Drug Safety Communications are used by the Food and Drug Administration to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone (...) between July 1, 2012 and June 30, 2013. Among the 594 respondents, two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited. Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep and seek out more information about the safety of their specific sleeping pill. Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications. (shrink)

Medium- and high-spin states of Pr-134 were populated using the Cd-116(Na-23, 5n) reaction and studied with the GAMMASPHERE spectrometer. Several new bands have been found in this nucleus, one of them being linked to the previously observed chiral-candidate twin-band structure. The ground state of Pr-134 could be determined through establishing a level structure that connects the two previously known long-lived isomeric states. Unambiguous spin-parity assignments for the excited states could be performed based on the known 2(-) spin-parity of the ground (...) state combined with the present experimental data. Intrinsic single-particle configurations have been assigned to the newly observed bands on the basis of the measured B(M1)/B(E2) ratios, alignments, band-crossing frequencies, bandhead spins, the observed single-particle configurations in the neighboring nuclei, and taking into account the predictions of total Routhian surface and tilted-axis cranking calculations. (shrink)

This book presents a collection of contemporary discourses that reconsider the relationship of democracy as a political ideology and American ideal and education as the foundation of preparing democratic citizens in America.

This paper was motivated by what we see as an inconsistency between a 1988 paper by Brennan and Buchanan expressing concern that public choice might erode public confidence in government and previous work by Buchanan, in particular Buchanan. The one advantage we saw with the 1988 paper was that it, all by itself, is all one needs to dismiss MacLean’s depiction of Buchanan as an ideologically rigid extremist. We also found the same inconsistency occurring simultaneously in Buchanan’s writing in 1979. (...) Yet, based on Wagner, we conclude that such inconsistencies may reflect a strength in Buchanan’s scholarship. (shrink)

In the management and business ethics literatures, stakeholder engagement has been demonstrated to lead to more ethical management practices. However, there may be limits on the extent to which stakeholder engagement can, as currently conceptualized, resolve some of the more difficult ethical challenges faced by managers. In this paper we argue that stakeholder engagement, when seen as a way of reducing five types of knowledge problems—risk, ambiguity, complexity, equivocality, and a priori irreducible uncertainty—can aid managers in resolving such ethical challenges. (...) Using a practical illustration of the ethical challenges surrounding the development and application of genetic modification technologies, we demonstrate how stakeholder engagement enables managers to better address these knowledge problems, thereby to manage more ethically. In this way, we suggest that stakeholder engagement has an even more crucial role to play in business ethics research and practice. (shrink)

Background: The Clinical Ethics Residency for Nurses was offered selectively to nurses affiliated with two academic medical centers to increase confidence in ethical decision-making. Research Question/Aim: To discover how effective the participants perceived the program and if their goals of participation had been met. Research design: A total of 65 end-of-course essays (from three cohorts) were analyzed using modified directed content analysis. In-depth and recursive readings of the essays by faculty were guided by six questions that had been posed to (...) graduates. Ethical considerations: Institutional review board approval was granted for the duration of the program and its reporting period. Confidentiality was maintained via the use of codes for all evaluations including the essays and potentially identifying content redacted. Findings: An umbrella theme emerged: participants had developed ethical knowledge and skills that provided a “moral compass to navigate the many gray areas of decision-making that confront them in daily practice.” Six major themes corresponding to questions posed to the participants included the ability to advocate for good patient care; to support and empower colleagues, patients, and families; they experienced personal and professional transformation; they valued the multimodal nature of the program; and were using their new knowledge and skills in practice. However, they also recognized that their development as moral agents was an ongoing process. Discussion: Findings support that enhancing nurse confidence in their moral agency with a multimodal educational approach that includes mentored practice in ethical decision-making, enhancing communication skills and role-play can mitigate moral distress. A majority found the program personally and professionally transformative. However, they recognized that ongoing ethics discussion involvement and supportive environments would be important in their continued development of ethical agency. Conclusion: Multimodal ethics education programs have potential to be transformative and enhance nurse confidence in their ethical decision-making. (shrink)

Using as a springboard a three-way debate between theoretical physicist Lee Smolin, philosopher of science Nancy Cartwright and myself, I address in layman’s terms the issues of why we need a unified theory of the fundamental interactions and why, in my opinion, string and M-theory currently offer the best hope. The focus will be on responding more generally to the various criticisms. I also describe the diverse application of string/M-theory techniques to other branches of physics and mathematics which render the (...) whole enterprise worthwhile whether or not “a theory of everything” is forthcoming. (shrink)

Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. Methods Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. Results 123 youth completed the questionnaire (mean age=15 (...) years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly. Conclusions Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking. (shrink)

The contributors to The Moral of the Story, all preeminent political theorists, are unified by their concern with the instructive power of great literature. This thought-provoking combination of essays explores the polyvalent moral and political impact of classic world literatures on public ethics through the study of some of its major figures-including Shakespeare, Dante, Cervantes, Jane Austen, Henry James, Joseph Conrad, Robert Penn Warren, and Dostoevsky. Positing the uniqueness of literature's ability to promote dialogue on salient moral and intellectual virtues, (...) editor Henry T. Edmonson III has culled together a wide-ranging exploration of such fundamental concerns as the abuse of authority, the nature of good leadership, the significance of "middle class virtues" and the needs of adolescents. This collection reinvigorates the study of classic literature as an endeavor that is not only personally intellectually satisfying, but also an inimitable and unique way to enrich public discourse. (shrink)

Research on language processing has shown that the disruption of conceptual integration gives rise to specific patterns of event-related brain potentials —N400 and P600 effects. Here, we report similar ERP effects when adults performed cross-domain conceptual integration of analogous semantic and mathematical relations. In a problem-solving task, when participants generated labeled answers to semantically aligned and misaligned arithmetic problems, the second object label in misaligned problems yielded an N400 effect for addition problems. In a verification task, when participants judged arithmetically (...) correct but semantically misaligned problem sentences to be “unacceptable,” the second object label in misaligned sentences elicited a P600 effect. Thus, depending on task constraints, misaligned problems can show either of two ERP signatures of conceptual disruption. These results show that well-educated adults can integrate mathematical and semantic relations on the rapid timescale of within-domain ERP effects by a process akin to analogical mapping. (shrink)

Almost 40 years ago, scholars identified a “chilly climate” for women in college classrooms. To examine whether contemporary college classrooms remain “chilly,” we conducted quantitative and qualitative observations in nine classrooms across multiple disciplines at one elite institution. Based on these 95 hours of observation, we discuss three gendered classroom participation patterns. First, on average, men students occupy classroom sonic space 1.6 times as often as women. Men also speak out without raising hands, interrupt, and engage in prolonged conversations during (...) class more than women students. Second, style and tone also differ. Men’s language is assertive, whereas women’s is hesitant and apologetic. Third, professors’ interventions and different structures of classrooms can alter existing gender status hierarchies. Extending Ridgeway’s gender system framework to college classrooms, we discuss how these gendered classroom participation patterns perpetuate gender status hierarchies. We thus argue that the chilly climate is an underexplored mechanism for the stalled gender revolution. (shrink)

Background: Recent changes to regulatory guidance in the US and Europe have complicated oversight of secondary research by rendering most uses of de-identified data exempt from human subjects oversight. To identify the implications of such guidelines for harms to participants and communities, this paper explores the secondary uses of one de-identified DNA sample collection with limited oversight: the Human Genome Diversity Project (HGDP)-Centre d'Etude du Polymorphisme Humain, Fondation Jean Dausset (CEPH) Human Genome Diversity Panel. Methods: Using a combination of keyword (...) and cited reference search, we identified English-language scientific articles published between 2002 and 2009 that reported analysis of HGDP Diversity Panel samples and/or data. We then reviewed each article to identify the specific research use to which the samples and/or data was applied. Secondary uses were categorized according to the type and kind of research supported by the collection. Results: A wide variety of secondary uses were identified from 148 peer-reviewed articles. While the vast majority of these uses were consistent with the original intent of the collection, a minority of published reports described research whose primary findings could be regarded as controversial, objectionable, or potentially stigmatizing in their interpretation. Conclusions: We conclude that potential risks to participants and communities cannot be wholly eliminated by anonymization of individual data and suggest that explicit review of proposed secondary uses, by a Data Access Committee or similar internal oversight body with suitable stakeholder representation, should be a required component of the trustworthy governance of any repository of data or specimens. (shrink)

Between 1940 and 1960, the British Government became increasingly concerned with the welfare of students coming to Britain from the dependent territories of the Commonwealth. The reasons were political, cultural, and economic. This essay traces the transition of official attitudes, from modest promotion to active policy. With the coming ‘end of Empire’, Britain chose a role that combined cooperation with the Commonwealth with future membership in the European community.

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)

This paper is a study about Philadelphia’s comprehensive user engagement sites (CUESs) as the authors address and examine issues related to the upcoming implementation of a CUES while seeking solutions for its disputed questions and plans. Beginning with the federal drug schedules, the authors visit some of the medical and public health issues vis-à-vis safe injection facilities (SIFs). Insite, a successful Canadian SIF, has been thoroughly researched as it represents a paradigm for which a Philadelphia CUES can expand upon. Also, (...) the existing criticisms against SIFs are revisited while critically unpackaged and responded to in favor of the establishment. In the main section, the authors propose the layout and services of the upcoming CUES, much of which would be in congruent to Vancouver’s Insite. On the other hand, the CUES would be distinct from Insite, as the authors emphasize, in that it will offer an information center run by individuals in recovery and place additional emphasis on early education for young healthcare professionals by providing them a platform to work at the site. The paper will also briefly investigate the implementation of a CUES site under an ethical scope of the Harm Reduction Theory. Lastly, the authors recommend some strategic plans that the Philadelphia City government may consider employing at this crucial stage. (shrink)

Background: Attending surgeons must maintain balance between promoting education and assuring safe, transparent patient care. This investigation aimed to define ethics that guide surgical training. We hypothesized that resident autonomy in the operating room is influenced by attending approach to patients, specifically patients considered to be vulnerable. Materials and Methods: After IRB approval, surgeons from three institutions were invited to participate in a pilot, survey, exploring how principles of patient autonomy, physician beneficence, nonmaleficence, and justice apply to participant opinions. Responses (...) were transcribed and coded for quantitative and qualitative analysis. Results: 51 attendings and 55 residents completed the survey. We identified that patient autonomy is upheld through transparent consent practices. Intraoperative supervision is a key practice that maintains the principles of physician beneficence and nonmaleficence and mitigates the risk of resident participation. Vulnerable patients were defined by respondents as those unable to participate in their own consent and those limited by social determinants of health and barriers to medical literacy. In contrast, resident participation is not limited in the care of vulnerable patients but is restricted in cases of higher complexity and those procedures deemed to have lower error margins. Conclusions: Although residents measure the success of their training based on their level of intraoperative independence, autonomy afforded to the resident does not only depend on objective skill. There are ethical considerations that the attending must navigate as they decide on effective teaching and safe surgical management, which is especially relevant in the care of complex cases. (shrink)

Although considerable research indicates that mental energy is an important factor in many domains, including athletic performance (Cook & Davis, 2006), athletic mental energy (AME) has never been conceptualized and measured. Therefore, the aim of this study was to conceptualize and develop a reliable and valid instrument to assess athletic mental energy. In Study 1, a focus group interview established the initial framework of athletic mental energy. Study 2 used a survey to collect athletes’ experiences of athletic mental energy and (...) develop a scale draft titled “Athletic Mental Energy Scale (AMES).” In Study 3, we examined the psychometric properties and the underlying structure of AMES via item analysis, internal consistency, and exploratory factor analysis (EFA). In Study 4, we used confirmatory factor analysis (CFA) to examine AMES’s factorial validity; and examined concurrent and discriminant validity by examining correlations with athletes’ life stress, positive state of mind, and burnout. In study 5, we examined the measurement invariance of the 6-factor, 18-item AMES with Taiwanese and Malaysian samples. Study 6 examined the predictive validity by comparing AMES scores of successful and unsuccessful martial artists. Across these phases, results showed a 6-factor, 18-item AMES had adequate content validity, factorial structure, nomological validity, discriminant validity, predictive validity, measurement invariance, and reliability. We suggest future studies may use AMES to examine its relationships with athletes’ cognition, affect, and performance. The application of AMES in sport psychology was also discussed. (shrink)

A situated agent is one which operates within an environment. In most cases, the environment in which the agent exists will be more complex than the agent itself. This means that an agent, human or artificial, which wishes to carry out non-trivial operations in its environment must use techniques which allow an unbounded world to be represented within a cognitively bounded agent. We present a brief description of some important theories within the fields of epistemology and metaphysics. We then discuss (...) ways in which philosophical problems of scepticism are related to the problems faced by knowledge representation. We suggest that some of the methods that philosophers have developed to address the problems of epistemology may be relevant to the problems of representing knowledge within artificial agents. (shrink)

Rationale: Deep brain stimulation (DBS) of the hippocampus is proposed for enhancement of memory impaired by injury or disease. Many pre-clinical DBS paradigms can be addressed in epilepsy patients undergoing intracranial monitoring for seizure localization, since they already have electrodes implanted in brain areas of interest. Even though epilepsy is usually not a memory disorder targeted by DBS, the studies can nevertheless model other memory-impacting disorders, such as Traumatic Brain Injury (TBI). Methods: Human patients undergoing Phase II invasive monitoring for (...) intractable epilepsy were implanted with depth electrodes capable of recording neurophysiological signals. Subjects performed a delayed-match-to-sample (DMS) memory task while hippocampal ensembles from CA1 and CA3 cell layers were recorded to estimate a multi-input, multi-output (MIMO) model of CA3-to-CA1 neural encoding and a memory decoding model (MDM) to decode memory information from CA3 and CA1 neuronal signals. After model estimation, subjects again performed the DMS task while either MIMO-based or MDM-based patterned stimulation was delivered to CA1 electrode sites during the encoding phase of the DMS trials. Each subject was sorted (post hoc) by prior experience of repeated and/or mild-to-moderate brain injury (RMBI), TBI, or no history (control) and scored for percentage successful delayed recognition (DR) recall on stimulated vs. non-stimulated DMS trials. The subject’s medical history was unknown to the experimenters until after individual subject memory retention results were scored. Results: When examined compared to control subjects, both TBI and RMBI subjects showed increased memory retention in response to both MIMO and MDM-based hippocampal stimulation. Furthermore, effects of stimulation were also greater in subjects who were evaluated as having pre-existing mild-to-moderate memory impairment. Conclusion: These results show that hippocampal stimulation for memory facilitation was more beneficial for subjects who had previously suffered a brain injury (other than epilepsy), compared to control (epilepsy) subjects who had not suffered a brain injury. This study demonstrates that the epilepsy/intracranial recording model can be extended to test the ability of DBS to restore memory function in subjects who previously suffered a brain injury other than epilepsy, and support further investigation into the beneficial effect of DBS in TBI patients. (shrink)

Colorado has consistently had one of the highest rates of suicide in the United States, and El Paso County has the highest number of suicide and firearm-related suicide deaths within the state. Community-based solutions like those of the Suicide Prevention Collaborative of El Paso County may be more effective in preventing suicide as they are specific to local issues, sensitive to local culture, and informed by local data, community members, and stakeholders.

Ever since Plato’s ‘Republic’ was written over two thousand years ago, one of the main concerns of social philosophy and later empirical social science was to understand the moral nature of human beings. The faculty to think and act in terms of overarching moral values is as much a defining hallmark of our species as is our intelligence, so _homo moralis_ is no less an appropriate term to describe humans as _homo sapiens_. This volume makes a case for the pivotal (...) role of social psychology as the core discipline for studying morality. The book is divided into four parts. First, the role of social psychological processes in moral values and judgments is discussed, followed by an analysis of the role of morality in interpersonal processes. The sometimes paradoxical, ironic effects of moral beliefs are described next, and in the final section the role of morality in collective and group behavior is considered. This book will be of interest to students and researchers in the social and behavioral sciences concerned with moral behavior, as well as professionals and practitioners in clinical, counseling, organizational, marketing and educational psychology where issues of ethics and morality are of importance. (shrink)

In this consensus report by a diverse group of academics who conduct and/or are concerned about social and behavioral genomics (SBG) research, the authors recount the often‐ugly history of scientific attempts to understand the genetic contributions to human behaviors and social outcomes. They then describe what the current science—including genomewide association studies and polygenic indexes—can and cannot tell us, as well as its risks and potential benefits. They conclude with a discussion of responsible behavior in the context of SBG research. (...) SBG research that compares individuals within a group according to a “sensitive” phenotype requires extra attention to responsible conduct and to responsible communication about the research and its findings. SBG research (1) on sensitive phenotypes that (2) compares two or more groups defined by (a) race, (b) ethnicity, or (c) genetic ancestry (where genetic ancestry could easily be misunderstood as race or ethnicity) requires a compelling justification to be conducted, funded, or published. All authors agree that this justification at least requires a convincing argument that a study's design could yield scientifically valid results; some authors would additionally require the study to have a socially favorable risk‐benefit profile. (shrink)

The use of Big Data—however the term is defined—involves a wide array of issues and stakeholders, thereby increasing numbers of complex decisions around issues including data acquisition, use, and sharing. Big Data is becoming a significant component of practice in an ever-increasing range of disciplines; however, since it is not a coherent “discipline” itself, specific codes of conduct for Big Data users and researchers do not exist. While many institutions have created, or will create, training opportunities to prepare people to (...) work in and around Big Data, insufficient time, space, and thought have been dedicated to training these people to engage with the ethical, legal, and social issues in this new domain. Since Big Data practitioners come from, and work in, diverse contexts, neither a relevant professional code of conduct nor specific formal ethics training are likely to be readily available. This normative paper describes an approach to conceptualizing ethical reasoning and integrating it into training for Big Data use and research. Our approach is based on a published framework that emphasizes ethical reasoning rather than topical knowledge. We describe the formation of professional community norms from two key disciplines that contribute to the emergent field of Big Data: computer science and statistics. Historical analogies from these professions suggest strategies for introducing trainees and orienting practitioners both to ethical reasoning and to a code of professional conduct itself. We include two semester course syllabi to strengthen our thesis that codes of conduct can be harnessed to support the development of ethical reasoning in, and a sense of professional identity among, Big Data practitioners. (shrink)

Meat is a multi-billion-dollar industry that relies on people performing risky physical work inside meat-processing facilities over long shifts in close proximity. These workers are socially disempowered, and many are members of groups beset by historic and ongoing structural discrimination. The combination of working conditions and worker characteristics facilitate the spread of SARS-CoV-2, the virus that causes COVID-19. Workers have been expected to put their health and lives at risk during the pandemic because of government and industry pressures to keep (...) this “essential industry” producing. Numerous interventions can significantly reduce the risks to workers and their communities; however, the industry’s implementation has been sporadic and inconsistent. With a focus on the U.S. context, this paper offers an ethical framework for infection prevention and control recommendations grounded in public health values of health and safety, interdependence and solidarity, and health equity and justice, with particular attention to considerations of reciprocity, equitable burden sharing, harm reduction, and health promotion. Meat-processing workers are owed an approach that protects their health relative to the risks of harms to them, their families, and their communities. Sacrifices from businesses benefitting financially from essential industry status are ethically warranted and should acknowledge the risks assumed by workers in the context of existing structural inequities. (shrink)

Humanist sociologists are activists rooted in the reality of history and change and guided by a concern for the 'real life' problems of equality, peace, and social justice. They view people as active shapers of social life, capable of creating societies in which everyone's potential can unfold. Alfred McClung Lee introduces this volume with 'Sociology: Humanist and Scientific' and develops the theme that a sociology that is humanist is also scientific. The other nine selections are grouped into four parts: 'The (...) Individual and Social Life;' 'Social Institutions: Technology, Science, and Formal Organization;' 'Political Structures: Issues of Justice and Equality;' and 'Methodological Critiques and Counterproposals.'. (shrink)

Over 40 years of research have shown that traumatic brain injury affects brain volume. However, technical and practical limitations made it difficult to detect brain volume abnormalities in patients suffering from chronic effects of mild or moderate traumatic brain injury. This situation improved in 2006 with the FDA clearance of NeuroQuant®, a commercially available, computer-automated software program for measuring MRI brain volume in human subjects. More recent strides were made with the introduction of NeuroGage®, commercially available software that is based (...) on NeuroQuant® and extends its utility in several ways. Studies using these and similar methods have found that most patients with chronic mild or moderate traumatic brain injury have brain volume abnormalities, and several of these studies found—surprisingly—more abnormal enlargement than atrophy. More generally, 102 peer-reviewed studies have supported the reliability and validity of NeuroQuant® and NeuroGage®. Furthermore, this updated version of a previous review addresses whether NeuroQuant® and NeuroGage® meet the Daubert standard for admissibility in court. It concludes that NeuroQuant® and NeuroGage® meet the Daubert standard based on their reliability, validity, and objectivity. Due to the improvements in technology over the years, these brain volumetric techniques are practical and readily available for clinical or forensic use, and thus they are important tools for detecting signs of brain injury. (shrink)

The sixteen essays in Gender Struggles address a wide range of issues in gender struggles, from the more familiar ones that, for the last thirty years, have been the mainstay of feminist scholarship, such as motherhood, beauty, and sexual violence, to new topics inspired by post-industrialization and multiculturalism, such as the welfare state, cyberspace, hate speech, and queer politics, and finally to topics that traditionally have not been seen as appropriate subjects for philosophizing, such as adoption, care work, and the (...) home. (shrink)