In The Ethics of Food, Gregory E. Pence brings together a collection of voices who share the view that the ethics of genetically modified food is among the most pressing societal questions of our time. This comprehensive collection addresses a broad range of subjects, including the meaning of food, moral analyses of vegetarianism and starvation, the safety and environmental risks of genetically modified food, issues of global food politics and the food industry, and the relationships among food, evolution, and human (...) history. (shrink)

The internet is widely used for health information and support, often by vulnerable people. Internet-based research raises both familiar and new ethical problems for researchers and ethics committees. While guidelines for internet-based research are available, it is unclear to what extent ethics committees use these. Experience of gaining research ethics approval for a UK study (SharpTalk), involving internet-based discussion groups with young people who self-harm and health professionals is described. During ethical review, unsurprisingly, concerns were raised about the vulnerability of (...) potential participants. These were dominated by the issue of anonymity, which also affected participant safety and consent. These ethical problems are discussed, and our solutions, which included: participant usernames specific to the study, a closed website, private messaging facilities, a direct contact email to researchers, information about forum rules displayed on the website, a ‘report’ button for participants, links to online support, and a discussion room for forum moderators. This experience with SharpTalk suggests that an approach to ethics, which recognises the relational aspects of research with vulnerable people, is particularly useful for internet-based health research. The solutions presented here can act as guidance for researchers developing proposals and for ethics committees reviewing them. (shrink)

© 2014 Taylor Francis. The Centers for Disease Control and Prevention recommends routine human immunodeficiency virus testing of every client presenting for services in venues where HIV prevalence is high. Because older adults have particularly poor prognosis if they receive their diagnosis late in the course of HIV disease, any screening provided to younger adults in these venues should also be provided to older adults. We examined aging-related disparities in recent and ever HIV testing in a probability sample of at-risk (...) adults seeking services in needle exchange sites, sexually transmitted disease clinics, and Latino community clinics that provide HIV testing. Using multiple logistic regression with generalized estimating equations, we estimated associations between age category and each HIV testing outcome. Even after controlling for covariates such as recent injection drug use, older adults had 40% lower odds than younger adults did of having tested in the past 12 months or ever. Aging-related disparities in HIV testing exist among clients of these high HIV prevalence venues and may contribute to known aging-related disparities in late diagnosis of HIV infection and poor long-term prognosis. (shrink)

BackgroundThere is increasing need for peer reviewers as the scientific literature grows. Formal education in biostatistics and research methodology during residency training is lacking. In this pilot study, we addressed these issues by evaluating a novel method of teaching residents about biostatistics and research methodology using peer review of standardized manuscripts. We hypothesized that mentored peer review would improve resident knowledge and perception of these concepts more than non-mentored peer review, while improving review quality.MethodsA partially blinded, randomized, controlled multi-center study (...) was performed. Seventy-eight neurology residents from nine US neurology programs were randomized to receive mentoring from a local faculty member or not. Within a year, residents reviewed a baseline manuscript and four subsequent manuscripts, all with introduced errors designed to teach fundamental review concepts. In the mentored group, mentors discussed completed reviews with residents. Primary outcome measure was change in knowledge score between pre- and post-tests, measuring epidemiology and biostatistics knowledge. Secondary outcome measures included level of confidence in the use and interpretation of statistical concepts before and after intervention, and RQI score for baseline and final manuscripts.ResultsSixty-four residents (82%) completed initial review with gradual decline in completion on subsequent reviews. Change in primary outcome, the difference between pre- and post-test knowledge scores, did not differ between mentored (−8.5%) and non-mentored (−13.9%) residents (p = 0.48). Significant differences in secondary outcomes (using 5-point Likert scale, 5 = strongly agree) included mentored residents reporting enhanced understanding of research methodology (3.69 vs 2.61; p = 0.001), understanding of manuscripts (3.73 vs 2.87; p = 0.006), and application of study results to clinical practice (3.65 vs 2.78; p = 0.005) compared to non-mentored residents. There was no difference between groups in level of interest in peer review (3.00 vs 3.09; p = 0.72) or the quality of manuscript review assessed by the Review Quality Instrument (RQI) (3.25 vs 3.06; p = 0.50).ConclusionsWe used mentored peer review of standardized manuscripts to teach biostatistics and research methodology and introduce the peer review process to residents. Though knowledge level did not change, mentored residents had enhanced perception in their abilities to understand research methodology and manuscripts and apply study results to clinical practice. (shrink)

Two essays relating Thomas and Whitehead have recently appeared. Coming To Be by James W. Felt, S.J., modifies Thomas by replacing his substantial form with Whitehead’s notion of subjective aim, the essencein-the-making introduced by God to guide the occasion’s act of coming into being. Felt also substitutes subjective aim for matter as the means of individuation. This is one of Whitehead’s individuating principles, although a case can be made that matter (the multiplicity of past actualities as proximate matter) is another. (...) “God and Creativity” by Stephen T. Franklin develops a reconciliation of these two ultimates by conceiving of God as the source of creativity, and seeing creativity in terms of the Thomistic esse. In my reflections on this project I explore four alternativeswith respect to the source of creativity: (a) creativity as derived from the past; (b) creativity as inherent in the present; (c) God as the source of transitional creativity (Franklin); (d) God as the source of concrescent creativity (Ford). The last two differ with respect to being’s relation to becoming. Does being undergird becoming, or does becoming bring about being, such that apart from it there would be no being? Our theory of creation depends upon this question. (shrink)

This book is a collection of secondary essays on America's most important philosophic thinkers—statesmen, judges, writers, educators, and activists—from the colonial period to the present. Each essay is a comprehensive introduction to the thought of a noted American on the fundamental meaning of the American regime.

In lieu of an abstract, here is a brief excerpt of the content:The Controversy Between Schelling and Jacobi LEWIS S. FORD SCHELLING, ALONGWITH FICHTE, has suffered the fate of being labelled one of tIegel's predecessors. Richard Kroner provides the classic expression of this viewpoint in his monumental study, Von Kant bis Hegel, which examines Schelling's thought primarily for its contribution to Hegel's final synthesis.I In English we have Josiah Royce's sympathetic and lively account of Schelling's early romantic exuberance, regarded (...) as a transitional stage in the development of German idealism. 2 But this emphasis on the early ScheUing has led to an unfortunate neglect of his work subsequent to the break with Hegel in 1807. Schelling's romanticism, so ably documented by E. D. Hirsch, Jr., 3 can only be regarded as one phase in the total sweep of his thought, for, after the break with Hegel, Schelling produced at least three major works: the essay •ber das Wesen der menschlichen Freiheit,4 wrestling with the problem of evil and human freedom, the fragmentary Weltalter, 5 which in scope and dialectical intricacy should be compared with Hegel's Logic, and the Philosophie der Mythologie und Offenbarung, 6 furnishing a fundamental critique of the whole dialectical enterprise. Save for the essay on human freedom, however, none of these works were published during his lifetinm, as Schelling withdrew from the public eye after his controversies with Hegel and Jacobi. Thus the publishing histories of Schelling and Hegel are exactly reverse. Schelling rushed into print his early speculative gropings, while Hegel suppressed his/making the Ph~nomenologic des Geistes his first major publication. Then while Hegel's Logic and Encyclopedia were being publicly acclaimed, Schelling remained silent. This accident of history is largely responsible for the illusion that Schelling is the older of the two x (Tiibingen: J. C. B. Mohr, 1921-24),2 vols. 2The Spirit of Modern Philosophy (Boston: Houghton Mifflin, 1892), Lecture VI, 164-189. Wordsworth and ScheUing, A Typological Study of Romanticism (New Haven: Yale University Press, 1960),Yale Studies in English, Vol. CXLV. 4Friedrich Wilhelm Joseph yon Sehelling, Philosophische Untersuchungen i~berdas Wesen der menschlichen Freyheit und die damit zusaramenhdngenden Gegenstdnde, 1809. Reprinted in the Sdmmtliche Werke, Erste Abtheilung, VII. Band (Stuttgart und Augsburg: J. G. Cotta, 1856), 331-416. English translation by James Gutmann: Of Human Freedom (Chicago: Open Court, 1936). 5Three fragmentary versions of the Weltalter have been published. The Urfassungen of 1811 and 1813were edited by Manfrcd SehrSter and published as a separate Naehlassband to the M~nchener Jubildumsausgabe of the collected works: Die Weltalter, Fragmente (Munich: Biederstein, Leibniz, 1946). A later version is published in S.W. I: 8, pp. 195-344,which has been translated by Frederick de Wolfe Bolman, Jr. : The Ages of the World (NewYork: Columbia University Press, 1942). 6Philosophie der Mythologie is published in S.W. II: 1-2; Philosophie der Offenbarung in S.W. II: 3-4. These essays were first collected and published by Herman Nohl in Hegels theologische Jugendschriften (Tiibingen: 1907).T. M. Knox translated them into English, with an introduction by Richard Kroner: GeorgWilhelm Friedrich Hegel, Early Theological Writings (Chicago: University of Chicago Press, 1948). [75] 76 HISTORY OF PHILOSOPHY thinkers (actually he was five years Hegel's junior), who retired from the philosophical scene after making his contribution to the Hegelian synthesis. Paul Tillich's doctoral dissertations s and Ernst Cassirer's studies in post-Kantian thought 9 made serious inroads on this conception, yet the iIInsion persisted. Their insistence on the importance of the later Schelling has been brilliantly sustained by two recent studies: Horst Fuhrmans's Schellings Philosophie der Weltalter1~and Walter Schulz's Die Vollendung des deutschen Idealismus in der Spdtphilosophie Schellings, ~ and we may hope that the conventional estimate of Schelling will be drastically revised. Fuhrmans has demonstrated that the split between the early and the later Schelling must be placed in the year 1806 when he came in contact with Franz yon Bander in Munich, who encouraged him to delve deeper into the theological and cosmological ramifications of Jacob Boehme's thought. TM The reorientation this caused is apparent in the essay on human freedom, published in 1809, but it was not fully exploited until the... (shrink)

Recovering Reason: Essays in Honor of Thomas L. Pangle is a collection of essays composed by students and friends of Thomas L. Pangle to honor his seminal work and outstanding guidance in the study of political philosophy. These essays examine both Socrates' and modern political philosophers' attempts to answer the question of the right life for human beings, as those attempts are introduced and elaborated in the work of thinkers from Homer and Thucydides to Nietzsche and Charles Taylor.

Gilbert and colleagues point out the discrepancy between the limited empirical data illustrating changes in personality following implantation of deep brain stimulating electrodes and the vast number of conceptual neuroethics papers implying that these changes are widespread, deleterious, and clinically significant. Their findings are reminiscent of C. P. Snow’s essay on the divide between the two cultures of the humanities and the sciences. This division in the literature raises significant ethical concerns surrounding unjustified fear of personality changes in the context (...) of DBS and negative perceptions of clinician-scientists engaged in DBS. These concerns have real world implications for funding future innovative, DBS trials aimed to reduce suffering as well as hampering true interdisciplinary scholarship. We argue that the philosophical tradition of pragmatism and the value it places on empirical inquiry, experiential knowledge, and inter-disciplinary scholarship – reflecting diverse ways of knowing – provides a framework to start to address the important questions Gilbert and colleagues raise. In particular, we highlight the importance of expert clinician knowledge in contributing to the neuroethical questions raised by Gilbert and colleagues. Finally, we provide illustrative examples of some of our interdisciplinary empirical research that demonstrate the iterative cycle of inquiry characteristic of pragmatism in which conceptual neuroethics questions have led to empirical studies whose results then raise additional conceptual questions that give rise to new empirical studies in a way that highlights the contributions of the humanities and the sciences. (shrink)

Introduction: Another Diction The hack. The salesman. The fired cop. The drifter. The betrayed criminal. Each of these constitutes a novel literary invention; each gives a new sense to the investigative character. They are not modifications of the classical model, stamped with the rational imprimatur of Sherlock Holmes, C. Auguste Dupin, or Joseph Rouletabille – there is no line of filiation from these to Vachss’s Burke, Pelecanos’s Nick Stefanos, or Himes’s Coffin Ed Johnson and Grave Digger Jones. Even Lacan’s powerful (...) psychoanalytic reading of Poe’s “The Purloined Letter” reveals Dupin to be a genius only in a game whose dialectical structure is given in advance. Although the subjects that come to occupy this structure only acquire determination through the assumption of their places, the dynamic form of the dialectic is itself “foreclosed” by the phallus whose circulation organizes the system. Dupin understands the circulation of the signifier only because this circulation is the figure of the law. Rejecting the phallocentric rationality of the mastermind, the new figurations of Vachss, Pelecanos, Himes, and others retain only in order to parody the grand orchestration of reason – their language is slang not deduction. They are not detectives but “dicks”: a name that incorporates within its reduction an empirical transformation of the transcendental. In fact, it is a transformation of the very sense of inquiry that requires this new type of conceptual personae in order to traverse its contours. The philosophical project of Gilles Deleuze – which he characterizes as a “transcendental empiricism” – is directed toward freeing thought from its determination by the philosophical traditions that constitute its history. Such a freeing would allow for a philosophical conceptualization of present events that are no longer able to be adequately conceptualized by that history. The distinctive character of Deleuze’s project comes from his insistence on the discontinuity between the tradition of thought and the new formulations that it is called upon to generate. For Deleuze, the philosopher is the one who asks about the generation of new concepts and thereby places herself in a double bind. On the one hand, the philosopher is historically conditioned, thrown into a tradition whose tools present a limited number of possible conceptual resolutions of a particular event. On the other hand, this conditional determination of philosophical thought is repeated, perpetually, so that the philosopher is always a parody of herself: solving the question of the determination of a present event by resolving the question of the determinability of the present by the past. This situation of parody is the limit of thinking; it is where thinking develops according to the vicissitudes of history. (shrink)

An outstanding group of leaders left evidence that a richer and more sustainable democracy could be achieved with American independence and democratic principles integrated into a new republican form of government. They were moved by principles that are the very spirit of democracy. These principles are needed to enhance democracy and improve well-being. Using the constructivist tradition of grounded theory and Aristotle’s conception of abstraction, the article proposes a theory of the first principles of democracy based on substantive data: the (...) Declaration of Independence, the Articles of Confederation, The Federalist Papers, and the United States Constitution. Knowledge, fairness, human dignity, hope, unity, and security are the first principles of democracy and are regarded as the bedrock of democracy and a government framework for the people. This theory contributed to a formal model of democratic social change. It also contributes a conceptual framework that supports Solum’s semantic originalism, a theory of constitutional interpretation. The principles of democracy can revitalize democracy and provide new possibilities by protecting education as an innate human right, abolishing capital punishment, criminalizing private prisons on the stock market, and reevaluating the proportionality of prison sentences. (shrink)

Existing social disparities in the United States are inconsistent with the promise of democracy; therefore, there was a need for critical conceptualization of the first principles that undergird American democracy and the genesis of democratic social change in America. This constructivist grounded theory study aimed to construct a grounded theory that provides an understanding of the process of American democratic social change as it emerged from the nation’s founding documents. A post hoc polytheoretical framework including Foucault’s, Bourdieu’s, and Marx and (...) Engels’s theories of power was used to understand power dynamics. The research question focused on understanding the process of democratic social change in America. The sample comprised the Articles of Confederation, the U.S. Declaration of Independence, The Federalist Papers, and the U.S. Constitution. The documents were retrieved from the National Archives and Library of Congress. The data analysis plan incorporated successive comparison, situational and dramaturgical analysis, deconstruction, and perspective taking as strategies. The result was the construction of a democratic social change process theory preceded by five grounded theories: (a) first principles of democracy, (b) first principles of democracy conceptual framework, (c) socio-ethical principles of democracy, (d) demoralizing process, and (e) either-or approach to democracy. Positive social change implications include applying a democratic social change process to future social change endeavors across domains and levels of analysis, a normative framework for a republican form of government, and a tool to analyze and minimize the latent consequences of social justice policies. (shrink)

Jōkei 貞慶, posthumously known as GEDATSU Shōnin 解脱上人, was a prominent scholar-monk of the Hossō 法相 school who lived during Japan’s momentous transition to a medieval society. Hossō 法相 is the East Asian transmission of the Indian Yogācāra system of thought. Jōkei is perhaps best known for his critique of Hōnen’s 法然 exclusive nenbutsu teachings, memorialized in a petition to the Court in 1205 C.E. to censure Hōnen and his followers. He is also noteworthy for promoting devotion to an eclectic (...) array of divine beings ranging from various Buddhas and bodhisattvas to popular kami. This essay will focus on Jōkei’s doctrinal reform efforts for which he has only recently been recognized. (shrink)

"An immensely valuable and detailed analysis of foreign, mainly American, assistance to Latin American higher education, To Export Progress provides an understanding of the 'what' and the 'why' of foreign aid to a key sector. This book will be a classic in its field." —Philip G. Altbach, Monan Professor of Higher Education, Boston College "Professor Daniel C. Levy, a leading authority in the field of higher education and the nonprofit sector in Latin America, once again has opened an otherwise neglected (...) field through his carefully researched and reported study of philanthropic support for university reform in the region. Drawing on a wealth of archival material, documentary evidence, interviews, and first hand experience with the actors and agencies involved, To Export Progress illuminates the vision and ideals inspiring international agencies, as much as the realities they confronted in deciding on grants and loans policy, from the 1960s to the 1980s. The book is strongly recommended for scholars and students of international education, for Latin American experts, and for philanthropic managers and educational administrators in the developing world." —Jorge Balan, Senior Program Officer for Higher Education, The Ford Foundation. In this study of the attempts to export the modern Western university, its ideas, and its form to the Third World, Daniel C. Levy examines the development assistance provided by the Ford Foundation, the U.S. Agency for International Development, and the Inter-American Development Bank and their relations with local partners in Latin America in the 1960s and 1970s. Levy considers the funders, how they selected partners, which countries and institutions were favored, and to what effect. Based on meticulous research and careful analysis, the book provides a detailed look at philanthropic assistance to the region during the era of modernization and development in Latin America. (shrink)

What are the processes, from conception to adulthood, that enable a single cell to grow into a sentient adult? Neuroconstructivism is a pioneering 2 volume work that sets out a whole new framework for considering the complex topic of development, integrating data from cognitive studies, computational work, and neuroimaging.

Elizabeth Barnes and Robert Williams have developed a theory of metaphysical indeterminacy, via which they defend the theoretical legitimacy of vague objects. In this paper, we argue that while the Barnes–Williams theory supplies a viable account of genuine metaphysical vagueness, it cannot underwrite an account of genuinely vague objects. First we clarify the distinction between these two key theses. Then we argue that the Barnes–Williams theory of metaphysical vagueness not only fails to deliver genuinely vague objects, it in fact provides (...) grounds for rejecting them. (shrink)

The present study investigated the extent to which moral disengagement and the tendency to consider moral rules as socio-conventional rules are distinct dimensions of morality, and their association with three different forms of participation in bullying. These two types of moral cognitions have been theorized in different models of morality and are usually studied independently, even if research on moral shifts suggests some possible overlaps. A group of 276 Italian students from primary and middle school completed self-reports assessing moral disengagement, (...) socio-conventional perception of moral rules, and participation in bullying as bully, defender of the victim and passive bystander. Results from structural equation modeling analysis confirmed that moral disengagement and socio-conventional comprehension of aggressions are separate and moderately connected morality dimensions. Controlling for age, gender and SES, only moral disengagement was positively associated with perpetrating bullying. These results point to moral disengagement as the critical component of moral cognitions to be addressed in interventions. (shrink)

Donald M. MacKinnon has been one of the most important and influential of post-war British theologians and religious philosophers. Generally eclectic, frequently allusive, usually intellectually generous, persistently richly challenging and always astonishingly erudite, he had a significant impact on the development and subsequent theological work of the likes of Rowan Williams, Nicholas Lash, David Ford and John Milbank. A younger generation largely emerging from Cambridge, but with influence elsewhere, has more recently brought MacKinnon's normally occasionalist writing to a larger (...) audience worldwide where it is beginning to receive noteworthy attention. In this collection several of MacKinnon's most outstanding papers not yet published in book format is collected together with an Editorial Introduction by a former student of one of MacKinnon's own students. They range from his reflections on theology as educational, the nature of moral reasoning, considerations of ecclesial practice, dogmatics and hope. Here is another reminder of MacKinnon's intellectual brilliance. (shrink)

This is a big-picture book, 2 written with a breadth of focus which I find admirable. It exhibits what's come to be known as the ‘intersubdiscplinary’ approach to philosophy, which is not restricted by traditional boundaries within the discipline but rather proceeds with an eye to all sorts of areas of philosophy where relevant arguments, results, analogies and strategies might be lurking. I approve of this way of doing philosophy; it seems to me that all too often that wheels are (...) reinvented, or crucial points missed, because of a lack of this sort of intersubdisciplinarity.To help guide us through such a broad landscape, this book needed to be well-signposted and clearly written, and it is. It cannot be denied, however, that the ambitious scale of The Nature of Normativity won't be to every taste. For one thing, not everyone likes big pictures. For another, this is a deep, dense and in many ways difficult book, which can only really be appreciated by sitting down with it for hours on end. It will not repay the casual skim-reader, nor is it likely to appeal to those who prefer dipping into philosophy books over reading them wholesale.The book is also long . The view under construction has a great many interlocking elements, including non-reductive normative naturalism, normative realism, a priorist intuitionism, normative internalism, the normativity of intentionality, conceptual-role semantics, contextualism, possible-worlds semantics, and certain ideas about ‘planning’ derived from the recent work of Allan Gibbard. It will be a tough read for specialists who do not share Wedgwood's familiarity with a wide range of subdisciplines, who will either have to content themselves with a superficial reading of many passages or else hunt down the necessary background material to …. (shrink)

Few philosophers today know much about Charles Peirce’s metaphysics, although a great many know something about his epistemology, philosophy of science, and logic. Indeed, few Peirce experts have written much on his metaphysics or made it the focus of their research. To an extent, this is understandable. Peirce’s writings were left in a disastrously disorganized state (mostly unpublished), and the crucial papers on metaphysics from his later years have not yet been republished in the first-rate chronological edition, the incomplete Writings (...) of Charles S. Peirce: A Chronological Edition , edited at Indianapolis by my friends. And then there is Peirce’s writing: an awkward, abrasive, arrogant, eclectic style that demands technical knowledge in diverse fields, especially logic, mathematics, and the natural sciences. His worst personality traits manifested themselves in his highly technical metaphysics—with its idiosyncratic, anti-Cantorian conception of continua, a pecularly mathematical phenomenology, and elaborate views on Darwinian and non-Darwinian evolution, for example. Finally, there is what might appear to be the bizarreness of the theory itself, as we shall see. Peirce was a kind of philosophical swashbuckler, a bold, courageous speculator on philosophical questions beyond most of our temperaments even to ponder. Ours is not the philosophical age of Errol Flynn but the minimalist age of Harrison Ford, with no grand gestures or speeches, just a series of small, no-nonsense gestures: we typically like our philosophy short, neat, "science-like," and isolated from other philosophical issues. (shrink)

The author addresses the question of how to use value-learning processes to integrate corporate social responsibility (CSR) in organizations as an interesting challenge in (higher) education. Two strategies have been proposed for the issue of CSR: a compliance strategy and a cultural change strategy (Karssing, 2001). This article focuses on the ethical and philosophical presuppositions of these different approaches. The incorporation of CSR in organizations cannot be accomplished by means of a compliance strategy only. Rather, it needs to be supplemented (...) by a strategy aimed at stimulating a transformation process on the corporate culture level. The perspective of change through dialogue is proposed as a means of innovating the curriculum and the primary processes of student education. This organizational change perspective is demonstrated by describing how (ethical) reflective aspects are integrated in the curriculum of the Free University of Amsterdam. An additional case study on organizational value learning is presented to illustrate the thesis that CSR presupposes that university is an adequate context where life-long learning begins. (shrink)

I am concerned that the military’s Rules of Engagement (ROE) exclusively focus on prescribing permissible actions but fail to consider the servicemembers’ blameworthiness. In explaining this concern, I will illuminate how permissible actions do not necessarily yield blamelessness. While permissibility is generally a function of rules or good outcomes, blameworthiness is at least a function of an agent’s intentions. Why should we care about permissible actions done with blameworthy intentions? I offer two distinct motivations. Using a self-defense situation as an (...) example, I explain that neglecting to consider blame can increase the magnitude of harm done to an apparent but merely possible attacker. Secondly, we should certainly be concerned about the harms done to servicemembers, and I show that ROE that fail to prescribe a blameless intention may result in increased harm to servicemembers in the form of a “moral injury”. In even more general terms, I am advocating for a more robust in bello consideration of intentions. (shrink)

Deep brain stimulation — a novel surgical procedure — is emerging as a treatment of last resort for people diagnosed with neuropsychiatric disorders such as severe obsessive-compulsive disorder. The US Food and Drug Administration granted a so-called humanitarian device exemption to allow patients to access this intervention, thereby removing the requirement for a clinical trial of the appropriate size and statistical power. Bypassing the rigors of such trials puts patients at risk, limits opportunities for scientific discovery, and gives device manufacturers (...) unique marketing opportunities. We argue that Congress and federal regulators should revisit the humanitarian device exemption to ensure that it is not used to sidestep careful research that can offer valuable data with appropriate patient safeguards. (shrink)