Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are (...) reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)

The new economy is characterized in the developing world by open capital markets and coordinated international regulation - neither of which existed in the colonial period.

The disagreement over whether Aristotle recognized rights in some form unavoidably involves disagreement over what rights are, and the theory of rights itself is still highly contested. There is no consensus concerning how " right'? is to be defined, how rights are to be theoretically grounded, or how rights theory is to be applied in particular circumstances. This is not, however, a good reason to dismiss the issue of whether there are rights in Aristotle: for Aristotle, like modern rights theorists, (...) is concerned about the moral and legal status of the individual within the community, and he expresses this in terms of claims of justice. The issue is worthy of study not only because it can lead to a deeper understanding of Aristotle's conceptions of justice and the common good, but also because it may shed valuable light on the theoretical foundations of human rights, since he offers a theory of political justice which is based on a metaphysical theory of human nature. (shrink)

We seek to change the conversation about brain death by highlighting the distinction between brain death as a biological concept versus brain death as a legal status. The fact that brain death does not cohere with any biologically plausible definition of death has been known for decades. Nevertheless, this fact has not threatened the acceptance of brain death as a legal status that permits individuals to be treated as if they are dead. The similarities between “legally dead” and “legally blind” (...) demonstrate how we may legitimately choose bright-line legal definitions that do not cohere with biological reality. Not only does this distinction bring conceptual coherence to the conversation about brain death, but it has practical implications as well. Once brain death is recognized as a social construction not grounded in biological reality, we create the possibility of changing the social construction in ways that may better serve both organ donors and recipients alike. (shrink)

The idea that there could be spatially extended mereological simples has recently been defended by a number of metaphysicians (Markosian 1998, 2004; Simons 2004; Parsons (2000) also takes the idea seriously). Peter Simons (2004) goes further, arguing not only that spatially extended mereological simples (henceforth just extended simples) are possible, but that it is more plausible that our world is composed of such simples, than that it is composed of either point-sized simples, or of atomless gunk. The difficulty for these (...) views lies in explaining why it is that the various sub-volumes of space occupied by such simples, are not occupied by proper parts of those simples. Intuitively at least, many of us find compelling the idea that spatially extended objects have proper parts at every sub-volume of the region they occupy. It seems that the defender of extended simples must reject a seemingly plausible claim, what Simons calls the geometric correspondence principle (GCP): that any (spatially) extended object has parts that correspond to the parts of the region that it occupies (Simons 2004: 371). We disagree. We think that GCP is a plausible principle. We also think it is plausible that our world is composed of extended simples. We reconcile these two notions by two means. On the one hand we pay closer attention to the physics of our world. On the other hand, we consider what happens when our concept of something—in this case space—contains elements not all of which are realized in anything, but instead key components are realized in different features of the world. (shrink)

Moral distress is a well-documented phenomenon for health care providers (HCPs). Exploring HCPs’ perceptions of participation in moral distress interventions using qualitative and quantitative methods enhances understanding of intervention effectiveness. The purpose of this study was to measure and describe the impact of a two-phased intervention on participants’ moral distress. Using a cross-over design, the project aimed to determine if the intervention would decrease moral distress, enhance moral agency, and improve perceptions about the work environment. We used quantitative instruments and (...) explored participants’ perceptions of the intervention using semi-structured interviews. Participants were from inpatient settings, within three major hospitals of a large, urban healthcare system in the Midwest, United States. Participants included nurses (80.6%) and other clinical care providers. Using generalized linear mixed modeling we assessed the change in each of the outcome variables over time controlling for groups. Interviews were audiotaped and professionally transcribed. The written narratives were coded into themes. The change in scores on study instruments trended in the desired direction however did not meet statistical significance. Qualitative interviews revealed that intervention effectiveness was derived from a combination of learning benefits, psychological benefits, and building community that promoted moral agency. Findings demonstrate a clear link between moral distress and moral agency and suggest that Facilitated Ethics Conversations can enhance the work environment. Findings provide insight for developing evidenced-based approaches to address moral distress of hospital nurses. (shrink)

Controversies about the diagnosis and meaning of brain death have existed as long as the concept itself. Here we review the historical development of brain death, and then evaluate the various attempts to justify the claim that patients who are diagnosed as brain dead can be considered dead for all legal and social purposes, and especially with regard to procuring their vital organs for transplantation. While we agree with most commentators that death should be defined as the loss of integration (...) of the functioning of the organism as a whole, we conclude that patients diagnosed as brain dead have not, in fact, lost this integrated functioning. We close with reflections on the implications of this conclusion generally and particularly with regard to organ transplantation, and briefly make reference to alternative approaches to justifying the procurement of transplantable organs that do not depend upon a flawed approach to the diagnosis of death. (shrink)

_Philosophy Through Science Fiction_ offers a fun, challenging, and accessible way in to the issues of philosophy through the genre of science fiction. Tackling problems such as the possibility of time travel, or what makes someone the same person over time, the authors take a four-pronged approach to each issue, providing · a clear and concise introduction to each subject · a science fiction story that exemplifies a feature of the philosophical discussion · historical and contemporary philosophical texts that investigate (...) the issue with rigor, and · glossary, plot profiles of pertinent science fiction stories and films, and questions for further reflection. _Philosophy Through Science Fiction_ includes stories from contemporary science fiction writers including Greg Egan and Mike Resnick, as well as from classic authors like Philip K. Dick and Robert Heinlein. Philosophy readings include historical pieces by René Descartes and David Hume, and contemporary pieces by John Searle and Mary Midgley. (shrink)

The principles for universal reading models proposed by Frost correspond to developmental theories, in which neurocognitive constraints and cultural experiences shape development. We question his contention that Hebrew word identification is fundamentally about roots, excluding verbal and nominal word-pattern morphemes; and we propose that readers use all information available in stimuli, adjusting for volume and usefulness.

A letter to the editor from Howard Brody, David Buchanan, and Franklin G. Miller in response to the recent article by Erik Malmqvist Understanding Exploitation," March-April 2011).

An overview of the concept of Strong Emergence, and a summary of the papers within the special issue.

A summary of the papers within the Philosophica special issue on Strong Emergence.

Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores (...) were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries. (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

: This paper presents a method of moral problem solving in clinical practice that is inspired by the philosophy of John Dewey. This method, called "clinical pragmatism," integrates clinical and ethical decision making. Clinical pragmatism focuses on the interpersonal processes of assessment and consensus formation as well as the ethical analysis of relevant moral considerations. The steps in this method are delineated and then illustrated through a detailed case study. The implications of clinical pragmatism for the use of principles in (...) moral problem solving are discussed. (shrink)

Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. Traditionally, death was understood to occur when a person stops breathing, their heart stops beating and they are cold to the touch. Today, physicians determine death by relying on a diagnosis of ‘total brain failure’ or by waiting a short while after circulation stops. Evidence has emerged, however, that the conceptual bases for these approaches to determining death are fundamentally flawed and depart substantially from (...) the established biological conception of death. We argue that the current approach to determining death consists of two different types of unacknowledged legal fictions. These legal fictions were developed for practices that are largely ethically legitimate but need to be reconciled with the law. The considerable debate over the determination of death in the medical and scientific literature has not informed the public that vital organs are being procured from still-living donors and it seems unlikely that this information can remain hidden for long. Given the instability of the status quo and the difficulty of making the substantial legal changes required by complete transparency, we argue for a second-best policy solution: acknowledging the legal fictions involved in determining death to move in the direction of greater transparency. This may someday result in more substantial legal change to directly confront the challenges raised by life-sustaining and life-preserving technologies without the need for fictions. (shrink)

As computer-based information systems start to have a great impact on people, organizations, and society as a whole, there is much debate about information technology in relation to social control and privacy, security and reliability, and ethics and professional responsibilities. However, more often than not, these debates reveal some fundamental disagreements, sometimes about first principles. In this article the authors suggest that a fruitful and interesting way to conceptualize some of these moral and ethical issues associated with the use of (...) information technology is to apply the principles of Aristotle's ethics to this topic. They argue that framing the moral and ethical choices associated with information technology in Aristotelian terms draws attention to the fact that there are fundamental dilemmas to be addressed. These dilemmas are discussed in relation to the four areas suggested by Dejoie, Fowler, and Paradice (1991): (a) privacy, (b) information accuracy, (c) access to information, and (d) intellectual property rights. The dilemmas associated with all four areas are illustrated with references to recent legal developments in Australia and New Zealand. (shrink)

This book contains new essays in honor of Melvin J. Lerner, a pioneer in the psychological study of justice. The contributors to this volume are internationally renowned scholars from psychology, business, and law. They examine the role of justice motivation in a wide variety of contexts, including workplace violence, affirmative action programs, helping or harming innocent victims and how people react to their own fate. Contributors explore fundamental issues such as whether people's interest in justice is motivated by self-interest (...) or a genuine concern for the welfare of others, when and why people feel a need to punish transgressors, how a concern for justice emerges during the development of societies and individuals, and the relation of justice motivation to moral motivation. How an understanding of justice motivation can contribute to the amelioration of major social problems is also examined. (shrink)

Der folgende Artikel ist im Jahr 2003 unter dem Titel „Clinical Pragmatism: A Method of Moral Problem Solving“ in dem Sammelband „Pragmatic bioethics“ erschienen, welcher sich mit der Bedeutung der pragmatistischen Philosophie für die Praxis befasst. In dem vom Internisten und Bioethiker Joseph J. Fins, dem Thoraxchirurgen Matthew D. Bacchetta und dem Philosophen und Medizinethiker Franklin G. Miller verfassten Beitrag wird der pragmatistische Ansatz in der klinischen Ethik anhand eines Fallbeispiels gleichzeitig beschrieben, begründet und demonstriert. Obgleich die Denkrichtung der (...) pragmatistischen Philosophie sowohl wissenschaftstheoretisch wie praktisch hoch bedeutsam ist – ohne diese ist weder die heutige sozialwissenschaftliche Forschung noch die angewandte, insbesondere die klinische Ethik denkbar –, werden pragmatistische Ansätze im deutschsprachigen Raum bis heute eher rudimentär rezipiert. (shrink)

Addressing himself to basic ethical questions -- What is the essential value of life? What is right action? What is the nature of a good social order? -- the author seeks to find his answers in the humanist spirit of philosophy. The author takes his quest beyond the limits of personal ethics. Viewing man both as an individual and as a member of society, he examines, among various themes, the meaning and implications of the community as an ethical concept. In (...) so doing, he refers to such related fields as religion, law, sociology and political theory, but the primary focus of the book is on basic sources and central issues. Far more than most writers on ethics, he deals with the concept of justice, and with human rights and liberties; the values of democracy he treats at length and relates to the individual. The result is a text of depth and distinction that deals with the total human personality in the dynamic context of a functioning society. (shrink)

At the threshold of the 21st Century many people are faced with a spiritual dilemma, where neither secularism nor religion seem adequate. _The Psychology of Mature Spirituality_ addresses this dilemma. In each of the book's three sections - integrity, wisdom, and transcendence - distinguished contributors describe and analyse a mature form of spirituality that will be a hallmark of future years. This timely volume will appeal to those involved in psychology, psychoanalysis and religious studies.

Since its publication, the Psychopathic Personality Inventory and its revision (Lilien- feld & Andrews, 1996; Lilienfeld & Widows, 2005) have become increasingly popular such that it is now among the most frequently used self-report inventories for the assessment of psychopathy. The current meta-analysis examined the relations between the two PPI factors (factor 1: Fearless Dominance; factor 2: Self-Centered Impulsivity), as well as their relations with other validated measures of psychopathy, internalizing and externalizing forms of psychopathology, general personality traits, and antisocial (...) personality disorder symptoms. Across 61 samples reported in 49 publications, we found support for the convergent and criterion validity of both PPI factor 2 and the PPI total score. Much weaker validation was found for PPI factor 1, which manifested limited convergent validity and a pattern of correlations with central criterion variables that was inconsistent with many conceptualizations of psychopathy. (shrink)