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)

Susan Sontag’s talk at the UNESCO meeting on which the French edition of Diogëne 201 was based has been replaced in this English edition of Diogenes 201 by extracts from her published work: her article ‘Looking At War’ in The New Yorker (December 2002).

Nature, as Spinoza conceives of it, contains individual things or finite modes, each with its own essence. Although we humans classify individuals into kinds, Spinoza is adamant that the resulting types or species “are nothing”. Despite Spinoza's nominalism, his mature works posit differences between animal kinds that are discoverable by reasoning and available to philosophical understanding. Spinoza's world is fluid in the sense that the powers of individuals are in flux, changing as they interact with one another. In Spinoza's view, (...) changes in an individual's power are typically the effects of its interactions with external things. Spinoza contrasts the affective dynamics between human natures with a lack of affective commonality between humans and other kinds of animals. In his political works Spinoza translates his account of natures or essences into juridical terms. The claim that mutual sociability is what makes an animal kind is of a piece with the rest of Spinoza's philosophy. (shrink)

My goal in this paper is to determine whether there exists good reason to apply to Rorty the label “deliberative democrat.” There are elements of Rorty’s work that count both for and against applying this label, which I investigate here. I conclude that, if we can conceive of a deliberative democracy that is not informed by a social epistemology that relies on Reason; if we can conceive of a deliberative democracy that has a wider view of reason and of reasons (...) than is traditionally understood, then we can think of Rorty as a deliberativist; perhaps as a virtue deliberativist with an expansive idea of what counts a reason and what counts as a virtue. (shrink)

Through an exacting yet accessible reconstruction of eleven of Freud's essential theoretical writings, Susan Sugarman demonstrates that the traditionally received Freud is the diametric opposite of the one evident in the pages of his own works. Whereas Freud's theory of the mind is typically conceived as a catalogue of uninflected concepts and crude reductionism - for instance that we are nothing but our infantile origins or sexual and aggressive instincts - it emerges here as an organic whole built from (...) first principles and developing in sophistication over time. Sugarman's exciting interpretation, tracking Freud's texts in the order in which he wrote them, grounds his claims in the reasoning that led to them and reveals their real intent. This fresh reading will appeal to specialists and students across a variety of disciplines. (shrink)

John Rawls posited that we could determine the nature of justice if we imagined ourselves observing conditions in society from behind a hypothetical “veil of ignorance.” Not knowing how or where we would end up—rich, poor, empowered, disabled—we would choose governing principles that did not leave one disadvantaged because of his or her circumstances. Rawls's concepts are implicitly embedded in the Affordable Care Act, which guarantees that vastly more Americans can obtain health insurance. The law effectively closed down the de (...) facto lottery that awarded coverage to most but left out millions of others. (shrink)

Retribution? Restitution? Reconciliation? “Justice” comes in many forms as witnessed by the spike in war crimes tribunals, Truth & Reconciliation Commissions, hybrid tribunals and genocide trials. Which, if any form is appropriate should be influenced by the culture of the people affected. It took Cambodia over three decades to finally address the ghosts of its Khmer Rouge past with the creation of a hybrid Khmer Rouge Tribunal. But how meaningful is justice to the majority of survivors of the Khmer Rouge (...) auto-genocide when only a handful of top officials are tried? Further, given the persistent abuse of political and economic rights in post-conflict Cambodia, we are skeptical that justice or reconciliation is presently possible. (shrink)

many contemporary pragmatists reject Richard Rorty’s views because they think he neglects an important, if not pivotal, aspect of the classical pragmatists’ thought: experience. His claim that Dewey’s metaphysics of experience unwittingly perpetuates foundationalism has been met with both incredulity and frustration among contemporary scholars who are interested in revitalizing Dewey’s work. Similarly, one of the main reasons feminists have offered for their hesitance to ally themselves with the neo-pragmatists, focusing their efforts instead on the allegiances to be forged between (...) and the resources to be borrowed from the classical pragmatists, is the former’s neglect of experience. For example, in Pragmatism and .. (shrink)

This dissertation provides a philosophical analysis of personal autonomy. Personal autonomy is defined as the condition of being self-directed. The conditions which make such self-direction possible are then explored. ;Self-direction requires that one's actions are motivated by authentic reasons for action. One makes some of one's desires authentic by critically reflecting upon and identifying with them. One identifies with a particular desire when one approves of it as a reason for action, thus desiring that it be an effective desire. Provided (...) that one's identification with a desire is decisive and one is not ambivalent with respect to it, identification is sufficient for the authenticity of one's desires. ;This capacity to adopt authentic reasons for action cannot be sufficient for the autonomy of one's desires or actions, though. For authenticity is a function solely of the psychological states of an individual; yet autonomy cannot be adequately explicated solely by reference to an agent's subjective states. I refer to those theories which make the autonomy of a person's desires solely a function of her psychological states as "internalist", and argue that such theories must be rejected. An "externalist" is one who denies that autonomy is wholly a function of the psychological states of the individual, and so holds that the autonomy of a desire is determined, at least in part, by facts which are independent of the subjective attitudes of the agent. ;I defend a form of externalism, which makes the autonomy of a desire depend upon the following conditions: the agent must approve of it as a reason for action; the agent must have the capacity to respond appropriately to whatever reasons there are for and against it; the agent must have been able to avoid falling into error concerning the object of the desire and the desire itself; the agent's approval of it is not caused solely by a restriction of her feasible options or coercion. ;I argue that this is a more plausible theory than other externalist positions, and it can meet the objections which have beset internalist theories. (shrink)

Hegel and Canada is a collection of essays that analyses the real, but under-recognized, role Hegel has played in the intellectual and political development of Canada. The volume focuses on the generation of Canadian scholars who emerged after World War Two: James Doull, Emil Fackenheim, George Grant, Henry S. Harris, and Charles Taylor.

A part of the “return to religion” now evident in European philosophy, this book represents the culmination of the career of a leading phenomenological thinker whose earlier works trace a trajectory from Marx through a genealogy of psychoanalysis that interprets Descartes’s “I think, I am” as “I feel myself thinking, I am.” In this book, Henry does not ask whether Christianity is “true” or “false.” Rather, what is in question here is what Christianity considers as truth, what kind of truth (...) it offers to people, what it endeavors to communicate to them, not as a theoretical and indifferent truth, but as the essential truth that by some mysterious affinity is suitable for them, to the point that it alone is capable of ensuring them salvation. In the process, Henry inevitably argues against the concept of truth that dominates modern thought and determines, in its multiple implications, the world in which we live. Henry argues that Christ undoes “the truth of the world,” that He is an access to the infinity of self-love, to a radical subjectivity that admits no outside, to the immanence of affective life found beyond the despair fatally attached to all objectifying thought. The Kingdom of God accomplishes itself in the here and now through the love of Christ in what Henry calls “the auto-affection of Life.” In this condition, he argues, all problems of lack, ambivalence, and false projection are resolved. (shrink)

In the last decade the public health movement has bolstered efforts to prevent interpersonal violence through bringing social policy attention and needed dollars to prevention initiatives. Features in a public health approach to prevention include an evidence-based conception of the risks and so-called ?protective? factors associated with the unwanted problem and the use of sophisticated evaluation tools to monitor prevention efforts. This article critically reviews public health prevention methodology as applied to interpersonal violence prevention at the primary level through drawing (...) on findings from a qualitative inquiry into the moral dimensions of violence prevention education. It examines the premise that an empirical evidence base can determine what is desirable in relationships, together with the assumption that expert violence prevention educators can use this evidence to teach others about relationship desirability. In relying on a scientific and empirical evidence base, it is argued that the public health prevention model fails to recognize important moral dimensions of human relationships. (shrink)

I argue that it is implausible to think that motives, As distinguished from intentions, Are relevant to literary criticism. The considerations leading to this conclusion offer some insights into the continuing debate over the relevance of artist's intentions to criticism. I also examine briefly why motives are not relevant to aesthetic judgments even though they are (plausibly) relevant to ethical ones. Some views of anscombe on intentions are discussed.

The pornography debate occupies a prominent site of apparent contradiction in contemporary culture: a site where the interests of cultural feminism merge with those of the far Right, where an underground enterprise becomes a major growth industry, and where forms of speculation turn alarmingly practical. Another more problematic confluence occurs as a result of this debate. That is, by juxtaposing the 1986 Final Report of the Attorney General’s Commission on Pornography and the Marquis de Sade’s 120 Days of Sodom, we (...) will see how pornography and the public discourse on pornography share the same comparative logic. An examination of such a logic shows how the pleasures of comparison—its gestures toward control, limit, and transcendence—are always balanced by its failures, even tragedies: the realization of the situated nature of all measurement, juxtaposition, subordination, and hierarchization. Thus this essay is designed to both discuss and illustrate a series of issues implicit in pornography’s predicament: the impossibility of describing desire without generating desire; the impossibility of separating form and content within the process of sublimation; and, most important, the impossibility of constructing a metadiscourse on pornography once we recognize the interested nature of all discursive practices. We cannot transcend the pornography debate, for we are in it. But by writing through it, by examining its assumptions, we can learn a great deal about the problems of representing desire and the concomitant problems of a cultural desire for unmediated forms of representation. Susan Stewart, whose most recent contribution to Critical Inquiry was “Shouts on the Street: Bakhtin’s Anti-linguistics” , is the author of two books of literary theory, Nonsense: Aspects of Intertextuality in Folklore and Literature and On Longing: Narrative of the Miniature, the Gigantic, the Souvenir, the Collection , and two books of poetry, Yellow Stars and Ice and The Hive . She is finishing a book on “crimes of writing,” of which this essay is a part, and a study of the five senses. (shrink)

The term “effective,” on its own, is honorific but vague. Interventions against serious mental illness may be “effective” at goals as diverse as reducing “apparent sadness” or providing housing. Underexamined use of “effective” and other success terms often obfuscates differences and incompatibilities in interventions, degrees of effectiveness, key omissions in effectiveness standards, and values involved in determining what counts as “effective.” Yet vague use of such success terms is common in the research, clinical, and policy realms, with consequences that negatively (...) affect the care offered to individuals experiencing serious mental illness. A pragmatist-oriented solution to these problems suggests that when people use success terms, they need to explain and defend the goals and supporting values embedded in the terms, asking and answering the questions, “Effective at what? For whom? How effective? And why that goal?” Practical and epistemic standards for effectiveness will likely remain plural for good reasons, but each standard should be well explained and well justified. (shrink)

One of the central themes of contemporary feminist literature is the exclusion of the female subject from the Western tradition. Luce Irigaray has made significant contributions to this literature. In this article I examine one aspect of Irigaray’s work on the feminine subject, her discussion of divine women. She argues that in order to achieve full subjectivity women must worship a female god that will give them the divinity that they lack, the divinity that the patriarchal god provides for men. (...) I argue that this thesis is both counterproductive and incoherent. It perpetuates the male/female binarism that is at the root of patriarchy. It also fails to define the concept of a female god which is at the centre of Irigaray’s argument. I conclude that the approach of process theology is much more successful in removing the maleness of God and providing women with a deity compatible with feminist beliefs. (shrink)

The nature and impact of authority have been central to social theory since antiquity, and most students of politics, culture and organizations have – in one manner or another – visited the topic. Theorists recognize that the exercise of authority is conditioned by the environment, but their work has not always integrated fundamental changes in communication infrastructure, and in particular the diffusion of mass media. With the daily evolution of telecommunications, this is a good historical moment to re-evaluate the notion (...) of authority. My goal is to assess ways to both preserve extraordinarily useful categories from the past, and at the same time, make those typologies more sensitive to contemporary mediated communication. Here I synthesize American research on media and political communication with recent theoretical approaches to authority, expanding current views of coercion and submission. (shrink)

Recent studies of early development in a number of ivertebrate and vertebrate species have suggested that growth factors and their receptors may play important roles in differentiation as well as cell proliferation. In the mouse embryo, the expression of the receptors for insulin and insulin‐like growth factors I and II (IGF‐I and ‐II) are temporally regulated. The ontogeny of receptor and ligand expression within the insulin and IGF gene family suggests that the very earliest stages of mammalian embryogenesis may be (...) subject to regulation by autocrine and paracrine factors from maternal and embryonic sources. (shrink)

Buben undertakes the ambitious project of providing "a compelling framework for understanding the ways in which philosophy has discussed death". This is a tall order for 136 pages of text, all the more so since he argues that the thinkers of western philosophy before Kierkegaard's and Heidegger's innovative existential philosophy of death can be broadly categorized into a Platonic strain, and an Epicurean strain. The Platonic strain suggests that death should not be feared, as the soul will survive the death (...) of the body. Thinkers such as the Apostle Paul, Plotinus, Augustine, Anselm, Aquinas, Luther, and Pascal are briefly discussed as examples. Membership in the Epicurean strain is marked by the conviction... (shrink)

_The Child That Haunts Us_ focuses on the symbolic use of the child archetype through the exploration of miniature characters from the realms of children’s literature. Jung argued that the child archetype should never be mistaken for the ‘real’ child. In this book Susan Hancock considers how the child is portrayed in literature and fairytale and explores the suggestion from Jung and Bachelard that the symbolic resonance of the miniature is inversely proportionate to its size. We encounter many instances (...) where the miniature characters are a visibly vulnerable ‘other’, yet often these occur in association with images of the supernatural, as the desired or feared object of adult imagination. In _The Child That Haunts Us_ it is emphasised that the treatment by any society, past or present, of its smallest and most vulnerable members is truly revealing of the values it really holds. This original and sensitive exploration will be of particular interest to undergraduate and postgraduate students as well as academics engaged in Jungian studies, children’s literature, childhood studies and those with an interest in socio-cultural constructions of childhood. (shrink)

In this paper, we reflect upon our experience in Mexico, as weIl as review the literature on reflection developed by adult educators in the United States in order to begin to develop a theory of “relevant retlection” useful for family literacy practitioners. We feel that engaging in relevant reflection can help to empower family literacy practitioners in the United States to work more effectively with participants and help participants think more critically about the meaning of literacy in their lives. It (...) is the participant’s perception of their life-world that we hold to be valid. In the context of family literacy, our initial interest is in promoting the exploration of the educational validity of a certain form of reflection as it relates to learning process and outcomes. Our theory derived from reviewing the literature on reflection and critical reflection is thus stated: When family literacy paticipants are encouraged to reflect upon the relevance of literacy as it relates to their life-world, learning is significantly enhanced. Relevant reflection can be facilitated through engaging participants in reflecting upon the relevance of literacy to their lives, their families, their communities and their livelihoods. Indeed, this can be done individuaIly, in dialogue with another and/or as a group. Family literacy practitioners are provided a framework for facilitating relevant reflection for participants. (shrink)

The purpose of this paper is to outline an ethics development activity that uses scenarios in university classes to further the knowledge, engagement, and enhancement of the ethical actions of the students. By starting with a brief review of the objective and use of scenarios in ethics research, the paper progresses to explain the activity, debrief the activity, and finally to provide an analysis of the activity with examples. Included in this activity are ways to incorporate a discussion of Kant’s (...) Categorical Imperative Theories, NCA Credo of Ethical Communication, and the use of videos for Milgram’s Blind Obedience and Stanford’s Prison studies—thus making this activity useful across all disciplines. (shrink)