I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

How should we make choices when we know so little about our futures? L. A. Paul argues that we must view life decisions as choices to make discoveries about the nature of experience. Her account of transformative experience holds that part of the value of living authentically is to experience our lives and preferences in whatever ways they evolve.

Graeme Laurie stepped down from the Chair in Medical Jurisprudence at the University of Edinburgh in 2019. This edited collection pays tribute to his extraordinary contributions to the field. Graeme has often spoken about the importance of 'legacy' in academic work and has forged a remarkable intellectual legacy of his own, notably through his work on genetic privacy, human tissue and information governance, and on the regulatory salience of the concept of liminality. The essays in this volume animate the (...) concept of legacy as lens of analysis for the study and practice of medical jurisprudence. In this light, legacy reveals characteristics of both benefit and burden, as both an encumbrance to and facilitator of the development of law, policy and regulation. Overall, the contributions reconcile the ideas of legacy and responsiveness and show that both dimensions are critical to achieve and sustain the health of medical jurisprudence itself as a dynamic, interdisciplinary and policy-engaged field of thinking. (shrink)

The coevolution of humans with their intestinal microflora has resulted in cooperative relationships that have shaped the biology and the genomes of these symbiotic partners. Bacteroides thetaiotaomicron is one such bacterial symbiont that is a dominant member of the intestinal microbiota of humans and other mammals. The recent report of the genome sequence of B. thetaiotaomicron1 is the first reported for an abundant Gram‐negative organism of the human colonic microbiota and, as such, provides the first glimpse on a genomic scale (...) of the genetic arsenal used by a Gram‐negative symbiont to dominate in this ecosystem. The genome has revealed large expansions of many paralogous groups of genes that encode products essential to the organism's ability to successfully compete in this environment. Most noteable is the organism's abundant machinery for utilizing a large variety of complex polysaccharides as a source of carbon and energy. The proteome also reveals the organism's extensive ability to adapt and regulate expression of its genes in response to the changing ecosystem. These factors, as well as others highlighted below, suggest an incredibly flexible and adaptable organism that is exquisitely equipped to dominate in its challenging and competitive niche. BioEssays 25:926–929, 2003. © 2003 Wiley Periodicals, Inc. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Response to Randall Allsup, “Species Counterpoint: Darwin and the Evolution of Forms”Lauri VäkeväI was thrilled to be asked to respond to Randall Allsup's paper as his standpoint appears to be close to my own.1 I take it that his interest in Darwinian metaphors [End Page 220] reflects at least moderate interest in naturalism—an approach that should be taken seriously in our field. However, there are many varieties of (...) naturalism. In the following, I will deliberately interpret Allsup's ideas from the standpoint of the so-called 'soft' or 'cultural' naturalism favored by later Dewey and his followers.2As I see it, the most powerful precept of naturalism is its attack on essentialism—paradoxically the doctrine which focuses most deliberately on the nature of things. The essentialist, however, thinks of nature as something inherent in how things are, making them ultimately what they are. This kind of ultimate nature is something that a contemporary naturalist can never touch, for she only relies on empirical inquiry that departs from and returns to the contingent realm of lived experience. It is the latter that we attempt to make sense of as to try to live our life as fully as possible. At its best, philosophy can help us in this undertaking.To a naturalist, then, the essentialist's use of the term 'nature' is an anachronism, a remnant of an age when philosophers searched for the "really real," certain, absolute, and immutable. Were we to follow philosophical naturalism today, we should rather be looking at how things become empirically realized for cultural agents in their various life-practices. Culture is not seen as distinct from nature but as continuous with it: both can be understood through same means. This also covers the realm of value, which naturalism does not conceive as transcendental in any metaphysically binding sense, but rather as something that is realized in daily life and that thus has an empirical stand.Applied to the philosophy of music, naturalism states that it is futile to look for the essence of this art (or for that matter any art) through philosophical introspection or through logical analysis for the simple reason that we are always in the process of formulating it in our lives. The nature of music depends on the interpretative horizons of cultural agents living in a situation. 'Situation' (understood here in the sense that Dewey used the term) is the existential point of departure of our understanding and as situations vary, so do types of inquiry; therefore, we do not have to take as inclusive any particular claims about music, as they are merely particular answers to certain types of problems. Any path of musical inquiry may be worth taking, not because they all lead to the same destination, but because they can guide us through the rich thicket of possible experience that gives music its significance. This implies an open attitude towards all things musical, a theme which I find strong in Allsup's paper.One can also read another important naturalist point in his essay: "music—like life—evolves." Evolution is indeed a recurring theme in contemporary philosophical naturalism: what was previously considered as static or as perennial in nature and in culture can be now seen as being under continuous change. [End Page 221] Even mountains (and this is one of Dewey's favorite similes3 ) can be considered as events in the long run and even the most persistent of culture's beliefs may crumble someday.This awareness of all-encompassing change may not be very comforting: it might be mentally healthier to cling to rationalizations of how things that appear to change in fact do not. It may be more comforting to think that there must be a stable principle, a system of universally set rules, governing the randomness. For centuries, philosophy has been driven by this belief. In the philosophy of music, this is reflected in the problem of how the most ephemeral of the arts can be explained as having everlasting value. Mutatis mutandis, when music educators have argued over the pedagogical significance of music, one of the most pervasive ideas has been that music... (shrink)

Many preventive intervention studies with adolescents address high-risk behaviors such as drug and alcohol use, and unprotected sex. Randomized controlled trials (RCT) are the gold standard methodology used to test the effectiveness of these behavioral interventions. Interventions outside the rigidly described protocol are prohibited. However, there are ethical challenges to implementing inflexible intervention protocols, especially when the target population is young, experiences many stressful events, and lives in a resource-poor environment. Teens who are at high risk for substance use or (...) sexual risk behaviors tend to be at risk for other problems such as exposure to violence, sexual and physical abuse, depression, and homelessness. How should investigators deal with the psychological and social needs of teenagers in prevention programs in an ethically appropriate way and at the same time preserve the validity of RCT results? We have identified program characteristics, participant characteristics, interaction with parents, and problems with adolescents not in the study as sources of ethical dilemmas in RCT with at-risk adolescents. As a result of our experience, we recommend that every behavioral intervention study develop an ethics protocol, which should include rules for providing help to participants, has contact information for experts to provide guidance, and an emergency procedure for dealing with life threatening situations. In addition, studies should have a resource manual, train research staff in these ethical issues, and work with a data safety and monitoring board or ethics committee. (shrink)

Irish Supreme Court upholds paramountcy of parental right to determine a child's best interests at the expense of the rights of children themselvesCan a court force on parents who are careful and conscientious a view of their child's welfare which is rational, but quite contrary to the parents sincerely held but non-rational beliefs? The Supreme Court of Ireland has recently held that it cannot do so, and that the Irish Constitution requires that the right of the family to determine its (...) own direction must be respected except in the most narrow of circumstances, such as an immediate threat to the life of the child or risk of serious injury. The ruling leaves the assessment of a child's best interests to the wide discretion of parents, but at the same time fails to offer a means to resolve potential conflicts between the rights of the family and the rights of the child.FACTS OF THE CASEIn North Western Health Board v W 1 an action was brought by a local health board against the parents of 14 month old Paul, seeking a declaration that their refusal to submit their son to the heel prick test for phenylketonuria was a failure to vindicate their son's rights and that it would be lawful to proceed without parental consent. Phenylketonuria is a metabolic condition which can lead to severe and untreatable mental impairment if not detected in its early stages, but a simple variation in diet can stave off this outcome. While Paul's parents did not doubt the veracity of this medical opinion, nor indeed the importance of the test, they refused to subject their son to the invasive heel prick, offering instead samples of urine or hair, such that the test could be carried out by non-invasive means. These means, however, are considerably …. (shrink)

Todd McGowan is professor of film studies at the University of Vermont and author of The Impossible David Lynch and Capitalism and Desire: The Psychic Cost of Free Markets. This most...

This essay engages the work of Italian feminist philosopher Adriana Cavarero and her concept of the narratable self. Her relational humanism, rooted in our exposure to others, offers an ontology of uniqueness whose critique of abstraction, masculinism, and identity politics still resonates today where the meaning of a unique “you” is negotiated in embodied exchanges that may offer care or wounds. Cavarero develops an altruistic ethics that cultivates this humanism. I argue that her work should be extended to better capture (...) the political purchase of the narratable self that interacts dynamically and often ambiguously with the “we” of collective politics. Putting her work into conversation with the nineteenth‐century abolitionist and women's rights advocate Sojourner Truth, I suggest that Cavarero's work illuminates Truth as a philosopher of the narratable self. Moreover, Truth's work extends Cavarero's concerns with exposure that may do violence or offer care by making explicit the challenges of narration in the context of inequality, especially in terms of race and class. Exposure as an ontological and phenomenological condition then needs to take account of a broader publicity of textual, individual, and collective exposure to others to develop the critical, ethical, and political purchase it offers. (shrink)

Despite the numerous benefits associated with forgiveness, many individuals find it difficult to forgive. This is especially true in organizations, where forgiveness is rare and can be under-valued. Across two studies, we explore how to facilitate forgiveness within organizational contexts and in the aftermath of workplace unfairness. We examine whether individuals can reduce the “injustice gap” that can be created by violations and enhance forgiveness through expressive writing interventions—guided writing techniques that can be self-administered. Participants wrote about their reactions to (...) a fictional scenario or an actual workplace experience. Results indicate that expressive writing was associated with higher reported perceived resolution. Whereas negative emotions mediated this relationship in Study 1, positive emotions and perceived injustice mediated this relationship in Study 2. Perceived resolution also mediated the relationship between expressive writing and forgiveness. Theoretical, methodological, and practical implications are discussed. (shrink)

W. Labov's & T. Labov's findings concerning their child grammar acquisition ("Learning the Syntax of Questions" in Recent Advances in the Psychology of Language, Campbell, R. & Smith, P. Eds, New York: Plenum Press, 1978) are interpreted in terms of different semantics of why & other wh-questions. Z. Dubiel.

Laurie Johnson Bagby examines the loss of the appreciation for honor in modern Western society through an examination of the political philosophy of English political philosopher Thomas Hobbes. She finds in Hobbes's thought a 'turning point for honor,' in which honor is rejected as too dangerous, and fear and self-interest are put in its place as the chief means of peace and good order.

In lieu of an abstract, here is a brief excerpt of the content:Philosophy of Music Education Review 11.2 (2003) 141-156 [Access article in PDF] Music Education as Critical PracticeA Naturalist View Lauri Väkevä University Of Oulu, Finland I This essay defends naturalism as a framework for philosophy of music education. I have three general reasons for supporting naturalism. First, by taking naturalism seriously we can keep our philosophies up-to-date with scientific inquiry. Second, naturalism can emancipate us from transcendental pseudo-questions and (...) instead help us to deal with the empirical problems of everyday life. Third, with naturalism, we can free ourselves from a priori theories of morals and aesthetics and thus view the active part that normative and aesthetic concerns play in human praxis. Even if I endorse naturalism, I do not subscribe to scientism. 1 Rather, I submit to a pragmatist view that stresses the role of philosophy (and science) in dealing with the questions of our life practices. Of the recent perspectives in the philosophy of music education my approach comes closest to the critical praxialism discussed in the MayDay group. 2All in all, I find a lot in common with the praxialist discussion (within or outside the MayDay group) and the kind of pragmatism that follows John Dewey's mature philosophy. 3 However, it seems to me that the naturalist bent of Deweyan pragmatism has not been thoroughly analyzed in our field. 4 One reason for this [End Page 141] might be the bad report that 'hard' or reductive naturalism has been given in connection with the experimental paradigm of music education research. 5 I want to argue that the critical potential of Deweyan pragmatism should not (and cannot) be separated from a naturalist approach. Taken together, critical and naturalist views can contribute to any philosophy, especially in fields that have a long tradition of leaning on otherworldly explanations.In what follows, I begin by outlining (in broad brushstrokes) the historical position of pragmatism and its status in present day philosophy. Next, I focus on the implications of Deweyan naturalist pragmatism and the possibility of maintaining a critical pragmatist attitude with naturalist presumptions in a pedagogical context. In the final part of the essay, I outline an interpretative framework for a critical pragmatism of music education that takes advantage of the naturalizing tendencies in contemporary philosophy without losing its grasp on the things that matter musically. II For a while, pragmatism had a bad name in academic philosophy. This was especially true after the linguistic turn in the first half of the last century. 6 By making the linguistic turn, many philosophers hoped to disassociate themselves from the speculative tradition(s) once and for all. Logical analysts also made it more difficult for philosophers to ignore the findings of scientists. Thus they paved the way for contemporary reductive naturalism that takes science as the measure of what can be known. 7However, analytic philosophers were not alone in their attempt to provide philosophy with scientific rigor. Classical pragmatists, too, had integrated a naturalist penchant in their output. Embracing naturalism with an open-ended experimental spirit, they wanted to focus on "the problems of men" as the chief subject matter of philosophy. 8 To many analytic philosophers, this seemed like a return to armchair speculation with an ingredient of sentimental ethics thrown in for good measure. Worse still, it looked as though the classical pragmatists were giving in to the spirit of the corporate West: speaking of the truth as "cash-value" surely seemed like a blasphemy to intellectuals who sought from formal logic and mathematics a purity of mind to clear up the messiness of everyday experience. 9Logical analysis also had its shortcomings. While many mainstream philosophers turned to logical analysis for clarity and certainty, at the same time they submitted to Cartesian-Kantian mind-body dualism with its problematic epistemology. Thus, they kept supporting the tensions between the rationalist and empiricist or analytic and synthetic domains of knowledge that haunted modernist neo-Kantian arguments.These distinctions turned out to be easy targets for postanalytic critics. 10 [End Page 142]Classical pragmatists anticipated this... (shrink)

Ancient Greek philosophers, medieval theologians, Enlightenment thinkers, and contemporary humanists alike have debated all aspects of human sexuality, including its purpose, permissibility, normalcy, and risks. _Philosophizing About Sex_ provides a philosophical guide to those longstanding and important debates. Each chapter takes a general issue and shows how ongoing public discussions of sexuality can be illuminated by careful philosophical investigation. Debates over topics such as sexual assault, sexual orientation, sex education, prostitution, and “sexting” involve larger questions about morality, law, science, and (...) politics and cannot be intelligently discussed in isolation from broader issues. By asking deceptively simple questions, this book shows how difficult but important it is to arrive at satisfying answers. (shrink)

Oxford anthropologist Ruben Andersson has written a book that is accessible for a general audience, because it is so engagingly written, and is full of information and arguments that should be read...

Although personal being plays an important role in G.W.F. Hegel's (1770–1831) philosophy he never provided a comprehensive definition of personality. Within the framework of his works it is thus possible to formulate different definitions of person and personality, and several conflicting definitions were presented among Hegelians during the 1830s and 1840s. In this paper I examine the role of personality in Hegel's system and discuss the relationship between personality and metaphysics. The question shall be analyzed in the context of various (...) works by Hegel and contrasted with two important precursors of Hegel, I. Kant (1724–1804) and J.G. Fichte (1762–1814). I shall also put the philosophy of Finnish Hegelian J.V. Snellman (1806–81) under scrutiny. The paper will indicate the importance of logic for Hegelian metaphysics and for Hegelian conception of personality. (shrink)

Late in the afternoon of July 11, 1995, the Bosnian Serb army, under the command of General Ratko Mladic, seized the northeastern Bosnia town of Srebrenica. Declared a by the United Nations two years earlier, the predominately Muslim community had swollen from a prewar population of 9,000 to over 40,000, many of whom had been from elsewhere in Bosnia. As Mladic's troops swarmed over the town, the women, children, elderly, and many of the men took refuge two kilometers away in (...) the United Nations's Srebrenica headquarters, staffed by a Dutch battalion, in the village of Potocari. Meanwhile, the remaining Srebrenica men and boysfled through the woods on foot, trying to reach Muslim-controlled territory, nearly 40 miles away. (shrink)

This article explores and compares cross-gender interactions of first and third graders in one child care center. Three prevalent forms of interaction are discussed: teasing, disputing, and playing. The author argues that these three forms of interaction are related to the use of space: Teasing often occurs when space is constricted, disputing is often the result of invaded space, and playing requires shared space and varying levels of cooperation. By focusing on the relationship between space and interaction, important power asymmetries (...) appear. Since boys are more likely to initiate invasions and more likely to determine the rules and terms of the play, they maintain a greater amount of power and control. (shrink)

Across three studies, the authors examine the interactive effects of moral identity and the negative reciprocity norm in predicting revenge. The general argument is that moral identity provides the motivational impetus for individuals’ responses, whereas the normative framework that people adopt as a basis for guiding moral action influences the direction of the response. Results indicated that moral identity and the negative reciprocity norm significantly interacted to predict revenge. More specifically, the symbolization dimension of moral identity interacted with the negative (...) reciprocity norm to predict revenge when individuals were the targets of mistreatment, whereas the internalization dimension of moral identity interacted with the negative reciprocity norm to predict revenge when individuals were the observers of mistreatment. Theoretical implications related to the differences between the symbolization and internalization dimensions of moral identity, the importance of examining normative frameworks, and the functionality of revenge are discussed. (shrink)

I argue for a property mereology and for mereological bundle theory. I then apply this theory to the one over many problem (universals) and puzzles concerning persistence and material constitution.

Race and Gender in the Classroom explores the paradoxes of education, race, and gender, as Laurie Cooper Stoll follows eighteen teachers carrying out their roles as educators in an era of “post-racial” and “post-gendered” politics.

Laurie Zoloth; Limiting Access to Medical Treatment in an Age of Medical Progress: Developing a Catholic Consensus: A Response from Jewish Tradition, Christian.

Introduction: Framing nature and culture.

The paper examines Johann Georg Hamann’s influence on Ludwig Wittgenstein’s late philosophy. Wittgenstein’s letters, diaries and Drury’s memoirs show that Wittgenstein read Hamann’s writings in the early 1930s and 1950s. Wittgenstein’s diary notes and the Cambridge lectures show that Wittgenstein’s discussion of Hamann’s views in 1931 corresponds to adopting a Hamannian view of symbols and rule-following. The view of language as an intertwining of signs, objects and meanings in use forms a common core in the philosophies of Hamann and Wittgenstein. (...) The harmony of language and reality takes place in communicative use, so non-communicative private languages and pre-linguistic ideal forms of representation are not possible. Language is a free response to reality, and it involves belief-systems and trust. (shrink)

BackgroundPatient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research.The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results.MethodsThis prospective, multicenter survey consisted in the (...) administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research.Logistic regression was used to determine factors contributing to “trust” versus “distrust” group membership and willingness to participate in each category of research.ResultsOne thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study.48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female, inactive in the employment market, and not-knowing the name of one’s disease are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.ConclusionDistrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials. (shrink)

The European Legacy, Volume 17, Issue 5, Page 685-687, August 2012.

Provides a collection of essays that offer varying viewpoints on the subject of ethics, covering such topics as what motivates people to act ethically, why ethical behavior is necessary, and how moral standards impact corporations and biomedical science.