Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of (...) the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process. (shrink)

Tocqueville pessimistically predicted that liberty and equality would be incompatible ideas. Robert Dahl, author of the classic _A Preface to Democratic Theory,_ explores this alleged conflict, particularly in modern American society where differences in ownership and control of corporate enterprises create inequalities in resources among Americans that in turn generate inequality among them as citizens. Arguing that Americans have misconceived the relation between democracy, private property, and the economic order, the author contends that we can achieve a society of (...) real democracy and political equality without sacrificing liberty by extending democratic principles into the economic order. Although enterprise control by workers violates many conventional political and ideological assumptions of corporate capitalism as well as of state socialism. Dahl presents an empirically informed and philosophically acute defense of "workplace democracy." He argues, in the light of experiences here and abroad, that an economic system of worker-owned and worker-controlled enterprises could provide a much better foundation for democracy, political equality, and liberty than does our present system of corporate capitalism. (shrink)

Written by the preeminent democratic theorist of our time, this book explains the nature, value, and mechanics of democracy. In a new introduction to this Veritas edition, Ian Shapiro considers how Dahl would respond to the ongoing challenges democracy faces in the modern world. “Within the liberal democratic camp there is considerable controversy about exactly how to define democracy. Probably the most influential voice among contemporary political scientists in this debate has been that of Robert Dahl.”—Marc Plattner, _New (...) York Times_ “An excellent introduction for novices, as well as a trusty handbook for experts and political science mavens.”—_Publishers Weekly_. (shrink)

Rich with historical and cultural value, these works are published unaltered from the original University of Minnesota Press editions.

One staple of living in our information society is having access to the web. Web-connected devices interpret our queries and retrieve information from the web in response. Today’s web devices even purport to answer our queries directly without requiring us to comb through search results in order to find the information we want. How do we know whether a web device is trustworthy? One way to know is to learn why the device is trustworthy by inspecting its inner workings, 156–170 (...) 1995; Humphreys 2004, Episteme, 6, 221–229 2009). But ordinary users of web devices cannot inspect their inner workings because of their scale, complexity, and the corporate secrecy which enshrouds both the procedures by which the devices operate and the companies that make them. Further piling on this predicament, authors have criticized web technology on the grounds that the invisibility of the web devices’ inner workings prevents users from critically assessing the procedures that produce a given output, in some cases, barring users from fulfilling their epistemic responsibilities, 343–355 2010; Miller and Record Episteme, 10, 117–134 2013). I consider four broad kinds of reasons which we can acquire without inspecting the inner workings of black-boxed technology: individual understanding, expert testimony, testing through experience, and social vetting; and show how each is a viable method of appraising black-boxed technology. By deploying these methods, we can remain responsible inquirers while nonetheless benefitting from today’s epistemic resources on the web. (shrink)

In its recent statement 'Sex Selection and Preimplantation Genetic Diagnosis', the Ethics Committee of the American Society of Reproductive Medicine concluded that preimplantation genetic diagnosis for sex selection for non-medical reasons should be discouraged because it poses a risk of unwarranted gender bias, social harm, and results in the diversion of medical resources from genuine medical need. We critically examine the arguments presented against sex selection using preimplantation genetic diagnosis. We argue that sex selection should be available, at least within (...) privately funded health care. (shrink)

If rationalization were ubiquitous, it would undermine a fundamental premise of human discourse. A review of key evidence indicates that rationalization is rare and confined to choices among comparable options. In contrast, reasoning is pervasive in human decision making. Within the constraints of reasoning, rationalization may operate in ambiguous situations. Studying these processes requires careful definitions and operationalizations.

In a recent comment on the HFEA’s public consultation on sex selection, Soren Holm claimed that proponents of family balancing are committed to embrace a laissez faire approach. Given that arguments in support of sex selection for family balancing also support sex selection for other social reasons, advocates of family balancing, he asserts, are simply inconsistent when calling for a limit on access to sex selection. In this paper, I argue that proponents of family balancing are in no way inconsistent. (...) Provided their advocacy of family balancing is aimed at preventing a severe distortion of the natural sex ratio, they are entirely justified in insisting on restrictions to sex selection. The real question is whether a concern for the sex ratio does indeed call for a limit on sex selection. Based on a recent survey on gender preferences and data from several Gender Clinics, I argue that a restriction on sex selection to family balancing is unwarranted. In the absence of any evidence for a pending sex ratio distortion, we are actually required to adopt a laissez faire approach to sex selection. (shrink)

Although there may be many questions about the meaning of life that will ultimately prove intractable, I think that there are some questions that can be answered. Furthermore, I think that progress towards answering them can be made through work that has and will be done in moral philosophy. In support of this I shall articulate a set of questions that I think are often at issue when people ask about the meaningfulness of life. These questions give rise to a (...) set of conditions that a fully adequate answer must satisfy. Among other things, these conditions explain why a familiar theological answer to the meaningfulness of life seems so attractive. However, they also create problems for this answer, as well as for an answer that has appeared attractive to a number of contemporary philosophers, that the meaning of life is created by the choices that people make and the desires that they have. I shall suggest that work in moral philosophy may provide an answer that falls between these two camps – that a moral life is a meaningful life. I shall sketch a theory of morality that satisfies the conditions that have been set out. H this sketch can be filled out, then a moral life will be at least part of what can make a life meaningful. Whether this account of the moral life leaves out anything important for the meaningfulness of life will be the subject of some concluding remarks. (shrink)

In this paper, political advertisements in Norway are characterized as an argumentative activity type, following the pragma-dialectal theory of argumentation. Drawing on insights from political theory, marketing theory, Norwegian media regulations and empirical research into Norwegian political communication the conventions of the activity type are discussed. It is also explained how these conventions influence the arguer’s strategic maneuvering.

Former NAACP chapter head Rachel Dolezal's attempted transition from the white to the black race occasioned heated controversy. Her story gained notoriety at the same time that Caitlyn Jenner graced the cover of Vanity Fair, signaling a growing acceptance of transgender identity. Yet criticisms of Dolezal for misrepresenting her birth race indicate a widespread social perception that it is neither possible nor acceptable to change one's race in the way it might be to change one's sex. Considerations that support transgenderism (...) seem to apply equally to transracialism. Although Dolezal herself may or may not represent a genuine case of a transracial person, her story and the public reaction to it serve helpful illustrative purposes. (shrink)

In her paper, The case for physician assisted suicide: not proven, Bonnie Steinbock argues that the experience with Oregon’s Death with Dignity Act fails to demonstrate that the benefits of legalising physician assisted suicide outweigh its risks. Given that her verdict is based on a small number of highly controversial cases that will most likely occur under any regime of legally implemented safeguards, she renders it virtually impossible to prove the case for physician assisted suicide. In this brief paper, we (...) suggest some ways that may enable us to weigh the risks and benefits of legalisation more fairly and, hopefully, allow us to close the case for physician assisted suicide. (shrink)

Emotional action and communication are integral to the development of morality, here conceptualized as our concerns for the well-being of other people and the ability to act on those concerns. Focusing on the second year of life, this article suggests a number of ways in which young children’s emotions and caregivers’ emotional communication contribute to early forms of helping, empathy, and learning about prohibitions. We argue for distinguishing between moral issues and other normative issues also in the study of early (...) moral development, for considering a wider range of emotional phenomena than the “moral emotions” most commonly studied, and for paying more attention to how specific characteristics of early emotional interactions facilitate children’s development of a concern for others. (shrink)

Virtually everyone will agree that according to Aristotle, for a particular substance to be is at least for it to be a thing of a certain kind. Every particular substance falls under a substance kind, where the essence of that particular substance at least includes the essence of its substance kind. For example, for a particular man to be is at least for him to be characterized by those predicates that make something a man. More generally, if A is said (...) of a particular A kath’ hauto, then the essence of that particular A will at least include the essence of the kind A. Let us call the first of these essences the essence of a particular A, and the second the essence of the kind A. The question now is whether Aristotle would maintain that the essence of a particular A includes the essence of the kind A for every kind A. In particular, would he maintain this when A is said of a particular subject kata sumbebêkos? For example, would he say that what it is for a particular pale man to be includes what it is to fall under the kind pale man? (shrink)

I explore how gender can shape the pragmatics of speech. In some circumstances, when a woman deploys standard discursive conventions in order to produce a speech act with a specific performative force, her utterance can turn out, in virtue of its uptake, to have a quite different force—a less empowering force—than it would have if performed by a man. When members of a disadvantaged group face a systematic inability to produce a specific kind of speech act that they are entitled (...) to perform—and in particular when their attempts result in their actually producing a different kind of speech act that further compromises their social position and agency—then they are victims of what I call discursive injustice. I examine three examples of discursive injustice. I contrast my account with Langton and Hornsby's account of illocutionary silencing. I argue that lack of complete control over the performative force of our speech acts is universal, and not a special marker of social disadvantage. However, women and other relatively disempowered speakers are sometimes subject to a distinctive distortion of the path from speaking to uptake, which undercuts their social agency in ways that track and enhance existing social disadvantages. (shrink)

While there is no shortage of philosophical and theological occupations with the problem of evil and theodicy, the phenomenological basis from which the problem arises often gets lost in abstract accounts. In delimiting the case to physical pain, this article attempts to provide a perspective on the problem of evil following the lead from one of the problem’s sources. Through a phenomenological analysis of pain, the article highlights the inner tension that belongs to the experience of pain. This contradiction can (...) be traced on various levels: pain as sensational impression, as bodily occurrence, and as posing a question of meaning. This phenomenology of pain can provide a perspective on the origin and nature of the problem of evil: both why intellectual responses must arise and why it cannot reach an adequate solution. (shrink)

This article summarizes some of the results of the BIOMED II project “Basic Ethical Principles in European Bioethics and Biolaw” connected to a research project of the Danish Research Councils “Bioethics and Law”. The BIOMED project was based on cooperation between 22 partners in most EU countries. The aim of the project was to identify the ethical principles of respect for autonomy, dignity, integrity and vulnerability as four important ideas or values for a European bioethics and biolaw. The research concluded (...) that the basic ethical principles cannot be understood as universal everlasting ideas or transcendental truths but they rather function reflective guidelines and important values in European culture. The method of the research was conceptual, philosophical analysis of the cultural background of the four values or normative ideas that people use and find important in their existence. Moreover, this was combined with analysis of empirical legal material and policy documents. Also, a number of qualitative interviews with relevant experts were carried out. Another important result of the BIOMED project was the partner's Policy Proposals to the European Commission, the Barcelona Declaration, unique as a philosophical and political agreement between experts in bioethics and biolaw from many different countries. The Policy Proposals are reprinted here at the end of the article. (shrink)

Miranda Fricker claims that a “gap” in collective hermeneutical resources with respect to the social experiences of marginalized groups prevents members of those groups from understanding their own experiences (Fricker 2007). I argue that because Fricker misdescribes dominant hermeneutical resources as collective, she fails to locate the ethically bad epistemic practices that maintain gaps in dominant hermeneutical resources even while alternative interpretations are in fact offered by non-dominant discourses. Fricker's analysis of hermeneutical injustice does not account for the possibility that (...) marginalized groups can be silenced relative to dominant discourses without being prevented from understanding or expressing their own social experiences. I suggest that a gap in dominant hermeneutical resources is ambiguous between two kinds of unknowing: hermeneutical injustice suffered by members of marginalized groups, and epistemically and ethically blameworthy ignorance perpetrated by members of dominant groups. (shrink)

Definition of the problem: Medical research with children, especially non-therapeutic research, requires particular consideration. In the current situation this kind of research is not clearly regulated by law in Germany. This entails practical problems in evaluating clinical studies from an ethical point of view. Arguments and conclusion: To develop a new policy framework the international ethical discussion is reviewed. The article analyzes the historical development of research with minors from an ethical perspective, the notion of minimal risk, criteria for evaluating (...) risk and harm in research, consent and assent procedures, and the participation of parents and children in the planning of clinical studies. A list of proposals for minimal standard in ethical regulation of research with minors is developed. (shrink)

This article tries to bring out the implication of Cavell’s critical comments on Derrida, clustered around Cavell’s charge that deconstruction entails a flight from the ordinary. Cavell’s and Derrida’s different readings of Austin’s ordinary language philosophy provide a common ground for elaborating their respective positions. Their writings are at once the closest but also the most divergent when addressing the moral implication of speech, or more precisely, when addressing their understanding of responsibility and voice. Employing Derrida’s so-called ‘double reading’ as (...) a leitmotif will not only shed light on the moral dimension of deconstruction, but also bring the central target of Cavell’s critique into the open. (shrink)

The principle of informed consent obligates physicians to explain possible side effects when prescribing medications. This disclosure may itself induce adverse effects through expectancy mechanisms known as nocebo effects, contradicting the principle of nonmaleficence. Rigorous research suggests that providing patients with a detailed enumeration of every possible adverse event?especially subjective self-appraised symptoms?can actually increase side effects. Describing one version of what might happen may actually create outcomes that are different from what would have happened without this information. This essay argues (...) that the perceived tension between balancing informed consent with nonmaleficence might be resolved by recognizing that adverse effects have no clear black or white?truth.? This essay suggests a pragmatic approach for providers to minimize nocebo responses while still maintaining patient autonomy through?contextualized informed consent,? which takes into account possible side effects, the patient being treated, and the particular diagnosis involved. (shrink)

In her paper, The case for physician assisted suicide: not proven, Bonnie Steinbock argues that the experience with Oregon’s Death with Dignity Act fails to demonstrate that the benefits of legalising physician assisted suicide outweigh its risks. Given that her verdict is based on a small number of highly controversial cases that will most likely occur under any regime of legally implemented safeguards, she renders it virtually impossible to prove the case for physician assisted suicide. In this brief paper, we (...) suggest some ways that may enable us to weigh the risks and benefits of legalisation more fairly and, hopefully, allow us to close the case for physician assisted suicide. (shrink)

Mass Hysteria examines the medical and cultural practices surrounding pregnancy, new motherhood, and infant feeding. Late eighteenth century transformations in these practices reshaped mothers' bodies, and contemporary norms and routines of prenatal care and early motherhood have inherited the legacy of that era. As a result, mothers are socially positioned in ways that can make it difficult for them to establish and maintain healthy and safe boundaries and appropriate divisions between public and private space.

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission (...) recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort. (shrink)

The early modern period is arguably the most pivotal of all in the study of the mind, teeming with a variety of conceptions of mind. Some of these posed serious questions for assumptions about the nature of the mind, many of which still depended on notions of the soul and God. It is an era that witnessed the emergence of theories and arguments that continue to animate the study of philosophy of mind, such as dualism, vitalism, materialism, and idealism. -/- (...) Covering pivotal figures in philosophy such as Descartes, Hobbes, Kant, Leibniz, Cavendish, and Spinoza, Philosophy of Mind in the Early Modern and Modern Ages provides an outstanding survey of philosophy of mind of the period. Following an introduction by Rebecca Copenhaver, sixteen specially commissioned chapters by an international team of contributors discuss key topics, thinkers, and debates, including: -/- Hobbes, Descartes’ philosophy of mind and its early critics, consciousness, the later Cartesians, Malebranche, Cavendish, Locke, Spinoza, Descartes and Leibniz, perception and sensation, desires, mental substance and mental activity, Hume, and Kant. Essential reading for students and researchers in philosophy of mind, enlightenment philosophy, and the history of philosophy, Philosophy of Mind in the Early Modern and Modern Ages is also a valuable resource for those in related disciplines such as religion, history of psychology, and history of science. (shrink)