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)

Recent ideological positioning on the world stage has born a startling resemblance to a form of positioning within nursing theory – that of taking complex ideas, reducing them to a simplistic binary form, and uncritically adopting one half of that form. In some cases, this adoption of a binary position has led to a passionately held form of ‘othering’ that prohibits a healthy and critical engagement with ideas. As alluring as settling for the binary form may be – we argue (...) for holding binaries in tension as a catalyst for stimulating dialogue – reasoning and exploration of new ways of wrestling with the social and moral complexity of nursing. (shrink)

This paper explores a position that combines contextualism regarding knowledge with the idea that the central point or purpose of the concept of knowledge is to feature in attributions that keep epistemic gate for contextually salient communities. After highlighting the main outlines and virtues of the suggested gate-keeping contextualism, two issues are pursued. First, the motivation for the view is clarified in a discussion of the relation between evaluative concepts and the purposes they serve. This clarifies why one's sense for (...) the point of an evaluative concept ought to constrain and inform one's understanding of the concept. Second, the paper explores ways of avoiding a problem in the author's earlier development of gate-keeping contextualism. The initial development of the view opened the door to a form of skepticism that would hobble an important facet of our social-epistemic lives. (shrink)

This chapter examines how epistemic norms could be social norms, with a reliance on work on the philosophy and social science of social norms from Bicchieri (on the one hand) and Brennan, Eriksson, Goodin and Southwood (on the other hand). We explain how the social ontology of social norms can help explain the rationality of epistemic cooperation, and how one might begin to model epistemic games.

John Henderson focuses on three key Letters visiting three Roman villas, and reveals their meaning as designs for contrasting lives. Seneca brings the philosophical epistle to Latin literature, creating models for moralizing which feature self-criticism, parody, and animated revision of myth. The Stoic moralist wrests writing away from Greek gurus and texts, and recasts it into critical thinking in Latin terms, within a Roman context. The Letters embody critical thinking on metaphor and translation, self-transformation and cultural tradition.

The intent of this essay is to examine what most would call an essential component to the theistic notion of a perfected agent in heaven: impeccability. In Part 1 I will attempt to softly defend the Christian dependence on the doctrine of impeccability, followed by an examination of what I believe to be the two basic moral conditions for impeccability: the deontic condition and the virtue condition. In Parts 2 and 3, I will examine the coherence of each of these (...) conditions by proposing recently raised objections to both. Ultimately, my hope for this essay is to further the discussion concerning the theistic notions of a perfected agent, and the coherence of a heavenly afterlife for that perfected agent. (shrink)

The phrase "natural kind term" has come into the linguistic and philosophical literature in connection with well-known work of Kripke (1972) and Putnam (1970, 1975a). I use that phrase here in the sense it has acquired from those and subseqnent works on related topics. This is not the transparent sense of the phrase. That is, if I am right in what follows there are words for kinds of things existing in nature which are not natural kind terms in the current (...) sense - e.g. planet, woman, and weed. I use the term "nondescriptional", following Salmon (1981), to mean "lacking a Fregean sense", where a Fregean sense is taken to be a property or group of properties semantically associated with an expression which determines its denotation. I hope that the term "nondescriptional" will be clarified in subsequent discussion, but perhaps a few words about it and its opposite, "descriptional", would be useful here. These terms (as Salmon notes (p.15, n. 11)) should be taken as technical terms. The idea is that descriptional words, of which bachelor is the overwhelmingly favorite example, express a semantic content, or sense, which is what mediates their denotation. Entities fall in their denotation in virtue of possessing the property or properties expressed as their sense. (It is not necessary, however, that this sense be as easily paraphrasable with descriptive synonyms as it is typically held to be in the case of bachelor, or even that it be paraphrasable at all.) In the case of nondescriptional words there is no Fregean sense to mediate the link between word and object. Hence such terms are described by what Salmon, following Kaplan, calls "the theory of direct reference". What it is that does associate such terms with their denotations is another question which will be touched on briefly at the end. I have several aims in this paper. The first is to defend a conservative position on nondescriptionality. I will argue that relatively few natural language words have this property. My other aims are primarily clarificatory. Among the issues I would like to clarify are those connected with the determination of this property and flae explanation of why it exists, its relationship with other properties such as rigid designation and essentiality, and its significance for lexical semantics. The organization of the paper is as follows. The first section identifies the position taken here on the question of which expressions are nondescriptional and provides a general defense of it. The second section is a critical examination of criteria associated with nondescriptionality. In the third section provide further defense for the conservative position, and in the fourth section we turn to related issues in lexical semantics. (shrink)

Ulrich Beck's best selling Risk Society established risk on the sociological agenda. It brought together a wide range of issues centering on environmental, health and personal risk, provided a rallying ground for researchers and activists in a variety of social movements and acted as a reference point for state and local policies in risk management. The Risk Society and Beyond charts the progress of Beck's ideas and traces their evolution. It demonstrates why the issues raised by Beck reverberate widely throughout (...) social theory and covers the new risks that Beck did not foresee, associated with the emergence of new technologies, genetic and cybernetic. The book is unique because it offers both an introduction to the main arguments in Risk Society and develops a range of critical discussions of aspects of this and other works of Beck. (shrink)

Szabó follows Heim in viewing familiarity, rather than uniqueness, as the essence of the definite article, but attempts to derive both familiarity and uniqueness implications pragmatically, assigning a single semantic interpretation to both the definite and indefinite articles. I argue that if there is no semantic distinction between the articles, then there is no way to derive these differences between them pragmatically.

Dispositionalism about modality is the view that metaphysical modality is a matter of the dispositions possessed by actual objects. In a recent paper, David Yates has raised an important worry about the formal adequacy of dispositionalism. This paper responds to Yates’s worry by developing a reply that Yates discusses briefly but dismisses as ad hoc: an appeal to a ’plenitude of powers’ including such powers as the necessarily always manifested power for 2+2\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} (...) \begin{document}$$2+2$$\end{document} to be 4. I argue that the reply is not ad hoc at all, by defending the metaphysics of dispositions that should underly it. I then argue, first, that a proper understanding of dispositions’ degrees provides us with an argument for such necessarily always manifested dispositions; second, that all the natural attempts to block that argument can be resisted without being ad hoc; and third, that pragmatic considerations explain our intuitive resistance to the ascription of necessarily always manifested dispositions. Dispositionalism can be formally adequate after all. (shrink)

Cosmological ideas influenced every aspect of traditional Chinese culture, from science and medicine to art, philosophy, and religion. Although other premodern societies developed similar conceptions, in no other major civilization were such ideas so pervasive or powerful. In The Development and Decline of Chinese Cosmology, John Henderson traces the evolution of Chinese thought on cosmic order from the classical era to the nineteenth century. Unlike many standard studies of premodern cosmologies, this book analyzes the origins, development, and rejection of (...) these models, not just their structure. Moreover, while historians often limit their studies of cosmic order to specialized fields like the history of science, Henderson examines how the cosmological ideas formulated in late classical times permeated various facets of Chinese life, from high philosophy to popular culture. (shrink)

This paper advances and defends a new solution to the so-called fundamental problem in christology (the problem being the apparent contradiction entailed by the christian doctrine of divine incarnation).

Cette introduction explique la perception, reconnue par Husserl sous le titre de "donation par esquisses". Il s'agit d'opérer une réduction radicale qui va de la critique du néant au monde comme a priori de tout apparaître. A ce monde correspond un sujet dont le sens d'être fait problème puisqu'il est à la fois un moment du monde et en rapport avec la totalité comme telle.

An extended analysis and account of the psychological/social/cognitive dynamics of intellectual controversy. The immediate focus is the recurrent failure of intellectual engagement, in encounters having to do with with truth, knowledge, language, science, and/or objectivity, between, on the one hand, rationalist-realist-objectivist philosophers and/or those they have instructed and, on the other hand, constructivist-pragmatist ("postmodern") theorists and/or those persuaded by their critiques and/or alternative views. Individual chapters examine critiques and defenses of objectivist-rationalist views in law, politics, literary studies, ethics, communication theory, (...) and philosophy of science. Theorists whose views are discussed critically at some length include legal scholar Robin West and philosophers Jürgen Habermas, Karl-Otto Apel, and Philip Kitcher. (shrink)

L'oeuvre de Merleau-Ponty est tout entiere commandee par le souci de mettre rigoureusement en oeuvre le mot d'ordre husserlien de retour aux choses memes, ce qui exige, conformement au geste amorce par Husserl dans la Krisis, de reconnaitre l'oeuvre de l'idealisation -c'est-a-dire de l'objectivation- la meme ou elle se fait oublier, afin de la neutraliser. A l'instar de Bergson, pour qui la tache de la philosophie etait d'aller chercher l'experience au-dessus du tournant ou, s'inflechissant dans le sens de l'utilite, elle (...) devient proprement l'experience humaine, pour Merleau-Ponty, la tache de la pensee est de se situer a ce tournant ou l'experience s'accomplit et se voile a la fois dans des productions ou elle se fait proprement humaine, de definir un sens de l'Etre anterieur a la bifurcation du preobjectif et de l'oeuvre idealisante. Le but des recherches est de tenter de clarifier la nature exacte du tournant de l'experience ainsi que le projet phenomenologique merleau-pontien. (shrink)

The dictum ‘“ought” implies “can”’ has a status in moral philosophy in some respects like that of ‘a good player needs good co-ordination’ in talk about ball-games. Clearly, you say something important but not conclusive about proficiency in playing a ball-game when you say that it requires good co-ordination: similarly, you say something important but not conclusive about obligation when you say that it implies a certain possibility or power or ability. Each dictum is a reminder: the one about such (...) courses of physical instruction, the other about such exhortations to duty, as are worth persevering with. It would be hopeless to keep on teaching a boy the moves and tricks of rugby football if he could never co-ordinate well enough to get his eye in, so to speak. Correspondingly, it would be meaningless to recommend that someone ought to do something the specification of which involved a contradiction, and pointless to suggest that he ought to do something which, for quite general reasons, was not, and was certain to remain not, within his power. So each dictum expresses a bluff, no-nonsense wisdom which we should count on before involving ourselves in certain more detailed commitments. But probably this is as far as the comparison between the two sayings can well be taken. (shrink)

This paper responds to the contributions by Alexander Bird, Nathan Wildman, David Yates, Jennifer McKitrick, Giacomo Giannini & Matthew Tugby, and Jennifer Wang. I react to their comments on my 2015 book Potentiality: From Dispositions to Modality, and in doing so expands on some of the arguments and ideas of the book.

This paper examines three medical student poems about death to explore how medical students use poetry to understand their encounters with dying patients and to discuss how these poems function as elegies in the context of medical culture.

This book presents the most important problems of reference and considers their solution. It presupposes no technical knowledge, presents analyses from first principles, illustrates every stage with examples, and is written with verve and clarity. This is the ideal introduction to reference for students of linguistics and philosophy of language.

A key philosophical feature of Peter Jackson’s film interpretation of J.R.R. Tolkien’s The Lord of the Rings is its use of fantasy to inspire a “recovery” of the actual or, in other words, a reawakening to the beauty of nature and the many possible ways of living in healthier ecological relation to the world. Though none of these ways is perfectly achieved, this pluralistic view is demonstrated in the various lifeways of Hobbits, Elves, Men, and Ents. All of the positive (...) relationships embodied in the films—to trees, mountains, horses, and vegetable gardens—involve loving care and attention, receiving nourishment and livelihood without instrumentalization, or reducing nature to mere resource. The films also vividly display a variety of ugly and destructive ways of using the land to accrue power and wealth. These noxious ways, specifically because they actively destroy the lands that they use, always need more. They will thus eventually annihilate the beautiful ways of being if they are not actively resisted. Some of those who would rather be tending their own trees, gardens, or horses or even wandering in the wild forests must therefore turn their attention to struggle and resistance instead. This is a struggle full of grief, and at times even verging on despair, but it is marked by the refusal to give up hope. Indeed, what Jackson and Tolkien have to say about hope is as important in responding to the ecological crisis as anything they have to say about nature, inasmuch as they help to remind us that even in our own times, “there is still hope.”. (shrink)

This book considers the context of the colonial policies of Britain, Locke's contribution to them, and the importance of these ideas in his theory of property. It also reconsiders the debate about John Locke's influence in America. The book argues that Locke's theory of property must be understood in connection with the philosopher's political concerns, as part of his endeavour to justify the colonialist policies of Lord Shaftesbury's cabinet, with which he was personally associated. The author maintains that traditional scholarship (...) has failed to do justice to Locke by ignoring the implications of contemporary British imperial policy for the interpretation of his political thought. (shrink)

Contemporary issues involving knowledge and science examined from a constructivist-pragmatist perspective often labeled "relativism." Individual chapters include a review of the difference between constructivist-pragmatist epistemology and "social constructivism;" an examination of recent writings by Bruno Latour; a critique of computational methods in literary studies; a skeptical look at current efforts to "integrate" the humanities and the natural sciences; and reflections on the social dynamics of belief in relation to denials of climate change and to hopes expressed by environmentalists.

The author argues that the fourth-century philosophers used protreptic discourses to market philosophical practices and to define and legitimize the school of higher learning.

In recent decades, scholars have come to see 1 Corinthians as a rhetorically unified response to the problem of divisions among Corinthian believers. This essay explores the ways in which Paul presents the cross as the organizing principle that can bind together three different forms of community division: the cult of the personality ; the freedom to eat idol meat ; and economic disparities when gathered for a meal. In each case, Paul appeals implicitly or explicitly to the cross as (...) a remedy for the all-too-familiar strains on the fractured community. In the end, Paul’s countercultural message about the cross offers a word of exhortation for the American church today, as it navigates a society that shares much in common with first-century Corinth. (shrink)