To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The (...) continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration. (shrink)

The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical and (...) scientific controversies associated with placebo-controlled trials, never far below the surface, have once again seized public attention. Clearly, concern about these issues within the professional community runs deep and wide, as evidenced by the volume of response generated by Kenneth Rothman and Karin Michels's recent Critique. Criticisms of the use of placebo controls in clinical research are scattered through the literatureo; our objective is to present the case against placebos in a compendious form that takes account of scientific and statistical as well as normative issues. (shrink)

The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical and (...) scientific controversies associated with placebo-controlled trials, never far below the surface, have once again seized public attention. Clearly, concern about these issues within the professional community runs deep and wide, as evidenced by the volume of response generated by Kenneth Rothman and Karin Michels's recent Critique. Criticisms of the use of placebo controls in clinical research are scattered through the literatureo; our objective is to present the case against placebos in a compendious form that takes account of scientific and statistical as well as normative issues. (shrink)

Walter Benjamin's Politics of 'bad tasteMichael Mac Modernity as an unfinished Project: Benjamin and Political RomanticismRobert Sinnerbrink Violence, ...

In summary, the usual elements of a typical health care ethics consultation note might reasonably accommodate the needs and expectations of relevant parties, and would therefore include: 1. identification of the relevant ethical issues, questions, or dilemmas; 2. reference to any relevant facts--medical, nursing, social, psychological, spiritual, legal, political, etc.; 3. a prioritized list of recommendations to improve coordinated care; 4. a clear and concise articulation of relevant arguments, wtih specific reference to the list of recommendations as well as to (...) the institution's overall ethos; 5. a contextual statement, identifying the perceived degree of consensus or support for the recommendations and conclusions, as well as any inherent agendas. (shrink)

Throughout his excellent book One Body, Alex Pruss relies upon the view that there is a requirement of universal love: each and every one of us is required to love each and every one of us. Although he often appeals to revealed truth in making arguments for his various theses, he supports the requirement of universal love primarily through a philosophical argument, an argument that I call the “argument from responsiveness to value.” The idea is that all persons bear a (...) sort of nonrelational value, and because this value gives every agent reasons to respond to it positively, each and every person is bound to love each and every person. The aim of this paper is to criticize this argument. Pruss’s argument has two important gaps, one concerning the sort of reasons that the value of persons gives and one concerning whether the required response is the response of love. (shrink)

OBJECTIVE: Pilot study to characterize treatment differences between patients treated in clinical trials and those treated in a clinical setting. Previous studies have shown higher survival rates for participants in trials of cancer therapy. This difference is observed even after rates are adjusted for important covariates such as age and stage of disease. DESIGN: Retrospective chart review. SETTING: Oncology outpatient department in a tertiary care hospital. PATIENTS: Ninety women 18 to 70 years of age with early-stage breast cancer who were (...) diagnosed in 1990. Fifty-one of the women were treated through clinical trials and 39 were treated outside of clinical trials. OUTCOME MEASURES: Number of blood tests, telephone calls, clinic visits and imaging procedures as well as intensity of chemotherapy and use of radiation therapy. The age of the patient and the stage of disease were important covariates. RESULTS: After the analysis was controlled for patient age and stage of disease, patients treated through a clinical trial were more likely to receive standard-dose chemotherapy (p = 0.020, 95% confidence interval 1.20 to 200.73) and more frequent blood tests (p < 0.001, 95% confidence interval 1.02 to 1.13) than other patients treated in the clinic. CONCLUSIONS: Our results provide a plausible mechanism for the observed survival advantage for participants in clinical trials in oncology. Further study is called for. If these results are confirmed, they have important implications for informed consent to participate in clinical trials and for clinical practice. (shrink)

OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty. DESIGN: Survey questionnaire. PARTICIPANTS: Cancer investigators from the United States and Canada. INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they would (...) enrol the patient in a trial and how sure they were of this decision. Demographic characteristics of the investigators were also collected. OUTCOME MEASURES: The difference in enrolment decisions between subjective and objective criteria, and the difference in the certainty associated with these decisions. RESULTS: Of 365 questionnaires sent out, 224 usable ones were returned. Compared with the objective criteria, the subjective criteria were associated with more variable enrolment decisions (p = 0.07 for the "eligible" scenario and p = 0.0001 for the "ineligible" and "uncertain" scenarios), and investigators were less sure about the decisions they made (p = 0.0001 for all scenarios). Demographic characteristics of the investigators failed to explain the observed differences. CONCLUSIONS: Subjective eligibility criteria may interfere with the conduct and interpretation of RCTs and, therefore, their use ought to be justified explicitly in the study protocol. RCT designers, funding agencies and research ethics boards have an important role in reviewing eligibility criteria for their necessity. (shrink)

The recent upsurge in “brain-training and perceptual-cognitive-training", proposing to improve isolated processes such as brain function, visual perception and decision-making, has created significant interest in elite sports practitioners, seeking to create an ‘edge’ for athletes. The claims of these related 'performance-enhancing industries' can be considered together as part of a process training approach proposing enhanced cognitive and perceptual skills and brain capacity, to support performance in everyday life activities, including sport. For example, the 'process-training industry' promotes the idea that playing (...) games not only makes you a better player, but also smarter, more alert, and a faster learner. In this position paper we critically evaluate the effectiveness of both types of process-training programmes in generalizing transfer to sport performance. These issues are addressed in three stages. First, we evaluate empirical evidence in support of perceptual-cognitive process training, and its application to enhancing sport performance. Second, we critically review putative modularised mechanisms underpinning this kind of training, addressing limitations and subsequent problems. Specifically, we consider merits of this highly specific form of training, which focuses on training of isolated processes such as cognitive processes (attention, memory, thinking) and visual perception processes, separately from performance behaviors and actions. We conclude that these approaches may, at best, may provide some 'general transfer' of underlying processes to specific sport environments, but lack 'specificity of transfer' to contextualize actual performance behaviors. A major weakness of process training methods is their focus on enhancing performance in body “modules” (e.g., eye, brain, memory, anticipatory sub-systems). What is lacking is evidence on how these isolated components are modified and subsequently interact with other process “modules”, which are considered to underlie sport performance. Finally, we propose how an ecological dynamics approach, aligned with an embodied framework of cognition undermines the rationale that modularised processes can enhance performance in competitive sport. An ecological dynamics perspective proposes that the body is a complex adaptive system, interacting with performance environments in a functionally integrated manner, emphasising that the inter-relation between motor processes, cognitive and perceptual functions and the constraints of a sport task is best understood at the performer-environment scale of analysis. (shrink)

In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print between January 1988 (...) and September 1994 for which a Clinical Alert had been issued. Eligibility criteria were further classified into five categories in order to examine the content of information loss, if any. On average, 82% of protocol eligibility criteria were reported in methods papers. Journal articles and Clinical Alerts fared somewhat worse: 63% of criteria were reported in journal articles, 19% in Clinical Alerts. In all three categories of medical communication, the reporting of criteria that defined the study disease tended to be complete; reporting of criteria relating to trial precision, patient safety, legal and ethical concerns, and administrative considerations, was not complete. We found that criteria for clinical trial eligibility are frequently under-reported in medical communications. Moreover, some of the criteria omitted are of considerable clinical importance. We suggest that in the design phase of clinical trials, proposed eligibility criteria be scrutinized closely. Those criteria that survive this scrutiny and that have clinical import must be reported upon fully and accurately when communicating trial results. (shrink)

We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference between NSABP studies (explanatory (...) trials) and POG studies (pragmatic trials) suggest that large numbers of eligibility criteria are not necessary for quality studies. We recommend that: (1) the inclusion/exclusion criteria distinction be abandoned; (2) eligibility criteria be explicitly justified; (3) the need for each criterion be assessed when new trials are planned; (4) criteria in phase III trials restricting patient accrual be minimized; and (5) further research be done to assess the impact of criteria on generalizability. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

The conversation seeks to extend and complicate Charles Taylor’s (2004) account of three constitutive formations of modern social imaginaries: market, the public sphere, and the nation-state based on popular sovereignty in two critical respects. First, it seeks to show how these key imaginaries, especially the market imaginary, are not contained and sealed within autonomous spheres. They are portable and they often leak into domains beyond the ones in which they originate. Second, it seeks to identify and explore the new (...) incipient and/or emergent imaginaries vying for recognition and demanding consideration in the constitution (as well as analysis) of contemporary social life, such as the risk-reward entrepreneurial culture. (shrink)

Résumé éditeur : This book tells two intertwined stories, centered on twentieth-century moral philosophers Elizabeth Anscombe, Mary Midgley, Philippa Foot, and Iris Murdoch. The first is the story of four friends who came up to Oxford together just before WWII. It is the story of their lives, loves, and intellectual preoccupations; it is a story about women trying to find a place in a man's world of academic philosophy. The second story is about these friends' shared philosophical project and their (...) unintentional creation of a school of thought that challenged the dominant way of doing ethics. That dominant school of thought envisioned the world as empty, value-free matter, on which humans impose meaning. This outlook treated statements such as “this is good” as mere expressions of feeling or preference, reflecting no objective standards. It emphasized human freedom and demanded an unflinching recognition of the value-free world. The four friends diagnosed this moral philosophy as an impoverishing intellectual fad. This style of thought, they believed, obscured the realities of human nature and left people without the resources to make difficult moral choices or to confront evil. As an alternative, the women proposed a naturalistic ethics, reviving a line of thought running through Plato, Aristotle, and Aquinas, and enriched by modern biologists like Jane Goodall and Charles Darwin. The women proposed that there are, in fact, moral truths, based in facts about the distinctive nature of the human animal and what that animal needs to thrive.". (shrink)

The papers collected in this book share a common motivation: All respond to certain kinds of injustice that unfairly and unreasonably prevent the insights and intellectual abilities of vulnerable and stigmatized groups from being given their due recognition. Most people are opposed to injustice in principle, and do not want to have mistaken views about others. But research in the social sciences reveals a disturbing truth: Even people who intend to be fair-minded and unprejudiced are influenced by unconscious biases and (...) stereotypes, as well as social structures and institutions that lead to unjust judgments. We may sincerely want to be epistemically just, but we frequently fail, and simply thinking harder about it will not fix the problem. -/- This volume collects 17 new essays that draw from cutting-edge social science research, to suggest how we can better manage our own unjust reactions, as well as resist patterns of epistemic injustice that we may face. The volume concludes with an afterward by Miranda Fricker, reflecting on these new lines of research and potential future directions to explore. (shrink)

Abstract The debate in the philosophy of perception between direct realists and representationalists should influence the debate in epistemology between internalists and externalists about justification. If direct realists are correct, there are more consciously accessible justifiers for internalists to exploit than externalists think. Internalists can retain their distinctive internalist identity while accepting this widened conception of internalistic justification: even if they welcome the possibility of cognitive access to external facts, their position is still quite distinct from the typical externalist position. (...) To demonstrate this, Alvin Goldman’s critique of internalism is shown to ignore important lessons from the case for direct realism about perception. In particular, it unjustifiably assumes that internalism entails that only facts simultaneous with the justification of a belief can justify the belief. Goldman’s definition of a “justifier” is also inconsistent with the overall guidance conception of epistemology he takes for granted in his critique of internalism. Content Type Journal Article Pages 1-26 DOI 10.1007/s12136-012-0146-4 Authors Benjamin Bayer, Department of Philosophy, Loyola University, New Orleans, 6363 St. Charles Avenue, Box 046, New Orleans, LA 70118, USA Journal Acta Analytica Online ISSN 1874-6349 Print ISSN 0353-5150. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Further ReflectionsCharles AltieriI see now that I was wrong in lumping Robert B. Pippin with other philosophers who adapt literary experience to philosophical purposes.1 And I was probably too taken with Walter Benjamin to appreciate fully Pippin's version of Proustian sensibility. I can invoke no authority to explain why I did not see adequately that tone is so central to J. M. Coetzee's Elizabeth Costello. So I am (...) very grateful to Pippin not only for pointing out my inadequate reading but also showing how, as critics, we both—for the most part—emphasize conditions of experience rendered by great literary texts. But I cannot apologize for some features of my argument, so I hope to refine them in this response.Pippin is not interested in providing explanations for texts or even, at his best, in using philosophy to extract "meaning." He limits himself to a subset of literary texts that engage philosophical thinking. Within these limits he proposes to do philosophy by literary means. That is, he wants to develop philosophically the particular situations eliciting philosophical concerns. His goal is not to stabilize the arguments underlying the text but to make more fully articulate the particular line of reflection carried out by the text and projected as a means of engaging thought on the part of the audience. Philosophy by other means becomes an engagement with literary practices concentrating on how the ways that thinking is handled in the text can take on a kind of concrete universality. This move toward generalizability does not depend on universals provided by argument (since, if one follows Ludwig Wittgenstein's On Certainty, the fictive cannot be said to provide any knowledge of objective conditions, despite Pippin's wavering on this point; see p. 240). Rather, [End Page 260] generalization occurs by fleshing out dramatic particular occasions that establish significant perspectives on cultural problems, especially those involving transformations in cultural life, like understandings of self-knowledge, the consequences of imperialism, and the ways language becomes increasingly difficult to trust for communicative purposes.The philosophical task for Pippin is to provide a language for why the situation in a literary text might matter beyond the details that give it much of its power. G. W. F. Hegel showed how works of art can embody modes of thinking that provide articulate moments shaping what before them had been isolated undercurrents marking fissures in cultural life. Pippin wants to revive this ambition to produce philosophically articulate moments that bring out cultural and ideological tensions formative for modern reflective lives. This desire, I think, springs largely from Pippin's commitment to preserve Hegel's way of reading literature so that he can provide an alternative to Hegel's argument that once the universals established in an Absolute become increasingly visible, the significance of art for understanding culture will diminish substantially.Pippin has explored two alternatives for defending a Hegelian approach capable of preserving the cultural importance of the arts: in visual arts by providing languages for social critique, and in literature by actually dramatizing the significance of how texts can engage and establish processes of thinking that address pressing philosophical concerns. In effect, only by showing how Hegel was wrong that philosophy could establish a possibility of knowing an Absolute that would render art a minor player in civilization's capacity for self-awareness could criticism show how art becomes possibly the only vehicle we have to honor the spiritual complexities experience can make manifest.But even when I am led to agree for the most part with Pippin's claims about literature as philosophy, his focus on cultural relevance bothers me because that focus provides constant temptations to minimize the complex experiences works produce. So I think I have to try again to articulate what I think I can save of my efforts to distinguish literary experience from Pippin's enlightened philosophical ways of engaging literary texts. Let me propose three features of my original argument that seem still worth considering. First, I will simply assert that Pippin's theorizing of two factors necessary for interpreting intentions—as authorial purposiveness and as historically based recontextualizations of the work—makes it very difficult... (shrink)

Framed as a critique of David Hume’s analysis of miracles, Peirce offers a sustained argument against an approach to historical inference he calls the “Method of Balancing Likelihoods‘ (MBL). In MBL the posterior probability that a disputed historical event has occurred is computed on the basis of the prior probability of that event occurring and the probability that each purported witness of the event has given accurate testimony. Peirce’s critique of this method is hierarchical: he denies that an objective probability (...) obtains for the truthfulness of witness testimony. Conceding this point, he asserts that, even if such objective probabilities exist, it is implausible to believe that witnesses are independent of one another. Conceding the first two points, Peirce argues that the very sampling process inherent to history necessarily introduces a strong probabilistic dependence that makes MBL unreliable. Finally, irrespective of the success of his first three criticisms, Peirce argues that MBL can be shown by empirical means to fail as a reliable method of inference. I reconstruct this hierarchical critique from a handful of Peirce’s manuscripts, and emphasize its continuing relevance for modern accounts of judgment aggregation. (shrink)

Umberto Eco argues that a mirror image is not a sign. At best it is a double, a thing that ceases to be once the reflected object is removed. Harry Mulisch narratively suggests that mirror images function metaphorically as gateways between human suffering and the divine. And interestingly, science employs mirrors and mirror images both to turn our gaze upwards and to show us reflections of our place in the cosmos. Tying together Eco's notion of the double, Mulisch's insistence that (...) mirror images reflect humanity's construction of the divine, and the Giant Magellan Telescope Project's cosmic images, it is my contention that modern, telescopic mirror images are much more than snapshots of the cosmos. They are constructions of human and divine meaning that—signifying—pose the question, what is reflected: the cosmos or humanity? (shrink)

This book offers a collection of contemporary essays that explore philosophical themes at work in chess. This collection includes essays on the nature of a game, the appropriateness of chess as a metaphor for life, and even deigns to query whether Garry Kasparov might—just might—be a cyborg. In twelve unique essays, contributed by philosophers with a broad range of expertise in chess, this book poses both serious and playful questions about this centuries-old pastime. -/- Perhaps more interestingly, philosophers have often (...) used chess in discussions of their work. Walter Benjamin compares the marching of history to an automaton playing chess. John Dewey and Charles Sanders Peirce utilize chess to explain their pragmatism. The linguist Ferdinand de Saussure employs the analogy of chess to explain the exchange of signifiers. There are approximately 181 uses of the word chess or one of its cognates in the published works of Ludwig Wittgenstein. John Rawls explains that one might want to make a distinction between constitutive and regulative rules, which can best be understood by examining a game of chess. John Searle, deeply convinced of this distinction, explains further: "The rules of football or chess are given as an example of constitutive rules because they 'create the very possibility of playing such games.'" Hubert Dreyfus and Daniel Dennett have had extensive public discussions about the issue of artificial intelligence and chess. Dreyfus, utilizing chess examples, has written extensively on what computers still cannot do. Meanwhile, in spite of his protestations, chess-playing computers continue to fascinate those who work in the area of artificial intelligence. -/- The game of chess has endured since at least the sixth century. Its earliest variant, the Indian game of Chaturanga, was from the beginning a game for thinkers. Since its inception, scholars, statesmen, strategists, and warriors have been fascinated by the game and its variants. German philosopher Emmanuel Lasker and famed French artist Marcel Duchamp were both Grandmasters at chess. Karl Marx played chess avidly, as did Sir Bertrand Russell, Jean-Paul Sartre, and the logical positivist Max Black. Jean-Jacques Rousseau mentions in his Confessions that, at the time, he "had another expedient, not less solid, in the game of chess, to which I regularly dedicated, at Maugis's, the evenings on which I did not go to the theater. I became acquainted with M. de Legal, M. Husson, Philidor, and all the great chess players of the day, without making the least improvement in the game." More recently, philosopher Stuart Rachels reports that his father, the late philosopher and prominent ethicist James Rachels, received a bribe from a Russian Grandmaster while he was the chair of the U.S. Chess Federation's Ethics committee. -/- "Whether you’re a professional philosopher, an armchair chess player, or something in between, Philosophy Looks at Chess gives you hours of thought-provoking reading. With chapters on technology, ethics, hip hop, and backward analysis, this book carves out a new space in the literature on both chess and philosophy" -/- —Jennifer Shahade, two-time U.S. Women's Champion and author of Chess Bitch -/- "Chess and philosophy are natural mates that have been awaiting the proper introduction. This wide-ranging collection of stimulating essays is the perfect opening gambit for philosophical chess enthusiasts." -/- —Will Dudley, author of Hegel, Nietzsche, and Philosophy: Thinking Freedom. (shrink)