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)

Standardly, epistemic peers regarding a given matter are said to be people of equal competence who share all relevant evidence. Alternatively, one can define epistemic peers regarding a given matter as people who are equally likely to be right about that matter. I argue that a definition in terms of likelihood captures the essence of epistemic peerhood better than the standard definition or any variant of it. What is more, a likelihood definition implies the truth of the central thesis in (...) the debate on peer disagreement, the so-called Equal Weight View, according to which we should give the opinions of our peers the same weight we give our own. Adopting a likelihood definition, however, does not end the debate on peer disagreement, because the alleged theoretical alternatives to the Equal Weight View, reinterpreted in the light of a likelihood definition, can in fact be shown to be compatible with this view—though the reinterpreted versions may appear less plausible than the original ones. (shrink)

Giorgio Colli ha sido uno de los autores contemporáneos que más han contribuido a revisar la figura de Apolo, entendiéndola como una potencia expresiva vinculada tanto a los designios asociados a su arco como a los coligados a su lira. Una ambigüedad expresiva que examinamos en este artículo y que, veremos, articulará simbólicamente la reforma histórica que Colli detectará en el paso de la sabiduría oral a la filosofía griega escrita, pero también la que se producirá entre una ontología-política arcaica (...) de ámbito contingente y una politeia, ya clásica, ligada a la necesidad, y de carácter retórico, estetizado y comunicativo. (shrink)

This article seeks to explain how it was possible that, until the first century BC, the Roman dictatorship was never abused and turned against the constitution itself. The traditional explanation is that, contrary to its first century imitations, the dictatorship was subject to formal restrictions, such as the six months' tenure, which were strictly applied. By contrast, this article suggests that informal constraints on the dictator's powers, such as moral and religious norms, were as important as formal constraints. It shows, (...) more particularly, how the fides, or the requirement of trust, was essential for preventing an abuse of dictatorial powers. (shrink)

Counterfactuals all the way down? Content Type Journal Article DOI 10.1007/s11016-010-9437-9 Authors Jim Woodward, History and Philosophy of Science, 1017 Cathedral of Learning, University of Pittsburgh, Pittsburgh, PA 15260, USA Barry Loewer, Department of Philosophy, Rutgers University, New Brunswick, NJ 08901, USA John W. Carroll, Department of Philosophy and Religious Studies, North Carolina State University, Raleigh, NC 27695-8103, USA Marc Lange, Department of Philosophy, University of North Carolina at Chapel Hill, CB#3125—Caldwell Hall, Chapel Hill, NC 27599-3125, USA Journal Metascience (...) Online ISSN 1467-9981 Print ISSN 0815-0796 Journal Volume Volume 20 Journal Issue Volume 20, Number 1. (shrink)

"We are omniscient but confused," says Leibniz. He also says that we live in the best of all possible worlds, yet do not causally interact. So what are we? Leibniz is known for many things, including the ideality of space and time, calculus, plans for a universal language, theodicy, and ecumenism. But he is not known for his ideas on the self and personal identity. This book shows that Leibniz offers an original, internally coherent theory of personal identity, a theory (...) that stands on its own even next to Locke's contemporaneous and more famous version. This book will appeal not only to students of Leibniz's thought but also to philosophers and psychologists interested in methodological problems in understanding or formulating theories of self and personal identity. (shrink)

The risks associated with the techniques of medically assisted procreation (MAP) rapidly became well-known, and in such a short space of time that no biomedical domain remained untouched by the great deal of thinking and the expression of a multitude of opinions it provoked. MAP is evolving between two poles: quality/misuse (even violation) and evidence/fantasy. The ethics will be evoked in the clinical reality from which they spring and where their justification lies. The three objects common to these ethics, the (...) oocyte, the embryo and the child, are illustrated in this context. MAP has as its corollary access to the oocyte, the fertilization of which will take place in vitro. Access to the embryo, on the other hand, enables the clinician, for the purposes of diagnosis [preimplantation genetic diagnosis (PGD), predictive medicine], or even soon for therapeutic purposes (gene therapy) to draw close to a boundary, to trespass beyond which may be seen by humanity to threaten its very origins and integrity: the alienation of the human genome. For the infertile couple, the missing child may take on a dimension of which they would have been unaware, had they not been forced to express their desire. The burden of the imaginary child may, in this way, become a heavier load to bear when, after such desire, he comes into being. MAP puts the goal of normalisation within reach and, in doing so, accentuates the risk of the burden of the attributed representation of the child. On the one hand, MAP offers a tremendous diagnostic and therapeutic potential, while on the other it opens the door to excess and delirium. In this melting pot, ethics, catalysed by this new source of problematics, has discovered a favourite area in which to define and redefine itself. We propose the intervention of ethics on three different levels. Before the elaboration of the law: on first reflection, ethics may influence the responsibilities of the legislator, by taking care that the law does not obscure the biomedical and socioeconomic contexts of MAP and, thereby, also include other related and complementary aspects dealing with the same subject. The secondary discussion of ethics should influence the application of legal protection, by taking into account the rapid technological and social development of MAP, there too, by discussing the whole, rather than the details which will obscure the object. The ethical reflection of the clinician, who is aware of these difficulties, is guided by elements that are specific to his position as a doctor. The cohesion of the team around the clinician and the ethics specialist enables us to develop consensual clinical ethics that are transmissible and therefore teachable. This complex role can, in our view, only be acted out directly in the clinical situation, where the constant, direct relationship with the object of the reflection and the treatment allows ethics to take into account the contingencies of medical practice: we invite the ethics specialist to take part in our clinical activity on a daily basis. (shrink)

Max Skjönsberg's The Persistence of Party: Ideas of Harmonious Discord in Eighteenth-Century Britain is a rich, detailed, and nuanced study of eighteenth-century ideas about party politics and the British political contexts that both inspired and were affected by their development. The study is ambitious in scope and extensively researched. With David Hume and Edmund Burke as its principal protagonists, the book is organised chronologically and centered on analyses of writings by Paul de Rapin-Thoyras, Henry St John, 1st Viscount Bolingbroke, Hume, (...) John Brown, and Burke to illustrate the centrality of party, as a concept, to political debate in the eighteenth... (shrink)

RÉSUMÉ: John Kekes soutient que l’objectif libéral de maximiser l’autonomie individuelle menace de compromettre nos tentatives pour prévenir les actions mauvaises. Il doit être clair, selon lui, qu’un accroissement de l’autonomie individuelle aura pour résultat une augmentation des actes mauvais dans les démocraties libérales existantes. Je soutiens pour ma part que Kekes ne fournit aucune raison plausible pour penser que la maximisation de l’autonomie individuelle menace ainsi de compromettre nos efforts pour prévenir les actions mauvaises. Aucune des stratégies qu’il propose (...) n’entre en conflit avec la conception libérale de l’autonomie individuelle. Il ne fournit aucune base plausible pour admettre la connexion causale qu’il allègue entre l’autonomie individuelle et la fréquence ou la gravité des actions mauvaises. (shrink)

In a recent article in this journal, Remsen attacked moral objections to killing birds for museum collections, objections that are frequently raised by the general public and scientific community alike. The only grounds for moral objections against killing birds that Remsen considers and rejects are reverence for all life or personal, that is sentimental reasons. What Remsen ignores is avian sentience and the moral imperative of respecting it.

This book defends morality against the critiques of egoims, subjectivism, and relativism. It argues that we can and should construe some moral standards as objective and that justice and self-development are the cornerstones of healthy morality. Opening with a dialogue meant to tease and provoke the reader, the book's subsequent chapters treat misconceptions about morality, the possibility of unselfish action, the nature of free will and moral responsibility, and the identity of moral right and wrong.

The riots by detainees in French administrative detention centers, which have over the past years remained classified, attracted media attention on the occasion of the fire at the Vincennes center in June, 2008. They bear witness at once to both the consequences of the growing repression against illegalized foreigners and the weak means of defense and exterior support available to detainees. In effect, these foreigners are the victims of an institutional violence exacerbated by techniques of arrest, the management of centers, (...) and finally expulsion. This brutalization, defended by public authorities, contaminates relations to the foreigner, particularly in the world of labor, and translates into a pressure on public agents for the detection and denunciation of the « undocumented ». In the face of this repression, the detainees, who contest the legitimacy of such treatment, have no other choice but self-mutilization, suicide or, when they achieve unity, collective hunger strikes in order to oppose their deportation. Their associative and defensive supports are increasingly criminalized. Yet they still represent an avant-garde in the defence of individual and public freedoms against the encroachments made by the culture of control and deregulation. The police battle against illegal aliens is nothing but a Trojan Horse in a war against the minorities of the South and civil society as a whole. (shrink)

Since 1965 Belgian has stopped recognizing governments confining itself to the recognition of states only and maintaining diplomatie relations with the recognized states through wathever government able of exercising effective controle of those states' territory. Nota single exception to this doctrine was made untill 1979.In 1979 however Belgium refused to recognize the government installed in Phnom Penh following the Vietnamese intervention. One year later it also stopped recognizing the Khmer Rouge. In the UN however Belgium went on to accept the (...) Khmer Rouge delegation as the representatives of Cambodia, a state thus being represented by a delegation accredited by an entity that Belgium did not consider to be a government. This contradiction was maintained untill present since neither the coalition between the Khmer Rouge, Sihanouk and Son Sann nor the Supreme National Council were regarded by Belgium as governments.The article reconstructs the Belgium position out of the many statements and arguments the government bas put forward in the UN and the Belgian Parliament. The Belgian position is than examined in the light of international law, its own recognition doctrine and the international and domestic political context.This led to the conclusion that the legal grounds for the Belgian policy were rather weak and that its position almost completly differred from its traditional doctrine. In the Cambodian case however political considerations appeared to have prevailed Belgium chose to join the US, China and Asean and manoeuvred as to follow them in their condemnation of the Vietnamese intervention. Acting even as one of the most faithfull followers of the Asean policy towards Cambodia, Belgium enjoyed the improvement of its own relations with Asean, also in the commercial field.The continuous domestic opposition in and out of the Parliament was not able to change this policy. Even the present Minister of Foreign Alf airs who declared to be inclined to adjust the Belgian position had to hold back in order not to affect the esthablised relations. (shrink)

The first five messages for the world day of peace (2014 through 2018) from Pope Francis highlight fraternity as ‘the foundation and pathway’ of peace. This paper examines two aspects of fraternity and peacebuilding: the first rooted in the transfiguring power of beauty; and the second in the call to holiness within the Father’s plan of loving goodness, which includes the call to an active nonviolent love and to a contemplative gaze upon our sisters and brothers. Francis’ writings are considered (...) broadly, and in conjunction with his predecessors Benedict XVI and John Paul II, as well as with contemporary theologians. (shrink)

This paper outlines the often striking parallels of various approaches to ontic vagueness, as well as their even more striking differences. Though circling around the same idea, some of these approaches were developed to solve quite diverse theoretical problems and encounter different challenges. In addition to these difficulties, the frequently disregarded epistemological problems of all theories of ontic vagueness turn out to be even more serious under critical scrutiny. The same holds for the difficulties of deciding, for every case of (...) vagueness, whether the vagueness involved is semantic or ontic. (shrink)

This paper discusses social mechanisms of discrimination and reviews existing field experimental designs for their identification. We first explicate two social mechanisms proposed in the literature, animus-driven and statistical discrimination, to explain differential treatment based on ascriptive characteristics. We then present common approaches to study discrimination based on observational data and laboratory experiments, discuss their strengths and weaknesses, and elaborate why unobtrusive field experiments are a promising complement. However, apart from specific methodological challenges, well-established experimental designs fail to identify the (...) mechanisms of discrimination. Consequently, we introduce a rapidly growing strand of research which actively intervenes in market activities varying costs and information for potential perpetrators to identify causal pathways of discrimination. We end with a summary of lessons learned and a discussion of challenges that lie ahead. (shrink)

The past two decades have witnessed the emergence of corporateassociation- and standards-based forms of environmental selfregulation. Private environmental governance is commonly presented as being a market-driven phenomenon. Firms seek to manage their environmental impacts as a means of achieving cost-based or differentiation-based advantages. Yet, these innovations are necessarily embedded in the regulatory policies and institutions of nation states and thus subject to the dynamics of regulatory change. Historically, economic crises have stimulated significant regulatory changes that have, more often than not, (...) resulted in an expansion of public regulation and a diminution of self-regulation. This Article considers the ramifications of the global financial crisis for the development of private environmental governance. (shrink)

L’herméneutique critique ou matérielle peut-elle être appliquée à des œuvres qui ne sont plus textuelles, mais picturales ? C’est la tentative effectuée ici à partir d’un tableau de Rembrandt (« Aristote ») en montrant également les limites méthodologiques de l’herméneutique traditionnelle ou de la phénoménologie ordinaire. La première ne parvenant pas à une « réduction » suffisante de la structure proprement picturale, la seconde n’exploitant pas assez les données historiennes des débats au sein desquels l’œuvre prend parti.

Is contemporary media society still interested in truth? This paper will try to unravel the vaguely suspicious epistemic relationship between information marketers and information consumers in today's society. There seems to have been forged a feeling of quasi-omniscience within the private and public spheres wherein people, due to the sheer volume of inforntation readily accessible for viewing at any time, become predisposed to exhibit an intriguingly relaxed relationship with knowledge. If the current systems of information seem to trivialize the question (...) of truth or falsehood, and since the public is apparently just interested in spectacles, then how must we view epistemologically the status of contemporary media discourse? Does it still reveal truth or is it simply empry talk? To address this question, the paper explores a possible parallelism between Plato's critique of rhetoric in his dialogue, Gorgias, and Jean Baudrillard's critique of contemporary media society. (shrink)