BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs (...) can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed? (shrink)

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs (...) for Neglected Diseases Initiative, an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis. The project involved the implementation of a novel ‘pre-review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. (shrink)

This article examines and critiques the use of the term “vulnerability” in U.S. and international regulations and guidelines on research ethics. After concluding that the term is currently used in multiple, often inconsistent, senses, it calls on regulators to differentiate between three distinct types of vulnerability: “consent-based vulnerability,”“risk-based vulnerability,” and “justice-based vulnerability.”.

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding (...) of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects. (shrink)

In “Should We Impose Quotas? Evaluating the ‘Disparate Impact’ Argument Against Legalization of Assisted Suicide,” Ronald Lindsay argues that it should make no difference to the debate over legalizing assisted suicide whether the risks associated with legalization would fall disproportionately on the poor, people with disabilities, racial minorities, or any other especially vulnerable social group. Even assuming such an inequitable distribution of risks would occur, he maintains, attempting to avoid such an outcome is not a good reason to deny assisted (...) suicide to “competent persons who truly voluntarily choose it.”Those of us who worry that legalization will differentially burden already disadvantaged segments of society have generally taken it for granted that the possibility of such disparities raises significant public policy concerns. By insisting on an explanation of this assumption — and, in so doing, making explicit the tension between autonomy and equality that underlies the assisted suicide debate — Lindsay has significantly advanced the ongoing conversation. While I disagree with his analysis, I commend him for a thoughtful, provocative, and important contribution to the literature. (shrink)

The question of legalizing physician-assisted suicide has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians (...) have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.As support for PAS grows, it becomes increasingly likely that the practice will be legalized in at least some states in the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients; a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted. (shrink)

Among the many explanations for antibiotic overprescription, some doctors cite the risk of malpractice liability if they deny a patient's request for an antibiotic and the patient's condition worsens. In this paper, I examine the merits of this concern—i.e., whether physicians could, in fact, face malpractice liability for refusing to prescribe an antibiotic when, from a public health perspective, the use of the antibiotic would be considered inappropriate. I conclude that the potential for liability cannot be dismissed entirely, but the (...) risk is remote—even in cases where there is a chance that the antibiotic might have benefited the patient. (shrink)

The question of legalizing physician-assisted suicide has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians (...) have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.As support for PAS grows, it becomes increasingly likely that the practice will be legalized in at least some states in the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients; a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted. (shrink)

On November 8, 1994, Oregon became the first state in the nation to legalize assisted suicide. Passage of Proposition 16 was a milestone in the campaign to make assisted suicide a legal option. The culmination of years of effort, the Oregon vote followed on the heels of failed referenda in California and Washington, and other unsuccessful attempts to enact state laws guaranteeing the right to suicide assistance. Indeed, in 1993, four states passed laws strengthening or clarifying their ban against assisted (...) suicide. No doubt, Proposition 16 is likely to renew the effort to legalize assisted suicide at the state level.The battle over assisted suicide is also unfolding in the courts. Litigation challenging Proposition 16 on the grounds that it violates the equal protection clause is ongoing in Oregon. More significantly, three cases, two in federal courts and one in Michigan state court, have been brought to establish assisted suicide as a constitutionally protected right. (shrink)

In “Should We Impose Quotas? Evaluating the ‘Disparate Impact’ Argument Against Legalization of Assisted Suicide,” Ronald Lindsay argues that it should make no difference to the debate over legalizing assisted suicide whether the risks associated with legalization would fall disproportionately on the poor, people with disabilities, racial minorities, or any other especially vulnerable social group. Even assuming such an inequitable distribution of risks would occur, he maintains, attempting to avoid such an outcome is not a good reason to deny assisted (...) suicide to “competent persons who truly voluntarily choose it.”Those of us who worry that legalization will differentially burden already disadvantaged segments of society have generally taken it for granted that the possibility of such disparities raises significant public policy concerns. By insisting on an explanation of this assumption — and, in so doing, making explicit the tension between autonomy and equality that underlies the assisted suicide debate — Lindsay has significantly advanced the ongoing conversation. While I disagree with his analysis, I commend him for a thoughtful, provocative, and important contribution to the literature. (shrink)

Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are “designed to develop or contribute to generalizable knowledge.” However, the “generalizable knowledge” standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some (...) individuals are exposed to greater-than-minimal risks for the potential benefit of others, at least when the activity in question is conducted or supported by federal agencies. Under such an approach, the fact that an activity constitutes research would be neither necessary nor sufficient to trigger prospective ethical oversight. (shrink)

In response to the increasing number of mentally ill people experiencing homelessness, some policy‐makers have called for the expanded use of involuntary commitment, even for individuals who are not engaging in behaviors that are immediately life‐threatening. Yet there is no evidence that involuntary commitment offers long‐term benefits, and significant reasons to believe that expanding the practice will cause harm. In addition, these proposals ignore research showing that most people with mental illness have the capacity to make medical decisions for themselves. (...) Rather than expanding the use of involuntary commitment, policy‐makers should support approaches proven to decrease the prevalence of homelessness, such as supportive housing. In addition, states should reevaluate their commitment standards for persons who pose no risk of harm to others. One promising approach is Northern Ireland's Mental Health Capacity Act of 2016, which establishes a uniform standard for imposing nonconsensual health care interventions, without any distinction between mental illnesses and other conditions in which capacity might be compromised. (shrink)

In recent years, the government, advocacy organizations, the press, and the public have pressured universities, academic medical centers, and physicianinvestigators to do more to ensure that their financial interests and relationships do not conflict with their duties to conduct high-quality research and protect the safety and welfare of clinical trial participants. A number of factors underlie the increased focus. First, private sector funding of clinical research has grown both in absolute terms and as a proportion of overall funding. In 2008, (...) the pharmaceutical, medical device, and biotechnology industries’ domestic research and development expenditures constituted approximately 60.9% of funding for biomedical research in the United States; the next largest funder, the National Institutes of Health, funded 27.9%. Private industry spent $58.6 billion on research in 2007, up from $40 billion in 2003, an increase of 25% after adjusting for inflation. (shrink)

The Ethics and Regulation of Research with Human Subjects, edited by Professors Carl Coleman of Seton Hall, Jerry Menikoff of the University of Kansas, Jesse Goldner of Saint Louis University, and Nancy Dubler of the Albert Einstein College of Medicine, is an up-to-date and authoritative collection of readings on ethical, legal, and policy issues in research with human subjects. The authors have modeled their text on the casebook style commonly used in law schools. At 746 pages, plus front (...) matter and an appendix, this book contains just about everything one needs to know for a thorough grasp on human subjects research, including federal and state regulations governing this research, interpretive guidance from federal agencies, international guidelines and codes, court decisions, historical documents and case studies, and selected readings from scholarly articles and books. The book includes written comments and questions to help students understand and interpret the readings. (shrink)

Longtermists have argued that humanity should significantly increase its efforts to prevent catastrophes like nuclear wars, pandemics, and AI disasters. But one prominent longtermist argument overshoots this conclusion: the argument also implies that humanity should reduce the risk of existential catastrophe even at extreme cost to the present generation. This overshoot means that democratic governments cannot use the longtermist argument to guide their catastrophe policy. In this paper, we show that the case for preventing catastrophe does not depend on longtermism. (...) Standard cost-benefit analysis implies that governments should spend much more on reducing catastrophic risk. We argue that a government catastrophe policy guided by cost-benefit analysis should be the goal of longtermists in the political sphere. This policy would be democratically acceptable, and it would reduce existential risk by almost as much as a strong longtermist policy. (shrink)

RésuméCet article offre une édition, une traduction et une analyse d'une préface adressée par Ḥunayn ibn Isḥāq, traducteur de Galien, à un mécène chrétien syro-oriental, le médecin Salmawayh ibn Bunān. Ḥunayn a composé cette Épître à Salmawayh ibn Bunān en syriaque, mais seule en a survécu une traduction arabe par son neveu. Le texte n'a reçu que peu d'attention depuis sa découverte, il y a plus de quatre-vingts ans; il n'a jamais été publié entièrement. L’Épître donne un nouvel aperçu des (...) débuts de Ḥunayn et du milieu chrétien dans lequel il évoluait, en montrant ses attaches au passé littéraire syriaque, bien illustrées par les préfaces d'un autre traducteur de Galien, son prédécesseur Sergius de Rēšʿaynā ; mais l’Épître indique aussi des éléments qui distinguent de leur prédécesseur les traducteurs abbassides comme Ḥunayn. Cette étude soutient que la demande accrue des mécènes et la lecture attentive des commentaires hippocratiques de Galien ont suscité un nouveau discours, dans l’Épître, selon lequel des lecteurs de tout niveau peuvent et devraient avoir accès aux textes scientifiques grecs. Cette Épître montre ainsi comment Ḥunayn comprenait son propre projet littéraire et scientifique et sa relation à la tradition grecque de l'Antiquité. (shrink)

Mr. Wellman’s highly original contribution to the relatively new field of justification in ethics consists of characterizing the different ways in which ethical statements can be challenged and showing how each sort of challenge can be met by an appropriate response, enabling reasonable men to appropriately discuss or reflect on ethical issues. In developing his unique, systematic, methodology of ethics, Mr. Wellman has, first, rigorously reviewed and refuted the main arguments for the view of the nature of all reasoning as (...) deductive and, second, convincingly presented arguments for the existence of nondeductive evidences in ethics. Mr. Wellman’s broad definition of reasoning and his rejection of the identification of justification with reasoning reveals new dimensions of justification which will have wide implications in other areas of human speculation. (shrink)

Over two decades ago, Davids et al. (1994) and Handford et al. (1997) raised theoretical concerns associated with traditional, reductionist, mechanistic perspectives of movement coordination and skill acquisition for sport scientists interested in practical applications for training designs. These seminal papers advocated an emerging consciousness grounded in an ecological approach, signalling the need for sports practitioners to appreciate the constraints-led, deeply entangled and non-linear reciprocity between the organism (performer), task and environment subsystems. Over two decades later, the areas of skill (...) acquisition, practice and training design, performance analysis and preparation, and talent development in sport science have never been so vibrant in terms of theoretical modelling, knowledge generation and innovation, and technological deployment. Viewed at an ecological level of analysis, the work of sports practitioners has progressively transitioned toward the facilitation of an evolving relationship between an organism (athlete, team) and its environment (sports competition). This commentary sets out to explore how these original ideas from Davids et al. (1994) and Handford et al. (1997) have been advanced through the theoretical lens of Ecological Dynamics. Concurrently, we provide case study exemplars, from applied practice in high-performance sports organisations, to illustrate how these contemporary perspectives are shaping the work of sports practitioners (sport ecology designers) in practice and performance preparation. (shrink)

I argue that Sellars’s naturalization of Kant should be understood in terms of how he used behavioristic psychology and cybernetics. I first explore how Sellars used Edward Tolman’s cognitive-behavioristic psychology to naturalize Kant in the early essay “Language, Rules, and Behavior”. I then turn to Norbert Wiener’s understanding of feedback loops and circular causality. On this basis I argue that Sellars’s distinction between signifying and picturing, which he introduces in “Being and Being Known,” can be understood in terms of what (...) I call cybernetic behaviorism. I interpret picturing in terms of cycles of cybernetic behavior and signifying in terms of coordination between cybernetic behavior systems, or what I call triangulated cybernetic behavior. This leads to a formal, naturalistic understanding of personhood as the capacity to engage in triangulated cybernetic behavior. I conclude by showing that Sellars’s thought has the resources, which he did not exploit, for introducing the concept of second-order cybernetics. This suggests that Sellars’s philosophy of mind could be developed in the direction of autopoiesis and enactivism. (shrink)

First published in 1999. Routledge is an imprint of Taylor & Francis, an informa company.

This book by one of America's preeminent legal theorists is concerned with the conflict between the goals of justice and economic efficiency in the allocation of risk, especially risk pertaining to safety. The author approaches his subject from the premise that the market is central to liberal political, moral, and legal theory. In the first part of the book, he rejects traditional "rational choice" liberalism in favor of the view that the market operates as a rational way of fostering stable (...) relationships and institutions within communities of individuals with broadly divergent conceptions of the good. However, markets are needed most where they are most difficult to create and sustain, and one way to understand contract law in liberal legal theory, according to Professor Coleman, is as an institution designed to reduce uncertainty and thereby make markets possible. Another target of this book is the prevalent view that tort law helps rectify market failures when transaction costs are too high to permit contracting. The author argues instead that tort law should be understood as a way of rectifying wrongful losses not inefficient exchanges. (shrink)

This chapter explores the unifying themes of “the Pittsburgh School” of Sellars, Brandom, and McDowell: a social pragmatist account of intentionality, the rejection of the Myth of the Given, and the partial rehabilitation of Hegel for analytic philosophy. In addition this chapter also discusses three points of disagreement within the Pittsburgh School: whether or not we should posit sense-impressions, whether perceptual intentionality is world-relational, and whether the natural sciences have epistemic authority over other ways of thinking about nature. The chapter (...) concludes with a metaphilosophical concern about the status of a return to Hegel within analytic philosophy. Analytic philosophy follows an anti-Hegelian neo-Kantian institution of a divide between philosophy and the social and natural sciences. Hegel would reject such a divide, since he conceives of philosophy as investigating “shapes of a world” and not just “shapes of consciousness”. In these terms the Pittsburgh School marks a return to Hegel trimmed to suit the needs of analytic philosophy rather than questioning those needs. (shrink)

This book offers a bold new theoretical understanding of the current ecological crisis via the Frankfurt School. Focusing on key notions of dialectics, natural history, and materialism, a critical theory of nature is outlined in favor of a more traditional Marxist theory of nature, albeit one which still builds on Marxist concepts to confirm humanity's centrality in manufacturing environmental misery. Pre-eminent thinkers including Georg Lukács, Ernst Bloch, and Theodor Adorno are highlighted for their potential to diagnose the interpenetration of capitalism (...) and nature in a way that neither absolutizes nor obliterates the boundary between the social and natural. (shrink)

Gottlob Frege has exerted an enormous influence on the evolution of twentieth-century philosophy, yet the real significance of that influence is still very much a matter of debate. This book provides a completely new and systematic account of Frege's philosophy by focusing on its cornerstone: the theory of sense and reference. Two features distinguish this study from other books on Frege. First, sense and reference are placed absolutely at the core of Frege's work; the author shows that no adequate account (...) of the theory can avoid analysing the notion of thought that underpins it, or explaining how it has clarified our concept of judgement. Second, the theory is situated within the development of Frege's thought; the author reveals how the theory caused Frege to alter many of his fundamental views. In doing so the author presents a clearer picture of the problems the theory was intended to solve, and delineates more sharply the characteristic features of Frege's philosophy. (shrink)

To enlarge the discussion of scientific responsibility for research integrity, this paper offers two historico-philosophical observations. First, in the broad history of ideas, modern ethics replaces social role responsibility with appeals to abstract principles; by contrast, discussions within the scientific community of responsibility for research integrity constitute a rediscovery of the continuing vitality of role responsibility. This is a rediscovery from which philosophy itself may benefit. Second, within the context of scientists’ concerns, the idea of role responsibility has undergone significant (...) evolution from “collective responsibility” to the notion of responsibility resting with a “trans-scientific community.” Further challenges nevertheless remain in order to relate scientific role responsibility for scientific integrity to the relationship between science and society. To promote a notion of integrity not just in science but in the science-society relationship, it may be useful to think in terms of a “co-responsibility” for scientific integrity. (shrink)

Ordinal Computability discusses models of computation obtained by generalizing classical models, such as Turing machines or register machines, to transfinite working time and space. In particular, recognizability, randomness, and applications to other areas of mathematics, including set theory and model theory, are covered.

Building on research in anthropology and philosophy, one can make a distinction between type I and type II energy ethics as a framework for advancing public debate about energy. Type I holds energy production and use as a fundamental good and is grounded in the assumption that increases in energy production and consumption result in increases in human wellbeing. Conversely, type II questions the linear relationship between energy production and progress by examining questions of equity and human happiness. The type (...) I versus type II framework helps to advance public debates about energy that address broad questions of profitability, regulation, and the environment, and in the process poses fundamental questions about the reverence for energy growth in advanced technological societies. (shrink)

Debates that revolve around the topic of morality and fiction rarely explicitly treat virtual worlds like, for example, Second Life. The reason for this disregard cannot be that all users of virtual worlds only do the right thing while online—for they sometimes even virtually kill each other. Is it wrong to kill other people in a virtual world? It depends. This essay analyzes on what it depends, why it is that killing people in a virtual world sometimes is wrong, and (...) how different virtual killings are wrong in different ways. I argue that killing people online is wrong if it is an instance of deliberately and non-consensually evoking disagreeable emotions in others. Establishing this conclusion requires substantial conceptual work, as virtual worlds feature new kinds of fictional agency, particular emotional responses to fiction, and unique ways in which the fiction of the virtual world relates to the wrongness of the killing. (shrink)

The Postscript to The Concept of Law contains Herbert Hart's only sustained and considered response to the objections pressed against his views by his distinguished critic, Ronald Dworkin. In this extraordinary collection, many of the leading legal philosophers in the world evaluate the success of Hart's responses to Dworkin on several of these counts. Notable contributors include Joseph Raz of Oxford University and Jules L. Coleman of the Yale Law School.

Engineering ethics calls the attention of engineers to professional codes of ethical responsibility and personal values, but the practice of ethics in corporate settings can be more complex than either of these. Corporations too have cultures that often include corporate social responsibility (CSR) practices and policies, but few discussions of engineering ethics make any explicit reference to CSR. This article proposes critical attention to CSR and role ethics as an opportunity to help prepare engineers to think through the ethics of (...) their professional practice. After a brief overview of the evolution of social responsibility within engineering ethics in the United States, this article shares empirical research with practicing engineers in the mining and energy industries to explore how their formal ethics training did and did not prepare them to grapple with the ethical dimensions of their professional practice. It then illustrates the ways in which these dilemmas and the strategies employed for navigating them are framed within CSR policies and practices and resonate more strongly with role ethics rather than ethical theory as currently taught in most US engineering programs. The article concludes that engineering ethics teaching and learning would benefit from explicitly incorporating critical discussions of role ethics and CSR. (shrink)