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...

As medicine and science advance, new ethical questions emerge. Over time, deliberation and analysis result in a somewhat settled approach to a problem. Often the settled approach is based on group...

As part of the regulatory review process, both the Food and Drug Administration and Office for Human Research Protections (U.S. Department of Health and Human Services [HHS]...

Volume 20, Issue 10, October 2020, Page 82-83.

Volume 20, Issue 4, May 2020, Page 111-113.

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.

Volume 20, Issue 4, May 2020, Page 8-10.

Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in (...) substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies. (shrink)

The authors of this article are previous or current members of the Clinical Ethics Consultation Affairs (CECA) Committee, a standing committee of the American Society for Bioethics and Humanities (ASBH). The committee is composed of seasoned healthcare ethics consultants (HCECs), and it is charged with developing and disseminating education materials for HCECs and ethics committees. The purpose of this article is to describe the educational research and development processes behind our teaching materials, which culminated in a case studies book called (...) A Case-Based Study Guide for Addressing Patient-Centered Ethical Issues in Health Care (hereafter, the Study Guide). In this article, we also enumerate how the Study Guide could be used in teaching and learning, and we identify areas that are ripe for future work. (shrink)

The rapid development of COVID-19 vaccines in 2020 involved an unprecedented clinical research initiative. The case here involves a Phase I clinical trial of “second-generation” COVID-19 vaccines d...

Volume 20, Issue 4, May 2020, Page 102-103.

Volume 20, Issue 10, October 2020, Page 90-91.

For many rare diseases, the availability of effective interventions is limited or non-existent. In this context, clinical research evaluating emerging interventions may be the only potentially “the...

Currently, there is consensus that community engagement and partnerships are essential to inclusive patient-centered clinical research. Yet there is variation about what it means to do this well an...

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)

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)

This study described the relationships between academic class and student moral sensitivity and reasoning and between curriculum design components for ethics education and student moral sensitivity and reasoning. The data were collected from freshman (n = 506) and senior students (n = 440) in eight baccalaureate nursing programs in South Korea by survey; the survey consisted of the Korean Moral Sensitivity Questionnaire and the Korean Defining Issues Test. The results showed that moral sensitivity scores in patient-oriented care and conflict were (...) higher in senior students than in freshman students. Furthermore, more hours of ethics content were associated with higher principled thinking scores of senior students. Nursing education in South Korea may have an impact on developing student moral sensitivity. Planned ethics content in nursing curricula is necessary to improve moral sensitivity and moral reasoning of students. (shrink)

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

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

This 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...

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)

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)

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)

Dans les stations de tourisme de montagne, les intersaisons correspondent à des creux d’activité durant lesquels les offres d’emploi alternatives sont peu nombreuses. Les saisonniers se trouvent donc confrontés à une période de chômage cyclique. Cette situation « intermédiaire », réunissant une forme d’incertitude de la relation d’emploi ainsi qu’une relative prévisibilité des périodes de recrutement n’est pas sans susciter certaines controverses. Dans ce contexte, comment sont vécues les phases de chômage saisonnier dans ces territoires? Ces séquences temporelles correspondent-elles à (...) un « temps mort » ou à un temps pluriel? Comment se négocie le temps pour soi dans le cadre d’embauches à contre-rythmes des temps sociaux dominants? Dans le cadre de cette forme d’emploi intermittente, le temps de chômage peut-il être conçu comme un temps de construction de la carrière professionnelle? Cet article s’intéresse aux formes d’adaptation aux rythmes d’emploi et de chômage des saisonniers en montagne et montre comment ces périodes hors-emploi participent de l’intériorisation de rythmicités spécifiques. (shrink)

Narrative has proven itself a continuous as well as adaptable means for environmentally oriented expression. Its role goes beyond the mediation of pre-existing knowledge imported into the realm of storytelling from other domains; rather, influential models of the natural world tend to circulate as storyworlds. This special issue of SubStance proceeds from the premise that narratives are not only a sequence of signs encoding a story but also “invisible, elusive representations that exist only in the mind”. Narrative forms generate and (...) transfer environmental knowledge; moreover, any specifically narrative concerns are important contributing factors to the models of agency, change... (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)

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)

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

Volume 19, Issue 10, October 2019, Page 97-98.

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)