y un verdadero clásico desde que se publicó en Ginebra en 1748.Montesquieu tardó cerca de viente años en escribir "Del espíritu de las leyes"{ obra ingente que "empecé y dejé" en numerosas ocasiones, entregando "mil veces á los vientos las hojas que había escrito" y que, finalmente, concluyó, con más de 1.000 páginas -hojas perennes- que le ofrecen una lectura imprescindible.Lex Nova pone ahora a su disposición, por primera vez, este cuidado facsímil que reproduce, en tres tomos, la edición que publicó el anónimo licenciado M.V.M. en Madrid, París y Londres -respectivamente- en 1821, traduciendo aquella obra "libremente al español".Un verdadero lujo a su alcance. (shrink)

Discusses heaven, the Creation, forgiveness, vanity, the theology of romantic love, responsibility, and the life of Jesus.

argues that ancient Greek medicine had a significant effect on the way in which Plato conceived of ethics, and (2) explores some ways in which Plato integrated medical concepts such as "health" into his ethics. Specific parallels between ancient medicine and such concepts as eudaimonia , soul, nature and convention, etc., are discussed, as is the relation between conceptions of health and medical treatment. Keywords: ancient medicine, ethics, health, Plato CiteULike Connotea Del.icio.us What's this?

Lidz also ponders the theory of syntactic bootstrapping by asking why it is that learners are considered to retain little of extralinguistic environments (i.e., their observations) during word learning, while being able to retain detailed representations of linguistic context, for example, the multiple syntactic frames in which a verb appears. Lidz argues that learners value syntactic information over extralinguistic context from the beginning of learning, consistent with syntactic bootstrapping as a key device for verb learning.