ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of the (...) standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

This case is about a study of burn patients that included a request to the IRB for a waiver of consent for perianal specimen collection–a request which ultimately was not approved by a reviewing IR...

The case (Dawson et al. 2024) raises tensions between the ethical demands of respect for patient autonomy, patients’ clinical needs, and research to improve clinical care. Given burn patients’ urge...

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Eyal et al have recently argued that researchers should consider conducting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) human challenge studies to hasten vaccine development. We have conducted (J. L.) and overseen (L. D.) human challenge studies and agree that they can be useful in developing anti-infective agents. We also agree that adults can autonomously choose to undergo risks with no prospect of direct benefit to themselves. However, we disagree that SARS-CoV-2 challenge studies are ethically appropriate at this time, for (...) 3 reasons: (1) current scientific knowledge of SARS-CoV-2 infection is insufficient to manage risks; (2) autonomous decision making, while necessary, does not override concerns about risk; and (3) undertaking challenge studies now would imperil confidence in the research enterprise, potentially undermining the global response to the coronavirus disease 2019 (COVID-19) pandemic. (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.

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of the (...) standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

Volume 20, Issue 10, October 2020, Page 39-41.

The case describes researchers who are seeking ethics guidance on communicating with participants in a phase-1 COVD-19 vaccine trial about FDA-authorized COVID-19 vaccines (Wilfond, Duenas, and Johnson 2023). The researchers want help choosing among three options they have identified for encouraging participants to obtain one of the authorized vaccines. We argue that research ethics consultants should consider going beyond this question to address another ethics concern the researchers might have overlooked.

The American Journal of Bioethics, Volume 12, Issue 6, Page 33-34, June 2012.

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not (...) yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. (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)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs,1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process.2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV as well (...) as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the difficulty of even engaging with community members in oppressive settings, where authorities severely restrict civil liberties of PWID so that even discussing issues related to drug use and enforcement may place individuals at risk. To overcome such limitations, he appropriately suggests interviewing confidentially those who have previously been detained in closed settings as part of the community engagement process. Similarly, Wolfe observes that critical issues can be overlooked with a narrow focus on study procedures if contextual factors before, during or after a study are ignored. For example, he cites the risk of overdose for study participants who have been abstinent during a study and subsequently resume injecting when the study concludes. These kinds of risks may not be obvious …. (shrink)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs, 1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process. 2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV (...) as well as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the... (shrink)

In many regions around the world, those at highest risk for acquiring HIV are young adults and adolescents. Young men who have sex with men in the USA are the group at greatest risk for HIV acquisition, particularly if they are part of a racial or ethnic minority group.1 Adolescent girls and young women have the highest incidence rates of any demographic subgroup in sub-Saharan Africa.2 To reverse the global AIDS pandemic’s toll on these high-risk groups, it is important to (...) deploy the most effective HIV prevention tools to young MSM in the USA, to adolescent girls and young women in sub-Saharan Africa, and to any other adolescents and young adults at high risk for HIV as products are proven to be safe and efficacious. Although prevention interventions with proven efficacy, such as oral pre-exposure prophylaxis, are available,3–8 they have not been sufficient to stem the tide and an expanded prevention toolkit is urgently needed to serve these populations. The field of HIV prevention continues to identify promising leads in the development of new biomedical prevention products, either delivering antiviral drug topically or systemically. The dapivirine ring has been shown to provide modest protection and is currently being tested in open label studies while injectable cabotegravir is being tested in a large efficacy trial for preventing HIV acquisition. Advances in the field of HIV prevention mean that scientists and regulators must plan for how they will bring prevention tools to populations at high risk for HIV as they conduct efficacy and effectiveness trials. For instance, safety data from younger age groups can also be used in combination with efficacy data from adult studies, where appropriate, as bridging studies to expand labelling to younger ages. If these …. (shrink)

Nationalism was a driving, moving spirit in the nineteenth-century Germany of Friedrich Schleiermacher. Jerry F. Dawson, through his thoughtful and well-wrought study of Friedrich Schleiermacher, provides an insight into contemporary nationalistic movements and the people who have a part in them. Schleiermacher, a prominent theologian and educator, was also a leading contributor to the tide of nationalism which swept Germany during the Napoleonic era. Dawson does not present Schleiermacher as an archetype for nationalists, but rather as an example (...) of one man who was willing to sacrifice everything for the good of the nation. Examining the influence of Pietism, rationalism, and romanticism on Schleiermacher, the author explains the origins of his subject's nationalistic activities and traces the evolution of his patriotic point of view. Dawson depicts the development of Schleiermacher's patriotism from Prussian particularism to German nationalism—an allegiance to an idealized Germany unified in religion, language, folkways. He describes the diverse approaches utilized by Schleiermacher to achieve a patriotic awakening among his countrymen: "…he preached nationalistic sermons; he delivered scholarly lectures; he repeatedly risked his life on dangerous missions which would help free Germany from France; he used his journalistic talents to try to stimulate the national consciousness of the German people; and he even served in the government of Prussia in an attempt to reconstruct the educational system so that nationalism might be advanced.". (shrink)

ABSTRACT It used to be said that shame culture waned in early modernity, but there is a growing body of historiography on the vital role that recognition and the opinion of others continued to play. Honour mattered; for some it was the mark and the maker of your true self. While philosophers like Hobbes, Locke, Mandeville, Hume, Smith, and Rousseau disagreed in their evaluations of the phenomenon, they were united in thinking that the great engine of recognition whirred like furious (...) clockwork through human society. When one listens to voices from the margins of power, however, to formerly enslaved black women and men, and white women, one hears a different story – that the machine is broken. I argue that, albeit from incomparable positions, they articulate a theory of misrecognition in the face of systematic power. Sensitive to the entanglements of epistemology and naturalised inequality, they offer a politics of vision that deconstructs the punitive lenses of gender and race which render people invisible and misunderstood, and in so doing they try to write themselves into view. They offer an account of the mysterious intractability of hegemonic ways of seeing that poses a challenge to both the putatively laissez-faire economy of recognition of their enlightened contemporaries, and to the emancipatory teleology of modern recognition theorists. (shrink)

This chapter contains sections titled: Metaphysical Approaches Metaphysical Problems References.

This essay series attempts to stimulate the debate about the moral challenges that internationalisation confronts us with, both in the Netherlands and abroad, and in particular for Artist-in-Residencies (AIRs). The publication is a reflection on how the crisis is reconsidering our international ambitions, starting from a post-COVID society. Internationalisation is an inevitable reality, inherent to the art landscape. The current time calls for a critical reflection on major issues such as climate inequality, plurality and the Western-dominant canon. 0With contributions and (...) critical insights by Jeanne van Heeswijk, Jack Segbars, Erik Hagoort, Pascal Gielen, Cecilia Bengtsson, Merlijn Twaalfhoven, Hicham Khalidi, reinaart vanhoe and Suzanne van der Beek. Thanks to Jan van Eyck Academie, Mondriaan Fonds, Prins Bernhard Cultuurfonds en het Amsterdams Fonds voor de Kunst for their support. (shrink)

This book provides a unique introduction for business leaders to the philosophical lexicon of classical and contemporary ideas—for and against—that are relevant to business and those destined to lead it. Rather than presenting the reader with a ‘philosophy of leadership’ the author uses his experiences in academia and as a leader in business to illustrate the practical application of philosophical ideas and methodologies covering the art and science of being a business leader: motivating stakeholders to deliver the initial phase of (...) a business plan for a new product or service; processing information (and risky ‘hidden-information’) that brings the company vision into reality; and ethically managing relationships to enhance the quality of decision-making and its outcomes. Creative aspiration, knowledge and ethical character are the three pillars of leadership. Within that construct, this book challenges leaders to seek their own path to self-development inspired by ideas that shape the ecology of capitalism and the opportunities it provides stakeholders to endow meaning and dignity to their lives through their participation in business. (shrink)

Thomas Hobbes was an English philosopher who was roiled by the bloodshed and turmoil of the English Civil War. During this period of ceaseless in-fighting, he wrote his masterpiece, Leviathan, which established the foundation for Western political thought. His work has inspired both hate and awe, as he reveals the darker side of human nature and the value of authority. Though he claims man's nature is inherently competitive and selfish, he also shows us how to utilize these traits to our (...) advantage to flourish, be fearless, and free. (shrink)

The general question to which this paper is addressed is whether knowledge and rationality carry within themselves the seeds of their own destruction. Some of those who set out in search of knowledge come to believe as a result of their inquiries that the object of their quest is not what they had taken it to be; seeking to discover the way the world actually is, they are led to conclude that all they can hope to find is a reflection (...) of their own needs and interests; the grail is but a beaker. Similarly, some of those whose aim is to formulate the principles of rational thought are led by reason to deny that any beliefs can be rationally justified; reasons are never reasons for believing but mere epiphenomena, produced by but not producing events whose only begetter is the passions; the quest is just another power struggle. The particular question I wish to ask is whether this picture is an accurate representation of social inquiry. (shrink)

Emergency nurses apply specialist knowledge to the practice of emergency care. This paper discusses the ways in which three emergency nurses understand the nature of their care from their own frames of reference and experiences and presents some of the data collected in a larger study. Various discourses, which compete to inform emergency nurses' understandings of practice, are linked with the notion of nurses as subjects; that is, each discourse may inform, shape and constitute the practice of the nurse and, (...) in turn, the ways in which the patient comes to be known and understood. I will examine the ways in which emergency nurses come to experience or position themselves vis‐à‐vis extant forms of knowledge of emergency care and the extent to which they articulate new or distinctive formulations of emergency care. This paper illuminates the commonalities that constitute the discourses of emergency nursing care, and also analyse nurses' language which demonstrates that within each discourse variations, contradictions and resistances exist. Emergency nursing care occurs in a context of a biomedical discourse that dominates, or tends to dominate, the work of the emergency setting and so to determine acceptable or possible practices. Nevertheless, nurses contest in various ways the ‘truths' that they understand to underpin their practice. Challenges to biomedical discourses are revealed, to some extent, by drawing attention to specific situations and particular struggles encountered in emergency nurses' everyday practice. (shrink)

Methodologies of poststructuralist theory and critical social theory may be appropriated for nursing research and practice. Researchers using either methodology employ an analysis of power to explore experiences in various fields, and raise issues diat are highly relevant to nursing. However, the two methodologies differ and, often, die respective dieories are sharply opposed. In diis paper, die differences bodi from widiin and between each approach are explored, showing dieir tensions and limits. I contend that a reflexive approach to discourse analysis (...) provides insight into some of die methodological challenges diat arise in die context of bodi dieories. It is argued diat die differences between poststructuralism and critical social dieory seem likely to be mellowed by encounters diat treat each other with respect. To some extent, such encounters may tend to converge die two positions. (shrink)

There is little information about the content of ethics consultations in pediatrics. We sought to describe the reasons for consultation and ethical principles addressed during EC in pediatrics through retrospective review and directed content analysis of EC records at St. Jude Children's Research Hospital. Patient-based EC were highly complex and often involved evaluation of parental decision making, particularly consideration of the risks and benefits of a proposed medical intervention, and the physician's fiduciary responsibility to the patient. Nonpatient consultations provided guidance (...) in the development of institutional policies that would broadly affect patients and families. This is one of the few existing reviews of the content of pediatric EC and indicates that the distribution of ethical issues and reasons for moral distress are different than with adults. Pediatric EC often facilitates complex decision making among multiple stakeholders, and further prospective research is need.. (shrink)

This paper examines how three Dutch political parties employ the Internet as a tool to enhance ‘digital democracy’. The potential of digital democracy is considered to be strongest in the sphere of collective action outside the domain of political institutions. In this article, however, attention is given to how institutionalized channels might be supportive of digital democracy. Three components of the democratic process – information provision, deliberation, and political decision-making – are examined in the content and user assessments of the (...) web sites of the Socialist Party, the Christian Democratic Party and the Green Party. Minor differences were found in the party web sites regarding information provision; substantial differences were found regarding the degree and nature of political deliberation available on the sites. Indicators of the third component, political decision-making, were least evident on all three web sites. User assessments of the sites and opportunities for political deliberation followed, more or less, the general public images of the related political parties. (shrink)

From ancient times to the present, the discovery and presentation of new proofs of previously established theorems has been a salient feature of mathematical practice. Why? What purposes are served by such endeavors? And how do mathematicians judge whether two proofs of the same theorem are essentially different? Consideration of such questions illuminates the roles that proofs play in the validation and communication of mathematical knowledge and raises issues that have yet to be resolved by mathematical logicians. The Appendix, in (...) which several proofs of the Fundamental Theorem of Arithmetic are compared, provides a miniature case study. (shrink)

Genomic sequencing is becoming more common both in clinical practice and as a routine aspect of much research. Over the last 15 years there has been ongoing discussion about the implications of gen...

Raanan Gillon is a noted defender of the four principles approach to healthcare ethics. His general position has always been that these principles are to be considered to be both universal and prima facie in nature. In recent work, however, he has made two claims that seem to present difficulties for this view. His first claim is that one of these four principles, respect for autonomy, has a special position in relation to the others: he holds that it is first (...) among equals. We argue that this claim makes little sense if the principles are to retain their prima facie nature. His second claim is that cultural variation can play an independent normative role in the construction of our moral judgments. This, he argues, enables us to occupy a middle ground between what he sees as the twin pitfalls of moral relativism and moral imperialism. We argue that there is no such middle ground, and while Gillon ultimately seems committed to relativism, it is some form of moral imperialism that will provide the only satisfactory construal of the four principles as prima facie universal moral principles. (shrink)

The ‘managed care’ idea: implications for health service systems in Australia The growth of corporatism in health‐care in the US, and the consequences arising from US models of health‐care delivery systems provide an enormously valuable point of comparison with health systems of other developed economies, such as Australia. If lessons are to be learnt from the US, then an analysis of the structure and performance of the US health‐care system provides important background for understanding and assessing contemporary policy changes to (...) administrative and organizational designs and techniques for patient care in Australia. (shrink)