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)

Through the personal stories of managers running global business, this book takes an inside look into the dilemmas of managers who are asked to make profits ethically according to the dictates of their company's ethics code. It examines what companies `think" they are doing to help managers in those situations and how those managers are actually affected. Thanks to the boost from the 1991 Sentencing Guidelines which minimizes penalties for companies with ethics codes caught in ethical wrongdoing, more than 85% (...) of US companies and two thirds of all Canadian companies and half of all European companies now have Codes of Ethics. Yet, over and over, we hear of stories of personal dilemmas and conflicts experienced by individual managers navigating those business waters in other cultures. "Eileen Morgan does an excellent job of mapping the course for navigating the previously uncharted global ethical waters. By identifying best practices, she leads the reader on a journey from Surviving, to Understanding to Knowing the ethical issues that frequently confront international business people. This is a must read for anyone who wants to successfully compete in world markets." -Michael J. Litwin, Executive Vice President, Chief Credit Officer, Heller Financial, Inc. "Eileen Morgan has combined the pragmatic concerns of the individual manager with the moral concerns that come from personal-life history, cultural roots, and corporate ethical culture …This book focuses on the constructive task of formulating and using an "ethical map," and is sure to be a tonic to conscientious managers who want to navigate cross-cultural commerce with integrity. It has done a superb job of creating order out of the complexity of cross-cultural moral experience by insisting that the complexity must be honored and appropriated rather than ignored or suppressed." -Dr. Richard Beauchamp, Professor of Ethics, Christopher Newport University "In this groundbreaking book, Eileen Morgan has provided scores of real-life examples and developed a framework for approaching ethical leadership in international business. This is mandatory reading for anyone involved in global management today...This is an important book on an important subject." -Stephen H. Rhinesmith, Ph.D. Author, A Manager's Guide to Globalization "Eileen Morgan provides us with a much needed roadmap for how to walk the path of ethical leadership with practical feet. She reminds us that ethical decision-making is a critical aspect of every day leadership, and that we can all choose to be 'ethical pioneers' in our companies and our communities. Every leader engaged in global business can benefit from the lessons and stories included in this book." -Christi A. Olson, Ph.D. Chair, Telecommunications Management Department, Golden Gate University "Eileen Morgan's thoughtful analysis of 'ethical capital' should be read by anyone who does business in a global environment…Morgan's book presents the issue clearly, comprehensively and compellingly, demonstrating that ethics is an indispensable aspect of individual leadership and organizational credibility. …It provides a clear roadmap for business leaders who need to communicate their commitment to integrity and accountability to their employees, their partners, and their customer, making their 'ethical capital' one of their most valuable assets." -Nell Minnow, Principal, Lens, The Corporate Governance Investors "Eileen Morgan gives excellent insight into ethical practices. She focuses on business but her insights have general application. This book also describes differences in ethical interpretation that can arise between diverse cultures. Ms. Morgan has made an excellent contribution to understanding the benefit of positive ethical practices." -David C. Lincoln, Sponsor, Lincoln Center for Applied Ethics, College of Business, Arizona State University President, Arizona Oxides, LLC · First in-depth look at how managers in global companies actually bridge the gap between their organizations and their daily decisions · Explains the need for internal and external ethical operations¦and how organizations often create confusion rather than clarity with the label of "ethics". (shrink)

IntroductionEngaging undergraduates in the research process is one of the most rewarding aspects of being a professor because it more deeply connects us to our work and helps shape the professional futures of students by immersing them in the culture of research (including peer-to-peer mentoring and authoring publications; Russell, Hancock, & McCullough, 2007). But there is a real trick to working with undergraduates in a way that both shapes students’ futures and produces high-quality, publishable research because mentors must invest a (...) great deal of time developing undergraduates’ technical and writing abilities, and this effort is time not spent on the research itself. In this article, we describe a powerful, flexible approach that makes the production of publishable research possible. For context, we teach and conduct research at a small liberal arts college with a population of just over 2000 undergraduates. Research at primarily undergraduate institutions (PUIs) does not benefit a system of graduate students, post-docs, and paid research staff, so we have found it necessary to developed a structured, team-based approach to faculty-student research that provides excellent mentorship and produces publishable research (see Detweiler-Bedell & Detweiler-Bedell, 2013). Importantly, this team-based model can be put into practice with a broad array of students, including underrepresented and first-generation students. What we have learned in adopting this approach reflects... (shrink)

Research on self-other framing suggests that self-judgements typically neglect information about others and instead use an ambiguous intrapersonal standard, making these judgements susceptible to the influence of mood as predicted by the affect infusion model (Forgas, 1995). Two experiments tested the hypothesis that mood-congruent judgements of personal success occur when these judgements are framed to maintain self-focus but are eliminated when participants first focus on other individuals. In Experiment 1, self-other framing moderated the influence of mood on perceived success for (...) an ambiguous object identification task. Happy participants reported greater perceived success, compared to sad participants, after judging their own success relative to others (self-focused frame) but not after directly judging the success of others (other-focused frame). Experiment 2 replicated these results with students' perceptions of their academic success. These findings suggest that the open, constructive processing accompanying most self-judgements is critical in producing mood-congruent perceptions of personal success. (shrink)

Kit Fine and Gideon Rosen propose to define constitutive essence in terms of ground-theoretic notions and some form of consequential essence. But we think that the Fine–Rosen proposal is a mistake. On the Fine–Rosen proposal, constitutive essence ends up including properties that, on the central notion of essence, are necessary but not essential. This is because consequential essence is closed under logical consequence, and the ability of logical consequence to add properties to an object’s consequential essence outstrips the ability of (...) ground-theoretic notions, as used in the Fine–Rosen proposal, to take those properties out. The necessary-but-not-essential properties that, on the Fine–Rosen proposal, end up in constitutive essence include the sorts of necessary-but-not-essential properties that, others have noted, end up in consequential essence. (shrink)

The application of constructivism to “nature” and “wilderness” is intellectually and politically objectionable. Despite a proclivity for examining the social underpinnings of representations, constructivists do not deconstruct their own rhetoric and assumptions; nor do they consider what socio-historical conditions support their perspective. Constructivists employ skewed metaphors to describe knowledge production about nature as though the loaded language use of constructivism is straightforward and neutral. They also implicitly rely on a humanist perspective about knowledge creation that privileges the cognitive sovereignty of (...) human subject over nature. Politically, the constructivist approach fails to take the scientific documentation of the biodiversity crisis seriously; it diverts attention toward discourses about the environmental predicament, rather than examining that predicament itself; and it indirectly cashes in on, and thus supports, human colonization of the Earth. (shrink)

Conspiracy theories have become a ubiquitous feature of contemporary culture. From a communication studies perspective, conspiracy theories undermine democratic communication by misleading the publ...

Hartry Field’s epistemological challenge to the mathematical platonist is often cast as an improvement on Paul Benacerraf’s original epistemological challenge. I disagree. While Field’s challenge is more difficult for the platonist to address than Benacerraf’s, I argue that this is because Field’s version is a special case of what I call the ‘sociological challenge’. The sociological challenge applies equally to platonists and fictionalists, and addressing it requires a serious examination of mathematical practice. I argue that the non-sociological part of Field’s (...) challenge amounts to a minor reformulation of Benacerraf’s original challenge. So, I contend, Field’s challenge is not an improvement on Benacerraf’s. What is new to Field’s challenge is as much a problem for the fictionalist as it is for the platonist. (shrink)

Essays link Gaian science to such global environmental quandaries as climate change and biodiversity destruction, providing perspectives from science, ...

Public, private, non-profit and for-profit nursing education enterprises in the U.S. are competing with one another in a newly complex and volatile educational landscape, placing academic leaders into situations fraught with moral, ethical and legal compromise with few precedents for guidance. This case study provides a richly contextualized narrative exploration of ethical and legal challenges to one leader’s moral courage, a fictionalized exploration drawn from multiple sources over time, to form a composite that is nonetheless firmly rooted in the complexity (...) and competitiveness characteristic of nursing education today. Our purpose is three-fold: 1) to direct the reader to moral and ethical questions that require thoughtful discourse and analysis among current and future academic nursing leaders; 2) to raise the issue of the need for regulations and oversight that reflect the changing realities of today’s increasingly complex and competitive educational arena; and 3) to encourage nursing education leaders to share additional cases that resonate for them, and in so doing, to expand the wellspring of ideas from which we can all draw in becoming more effective and morally courageous leaders. (shrink)

This book attempts to reframe abortion rights by focusing not on a woman's right to choose abortion, but rather on a woman's right to consent to pregnancy. Drawing on legal, medical, and philosophical definitions of pregnancy, it disaggregates the consent to sexual intercourse from the consent to pregnancy and argues that men and women have equal right to bodily integrity, which is defined as the freedom from nonconsensual bodily intrusion. The work provides the grounds for a woman's right to an (...) abortion and state funding of abortions. (shrink)

Volume 33, Issue 1, February 2023, Page 1-14.

How can women’s rights be seen as a universal value rather than a Western value imposed upon the rest of the world? Addressing this question, Eileen Hunt Botting offers the first comparative study of writings by Mary Wollstonecraft and John Stuart Mill. Although Wollstonecraft and Mill were the primary philosophical architects of the view that women’s rights are human rights, Botting shows how non-Western thinkers have revised and internationalized their original theories since the nineteenth century. Botting explains why this (...) revised and internationalized theory of women’s human rights—grown out of Wollstonecraft and Mill but stripped of their Eurocentric biases—is an important contribution to thinking about human rights in truly universal terms. (shrink)

It is encouraging to note the renewed interest in the study of Hegel, not only in Europe, but also in the United States. For too long has Hegel been known only through his adversaries, so much so that a “Hegel Myth” has grown up with little regard for either historical accuracy or fair judgment. Recent indications are that this myth is being dissipated by the work of serious scholars, and a more authentic knowledge of Hegel’s position is becoming possible. No (...) one that I know of desires to reestablish the complete Hegelian system, but many scholars and philosophers hope to find new insight from the study of undistorted Hegelian thought. (shrink)

Soren Kierkegaard and William Faulkner are, to my mind, the most seminal religious thinker and the most brilliant novelist of our time. For a good many years I admired their works from a distance. Then in 1966 or so, my good friend and teacher William H. Poteat of Duke University suggested that I get to know them better by doing an essay on them. This book is the result, though I by no means want to hold Professor Poteat responsible for (...) anything but merit of this venture, if, indeed, it has any. (shrink)

Conversations in Metaphysics: Ever Ancient, Ever New introduces students to metaphysics through a set of contemporary readings based on classical metaphysical texts, thinkers, and concepts. It challenges readers to consider and seek possible answers to questions of metaphysics relative to human knowledge and the nature of reality. Organized historically, the readings endeavor to define and probe the concepts of metaphysics, existence, being, God, evil, and morality from antiquity to the present. The historical lens provides students with deeper context for the (...) contemporary readings and helps them establish a basic knowledge of metaphysics and its place within philosophical tradition. In later readings, students are invited to explore how metaphysics relates to religion, science, and technology in the modern world, as well as how metaphysics has shaped and continues to shape the reality of our universe. Rich with engaging material and endless opportunities for critical thought, Conversations in Metaphysics is an ideal ancillary text for courses in philosophy that call attention to metaphysics and philosophy of religion. (shrink)

In “Mathematical Truth,” Paul Benacerraf raises an epistemic challenge for mathematical platonists. In this paper, I examine the assumptions that motivate Benacerraf’s original challenge, and use them to construct a new causal challenge for the epistemology of mathematics. This new challenge, which I call ‘Gödel’s Gap’, appeals to intuitive insights into mathematical knowledge. Though it is a causal challenge, it does not rely on any obviously objectionable constraints on knowledge. As a result, it is more compelling than the original challenge. (...) It is also more general; the challenge applies equally to platonistic and non-platonistic accounts of mathematical truth. And it can be generalized beyond the case of mathematical knowledge to pose a challenge for, e.g., moral knowledge. (shrink)

Over the course of the past twenty-five years, feminist theory has had a forceful impact upon the history of Western philosophy. The present collection of essays has as its primary aim to evaluate past women’s published philosophical work, and to introduce readers to newly recovered female figures; the collection will also make contributions to the history of the philosophy of gender, and to the history of feminist social and political philosophy, insofar as the collection will discuss women’s views on these (...) issues. The volume contains contributions by an international group of leading historians of philosophy and political thought, whose scholarship represents some of the very best work being done in North and Central America, Canada, Europe and Australia. (shrink)

This article explores the epistemological and strategic issues facing feminists embarking upon narrative explorations into women's experiences. It considers the implications for feminist epistemology of acknowledging women's participation in dominant ideologies about their social role. Focusing upon questions of women's agency, it asks how this `conforming knowledge' might complicate postmodernist feminist notions of resisting and reconstructing law's categorisation of `Woman'. It also represents an attempt to clarify, in advance of my own analysis of women's agency in abortion decision-making, why postmodern (...) feminists might talk to women – the `subjects' of law's constructive power. It seeks additionally to open a discussion among a wider audience of feminists about what we might do with the information uncovered through listening to women's own stories in an area pronounced upon authoritatively by a multitude of discourses. (shrink)

Bryan Ronald Wilson, a Fellow of the British Academy, was a world-renowned sociologist of religion. He was awarded a D.Litt. by the University of Oxford in 1994, the same year that he was elected a Fellow of the British Academy. Wilson was also awarded an Arnold Gerstenberg studentship, which allowed him to take up a place at the London School of Economics, where Maurice Ginsberg introduced him to the literature of the sociology of religion and where he developed a life-long (...) interest in sectarian movements. He returned to Yorkshire to take up an Assistant Lectureship in Sociology in the Department of Social Studies at the University of Leeds in October 1955, being promoted to Lecturer in 1957. There Wilson taught courses on urban sociology, sociological theory, and the social institutions of modern Britain, as well as on the sociology of religion. He was a Fellow of All Souls College for thirty years. The themes of secularisation, rationalism, and sectarianism were of particular interest to Wilson throughout his academic life. (shrink)

Creationism and evolutionism are taken to typify a fundamental opposition among the diverse beliefs about creation to be found in the United Kingdom and the United States. A comparison between the two types and the two countries suggests that people may be more concerned about the credibility and consequences of belief in an alternative account of our origins than about the actual method by which we were created. Examples of concern include interpretations of the Bible, ethical implications, and the epistemological (...) standings of revelation and/or science that are thought to follow from acceptance of a particular belief concerning how we got here. (shrink)