This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to (...) guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview. (shrink)

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes (...) oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight. (shrink)

Within psychology, at least two research communities study spatial cognition. One community studies systematic errors in spatial memory and judgement, accounting for them as a consequence of and clue to normal perceptual and cognitive processing. The other community studies navigation in real space, isolating the contributions of various sensory cues and sensori- motor systems to successful navigation. The former group emphasizes error, the latter, selective mechanisms, environmental or evolutionary, that produce fine-tuned correct responses. How can these approaches be reconciled and (...) integrated? First, by showing why errors are impervious to selective pressures. The schematization that leads to errors is a natural consequence of normal perceptual and cognitive processes; it is inherent to the construction of mental spaces and to using them to make judgments in limited capacity working memory. Selection can act on particular instances of errors, yet it is not clear that selection can act on the general mechanisms that produce them. Next, in the wild, there are a variety of correctives. Finally, closer examination of navigation in the wild shows systematic errors, for example, over-shooting in dead reckoning across species. Here, too, environments may provide correctives, specifically, landmarks. General cognitive mechanisms generate general solutions. The errors inevitably produced may be reduced by local specific sensori-motor couplings as well as local environmental cues. Navigation, and other behaviors as well, are a consequence of both. (shrink)

In order to make scientific results relevant to practical decision making, it is often necessary to transfer a result obtained in one set of circumstances—an animal model, a computer simulation, an economic experiment—to another that may differ in relevant respects—for example, to humans, the global climate, or an auction. Such inferences, which we can call extrapolations, are a type of argument by analogy. This essay sketches a new approach to analogical inference that utilizes chain graphs, which resemble directed acyclic graphs (...) (DAGs) except in allowing that nodes may be connected by lines as well as arrows. This chain graph approach generalizes the account of extrapolation I provided in my (2008) book and leads to new insights that integrate the contributions of the other participants of this symposium. More specifically, this approach explicates the role of “fingerprints,” or distinctive markers, as a strategy for avoiding an underdetermination problem having to do with spurious analogies. Moreover, it shows how the extrapolator’s circle, one of the central challenges for extrapolation highlighted in my book, is closely tied to distinctive markers and the Markov condition as it applies to chain graphs. Finally, the approach suggests additional ways in which investigations of a model can provide information about a target that are illustrated by examples concerning nanomaterials in sunscreens and Wendy Parker’s discussion of fingerprints in climate science. (shrink)

One hundred years after Luigi Russolo's "The Art of Noises," this book exposes a cross-section of the current motivations, activities, thoughts, and reflections of composers, performers, and artists who work with noise in all of its many forms. The book's focus is the practice of noise and its relationship to music, and in particular the role of noise as musical material--as form, as sound, as notation or interface, as a medium for listening, as provocation, as data. Its contributors are first (...) and foremost practitioners, which inevitably turns attention toward how and why noise is made and its potential role in listening and perceiving. Contributors include Peter Ablinger, Sebastian Berweck, Aaron Cassidy, Marko Ciciliani, Nick Collins, Aaron Einbond, Matthias Haenisch, Alec Hall, Martin Iddon, Bryan Jacobs, Phil Julian, Michael Maierhof, Joan Arnau Pàmies, and James Whitehead (JLIAT). The book also features a collection of short responses to a two-question "interview"--"what is noise (music) to you?" and "why do you make it?"--by some of the leading musicians working with noise today. Their work spans a wide range of artistic practice, including instrumental, vocal, and electronic music; improvisation; notated composition; theater; sound installation; DIY; and software development. Interview subjects include Eryck Abecassis, Franck Bedrossian, Antoine Chessex, Ryan Jordan, Alice Kemp (Germseed), George Lewis, Lasse Marhaug, Maja Solveig Kjelstrup Ratkje, Diemo Schwarz, Ben Thigpen, Kasper Toeplitz, and Pierre Alexandre Tremblay."--Page 4 of covers. (shrink)

Wakefield’s harmful dysfunction analysis asserts that the concept of medical disorder includes a naturalistic component of dysfunction and a value component, both of which are required for disorder attributions. Muckler and Taylor, defending a purely naturalist, value-free understanding of disorder, argue that harm is not necessary for disorder. They provide three examples of dysfunctions that, they claim, are considered disorders but are entirely harmless: mild mononucleosis, cowpox that prevents smallpox, and minor perceptual deficits. They also reject the proposal that dysfunctions (...) need only be typically harmful to qualify as disorders. We argue that the proposed counterexamples are, in fact, considered harmful; thus, they fail to disconfirm the harm requirement: incapacity for exertion is inherently harmful, whether or not exertion occurs, cowpox is directly harmful irrespective of indirect benefits, and colorblindness and anosmia are considered harmful by those who consider them disorders. We also defend the typicality qualifier as viably addressing some apparently harmless disorders and argue that a dysfunction’s harmfulness is best understood in dispositional terms. (shrink)

Cheaters and noncheaters were assessed on 2 types of motivation, on perceived social norms regarding cheating, on attitudes about cheating, and on knowledge of institutional policy regarding cheating behavior. All 5 factors were significant predictors of cheating rates. In addition, cheaters were found lower in mastery motivation and higher in extrinsic motivation in courses in which they cheated than in courses in which they did not cheat. Cheaters, in courses in which they cheated, were also lower in mastery motivation and (...) higher in extrinsic motivation than were noncheaters. Finally, cheaters differed from noncheaters on perceived social norms regarding cheating, on their knowledge of institutional policy regarding cheating, and on their attitudes toward cheating. Implications of these findings for institutional interventions are discussed. (shrink)

Presents a portrait of Alamaba rivers, from their origins in the Appalachian highlands to their confluence with the Gulf of Mexico, and promotes the stewardship and preservation of these natural regions.

In ‘Rethinking Disease’, Powell and Scarffe1 propose what in effect is a modification of Jerome Wakefield’s2 3 harmful dysfunction analysis of medical disorder. The HDA maintains that ‘disorder’ is a hybrid factual and value concept requiring that a biological dysfunction, understood as a failure of some feature to perform a naturally selected function, causes harm to the individual as evaluated by social values. Powell and Scarffe accept both the HDA’s evolutionary biological function component and its incorporation of a value component. (...) Their proposed ‘new twist’ is to revise the value component: ‘Our proposed definition of disease is as follows: a biomedical state is a disease only if it implicates a biological dysfunction that is, or would be, properly disvalued’. So, they propose that a disorder is a ‘properly disvalued dysfunction’ rather than a ‘harmful dysfunction’, an approach they term ‘thickly normative’ in contrast to the thin normative approach of the HDA. There has been a surge of interest recently in better understanding the ‘harm’ component of the HDA. Powell and Scarffe’s analysis is a helpful contribution to this discussion. We focus here exclusively on their proposal regarding the analysis of the concept of disorder and ignore many important related issues that the authors address, ranging from prioritising resource allocation between disorders and non-disorders to whether the concept of disorder should be replaced by a generic welfarist concept. The resolution of these additional issues depends on first understanding ‘disorder’. The authors’ proposed changes to the HDA also deserve evaluation because the HDA, which has been endorsed by leading nosologists,4 plays an influential role in nosological debate across categories of disorder ranging, for example, from sexual paraphilias5 to psychopathy.6 A basic problem is that Powell and Scarffe misinterpret …. (shrink)

In this essay, I present three arguments for the claim that theists should reject divine command theory in favor of divine attitude theory. First, DCT implies that some cognitively normal human persons are exempt from the dictates of morality. Second, it is incumbent upon us to cultivate the skill of moral judgment, a skill that fits nicely with the claims of DAT but which is superfluous if DCT is true. Third, an attractive and widely shared conception of Jewish/Christian religious devotion (...) leads us naturally to an attitude-based conception of morality rather than a command-based one. (shrink)

What does the term academic ethics mean? How does this term relate to others in the academic integrity literature, such as research misconduct? Does conceptual confusion in the study of academic ethics complicate development of valid analyses of ethical behavior in an academic setting? The intended goal of many empirical projects on academic ethics is to draw causal conclusions about the factors that lead to faculty or students possessing or disregarding academic integrity. Yet, it is not clear that scholars using (...) the concept academic ethics are measuring the same phenomenon when they use associated concepts, such as responsible conduct of research. The purpose of this paper is to develop a taxonomy of concepts for the empirical study of academic ethics. Based in research on comparative analysis of democracy, another normatively preferable but multifaceted concept, I argue for a taxonomy of concepts for the study of academic integrity that reduces problems of “conceptual stretching” and challenges to the validity of empirical research in this field. (shrink)

Indigenous communities have always cultivated social studies learning that is interactive, dynamic, and integrated with traditional knowledges. To confront the assimilative and deculturalizing education that accompanied European settlement of the Americas, Montana has adopted Indian Education for All (IEFA). This case study evaluates the Digital Storywork Partnership (DSP), which strives to advance the goals of IEFA within and beyond the social studies classroom through community-centered research and filmmaking. Results demonstrate the potential for DSP projects to advance culturally revitalizing education, community (...) connectedness, and identity-development. The DSP offers a model for social studies education that is not only culturally affirming and revitalizing for Indigenous communities, but also holds potential for use in all communities. We conclude with recommendations for educators, scholars, and community members engaged in similar efforts. (shrink)

In the age of the digital generation, written public data is ubiquitous and acts as an outlet for today's society. Platforms like Facebook, Twitter, Google+ and LinkedIn have profoundly changed how we communicate and interact. They have enabled the establishment of and participation in digital communities as well as the representation, documentation and exploration of social behaviours, and had a disruptive effect on how we use the Internet. Such digital communications present scholars with a novel way to detect, observe, analyse (...) and understand online communities over time. This article presents the formalization of a Social Observatory: a low latency method for the observation and measurement of social indicators within an online community. Our framework facilitates interdisciplinary research methodologies via tools for data acquisition and analysis in inductive and deductive settings. By focusing our Social Observatory on the public Facebook profiles of 187 federal German politicians we illustrate how we can analyse and measure sentiment, public opinion, and information discourse in advance of the federal elections. To this extent, we analysed 54,665 posts and 231,147 comments, creating a composite index of overall public sentiment and the underlying conceptual discussion themes. Our case study demonstrates the observation of communities at various resolutions: “zooming” in on specific subsets or communities as a whole. The results of the case study illustrate the ability to observe published sentiment and public dialogue as well as the difficulties associated with established methods within the field of sentiment analysis within short informal text. (shrink)

The term "human dignity" is the source of considerable confusion in contemporary bioethics. It has been used by Kantians to refer to autonomy, by others to refer to the sanctity of life, and by still others to refer—albeit obliquely—to an important but infrequently discussed set of human goods. In the first part of this article, I seek to disambiguate the notion of human dignity. The second part is a defense of the philosophical utility of such a notion; I argue that (...) there is nothing implausible about appealing to a deontological "principle of dignity" to solve bioethical problems, especially those concerning the development of new biotechnologies. There may, however, be problems associated with any attempt to use dignity as a basis for public policy. This sort of worry is explained and briefly addressed in the final section. (shrink)

Consider the proposition that: A: "while it is impermissible, epistemically or morally, to believe the propositions of theism as they lack sufficient evidence, it is permissible, epistemically or morally, to hope that those propositions are true and thereby to act as if they are true." I examine a problem facing anyone who endorses (A), and advocates erecting the superstructure of theistic commitment on a base of theistic hope. Concisely put, those who endorse (A) will very likely violate the evidentialist standards (...) which drove them toward (A) in the first place. This problem is in many respects a simple one, but even so, an intractable problem rendering conformity to (A) problematic. (shrink)

How far is Thomas Aquinas available for current discussions in political philosophy? While there are certainly things to be learned from him about our political preoccupations, the pedagogy of his moral teaching typically resists our familiar questions. This holds even when the question is put in terms that Thomas should recognize—say, as a question about the virtues appropriate for a democracy. Thomas not only gives different meanings to these terms, he moves political topics away from the center of theological attention (...) and so organizes them very differently. A reader can notice these differences at many points but perhaps especially in the attention that Thomas gives in the Summa to the gifts of the Holy Spirit. His account of these gifts qualifies significantly what he says of virtue and suggests large limits on human agency, whether in ethics or in politics. (shrink)

Here, some of the most influential thinkers in theological and philosophical ethics develop new directions for research in contemporary moral thought. Taking as their starting point Ricoeur's recent work on moral anthropology, the contributors set a vital agenda for future conversations about ethics and just community.

Growing opioid misuse in the United States has resulted in more children living with an adult with an opioid use history. Although an abundance of research has demonstrated a link between opioid misuse and negative parenting behaviors, few intervention efforts have been made to target this underserved population. The Family Check-Up has been tested in more than 25 years of research, across multiple settings, and is an evidence-based program for reducing risk behavior, enhancing parenting skills, and preventing the onset of (...) substance use. It is designed to motivate parents to engage in positive parenting practices and to change problematic parenting and has been tested across a variety of ages including early childhood and adolescence. It is highlighted in NIDA’s Principles of Substance Use Prevention for Early Childhood: A research-based guide as one of only three effective selective prevention programs for substance abuse among families with young children. Recently, we developed an online version of the FCU that has now been adapted for early childhood and families with opioid use histories. The online platform and telehealth model allow for wide-scale dissemination, ease of training with community providers, and increased public health reach for families in remote, rural areas. This is particularly important when targeting families with opioid misuse and addiction because there are high rates of addiction in remote areas, yet few services available. In this article, we describe the FCU Online and review new content in the model that targets a population of young adult parents with substance abuse histories, including opioid use. New modules include content focused on harm reduction for this high-risk population of parents, such as safety in the home, substance use while parenting, and managing conflict with partners and friends. (shrink)

This article examines clinical wisdom, which has emerged from a broader study about nurse managers' influence on proficient registered nurse turnover and retention. The purpose of the study was to increase understanding of proficient nurses' experience and clinical practice by giving voice to the nurses themselves, and to look for differences in their practice. This was a qualitative study based on semistructured interviews followed by analysis founded on Gadamerian hermeneutics. The article describes how proficient nurses experience their practice. Proficient practice (...) constitutes clinical wisdom based on responsibility, thinking and ethical discernment, and a drive for action. The study showed that poor working conditions cause proficient nurses to regress to non-proficient performance. Further studies are recommended to allow deeper searching into the area of working conditions and their relationship to lack of nurse proficiency. (shrink)

This is the first description of the questions that clinicians ask a department of clinical law, relating to the legal rules applicable to the care of their patients.ObjectivesTo describe in detail the demography of clinical legal enquiries made by clinicians of all professions concerning the care of their patients. To collate and categorise the varieties of enquiry, to identify phenotypic patterns. To provide colleges, regulators, commissioners, educators and the NHS with an insight into hitherto undescribed subject matter, better to understand (...) and respond to this aspect of clinical practice.DesignProspective collection of all clinical legal referrals recorded in writing over 12 years by a department of clinical law.SettingAn English Tertiary Hospital NHS Trust.ParticipantsClinical staff of the regulated professions, all seeking to have their clinical legal enquiries answered.Main outcome measuresThe description of the demography of clinical law.Results1251 written records were identified and reviewed. These were divided into nine broad clinical legal subject areas (domains): mental disorders, parents and children, incapacity, consent for treatment, disclosure of private information, other statutory, regulated practice, professional practice, clinical practice. Within these, 149 clinical legal phenotypes were identified to which each case could be assigned.ConclusionsAmong a broad range of enquiries, recognisable clinical legal phenotypes exist and have for the first time been described and categorised. These are clinical situations which clinicians need to be able to recognise and equipped to deal with. Doing so will likely facilitate timely and better treatment. (shrink)

We reflect on our experience co-teaching a medical humanities elective, “Pandemics and Plagues,” which was offered to undergraduates during the Spring 2021 semester, and discuss student reactions to studying epidemic disease from multidisciplinary medical humanities perspectives while living through the world Covid-19 pandemic. The course incorporated basic microbiology and epidemiology into discussions of how epidemics from the Black Death to HIV/AIDS have been portrayed in history, literature, art, music, and journalism. Students self-assessed their learning gains and offered their insights using (...) the SALG, describing how the course enhanced their understanding of the current pandemic. In class discussions and written assignments, students paid particular attention to issues of social justice, political context, and connections between past pandemics and Covid-19. Student responses indicate enhanced understanding of the scientific and medical aspects of epidemics and also increased appreciation of the insights to be gained from the medical humanities. We discuss co-teaching the class during a real-time, twenty-four-hour-news-cycle pandemic, and the ways in which that experience underlines the value of a “critical medical humanities” approach for undergraduates. (shrink)

Since at least the tenth century, some theists have argued that God’s sovereignty as creator exempts God from moral evaluation, and so any argument employing moral principles or the idea of God as morally perfect is fallacious. In particular, any argument contending that the occurrence of pointless evil presents strong evidence against the existence of God is flawed, as God morally owes his creation nothing. This appeal to divine sovereignty, however, fails to rescue any theistic tradition proclaiming that God loves (...) humans, as no one would be indifferent concerning the pointless suffering of her beloved. (shrink)

The review by Müller and colleagues (2015) of published case studies of neurosurgical treatment of anorexia nervosa (AN) is generally sound. However, we believe that their, somewhat surprising, pro...

The goal of this small book and accompanying DVD is to help you to have a better experience in your laboratory by getting you to step back and take a global look at what is involved in making progress in the laboratory.

At the request of the Classical Journals Board we have undertaken for the present to edit this Journal. In so doing we confidently rely upon the co-operation of those who have hitherto been contributors, as well as of others who may be in a position to assist us.