This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes (...) oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight. (shrink)

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to (...) guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview. (shrink)

The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration , Environmental Protection Agency , Department of Agriculture , Occupational Safety and Health Administration , and National Institutes of Health . All can learn from assessment of the successes and failures of past oversight efforts aimed at (...) emerging technologies. This article reports on work funded by the National Science Foundation aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight. (shrink)

Examines political philosophies of the classic theorists as a means to understand international dilemmas in the post-Cold War world.

The companion piece to this article, “Situating Moral Justification,” challenges the idea that moral epistemology's mission is to establish a single, all‐purpose reasoning strategy for moral justification because no reasoning practice can be expected to deliver authoritative moral conclusions in all social contexts. The present article argues that rethinking the mission of moral epistemology requires rethinking its method as well. Philosophers cannot learn which reasoning practices are suitable to use in particular contexts exclusively by exploring logical relations among concepts. Instead, (...) in order to understand which reasoning practices are capable of justifying moral claims in different types of contexts, we need to study empirically the relationships between reasoning practices and the contexts in which they are used. The article proposes that philosophers investigate case studies of real‐world moral disputes in which people lack shared cultural assumptions and/or are unequal in social power. It motivates and explains the proposed case study method and illustrates the philosophical value of this method through a case study. (shrink)

The question of when or if a nation should intervene in another country’s affairs is one of the most important concerns in today’s volatile world. Taking John Stuart Mill’s famous 1859 essay “A Few Words on Non-Intervention” as his starting point, international relations scholar Michael W. Doyle addresses the thorny issue of when a state’s sovereignty should be respected and when it should be overridden or disregarded by other states in the name of humanitarian protection, national self-determination, or national (...) security. In this time of complex social and political interplay and increasingly sophisticated and deadly weaponry, Doyle reinvigorates Mill’s principles for a new era while assessing the new United Nations doctrine of responsibility to protect. In the twenty-first century, intervention can take many forms: military and economic, unilateral and multilateral. Doyle’s thought-provoking argument examines essential moral and legal questions underlying significant American foreign policy dilemmas of recent years, including Libya, Iraq, and Afghanistan. (shrink)

This is the first of two companion articles drawn from a larger project, provisionally entitled Undisciplining Moral Epistemology. The overall goal is to understand how moral claims may be rationally justified in a world characterized by cultural diversity and social inequality. To show why a new approach to moral justification is needed, it is argued that several currently influential philosophical accounts of moral justification lend themselves to rationalizing the moral claims of those with more social power. The present article explains (...) how discourse ethics is flawed just in this way. The article begins by identifying several conditions of adequacy for assessing reasoning practices designed to achieve moral justification and shows that, when used in contexts of cultural diversity and social inequality, discourse ethics fails these conditions. It goes on to argue that the failure of discourse ethics is rooted in its reliance on a broader conception of moral epistemology that is invidiously idealized. It concludes by pointing to the need to rethink both the mission and the method of moral epistemology. (shrink)

We leverage the notion that abstraction enables prediction to generate novel insights and hypotheses for the literatures on attitudes and mate preferences. We suggest that ideas about liking are more abstract than experiences of liking, and that ideas about liking may facilitate mental travel beyond the here-and-now.

En las tres últimas décadas del siglo XX, muchos filósofos analíticos han abordado cuestiones de ética práctica, ampliando radicalmente el campo de la filosofía moral más allá de los temas metaéticos que habían sido su foco principal durante la mayor parte del siglo. Sin embargo, abordar este tipo de controversias prácticas rápidamente hizo surgir la cuestión de cómo justificar las afirmaciones morales normativas. Muchos filósofos analíticos se basaron en el intuicionismo, que tiene un linaje muy antiguo dentro de la filosofía (...) moral anglófona. Este artículo evalúa tres formas en las que los filósofos analíticos del siglo XX recurrieron a las intuiciones para apoyar o rebatir las afirmaciones morales. Argumentamos que esos métodos fracasaron en su objetivo de promover un conocimiento moral digno de confianza porque se basaron en supuestos que, cuando se presumen en contextos de injusticia epistémica estructural, son sistemáticamente engañosos. A pesar de que las intuiciones se encuentran entre las fuentes de conocimiento en las que los agentes morales deben confiar, la epistemología moral debe prestar especial atención a los procesos sociales a través de los cuales se recogen, refinan y evalúan las intuiciones y otras formas de evidencia. Producir un conocimiento moral digno de confianza requiere procesos de razonamiento democráticos que sean sensibles a la omnipresencia de la injusticia epistémica y la dominación, así como desarrollar estrategias para contrarrestarlas. (shrink)

Ethical dilemmas involving tax issues were identified by members of the American Institute of Certified Public Accountants as posing the most difficult ethical problem for them (Finn et al., Journal of Business Ethics 7(8), pp. 607–609, 1988). The KPMG tax shelter fraud case proves that the tax profession has not gone untainted in the age of numerous accounting and corporate scandals, such as the Enron débâcle (Sikka and Hampton, Accounting Forum 29(3), 325–343, 2005). High-profile scandals serve to highlight the problems (...) caused by differences in ethical judgement among accountants and tax practitioners and the issue of ethics has been brought publicly to the forefront of the profession. Nevertheless, the nature and dimension of ethical issues in tax practice have been largely unexplored (Erard, Journal of Public Economics 52(2), 163–197, 1993; Marshall et al., Journal of Business Ethics 17(12), 1265–1279, 1998; Frecknall Hughes, Unpublished PhD Thesis, The University of Leeds, 2002). This research aims to contribute to the debate on ethics in tax practice by reporting interview data on tax practitioners’ perceptions of ethics in the jurisdictions of Ireland and the United Kingdom and exploring the link or equation of ethics with risk management. (shrink)

We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose (...) unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established. **NB we did not reccommend a NAC, we think it might be appropriate**. (shrink)

This paper focuses on the boundaries of political sovereignty, one key aspect of global political justice and an important background condition to the issues of global economic justice treated in the other papers of this volume. I first present an interpretive summary of the traditional arguments against and for intervention, stressing, to a greater extent than is usual, the consequentialist character of the ethics of intervention. It makes a difference whether we think that an intervention will do more good than (...) harm, and some of the factors that determine the outcome are matters of strategy and institutional choice. I then explore the significance of a key factor that makes for much of what is new in the new interventionism: the role of multilateral and particularly U.N. authorization and implementation. I argue that the more salient role of the United Nations should lead us to a more expansive tolerance of international intervention and that global standards of justice, both political and economic, can therefore be more widely enforced against claims to national autonomy. (shrink)

Comparing Mill's "Non-Intervention" and Walzer's "Just and Unjust Wars" links two classic statements on just wars of intervention. Doyle concludes that interventionist arguments should go beyond the three paradigmatic cases Walzer explores in "Just and Unjust Wars.".

In a widely cited and controversial speech, UN Secretary-General Kofi Annan highlighted the moral character of the boundaries of political sovereignty when he questioned whether respecting national sovereignty everywhere and always precluded the international protection of human rights. He argued that it did not and highlighted the importance of multilateral authorization. In this article, I explore the difference that multilateral authority, as opposed to unilateral national decision, should make in justifying armed intervention. Should the more salient role of the United (...) Nations lead us to a more expansive tolerance of international intervention? And, if multilateralism does make a difference—and many think its impartiality is key—are good intentions enough? Had the international community also discovered how to intervene more effectively, with a better prospect of self-sustaining self-determination, at an acceptable humanitarian cost? I will conclude that multilateralism should widen our acceptance of intervention, even though the intentions at play are not reliably superior to unilateral intentions. (shrink)

Although many studies have found a positive relationship between corporate social performance and employer attractiveness, few have examined how different forms of responsibility might mediate that attraction, particularly when those social practices afford different degrees of employee participation. The current study undertook this line of inquiry by examining prospective employees’ attraction to three common approaches to corporate social performance (CSP) that offer increasing levels of participation: donation, volunteerism, and operational integration. Unexpectedly, findings from an empirical investigation challenged the study's main (...) hypothesis; that is, prospective employees were least attracted to firms that integrated their social and financial goals. Consequently, important implications and questions remain for both employers and business educators. (shrink)

This book applies Augustine's thought to current questions of teaching and learning. The essays are written in an accessible style and is not intended just for experts on Augustine or church history.

Functional diversity holds the promise of understanding ecosystems in ways unattainable by taxonomic diversity studies. Underlying this promise is the intuition that investigating the diversity of what organisms actually do—i.e. their functional traits—within ecosystems will generate more reliable insights into the ways these ecosystems behave, compared to considering only species diversity. But this promise also rests on several conceptual and methodological—i.e. epistemic—assumptions that cut across various theories and domains of ecology. These assumptions should be clearly addressed, notably for the sake (...) of an effective comparison and integration across domains, and for assessing whether or not to use functional diversity approaches for developing ecological management strategies. The objective of this contribution is to identify and critically analyze the most salient of these assumptions. To this aim, we provide an “epistemic roadmap” that pinpoints these assumptions along a set of historical, conceptual, empirical, theoretical, and normative dimensions. (shrink)

If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.

We live in an era where our health is linked to that of others across the globe, and nothing brings this home better than the specter of a pandemic. This paper explores the findings of town hall meetings associated with the Canadian Program of Research on Ethics in a Pandemic , in which focus groups met to discuss issues related to the global governance of an influenza pandemic. Two competing discourses were found to be at work: the first was based (...) upon an economic rationality and the second upon a humanitarian rationality. The implications for public support and the long-term sustainability of new global norms, networks, and regulations in global public health are discussed. (shrink)

Balancing Change and Tradition in Global Education Reform is an invaluable resource for policymakers, faculty, students, and anyone interested in how decisions made about the education system ultimately affect the quality of education, educational access, and social justice.

The target article by Cohen Kadosh & Walsh (CK&W) raises questions as to the precise nature of the notion of abstractness that is intended. We note that there are various uses of the term, and also more generally in mathematics, and suggest that abstractness is not an all-or-nothing property as the authors suggest. An alternative possibility raised by the analysis of numerical representation into automatic and intentional codes is suggested.

The massive disparity between the relative wealth of most citizens in affluent countries and the profound poverty of billions of people struggling elsewhere for survival is morally jolting. But why exactly is this disparity so outrageous and how should the citizens of affluent countries respond? Political philosopher, Thomas Pogge, has emerged as one of the world’s most ardent critics of global injustice which, he argues, is caused directly by the operation of a global institutional order that not only systematically disadvantages (...) poor countries but is imposed on them by precisely those wealthy, powerful countries that benefit the most from the order’s injustice. In allowing their governments to perpetrate this injustice, Pogge contends that citizens of the wealthy countries collude in a monumental crime against humanity. In this book Pogge’s challenging and controversial ideas are debated by leading political philosophers from a range of philosophical viewpoints. With a clear and informative introduction by Alison Jaggar, and original contributions from Neera Chandhoke, Jiwei Ci, Joshua Cohen, Erin Kelly, Lionel McPherson, Charles W. Mills, Kok-Chor Tan, and Leif Wenar, this volume deepens and expands the debate over global justice and moral responsibility in the world today. (shrink)

My project is to explain why the question ‘How does it feel to be a white problem?’ cannot be answered in the fluttering grammar of white talk. The whiteness of white talk lies not only in its having emerged from white mouths, but also in its evasiveness—in its attempt to suppress fear and anxiety, and its consequential [if unintended] reinscription and legitimation of racist oppression. I White talk is designed, indeed scripted, for the purposes of evading, rejecting, and remaining ignorant (...) about the injustices that flow from whiteness and its attendant privileges. I want to suggest a new point of entry—a way to flip the script, so to speak. -/- I begin with some observations about the basic advantages and disadvantages of using white talk as a route into the white problem. My account develops an expanded version of Alice MacIntyre’s definition of white talk that is attentive to the racialized bodily scripts that accompany white talk. I argue that white talk persists because it has an enduring and powerful moral, ontological, and epistemic pay off for white folks. I explore each payoff with an eye towards clarifying how white talk functions to maintain the illusion that we are invulnerable beings. Next, I pause to reply to the popular objection that this particular critique of white talk silences white people in conversations on race. If we cannot address the question ‘how does it feel to be a white problem’ in the fluttering grammar of white talk, then how shall we begin? In closing, I suggest that we might reduce fluttering by replacing white talk with a discourse of vulnerability, where vulnerability is defined not as weakness, but as a condition for potential. I offer some brief guidelines for how we might start this conversation. (shrink)