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)

Only human beings have a rich conceptual repertoire with concepts like tort, entropy, Abelian group, mannerism, icon and deconstruction. How have humans constructed these concepts? And once they have been constructed by adults, how do children acquire them? While primarily focusing on the second question, in The Origin of Concepts , Susan Carey shows that the answers to both overlap substantially. Carey begins by characterizing the innate starting point for conceptual development, namely systems of core cognition. Representations of core (...) cognition are the output of dedicated input analyzers, as with perceptual representations, but these core representations differ from perceptual representations in having more abstract contents and richer functional roles. Carey argues that the key to understanding cognitive development lies in recognizing conceptual discontinuities in which new representational systems emerge that have more expressive power than core cognition and are also incommensurate with core cognition and other earlier representational systems. Finally, Carey fleshes out Quinian bootstrapping, a learning mechanism that has been repeatedly sketched in the literature on the history and philosophy of science. She demonstrates that Quinian bootstrapping is a major mechanism in the construction of new representational resources over the course of childrens cognitive development. Carey shows how developmental cognitive science resolves aspects of long-standing philosophical debates about the existence, nature, content, and format of innate knowledge. She also shows that understanding the processes of conceptual development in children illuminates the historical process by which concepts are constructed, and transforms the way we think about philosophical problems about the nature of concepts and the relations between language and thought. (shrink)

The nature/nurture debate is not dead. Dichotomous views of development still underlie many fundamental debates in the biological and social sciences. Developmental systems theory offers a new conceptual framework with which to resolve such debates. DST views ontogeny as contingent cycles of interaction among a varied set of developmental resources, no one of which controls the process. These factors include DNA, cellular and organismic structure, and social and ecological interactions. DST has excited interest from a wide range of researchers, from (...) molecular biologists to anthropologists, because of its ability to integrate evolutionary theory and other disciplines without falling into traditional oppositions. The book provides historical background to DST, recent theoretical findings on the mechanisms of heredity, applications of the DST framework to behavioral development, implications of DST for the philosophy of biology, and critical reactions to DST. (shrink)

The concept of "fitness" is a notion of central importance to evolutionary theory. Yet the interpretation of this concept and its role in explanations of evolutionary phenomena have remained obscure. We provide a propensity interpretation of fitness, which we argue captures the intended reference of this term as it is used by evolutionary theorists. Using the propensity interpretation of fitness, we provide a Hempelian reconstruction of explanations of evolutionary phenomena, and we show why charges of circularity which have been levelled (...) against explanations in evolutionary theory are mistaken. Finally, we provide a definition of natural selection which follows from the propensity interpretation of fitness, and which handles all the types of selection discussed by biologists, thus improving on extant definitions. (shrink)

This paper will suggest a mapping for human dynamics to see where emerging digital technology currently and could further affect the dynamics of the human, technological and natural, and the cultural forms that define them. Emerging technology will be seen to reveal and surpass the limitations of human measures built on human abilities and perception. and the social structures that are derived from them. The formation of this conceptual mapping is based on the premise that digital technology has the ability (...) to better relay and hence refine dynamics working at points where culture is created and necessitated in our perception of a shared reality. Technology thus alleviates the layering, representation, labelling, and reification notions of culture that are based in human perceptual limitations. Information as referential will be seen against the tendency of technology to offer succinct mediation and direct actions as a format for any change and application with refined cultural constructions. The mapping presents a notion of homeostasis or more bereft of balance at the point where the proximal dynamics of the unit, that is, the individual, is closely supported by the technology with a changing orientation to the dynamics of a natural environment. The notion of a person as an individual is also reconsidered in terms of technology and how this changing definition is part of how we conceptualize a balanced world. Nonlinear mapping rendered in a complex will be introduced to align these mixed dynamics. Complex is here defined as a concurrence of dynamics evident in shifts of change that act as a whole and where each action affects the whole. As measures are revealed so, too, will be the source of notions of linearity and nonlinearity; mapping; point of view as a basis of complexity; and evolutionary theory as a function of a labeling of cultural dynamics. (shrink)

Conventional wisdom and commonsense morality tend to take the integrity of persons for granted. But for people in systematically unjust societies, self-respect and human dignity may prove to be impossible dreams.Susan Babbitt explores the implications of this insight, arguing that in the face of systemic injustice, individual and social rationality may require the transformation rather than the realization of deep-seated aims, interests, and values. In particular, under such conditions, she argues, the cultivation and ongoing exercise of moral imagination is (...) necessary to discover and defend a more humane social vision. Impossible Dreams is one of those rare books that fruitfully combines discourses that were previously largely separate: feminist and antiracist political theory, analytic ethics and philosophy of mind, and a wide range of non-philosophical literature on the lives of oppressed peoples around the world. It is both an object lesson in reaching across academic barriers and a demonstration of how the best of feminist philosophy can be in conversation with the best of “mainstream” philosophy—as well as affect the lives of real people. (shrink)

Throughout, the emerging theory of aspect is extensively compared with alternative theories, and the book concludes with general reflections on the semantic ...

In lieu of an abstract, here is a brief excerpt of the content:Hume Studies Volume XXIII, Number 2, November 1997, pp. 195-212 The Moral Self and the Indirect Passions SUSAN M. PURVIANCE David Hume1 and Immanuel Kant are celebrated for their clear-headed rejection of dogmatic metaphysics, Hume for rejecting traditional metaphysical positions on cause and effect, substance, and personal identity, Kant for rejecting all judgments of experience regarding the ultimate ground of objects and their relations, not just judgments of (...) cause and substantiality. Nevertheless, each argues that practical activity is not compromised by the rejection of metaphysical claims that others had taken to be crucial. Kant and Hume thought that political and moral life did not depend upon theoretical knowlege of the nature of the self, free will, or knowledge of the true motives of actions or the character of the agent. Because the grounds of morality and politics were too important to leave to the mercies of speculative metaphysics, each moved their foundations to higher ground, insulating the grounds of practical activity from the threat of metaphysical turmoil and skepticism. Contemporary philosophers have generally followed Hume and Kant in this regard, but often select very different strategies. Some think that the best way to avoid the problems associated with contemporary scientific ontologies is to separate ethics from the factual domain entirely. Some give moral and political language a noncognitivist interpretation, and others have interpreted values as a projection of the passions and affections of the subject or as the constructions of suitably situated practical reasoners.2 At the same time there has been a resurgence of interest in moral realism. Moral realists think that the objectivity of moral discourse, and hence the Susan M. Purviance is at the Department of Philosophy, The University of Toledo, Toledo OH 43606-3390 USA. 196 Susan M. Purviance possibility of moral truth, depend upon the existence of moral facts.3 Moral realists have tended to concentrate on the role of facts in establishing the truth of general moral principles, or the Tightness or moral value of particular individual actions. For moral realists, moral facts are the states of affairs that make general moral principles or particular moral judgments true. Whether these facts are of a naturalistic sort or not, whether they are literally on a par with natural facts, or whether they simply play the same role in practical knowledge that natural facts play in theoretical knowledge, is an open question. Moral realists often are naturalists, like David O. Brink and Jonathan Dancy, but they may be nonnaturalists, like G. E. Moore.4 Ethical naturalism accounts for moral motivation and the cultivation of good character in terms of moral qualities, and many hope to ground it in (or at least show that it is compatible with) the scientific understanding of objects and their relations and qualities. Naturalism is only one option, but realism has received support because it is not clear that antirealists have developed a convincing alternative to the grounding of concepts of moral agency and moral judgment in some sort of moral facts. Questions abound about what it means to ascribe responsibility to a moral self and how we can defend a notion of enduring character. Although moral realists have paid less attention to the ontological status of virtues and character traits than to moral principles, their status is equally important. Here the concern is with the sort of metaphysics of the self thought to be necessary to account for moral agency, responsibility, praise, and blame. I shall argue that there is a class of moral facts that justify or perhaps merely vindicate the ascription of moral powers to agents, and that these are the sorts of facts another sort of theorist is interested in, whereas the states of affairs that make moral judgments true are the sorts of facts that moral realists have been interested in. In order to distinguish this use of moral facts I shall call this sort of theory a Fact of Agency Theory, and it is a version of this theory that can be found in Hume's discussion of the problem of the self and the indirect passions. A realist metaphysics of morals needs to address two questions, the question of the reality of the... (shrink)

In this book, Sara Monoson challenges the longstanding and widely held view that Plato is a virulent opponent of all things democratic. She does not, however, offer in its place the equally mistaken idea that he is somehow a partisan of democracy. Instead, she argues that we should attend more closely to Plato's suggestion that democracy is horrifying and exciting, and she seeks to explain why he found it morally and politically intriguing.Monoson focuses on Plato's engagement with democracy as he (...) knew it: a cluster of cultural practices that reach into private and public life, as well as a set of governing institutions. She proposes that while Plato charts tensions between the claims of democratic legitimacy and philosophical truth, he also exhibits a striking attraction to four practices central to Athenian democratic politics: intense antityrantism, frank speaking, public funeral oratory, and theater-going. By juxtaposing detailed examination of these aspects of Athenian democracy with analysis of the figurative language, dramatic structure, and arguments of the dialogues, she shows that Plato systematically links democratic ideals and activities to philosophic labor. Monoson finds that Plato's political thought exposes intimate connections between Athenian democratic politics and the practice of philosophy.Situating Plato's political thought in the context of the Athenian democratic imaginary, Monoson develops a new, textured way of thinking of the relationship between Plato's thought and the politics of his city. (shrink)

To explain the causal relation between institutional rules and people’s actions and expectations, Searle relies upon his concept of the Background, the thesis that intentional states function only given a background of capacities that do not themselves consist in intentional phenomena. Any sentence, for instance, only acquires truth conditions or other conditions of satisfaction against a background of capacities, dispositions, know-how, etc. that are not themselves part of the content of the sentence. The Background also structures expectations. La Rouchefoucauld said, (...) for instance, that few people would fall in love if they had never read about it. (shrink)

A theory of conceptual development must specify the innate representational primitives, must characterize the ways in which the initial state differs from the adult state, and must characterize the processes through which one is transformed into the other. The Origin of Concepts (henceforth TOOC) defends three theses. With respect to the initial state, the innate stock of primitives is not limited to sensory, perceptual, or sensorimotor representations; rather, there are also innate conceptual representations. With respect to developmental change, conceptual development (...) consists of episodes of qualitative change, resulting in systems of representation that are more powerful than, and sometimes incommensurable with, those from which they are built. With respect to a learning mechanism that achieves conceptual discontinuity, I offer Quinian bootstrapping. TOOC concludes with a discussion of how an understanding of conceptual development constrains a theory of concepts. (shrink)

Organizations are increasingly embedded with consultants and other non-employees who have the opportunity to engage in wrongdoing. However, research exploring the reporting intentions of employees regarding the discovery of wrongdoing by consultants is scant. It is important to examine reporting intentions in this setting given the enhanced presence of consultants in organizations and the fact that wrongdoing by consultants changes a key characteristic of the wrongdoing. Using an experimental approach, the current paper reports the results of a study examining employees' (...) reporting intentions subsequent to their discovery of wrongdoing by a consultant. The results of the study indicate that perceptions about the seriousness of a wrongdoing, personal costs and personal responsibility related to reporting a wrongdoing, and moral-equity judgments are significantly associated with reporting intentions for a normal reporting channel. Only perceptions of seriousness and personal costs are significantly associated for an anonymous reporting channel. Lastly, while personal costs for the anonymous reporting channel were lower than the normal reporting channel, reporting intentions were similar across the two channels. (shrink)

The United States Government does not mandate that US based firms follow US social and environmental law in foreign markets. However, because many developing countries do not have strong human rights, labor, and environmental laws, many multinationals have adopted voluntary corporate responsibility initiatives to self-regulate their overseas social and environmental practices. This article argues that voluntary actions, while important, are insufficient to address the magnitude of problems companies confront as they operate in developing countries where governance is often inadequate. The (...) United States can do more to ensure that its multinationals act responsibly everywhere they operate. First, policymakers should define the social and environmental responsibilities of global companies. They must consistently make their expectations for global business clear – and underscore that this objective can often be accomplished without mandates. Second, the US should closely examine the policies that undermine global Corporate Social Responsibility (CSR) and address the many conflicting signals sent by policymakers. Third, the President should make the US government a CSR model by examining how to use its purchasing power to promote human rights. Finally, the US government should require pension funds to report on the social and environmental consequences of their investments. In these ways, Americans can mind our business – and thus make sure that US based firms do not undermine social and environmental progress when they operate in the developing world. (shrink)

While endorsing Gopnik's proposal that studies of the emergence and modification of scientific theories and studies of cognitive development in children are mutually illuminating, we offer a different picture of the beginning points of cognitive development from Gopnik's picture of "theories all the way down." Human infants are endowed with several distinct core systems of knowledge which are theory-like in some, but not all, important ways. The existence of these core systems of knowledge has implications for the joint research program (...) between philosophers and psychologists that Gopnik advocates and we endorse. A few lessons already gained from this program of research are sketched. (shrink)

The phenomenon of multiple personality--Like the "split-Brain" phenomenon--Involves a disintegration of the normally unified self to the point where one must question whether there is one, Or more than one, Person associated with the body even at a single moment in time. Besides the traditional problem of determining identity over time, There is now a new problem of personal identity--Determining identity at a single moment in time. We need the conceptual apparatus to talk about this new problem and a test, (...) Like the one I propose, For determining the number of persons associated with a body at a single moment in time. (shrink)

The book is an investigation of the semantics of numericals, counting and measuring, and its connection to the mass/count distinction from a theoretical and crosslinguistic perspective. It reviews some recent major linguistic results in these topics, and presents the author's new research including in-depth case studies of a number of typologically unrelated languages.

_A surprising, sweeping, and deeply researched history of empathy—from late-nineteenth-century German aesthetics to mirror neurons_ _Empathy: A History_ tells the fascinating and largely unknown story of the first appearance of “empathy” in 1908 and tracks its shifting meanings over the following century. Despite empathy’s ubiquity today, few realize that it began as a translation of _Einfühlung _or “in-feeling” in German psychological aesthetics that described how spectators projected their own feelings and movements into objects of art and nature. Remarkably, this early (...) conception of empathy transformed into its opposite over the ensuing decades. Social scientists and clinical psychologists refashioned empathy to require the deliberate putting aside of one’s feelings to more accurately understand another’s. By the end of World War II, interpersonal empathy entered the mainstream, appearing in advice columns, popular radio and TV, and later in public forums on civil rights. Even as neuroscientists continue to map the brain correlates of empathy, its many dimensions still elude strict scientific description. This meticulously researched book uncovers empathy’s historical layers, offering a rich portrait of the tension between the reach of one’s own imagination and the realities of others’ experiences. (shrink)

A defendant’s failure to show remorse is one of the most powerful factors in criminal sentencing, including capital sentencing. Yet there is currently no evidence that remorse can be accurately evaluated in a courtroom. Conversely there is evidence that race and other impermissible factors create hurdles to evaluating remorse. There is thus an urgent need for studies about whether and how remorse can be accurately evaluated. Moreover, there is little evidence that remorse is correlated with future law-abiding behavior or other (...) legitimate penal purposes, and, in fact, there is evidence that remorse is often conflated with shame, which is correlated with increased future criminality. More accurate information on the nature and evaluation of remorse can be used to reform the criminal justice system. (shrink)

In reworking a variety of biological concepts, Developmental Systems Theory (DST) has made frequent use of parity of reasoning. We have done this to show, for instance, that factors that have similar sorts of impact on a developing organism tend nevertheless to be invested with quite different causal importance. We have made similar arguments about evolutionary processes. Together, these analyses have allowed DST not only to cut through some age-old muddles about the nature of development, but also to effect a (...) long-delayed reintegration of development into evolutionary theory. Our penchant for causal symmetry, however (or 'causal democracy', as it has recently been termed), has sometimes been misunderstood. This paper shows that causal symmetry is neither a platitude about multiple influences nor a denial of useful distinctions, but a powerful way of exposing hidden assumptions and opening up traditional formulations to fruitful change. (shrink)

Dehaene (this volume) articulates a naturalistic approach to the cognitive foundations of mathematics. Further, he argues that the ‘number line’ (analog magnitude) system of representation is the evolutionary and ontogenetic foundation of numerical concepts. Here I endorse Dehaene’s naturalistic stance and also his characterization of analog magnitude number representations. Although analog magnitude representations are part of the evolutionary foundations of numerical concepts, I argue that they are unlikely to be part of the ontogenetic foundations of the capacity to represent natural (...) number. Rather, the developmental source of explicit integer list representations of number are more likely to be systems such as the object–file representations that articulate mid–level object based attention, systems that build parallel representations of small sets of individuals. (shrink)

Does Spinoza present philosophy as the preserve of an elite, while condemning the uneducated to a false though palliative form of ‘true religion’? Some commentators have thought so, but this contribution aims to show that they are mistaken. The form of religious life that Spinoza recommends creates the political and epistemological conditions for a gradual transition to philosophical understanding, so that true religion and philosophy are in practice inseparable.

The Physician Payments Sunshine Act requires health care product manufacturers to report to the federal government payments more than $10 to physicians. Bringing unprecedented transparency to medicine, PPSA holds great potential for enabling medical stakeholders to manage conflicts of interest and build patient trust—crucial responsibilities of medical professionalism. The authors conducted six focus groups with 42 physicians in Chicago, IL, San Francisco, CA, and Washington, DC, to explore attitudes and experiences around PPSA. Participants valued the concept of transparency but were (...) wary of the law's design and consequences. They downplayed PPSA's potential and felt it undermined public trust. Showing broad unawareness of COI, they dismissed the notion of industry influence and welcomed company “perks.” Misapprehensions may leave physicians unprepared to advance the opportunities PPSA holds for professionalism. The authors offer recommendations for government and medicine to improve physicians' and other stakeholders' understandings and use of the data. (shrink)

This study investigates the effectiveness of pedagogical practices used to teach business ethics. The business community has greatly increased its demands for better ethics education in business programs. Educators have generally agreed that the ethical principles of business people have declined. It is important, then, to examine how common methods of instruction used in business ethics could contribute to the development of higher levels of moral judgment competence for students. To determine the effectiveness of these methods, moral judgment competence levels (...) for undergraduate and graduate students from three institutions were measured and compared based upon the pedagogical method used in a business class. Significant differences were found for moral reasoning and moral competence scores depending on the method used for ethics instruction. Students in classes with more highly integrated ethics coverage scored higher in moral reasoning and moral competence. (shrink)

Public bioethics bodies are used internationally as institutions with the declared aims of facilitating societal debate and providing policy advice in certain areas of scientific inquiry raising questions of values and legitimate science. In the United States, bioethical experts in these institutions use the language of consensus building to justify and define the outcome of the enterprise. However, the implications of public bioethics at science-policy boundaries are underexamined. Political interest in such bodies continues while their influence on societal consensus, public (...) debate, and science policy remains ambiguous. This article presents a theoretical discussion of public bioethics bodies as boundary organizations and examines them in terms of relationship to the moral and cognitive authority of science and other forms of expertise, mechanisms for public participation in controversial science policy, and the deployment of consensus models. The theoretical discussion is examined in the case of the U.S. Human Embryo Research Panel. (shrink)