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)

In "The Philosophy of Nature," Brian Ellis provides a clear and forthright general summation of, and introduction to, the new essentialist position. Although the theory that the laws of nature are immanent in things, rather than imposed on them from without, is an ancient one, much recent work has been done to revive interest in essentialism and "The Philosophy of Nature" is a distinctive contribution to this lively current debate. Brian Ellis exposes the philosophical and scientific credentials of (...) the prevailing Humean metaphysic as less than compelling and makes the case for new essentialism as an alternative metaphysical perspective in lucid and unambiguous terms. This book develops this alternative metaphysic and considers the consequences for philosophy, and for some other areas of investigation, of working with such a metaphysic. Ellis argues that these consequences are profound and that a new essentialism provides a comprehensive new philosophy of nature for a modern scientific understanding of the world. (shrink)

This book is an important contribution to the philosophy of music. Whereas most books in this field focus on the creation and reproduction of music, Bruce Benson's concern is the phenomenology of music making as an activity. He offers the radical thesis that it is improvisation that is primary in the moment of music making. Succinct and lucid, the book brings together a wide range of musical examples from classical music, jazz, early music and other genres. It offers a rich (...) tapestry incorporating both analytic and continental philosophy, musicology and performance-practice issues. It will be a provocative read for philosophers of art and musicologists and, because it eschews technicality, should appeal to general readers, especially those who perform. (shrink)

"First Published in 1999, Routledge is an imprint of Taylor & Francis, an informa company.".

Social contract thought has always contained multiple and mutually conflicting lines of argument; the minimalist contractarianism so influential today represents the weaker of two main constellations of claims. I make the case for a Kantian contract theory that emphasizes the bedrock principle of consent of the governed instead of the mere heuristic device of the exit from the state of nature. Such a shift in emphasis resolves two classic difficulties: tradi- tional contract theory’s ahistorical presumption of a pre-political settlement, and (...) its impossibly high demands on citizens seeking to practice self-rule. Kant’s solutions to these problems of property rights and citizenship are found in his political works, rather than the ethical works through which Kant’s political theory is usually interpreted. (shrink)

"In the same period Wagner was deeply inspired by the works of Shakespeare, an influence that runs throughout this volume. The title essay, "Actors and Singers," is one of Wagner's most deliberate and philosophical writings. He wrote, "Art ceases, strictly speaking, to be Art from the moment it presents itself as Art to our reflecting consciousness. " He described how the unconsciousness of art, and thus art's power, connected natural genius to cultivate traditions.

In this paper it will be argued that causal laws describe the actions of causal powers. The process which results from such an action is one which belongs to a natural kind, the essence of which is that it is a display of this causal power. Therefore, if anything has a given causal power necessarily, it must be naturally disposed to act in the manner prescribed by the causal law describing the action of this causal power. In the formal expressions (...) of causal laws, the necessity operators occur within the scopes of the universal quantifiers. Hence the necessities must hold of each instance. The causal laws may thus be shown to be concerned with necessary connections between events or circumstances of precisely the sort required for a decent account of singular causation. (shrink)

Physical realism is the thesis that the world is more or less as present‐day physical theory says it is, i.e. a mind‐independent reality, that consists fundamentally of physical objects that have causal powers, are located in space and time, belong to natural kinds, and interact causally with each other in various natural kinds of ways. It is thus a modern form of physicalism that takes due account of the natural kinds structure of the world. It is a thesis that many (...) present‐day scientific realists would surely accept. Indeed, some might say that physical realism just is scientific realism, but under another name. However, the argument that is presented for physical realism is not the standard one for scientific realism. It is not a two‐stage argument from the success of science to the truth of scientific theories to the reality of the entities postulated in these theories. It is more powerful than this, because it is more direct, and its premisses are more secure. It is more direct, because it develops what is basically a physicalist ontology as the only plausible metaphysical explanation of the new scientific image of the world. It is more secure, in that it does not depend, as the standard argument does, on any doubtful generalisations about the nature or role of scientific theory. (shrink)

Any physical explanation of consciousness seems to leave unresolved the ‘explanatory gap': Isn't it conceivable that all the elements in that explanation could occur, with the same information processing outcomes as in a conscious process, but in the absence of consciousness? E.g. any digital computational process could occur in the absence of consciousness. To resolve this dilemma, we propose a biological-process-oriented physiological- phenomenological characterization of consciousness that addresses three ‘paradoxical’ qualities seemingly incompatible with the empirical realm: The dual location of (...) phenomenal properties ‘out there’ yet ‘in here’ in consciousness; the mysterious ‘thickness’ of the specious present; the feeling of ‘free agency', that we can voluntarily direct our actions, including the act of conscious attention, while at the same time attention and the emotions that direct it seem responsive to physiological substrates with physical causes. These paradoxes are then resolved by relating three elements of consciousness: organismically interested anticipation; sensory and proprioceptive imagery generated by the interested anticipation rather than by sensory input; resonating of these activities with activity stimulated by sensory data, where the interested anticipation precedes the processing of the input. Each of these elements is bridged to physiological processes such that, if they occur in a certain relation to each other, we can understand why they would inevitably be accompanied by the corresponding elements of conscious experience. (shrink)

Enactivism has the potential to provide a sense of teleology in purpose-directed action, but without violating the principles of efficient causation. Action can be distinguished from mere reaction by virtue of the fact that some systems are self-organizing. Self-organization in the brain is reflected in neural plasticity, and also in the primacy of motivational processes that initiate the release of neurotransmitters necessary for mental and conscious functions, and which guide selective attention processes. But in order to flesh out the enactivist (...) approach in a way that is plausible and not merely an epiphenomenon, it is necessary to confront the problem of causal closure in a serious way. Atoms and molecules in the brain do not violate the normal causal principles that govern them in other contexts. The theory of self-organizing dynamical systems must be developed in a way that is compatible with causal closure rather than contradicting it. (shrink)

Benefits and costs on prospective memory performance, of enactment at encoding and a semantic association between a cue-action word pair, were investigated in two experiments. Findings revealed superior performance for both younger and older adults following enactment, in contrast to verbal encoding, and when cue-action semantic relatedness was high. Although younger adults outperformed older adults, age did not moderate benefits of cue-action relatedness or enactment. Findings from a second experiment revealed that the inclusion of an instruction to perform a prospective (...) memory task led to increments in response latency to items from the ongoing activity in which that task was embedded, relative to latencies when the ongoing task only was performed. However, this task interference ‘cost’ did not differ as a function of either cue-action relatedness or enactment. We argue that the high number of cue-action pairs employed here influenced meta-cognitive consciousness, hence determining attention allocation, in all experimental conditions. (shrink)

While the phrase "metaphysics of science" has been used from time to time, it has only recently begun to denote a specific research area where metaphysics meets philosophy of science—and the sciences themselves. The essays in this volume demonstrate that metaphysics of science is an innovative field of research in its own right. The principle areas covered are: The modal metaphysics of properties: What is the essential nature of natural properties? Are all properties essentially categorical? Are they all essentially dispositions, (...) or are some categorical and others dispositional? Realism in mathematics and its relation to science: What does a naturalistic commitment of scientific realism tell us about our commitments to mathematical entities? Can this question be framed in something other than a Quinean philosophy? Dispositions and their relation to causation: Can we generate an account of causation that takes dispositionality as fundamental? And if we take dispositions as fundamental, what is the ontological ground of dispositions? Pandispositionalism: Could all properties be dispositional in nature? Natural kinds: Are there natural kinds, and if so what account of their nature should we give? For example, do they have essences? Here we consider how these issues may be illuminated by considering examples from reals science, in particular biochemistry and neurobiology. (shrink)

This book is an attempt to come to grips with problems of the epistemological basis of ethical beliefs by building on criticisms of approaches to this problem which have been attempted in the recent past. Because of the extensive discussions and criticism of these various alternatives, the book is useful to all who are concerned with the epistemology of ethics.

Francis Bacon, the English philosopher, statesman and jurist, is best known for developing the empiricist method which forms the basis of modern science. Bacon's writings concentrated on philosophy and judicial reform. His most significant work is the Instauratio Magna comprising two parts - The Advancement of Learning and the Novum Organum. The first part is noteworthy as the first major philosophical work published in English. James Spedding and his co-editors arranged this fourteen-volume edition, published in London between 1857 and 1874, (...) not in chronological order but by subject matter, so that different volumes would appeal to different audiences. The material is divided into three parts: philosophy and general literature; legal works; and letters, speeches and tracts relating to politics. Volume 10, published in 1868, contains Bacon's letters and political writings from 1601 to 1607. Of note is Bacon's support of the union of England and Scotland. (shrink)

Francis Bacon, the English philosopher, statesman and jurist, is best known for developing the empiricist method which forms the basis of modern science. Bacon's writings concentrated on philosophy and judicial reform. His most significant work is the Instauratio Magna comprising two parts - The Advancement of Learning and the Novum Organum. The first part is noteworthy as the first major philosophical work published in English. James Spedding and his co-editors arranged this fourteen-volume edition, published in London between 1857 and 1874, (...) not in chronological order but by subject matter, so that different volumes would appeal to different audiences. The material is divided into three parts: philosophy and general literature; legal works; and letters, speeches and tracts relating to politics. Volume 11, published in 1868, contains Bacon's political writings and letters from 1608 to 1613, including his treatise on the Irish plantations presented to King James I. (shrink)

Francis Bacon, the English philosopher, statesman and jurist, is best known for developing the empiricist method which forms the basis of modern science. Bacon's writings concentrated on philosophy and judicial reform. His most significant work is the Instauratio Magna comprising two parts - The Advancement of Learning and the Novum Organum. The first part is noteworthy as the first major philosophical work published in English. James Spedding and his co-editors arranged this fourteen-volume edition, published in London between 1857 and 1874, (...) not in chronological order but by subject matter, so that different volumes would appeal to different audiences. The material is divided into three parts: philosophy and general literature; legal works; and letters, speeches and tracts relating to politics. Published in 1869, Volume 12 contains Bacon's letters and writings between 1613 and 1616, which primarily relate to his appointment as Attorney General. (shrink)

Francis Bacon, the English philosopher, statesman and jurist, is best known for developing the empiricist method which forms the basis of modern science. Bacon's writings concentrated on philosophy and judicial reform. His most significant work is the Instauratio Magna comprising two parts - The Advancement of Learning and the Novum Organum. The first part is noteworthy as the first major philosophical work published in English. James Spedding and his co-editors arranged this fourteen-volume edition, published in London between 1857 and 1874, (...) not in chronological order but by subject matter, so that different volumes would appeal to different audiences. The material is divided into three parts: philosophy and general literature; legal works; and letters, speeches and tracts relating to politics. Volume 13, published in 1872, contains Bacon's papers from 1616 to 1618 and relate to his appointment as Lord Chancellor, and England's relations with Ireland and Spain. (shrink)

Francis Bacon, the English philosopher, statesman and jurist, is best known for developing the empiricist method which forms the basis of modern science. Bacon's writings concentrated on philosophy and judicial reform. His most significant work is the Instauratio Magna comprising two parts - The Advancement of Learning and the Novum Organum. The first part is noteworthy as the first major philosophical work published in English. James Spedding and his co-editors arranged this fourteen-volume edition, published in London between 1857 and 1874, (...) not in chronological order but by subject matter, so that different volumes would appeal to different audiences. The material is divided into three parts: philosophy and general literature; legal works; and letters, speeches and tracts relating to politics. The philosophical works in Latin are also given in translation, while Volumes 8 to 14 consist of letters, diaries and biographical information from 1560 to 1626. (shrink)

A significant body of research has emerged in order to better understand unethical behavior at work and how gender plays a role in the process. In this study, we look to add to this literature by exploring how perpetrator gender influences reactions to distinct types of unethicality. Rather than viewing unethical behavior as a unitary construct, where all forms of lying, cheating, and stealing are the same, we integrate theories and concepts from the criminal justice and moral psychology literatures to (...) categorize certain unethical behaviors as either impulsive or premeditated. Given the agentic nature of premeditated unethical behavior, we draw from role congruity theory to predict that women will be punished more severely than men for their role incongruous actions. Impulsive unethical behavior, on the other hand, will be less likely to elicit perceptions of congruity or incongruity, leading to less of a gender effect. Results from three studies sampling both undergraduates and working adults in the United States, Singapore, and South Korea showed that participants were more likely to associate premeditated unethical behavior with a male perpetrator because it was seen as less feminine, and female perpetrators who engaged in premeditated unethical behavior received more severe punishment than male perpetrators due to the perceived role incongruity of their actions. Implications are discussed as well as possible limitations and directions for future research. (shrink)

When should we expect compliance with international human rights norms? Previous literature on the causal mechanisms underlying compliance have focused independently on the roles of state willingness, thought of as the preferences of the regime leadership, and on state capacity, in improving human rights practices within a state. We build an argument that neither of these factors are sufficient on their own to improve compliance with human rights norms. Instead, improved human rights practices require both “the will and the way.” (...) Our central hypothesis is that capacities and willingness, acting jointly, are key determinants of improvements in compliance with international human rights norms. The paper confirms this proposition using two-staged and single-stage regression models and a time-series cross-sectional approach at the country-year level. A highly capable bureaucracy and a state that has signaled its willingness through the acceptance of individual complaint and inquiry procedures in the UN treaty regime are jointly necessary for improved human rights practices. (shrink)

Sir Francis Bacon, statesman, essayist and philosopher, studied law and rose to high office as Lord Chancellor. He had enormous influence on the change of direction for scientific method from speculative and philosophical in the Aristotelian tradition to experimental and factual. Bacon's philosophical influence extended to Locke and through him to subsequent English schools of psychology and ethics. Abroad, his influence also extended to Leibniz, Huygens and Voltaire who called him 'le pere de la philosophie experimentale'. This edition contains all (...) Bacon's philosophical works as well as translations, plus literary and professional works, and includes illuminating introductions and explanatory footnotes by the three editors as well as a new introduction by Graham Rees. (shrink)

Argues that categorization, and not syntax, is the most important aspect of language, suggests that some philosophical problems are caused by an inadequate theory of language, and promotes a fresh approach to linguistic theory.

This paper is a response to the "panel discussion of simultaneity by slow clock transport in the special and general theories of relativity" ("philosophy of science", 36, (march, 1969), Pp. 1-81) which arose out of a paper by brian ellis and peter bowman on "conventionality in distant simultaneity", ("philosophy of science", 34, (june, 1967), Pp. 116-36). It is argued that the basic disagreement between the pittsburgh panel and us is an epistemological one. In particular, Our concept of a good (...) physical reason is radically different from the pittsburgh panel's. For us the known existence of a number of concordant, Isotropic, And logically independent criteria for distant simultaneity, And the non-Existence of any known discordant but isotropic criteria for distant simultaneity is a good physical reason for choosing one of these criteria. For the pittsburgh panel it is not. (shrink)

Bruce Ellis Benson puts forward the surprising idea that Nietzsche was never a godless nihilist, but was instead deeply religious. But how does Nietzsche affirm life and faith in the midst of decadence and decay? Benson looks carefully at Nietzsche's life history and views of three decadents, Socrates, Wagner, and Paul, to come to grips with his pietistic turn. Key to this understanding is Benson's interpretation of the powerful effect that Nietzsche thinks music has on the human spirit. Benson (...) claims that Nietzsche's improvisations at the piano were emblematic of the Dionysian or frenzied, ecstatic state he sought, but was ultimately unable to achieve, before he descended into madness. For its insights into questions of faith, decadence, and transcendence, this book is an important contribution to Nietzsche studies, philosophy, and religion. (shrink)

This book traces a deep misunderstanding about the relation of concepts and reality in the history of philosophy. It exposes the influence of the mistake in the thought of Locke, Berkeley, Kant, Nietzche and Bradley, and suggests that the solution can be found in Hegelian thought. Ellis argues that the treatment proposed exemplifies Hegel's dialectical method. This is an important contribution to this area of philosophy.

Last night I had a desire for a glass of wine. Luckily I had a bottle in the fridge and could satisfy my desire. Earlier in the day I had a desire to run on the heath and I satisfied this desire too. And today, tired of reading yet more stuff on desire, I satisfied my desire to start writing. So desires can be satisfied. Not that they are guaranteed to be satisfied – the bottle in my fridge might have (...) failed to materialize, and something might have prevented me from going for a run or getting down to writing – but that they can be satisfied. Witness C.S. Lewis: Creatures are not born with desires unless satisfaction for those desires exists. A baby feels hunger: well, there is such a thing as food. A duckling wants to swim: well, there is such a thing as water. Men feel sexual desire: well, there is such a thing as sex. (shrink)