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)

I argue for a property mereology and for mereological bundle theory. I then apply this theory to the one over many problem (universals) and puzzles concerning persistence and material constitution.

The phenomenon of the New Genetics raises complex social problems, particularly those of privacy. This book offers ethical and legal perspectives on the questions of a right to know and not to know genetic information from the standpoint of individuals, their relatives, employers, insurers and the state. Graeme Laurie provides a unique definition of privacy, including a concept of property rights in the person, and argues for stronger legal protection of privacy in the shadow of developments in human genetics. (...) He challenges the role and the limits of established principles in medical law and ethics, including respect for patient autonomy and confidentiality. This book will interest lawyers, philosophers and doctors concerned both with genetic information and issues of privacy; it will also interest genetic counsellors, researchers, and policy makers worldwide for its practical stance on dilemmas in modern genetic medicine. (shrink)

W. Labov's & T. Labov's findings concerning their child grammar acquisition ("Learning the Syntax of Questions" in Recent Advances in the Psychology of Language, Campbell, R. & Smith, P. Eds, New York: Plenum Press, 1978) are interpreted in terms of different semantics of why & other wh-questions. Z. Dubiel.

First published in 1994. Routledge is an imprint of Taylor & Francis, an informa company.

Figuring prominently in their decisions regarding which theories to pursue are scientists' appeals to the promise or lack of promise of those theories. Yet philosophy of science has had little to say about how one is to assess theory promise. This essay identifies several indices that might be consulted to determine whether or not a theory is promising and worthy of pursuit. Various historical examples of appeals to such indices are introduced.

This article represents an attempt to organize, critique, and extend research findings on gender differences in business ethics. The focus is on two dependent variables—ethical judgment and behavioral intent. Differences in findings between student and professional groups are noted and theoretical implications are discussed. The new research provided for this article contains two benchmark studies undertaken with identical stimuli and identical measures. These studies were followed by two additional studies, using the same measures but different stimuli, as a partial replication (...) and extension of the first two. Findings suggest that little difference exists between the genders on behavioral intent for professional groups and only minimal differences for the ethical judgment measures. Student results, however, produced more substantial differences for behavioral intention. (shrink)

Drawing on diverse historical cases, this paper describes and examines various aspects of a modality of scientific appraisal which has remained largely unexplored, theory pursuit. Specifically, it addresses the following issues: the epistemic and pragmatic commitments involved in theory pursuit, including how these differ from those characteristic of theory acceptance; how the research interests of scientists enter into their pursuit decisions; some of the strategies for the refinement and extension of a theory's empirical abilities which typify theory pursuit; and the (...) need to distinguish between individual and community rationality in contexts of pursuit. (shrink)

The term ‘phenomenology’ has become almost as over-used and emptied of meaning as that other word from Continental Philosophy, namely ‘existentialism’. Yet Husserl, who first put forward the phenomenological method, considered it a rigorous alternative to positivism, and in the hands of Merleau-Ponty, a disciple of Husserl in France, phenomenology became a way of gaining a disciplined and coherent perspective on the world in which we live. When this study originally published in 1977 there were only a few books in (...) English on Merleau-Ponty’s philosophy. It introduced the reader and suggested how his thought might throw light on some of the assumptions and presuppositions of certain contemporary forms of Anglo-Saxon philosophy and social science. It also demonstrates how phenomenology seeks to unite philosophy and social science, rather than define them as mutually exclusive domains of knowledge. (shrink)

To practice medicine and ethics, physicians need wisdom and integrity to integrate scientific knowledge, patient preferences, their own moral commitments, and society's expectations. This work of integration requires a physician to pursue certain goals of care, determine moral priorities, and understand that conscience or integrity require harmony among a person's beliefs, values, reasoning, actions, and identity. But the moral and religious pluralism of contemporary society makes this integration challenging and uncertain. How physicians treat patients will depend on the particular beliefs (...) and values they and other health professionals bring to each instance of shared decision making. This book offers a framework for practical wisdom in medicine that addresses the need for integrity in the life of each health professional. In doing so, it acknowledges the challenge of moral pluralism and the need for moral dialogue and humility as professionals fulfil their obligations to patients, themselves, and society. (shrink)

Across three studies, the authors examine the interactive effects of moral identity and the negative reciprocity norm in predicting revenge. The general argument is that moral identity provides the motivational impetus for individuals’ responses, whereas the normative framework that people adopt as a basis for guiding moral action influences the direction of the response. Results indicated that moral identity and the negative reciprocity norm significantly interacted to predict revenge. More specifically, the symbolization dimension of moral identity interacted with the negative (...) reciprocity norm to predict revenge when individuals were the targets of mistreatment, whereas the internalization dimension of moral identity interacted with the negative reciprocity norm to predict revenge when individuals were the observers of mistreatment. Theoretical implications related to the differences between the symbolization and internalization dimensions of moral identity, the importance of examining normative frameworks, and the functionality of revenge are discussed. (shrink)

This essay engages the work of Italian feminist philosopher Adriana Cavarero and her concept of the narratable self. Her relational humanism, rooted in our exposure to others, offers an ontology of uniqueness whose critique of abstraction, masculinism, and identity politics still resonates today where the meaning of a unique “you” is negotiated in embodied exchanges that may offer care or wounds. Cavarero develops an altruistic ethics that cultivates this humanism. I argue that her work should be extended to better capture (...) the political purchase of the narratable self that interacts dynamically and often ambiguously with the “we” of collective politics. Putting her work into conversation with the nineteenth‐century abolitionist and women's rights advocate Sojourner Truth, I suggest that Cavarero's work illuminates Truth as a philosopher of the narratable self. Moreover, Truth's work extends Cavarero's concerns with exposure that may do violence or offer care by making explicit the challenges of narration in the context of inequality, especially in terms of race and class. Exposure as an ontological and phenomenological condition then needs to take account of a broader publicity of textual, individual, and collective exposure to others to develop the critical, ethical, and political purchase it offers. (shrink)

Gilbert et al. have raised important questions about the empirical grounding of neuroethical analyses of the apparent phenomenon of Deep Brain Stimulation ‘causing’ personality changes. In this paper, we consider how to make neuroethical claims appropriately calibrated to existing evidence, and the role that philosophical neuroethics has to play in this enterprise of ‘evidence-based neuroethics’. In the first half of the paper, we begin by highlighting the challenges we face in investigating changes to PIAAAS following DBS, explaining how different trial (...) designs may be of different degrees of utility, depending on how changes to PIAAAS following DBS are manifested. In particular, we suggest that the trial designs Gilbert et al. call for may not be able to tell us whether or not DBS directly causes changes to personality. However, we suggest that this is not the most significant question about this phenomenon; the most significant question is whether these changes should matter morally, however they are caused. We go on to suggest that neuroethical analyses of novel neuro-interventions should be carried out in accordance with the levels of evidence hierarchy outlined by the Centre for Evidence-Based Medicine, and explain different ways in which neuroethical analyses of changes to PIAAAS can be evidence-based on this framework. In the second half of the paper, we explain how philosophical neuroethics can play an important role in contributing to mechanism-based reasoning about potential effects on PIAAAS following DBS, a form of evidence that is also incorporated into the CEBM levels of evidence hierarchy. (shrink)

Backround Education in ethics and professionalism should reflect the realities medical students encounter in the hospital and clinic. Method We performed content analyses on Case Observation and Assessments (COAs) written by third-year medical students about ethical and professional issues encountered during their internal medicine and paediatrics clinical clerkships. Results A cohort of 141 third-year medical students wrote 272 COAs. Content analyses identified 35 subcategories of ethical and professional issues within 7 major domains: decisions regarding treatment (31.4%), communication (21.4%), professional duties (...) (18.4%), justice (9.8%), student-specific issues (5.4%), quality of care (3.8%), and miscellaneous (9.8%). Conclusions Students encountered a wide variety of ethical and professional issues that can be used to guide pre-clinical and clinical education. Comparison of our findings with results from similar studies suggests that the wording of an assignment (specifying “ethical” issues, “professional” issues, or both) may influence the kinds of issues students identify in their experience-based clinical narratives. (shrink)

This article argues for the importance of conceptual clarity in the debate about the so-called right not to know. This is vital both at the theoretical and the practical level. It is suggested that, unlike many formulations and attempts to give effect to this right, what is at stake is not merely an aspect of personal autonomy and therefore cannot and should not be reduced only to a question of individual choice. Rather, it is argued that the core interests that (...) can be protected by the right not to know are better conceived of as privacy interests rather than autonomy interests. This not only helps us to understand what is in play but also informs regulatory, professional, and legal responses to handling information and taking decisions about whether or not to disclose information to persons about themselves. The practical implications of this conceptualization are explored in the context of feedback policies in health-related research. (shrink)

Discussion of uses of biomedical data often proceeds on the assumption that the data are generated and shared solely or largely within the health sector. However, this assumption must be challenged because increasingly large amounts of health and well-being data are being gathered and deployed in cross-sectoral contexts such as social media and through the internet of things and wearable devices. Cross-sectoral sharing of data thus refers to the generation, use and linkage of biomedical data beyond the health sector. This (...) paper considers the challenges that arise from this phenomenon. If we are to benefit fully, it is important to consider which ethical values are at stake and to reflect on ways to resolve emerging ethical issues across ecosystems where values, laws and cultures might be quite distinct. In considering such issues, this paper applies the deliberative balancing approach of the Ethics Framework for Big Data in Health and Research to the domain of cross-sectoral big data. Please refer to that article for more information on how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. (shrink)

We introduce a new framework for classifying logics on finite structures and studying their expressive power. This framework is based on the concept of almost everywhere equivalence of logics, that is to say, two logics having the same expressive power on a class of asymptotic measure 1. More precisely, if L, L ′ are two logics and μ is an asymptotic measure on finite structures, then $\scr{L}\equiv _{\text{a.e.}}\scr{L}^{\prime}(\mu)$ means that there is a class C of finite structures with μ (C)=1 (...) and such that L and L ′ define the same queries on C. We carry out a systematic investigation of $\equiv _{\text{a.e.}}$ with respect to the uniform measure and analyze the $\equiv _{\text{a.e.}}$ -equivalence classes of several logics that have been studied extensively in finite model theory. Moreover, we explore connections with descriptive complexity theory and examine the status of certain classical results of model theory in the context of this new framework. (shrink)

In this rewarding book, Laurie A. Finke challenges assumptions about gender, the self, and the text which underlie fundamental constructs of contemporary feminist theory. She maintains that some of the key concepts structuring feminist literary criticism need to be reexamined within both their historical context and the larger framework of current theory concerning language, representation, subjectivity, and value.

The right not to know is a contested matter. This can be because the inversion of the normal framing of entitlement to information about one's own health is thought to be illogical and inconsistent with self-authorship and/or because the very idea of claiming a right not to know information is an inappropriate appeal to the discourse of rights that places impossible responsibilities on others. Notwithstanding, there has been a sustained increase in this kind of appeal in recent years fueled in (...) large part by the rise and rise of the importance of personal autonomy in health care ethics, and by domestic and international health law. The right not to know has been acknowledged in at least two important international legal instruments. For example, the UNESCO Universal Declaration on the Human Genome and Human Rights, Article 5c provides: “The right of every individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.”. (shrink)

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research as the field debated the issues of consent, moral status, use (...) of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate. (shrink)

This study investigates the differences in individuals'' ethical decision making between Canadian university business students and accounting professionals. We examine the differences in three measures known to be important in the ethical decision-making process: ethical awareness, ethical orientation, and intention to perform questionable acts. We tested for differences in these three measures in eight different questionable actions among three groups: students starting business studies, those in their final year of university, and professional accountants.The measures of awareness capture the extent to (...) which respondents felt that a particular action was unethical according to each of several ethical criteria. We found few differences between the two student groups on these measures, suggesting that their education had minimal effect on raising their awareness of the ethical issues in the vignettes. Indeed, overall, the graduating student''s scores were marginally lower than those of the entry-level students. However, the professionals viewed some actions as significantly less ethical than did the graduating students. (shrink)

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or (...) limit adolescent participation, jeopardizing study findings’ validity. This paper presents recommendations on when researchers and Institutional Review Boards should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible. (shrink)

Is sex identity a feature of one's mind or body, and is it a relational or intrinsic property? Who is in the best position to know a person's sex, do we each have a true sex, and is a person's sex an alterable characteristic? When a person's sex assignment changes, has the old self disappeared and a new one emerged; or, has only the public presentation of one's self changed? "You've Changed" examines the philosophical questions raised by the phenomenon of (...) sex reassignment, and brings together the essays of scholars known for their work in gender, sexuality, queer, and disability studies, feminist epistemology and science studies, and philosophical accounts of personal identity. An interdisciplinary contribution to the emerging field of transgender studies, it will be of interest to students and scholars in a number of disciplines. (shrink)

Laurie Shrage attributes much of the long-standing controversy about abortion to Roe v. Wade and to the Supreme Court's controversial regulatory scheme in that 1973 decision. Shrage explores the origins of that scheme but argues for an alternate scheme - therapeutic abortions shorter than six months can protect women's interests and advance important public interests, but that reproductive rights campaigns should also focus on the social and economic conditions that prevent women having access to the abortion services they need. (...) Including over 40 illustrations of pro-life and pro-choice advertisements to demonstrate the nature of the debate, this timely and provocative work will appeal to feminists in a wide range of fields including philosophy, political science, women's studies, communication, and public policy. (shrink)

The concept of a generalized quantifier of a given similarity type was defined in [12]. Our main result says that on finite structures different similarity types give rise to different classes of generalized quantifiers. More exactly, for every similarity type t there is a generalized quantifier of type t which is not definable in the extension of first order logic by all generalized quantifiers of type smaller than t. This was proved for unary similarity types by Per Lindström [17] with (...) a counting argument. We extend his method to arbitrary similarity types. (shrink)

Ancient Greek philosophers, medieval theologians, Enlightenment thinkers, and contemporary humanists alike have debated all aspects of human sexuality, including its purpose, permissibility, normalcy, and risks. _Philosophizing About Sex_ provides a philosophical guide to those longstanding and important debates. Each chapter takes a general issue and shows how ongoing public discussions of sexuality can be illuminated by careful philosophical investigation. Debates over topics such as sexual assault, sexual orientation, sex education, prostitution, and “sexting” involve larger questions about morality, law, science, and (...) politics and cannot be intelligently discussed in isolation from broader issues. By asking deceptively simple questions, this book shows how difficult but important it is to arrive at satisfying answers. (shrink)

Decision-making in health care is often challenging and therefore requires practical wisdom. The domains of such wisdom involve goals, perception, ethics, deliberation, and motivation. For Christian patients, there is a need for practical wisdom founded on Christian commitments that shape and guide these domains according to a Christian understanding of life, health, technology, illness, suffering, and death. In this essay, I outline a Christian approach to practical wisdom in health care by infusing Christian beliefs and values into a general framework (...) for practical wisdom in medicine I have described previously. I organize this approach by referring to Christian purpose, vision, ethics, piety, and practice. The result is a framework that intends to integrate faith and reason so that what we believe as Christians forms how we think about health and guides what we choose or decline when considering the possibilities that come before us in health care. (shrink)