Background: The traditional approach to resolving ethics concerns may not address underlying organisational issues involved in the evolution of these concerns. This represents a missed opportunity to improve quality of care “upstream”. The purpose of this study was to understand better which organisational issues may contribute to ethics concerns. Methods: Directed content analysis was used to review ethics consultation notes from an academic children’s hospital from 1996 to 2006 (N = 71). The analysis utilised 18 categories of organisational issues derived (...) and modified from published quality improvement protocols. Results: Organisational issues were identified in 68 of the 71 (96%) ethics consult notes across a range of patient settings and reasons for consultation. Thirteen of the 18 categories of organisational issues were identified and there was a median of two organisational issues per consult note. The most frequently identified organisational issues were informal organisational culture (eg, collective practices and approaches to situations with ethical dimensions that are not guided by policy), policies and procedures (eg, staff knows policy and/or procedural guidelines for an ethical concern but do not follow it) and communication (eg, communication about critical information, orders, or hand-offs repeatedly does not occur among services). Conclusions: Organisational issues contribute to ethical concerns that result in clinical ethics consults. Identifying and addressing organisational issues such as informal culture and communication may help decrease the recurrence of future similar ethics concerns. (shrink)

Health behaviors such as tobacco use contribute significantly to poor health. It is widely recognized that efforts to prevent poor health outcomes should begin in early childhood. Biomedical enhancements, such as a nicotine vaccine, are now emerging and have potential to be used for primary prevention of common diseases. In anticipation of such enhancements, it is important that we begin to consider the ethical and policy appropriateness of their use with children. The main ethical concerns raised by enhancing children relate (...) to their impact on children’s well-being and autonomy. These concerns are significant, however they do not appear to apply in the case of the nicotine vaccine; indeed the vaccine could even further these goals for children. Nevertheless, concerns about broadly applying this enhancement may be more challenging. The vaccine may be less cost-effective than alternative public efforts to prevent tobacco use, utilizing it could distract from addressing the foundational causes of smoking and it might not be publically acceptable. Empirical research about these concerns is needed to ascertain their likelihood and impact as well as how they could be minimized. This research could help determine whether behavior-related enhancements hold promise for improving children’s health. (shrink)

The target articles in this issue advance our understanding of bioethical considerations in pragmatic trials (Garland, Morain, and Sugarman 2023; Morain and Largent 2023). Both articles appreciate...

The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

Background: Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study. (...) Methods: As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes. Results: We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care. Conclusions: This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges. (shrink)

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...) negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)

The case presented here is tragic, not just in the sense of being a sad story, but in the dramatic meaning of tragedy. It presents us with a situation where there is no clear path, where moral ambiguity exists, and where no possible solution could unequivocally be declared the right or good one. Ethical deliberation can help here, but only as a way of clarifying the issues and offering reasonable solutions. It cannot show us the one right way.Baby G has (...) profound medical conditions, including respiratory failure, a chest wall deformity that will require surgery, and profound neurodevelopmental disability. Even a best case scenario portends a shortened lifespan and.. (shrink)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

In International Law and World Order, B. S. Chimni articulates an integrated Marxist approach to international law combining the insights of Marxism, socialist feminism and postcolonial theory. The book uses IMAIL to systematically and critically examine the most influential contemporary theories of international law including new, feminist, realist and policy-oriented approaches. In doing so, it discusses a range of themes relating to the history, structure and process of international law. The book also considers crucial world order issues and problems that (...) the international legal process has to contend with, including the welfare of weak groups and nations, the ecological crisis and the role of human rights. This extensively revised second edition provides an invaluable, in-depth and updated review of the key literature and scholarship within this field of study. It will be of particular interest to students and scholars of international law, international relations, international politics and global studies. (shrink)

This paper investigates a well-known case of simultaneous discovery in twentieth-century chemistry, the origins of the concept of hybridisation, in the light of Kuhn's insights. There has been no ambiguity as to who discovered this concept, when it was "rst in print, and how important it was. The full-#edged form of the concept was published in 1931 independently by two American scientists John C. Slater (1900}1976) and Linus Pauling (1901}1994), although both of them had made their ideas public earlier: Slater (...) at the American Physical Society meetings in 1930, and Pauling in the Proceedings of the National Academy of Sciences in 1928. Slater and Pauling both argued for the necessity of using an s orbital as well as three p orbitals in the carbon atom in order to explain carbon's four valences and the tetrahedral structure of methane. The metaphor &hybridisation' for denoting this mix of s and p orbitals was "rst used by Robert S. Mulliken and J. H. Van Vleck before gaining currency with the scienti"c community around 1935.2 The concept of hybridisation was indeed indispensable for extending the quantum-mechanical interpretation of the chemical bond as an electron pairing from diatomic molecules to polyatomic ones. To be sure, the emergence of hybridisation attests to scientists' growing interest in exploring the borderland between physics and chemistry, a trend that led to the creation of physical chemistry in the late nineteenth century and of chemical physics and quantum chemistry in the 1920s and 30s. Slater and Pauling themselves experienced and on many occasions talked about the fruitfulness of interdisciplinary research; and historians have legitimately illuminated their works by examining them in this broad context.3 Yet the careful analysis of their research notes and published papers reveals that Slater and Pauling were working in quite disparate disciplinary traditions, with di!erent approaches, for di!erent audiences, and towards di!erent goals. The aim of this paper is to explore their di!erent routes to a common destination*hybridisation*and thereby to explicate tensions existing between physics and chemistry amidst the institutional and conceptual overlapping of the two disciplines. (shrink)

Drawing from the Boulding''s (1956) framework for general systems theory, the need to employ richer paradigm in the study of organizations (Pondy and Mitroff, 1979) is reiterated. It is argued that a better understanding of organizational ethical behavior is contingent upon viewing organizations as symbol processing systems of shared language and meanings. Further, it is proposed that organizations, like individuals, develop into collectivities of shared cognitions and rationale, over a period of time. The study adapts Kohlberg''s (1983) model of moral (...) development to examine if organizations can be viewed as passing through different stages of moral development depending on the type of moral reasoning employed to explain their behaviors in the face of ethical crises. Several cases raising questions about the ethics of corporate behavior were researched. An instrument entitled Organization Response Analysis was constructed using statements made by various spokespersons representing five of these organizations. The instrument was administered to 246 graduate and undergraduate students of business (N = 246). Results indicated a great degree of concurrence among respondents of differing genders, levels of education and work experience in determining the stages of moral development of organizations. Limitations of the current study and implications for future research and practice are discussed. (shrink)

In his account of probable reasoning, Poincaré used the concept, or at least the language, of conventions. In particular, he claimed that the prior probabilities essential for inverse probable reasoning are determined conventionally. This paper investigates, in the light of Poincaré's well known claim about the conventionality of metric geometry, what this could mean, and how it is related to other views about the determination of prior probabilities. Particular attention is paid to the similarities and differences between Poincaré's conventionalism as (...) it applies to probabilities and de Finetti's subjectivism. The aim of the paper is to suggest that in accounts of the development of ideas about probable reasoning, particularly those customarily described as Bayesian, Poincaré's discussion deserves more attention than it has so far received. (shrink)

In his account of probable reasoning, Poincare used the concept, or at least the language, of conventions. In particular, he claimed that the prior probabilities essential for inverse probable reasoning are determined conventionally. This paper investigates, in the light of Poincare's well known claim about the conventionality of metric geometry, what this could mean, and how it is related to other views about the determination of prior probabilities. Particular attention is paid to the similarities and differences between Poincare's conventionalism as (...) it applies to probabilities and de Finetti's subjectivism. The aim of the paper is to suggest that in accounts of the development of ideas about probable reasoning, particularly those customarily described as Bayesian, Poincare's discussion deserves more attention than it has so far received. (shrink)

Simultaneous discovery in science has been a subject of close historical investigations, not only for assessing claims of priority, which occasionally generate controversy rather than consensus, but also for understanding the cultural and intellectual context of the time. Thomas S. Kuhn is a pioneer in the contextual study of simultaneous discovery, and his paper on the formulation of the first law of thermodynamics has already become a classic.

This paper addresses whether universal, general education programs are enough to satisfy basic criteria of human rights, or whether comprehensive family planning programs, in conjunction with universal education programs, might also be morally required. Even before the Reagan administration instituted the ‘global gag rule’ at the 1984 conference in Mexico City, prohibiting funding to nongovernmental organizations that included providing information about abortion as a possible method of family planning, the moral acceptability of family planning programs has been called into question. (...) This paper makes a moral argument for family planning by appealing to both data and to theory: data about the efficacy of universal and comprehensive family planning education programs at reducing fertility and infant mortality, and theory about what is required for the establishment of autonomy. It reasons that universal educational programs are insufficient for the promotion of autonomy, and therefore argues on substantive autonomy grounds for comprehensive family planning programs in addition to universal education programs. (shrink)