This paper argues that the Food and Drug Administration’s (FDA) policy for health and wellness apps is ethically problematic. Currently, the FDA does not regulate health and wellness apps that are not intended for medical use. As a result of this hands‐off policy, preventing harm to consumers is left primarily to developers and app marketplaces. We argue that the FDA’s duties to prevent harm and maintain accountability to the American public require that they play a much stronger role. We also (...) discuss concerns about efficiency and fostering innovation, and argue that while they should help shape FDA regulation of health and wellness apps, they do not justify complete absence of FDA involvement. -/- . (shrink)

The first English translation of Fichte’s second set of 1804 lectures on the Wissenschaftslehre.

This dissertation argues for a particular interpretation of John Stuart Mill’s utilitarianism, namely that Mill is best read as a sanction utilitarian. In general, scholars commonly interpret Mill as some type of act or rule utilitarian. In making their case for these interpretations, it is also common for scholars to use large portions of Mill’s Utilitarianism as the chief source of insight into his moral theory. By contrast, I argue that Utilitarianism is best read as an ecumenical text where Mill (...) explains and defends the general tenets of utilitarianism rather than setting out his own preferred theory. The exception to this ecumenical approach to the text comes in the fifth chapter on justice which, I argue on textual and historical grounds, outlines the central features of Mill’s utilitarianism. -/- With this understanding of Utilitarianism in place, many of the passages commonly cited in favor of the previous interpretations are rendered less plausible, and interpretations emphasizing Mill’s other writings are strengthened. Using this methodology, I critique four of the most prominent act or rule utilitarian interpretations of Mill’s moral theory. I then provide an interpretation of Mill’s theory of moral obligation and utilitarianism. On Mill’s account of moral obligation (which purportedly holds for moral theories generally, not just utilitarianism) there is a tight relation between an action being wrong and it being subject to punishment by an agent’s conscience. The utilitarian aspect of Mill’s theory concerns the role of rules in an agent’s conscience. According to Mill’s sanction utilitarian view, the actions that are punished are those actions that violate the moral rules which, if widely internalized across society, would promote general utility. On this account, an action is wrong when an agent violates a justified moral rule and is properly punished, at least by one’s conscience. An action is right when conditions are such that if the action were not performed, then the action would be properly punished by at least the agent’s conscience. I apply this interpretation to other notable components of Mill’s approach such as his account of practical action (the Art of Life) and his theory of liberty. (shrink)

A major voice in late twentieth-century philosophy, Alan Donagan is distinguished for his theories on the history of philosophy and the nature of morality. The Philosophical Papers of Alan Donagan, volumes 1 and 2, collect 28 of Donagan's most important and best-known essays on historical understanding and ethics from 1957 to 1991. Volume 2 addresses issues in the philosophy of action and moral theory. With papers on Kant, von Wright, Sellars, and Chisholm, this volume also covers a range of (...) questions in applied ethics—from the morality of Truman's decision to drop atomic bombs on Hiroshima and Nagasaki to ethical questions in medicine and law. (shrink)

Rapid advances in high throughput genomic technologies and next generation sequencing are making medical genomic research more readily accessible and affordable, including the sequencing of patient and control whole genomes and exomes in order to elucidate genetic factors underlying disease. Over the next five years, the Human Heredity and Health in Africa (H3Africa) Initiative, funded by the Wellcome Trust (United Kingdom) and the National Institutes of Health (United States of America), will contribute greatly towards sequencing of numerous African samples for (...) biomedical research. (shrink)

Background:The severity of the Coronavirus pandemic has led to lockdowns in different countries to reduce the spread of the infection. These lockdown restrictions are likely to be detrimental to mental health and well-being in adolescents. Physical activity can be beneficial for mental health and well-being; however, research has yet to examine associations between adolescent physical activity and mental health and well-being during lockdown.Purpose:Examine the effects of adolescent perceived Coronavirus prevalence and fear on mental health and well-being and investigate the extent (...) to which physical activity can be a protective factor against these concerns.Methods:During United Kingdom lockdown restrictions, 165 participants (100 female, aged 13–19) completed an online questionnaire assessing perceived Coronavirus prevalence and fear, physical activity, and indicators of mental health and well-being (stress, anxiety, depression, fatigue, vitality, and perceived health). Separate hierarchical multiple linear regression analyses (with age, gender, perceived Coronavirus prevalence, and fear entered in step 1, and physical activity in step 2) were run to predict each well-being outcome.Results:Regression analyses indicated that in general, while Coronavirus fear was a negative predictor, physical activity was a positive and stronger predictor of enhanced mental health and well-being outcomes.Conclusion:Findings suggest that physical activity during the Coronavirus pandemic can counteract the negative effects of Coronavirus fear on adolescent mental health and well-being. Therefore, physical activity should be promoted during lockdown to support good mental health and well-being. (shrink)

In our article, we share the lessons we have learned after creating and running a successful legal laboratory over the past seven years at Yale Law School. Our legal laboratory, which focuses on the intersection of law and severe brain injury, represents a unique pedagogical model for legal academia, and is closely influenced by the biomedical laboratory.

E. J. Lowe; Wright versus Lewis on the transitivity of counterfactuals, Analysis, Volume 44, Issue 4, 1 October 1984, Pages 180–183, https://doi.org/10.1093/ana.

E. J. Lowe; Reply to wright on conditionals and transitivity, Analysis, Volume 45, Issue 4, 1 October 1985, Pages 200–202, https://doi.org/10.1093/analys/45.4.2.

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)

A translation of the main text for only published version J. G. Fichte's later WL. (Hitzig: Berlin 1810). It excludes Fichte's Preface.

Background: The factors influencing parents’ willingness to enroll their children in biobanks are poorly understood. This study sought to assess parents’ willingness to enroll their children, and their perceived benefits, concerns, and information needs under different consent and data-sharing scenarios, and to identify factors associated with willingness. Methods: This large, experimental survey of patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups. Participants were randomized to receive one of (...) three consent and data-sharing scenarios. Results: In total, 90,000 surveys were mailed and 13,000 individuals responded (15.8% response rate). 5737 respondents were parents of minor children. Overall, 55% (95% confidence interval 50–59%) of parents were willing to enroll their youngest minor child in a hypothetical biobank; willingness did not differ between consent and data-sharing scenarios. Lower educational attainment, higher religiosity, lower trust, worries about privacy, and attitudes about benefits, concerns, and information needs were independently associated with less willingness to allow their child to participate. Of parents who were willing to participate themselves, 25% were not willing to allow their child to participate. Being willing to participate but not willing to allow one’s child to participate was independently associated with multiple factors, including race, lower educational attainment, lower annual household income, public health care insurance, and higher religiosity. Conclusions: Fifty-five percent of parents were willing to allow their youngest minor child to participate in a hypothetical biobank. Building trust, protecting privacy, and addressing attitudes may increase enrollment and diversity in pediatric biobanks. (shrink)

Incapacitated adults with a legally appointed guardian or conservator may be recruited for or involved with medical, behavioral, or social science research. Much of the research in which such persons participate is aimed at evaluating medical interventions for them, or contributing to general knowledge about disorders from which they may suffer. In this paper we will consider how the appointment of guardians for patients with disorders of consciousness —severe brain injuries that affect a patient’s level of arousal and ability to (...) interact —impacts such patients’ access to research.Such persons may be under guardianship because they have lost decisional capacity (i.e., those in a coma or... (shrink)

Open peer commentary on the target article “From Objects to Processes: A Proposal to Rewrite Radical Constructivism” by Siegfried J. Schmidt. Upshot: The aim is to show that, although Schmidt’s thesis must in most respects be warmly welcomed, there is an unexpressed implication concerning the dialogic structure of language that, when drawn out plainly, reveals a further valuable move open to the theory. I offer it therefore as a clarification of his theory with which I hope Schmidt may agree. He (...) has already stressed the differences in understanding between one agent and another; it is because of this that, in order to communicate, agents must play without believing the mutual hypothetical projections of “truth,” “sincerity,” “objectivity,” “reference,” and other ideals of social “reality.” In the language process it is faith upon which this rests rather than blind trust. It is argued that only faith can properly take account of the risks of contingency. (shrink)

Psychiatric diagnostic covariation suggests that the underlying structure of psychopathology is not one of circumscribed disorders. Quantitative modeling of individual differences in diagnostic patterns has uncovered several broad domains of mental disorder liability, of which the Internalizing and Externalizing spectra have garnered the greatest support. These dimensions have generally been estimated from lifetime or past-year comorbidity patters, which are distal from the covariation of symptoms and maladaptive behavior that ebb and flow in daily life. In this study, structural models are (...) applied to daily diary data ( Median = 94 days) of maladaptive behaviors collected from a sample ( N = 101) of individuals diagnosed with personality disorders (PDs). Using multilevel and unified structural equation modeling, between-person, within-person, and person-specific structures were estimated from 16 behaviors that are encompassed by the Internalizing and Externalizing spectra. At the between-person level (i.e., individual differences in average endorsement across days) we found support for a two-factor Internalizing–Externalizing model, which exhibits significant associations with corresponding diagnostic spectra. At the within-person level (i.e., dynamic covariation among daily behavior pooled across individuals) we found support for a more differentiated, four-factor, Negative Affect-Detachment-Hostility-Disinhibition structure. Finally, we demonstrate that the person-specific structures of associations between these four domains are highly idiosyncratic. (shrink)

Institutions receiving federal funding for research from the U.S.Public Health Service need to have policies and procedures to both prevent research misconduct and to adjudicate it when it occurs. The person who is designated to handle research misconduct is typically referred to as the research integrity officer (RIO). In this interview study we report on 79 RIOs who describe how they would handle allegations of research misconduct. Their responses were compared to two expert RIOs. The responses to the allegations in (...) the scenarios demonstrated that RIOs are not uniformly well prepared to handle activities associated with reported allegations of research misconduct. We recommend greater preparation through directed training, use of check lists of possible behaviors necessary to consider when situations arise, being involved in a network of RIOs so one can discuss options, and the possible need to certify RIOs. (shrink)

Canada has a marked shortfall between the supply and demand for kidneys for transplantation. Median wait times for deceased donor kidney transplantation vary from 5.8 years in British Columbia, 5.2 years in Manitoba and 4.5 years in Ontario to a little over 2 years in Quebec and Nova Scotia. Living donation provides a viable option for some, but not all people. Consequently, a small number of people travel abroad to undergo kidney transplantation by commercial means. The extent to which they (...) are aware of the potential risks to their health and the health of the kidney vendors is unclear. Travel abroad to obtain a kidney commercially i.e. transplant tourism (TT), raises ethical issues which include the exploitation of the poor, uncertainty of donor informed consent to nephrectomy, poor clinical care and lack of follow up for the donor, commodification of the body and inequity of access to medical care for donors. Also, TT widens socioeconomic disparities in access to transplantation, differing from the Canadian system of universal coverage for healthcare. The Canadian transplant community has discussed how to respond to patients who plan to travel abroad for TT or return with a purchased kidney. Unease rests in the tension between the duty to care for legitimate Canadian residents and the unwillingness to enable TT. This paper discusses three anonymized cases and the Canadian responses to TT as recorded in academic literature and a formal statement by relevant professional bodies. (shrink)

This considerably revised second edition of Wittgenstein's 1914-16 notebooks contains a new appendix with photographs of Wittgenstein's original work, a new preface by Elizabeth Anscombe, and a useful index by E.D. Klemke. Corrections have been made throughout the text, and notes have been added, making this the definitive edition of the notebooks. The writings intersperse Wittgenstein's technical logical notations with his thoughts on the meaning of life, happiness, and death. "When the first edition of this collection of remarks appeared in (...) 1961 we were provided with a glimpse of the workings of Wittgenstein's mind during the period when the seminal ideas of the _Tractatus Logico-Philosophicus_ were being worked out. This second edition provided the occasion to be struck anew by the breadth, rigor, and above all the restlessness of that mind."—T. Michael McNulty, S. J., _The Modern Schoolman_. (shrink)

Language, either oral or written, is meant both to convey and to preserve meaning. Semiotics is thediscipline which permits the extraction of a meaning from systems of linguistic signs. Written texts arestatic, while the world is about them is in flux. Meaning is thus intimately connected to this marriageof flux and stasis in texts.Here, three views on semiotics are examined:First, Plato’s treatment of signs and flux in the dialogue Kratylos is dissected. The conventional andmimetic aspects of signs are contrasted, and (...) a connection between inquiry and stasis is intimated.Next, the Augustinian theory of signs, as delineated in De Doctrina Christiana, is presented. Thediversity of signs and several principles of hermeneutics are considered. In addition, the existence ofthe some Post-Modern notions of polysemy, trace, and fore-structures of understanding in Augustine’sthought is indicated. Also, the concepts of ineffability and of res summa in De Doctrina Christiana areexamined as starting points for a deconstructive critique of Augustinian semiotics.Third, Derrida's treatment of signifiers in Of Grammatology is analyzed as a turn to a semiotics ofthe flux. Finally, the oral concept of memory reveals a connection between flux and stasis. Thememory plays a role in the system of signs in creating a "generative reconstruction". According toAugustine, sign-making is also "incarnational." Humans retain something of the signs in memory;memory preserves the basis of the sign. This mnemic fundament may be constantly adjusted to thepresent reality, i.e. the flux; the epistemological and semiotic data base in oral cultures is generative orfluid.Memory ameliorates the semiotic tension between the flux of the world and the stasis of information in the system of signs. (shrink)

Hypocretin regulates brain reward function and cocaine consumption in rats. The hypocretinergic (Hcrt) system is implicated in energy homeostasis, feeding and sleep regulation. Hypocretinergic cell bodies are located in the lateral hypothalamus (LH) and project throughout the brain. The aim of the present studies was to investigate the role of the Hcrt system in regulating brain reward function and the reinforcing properties of cocaine in rats. Intracranial self-stimulation (ICSS) thresholds provide an accurate measure of brain reward function in rats. Here (...) we show that a single injection of Hcrt-1 (5 µg icv) induced persistent, long-lasting elevations in ICSS thresholds in drug-naïve rats. Indeed, Hrct-1 elevated ICSS thresholds for 36 h, with peak elevations between 6 and 12 hours after injection. Hrct-1-induced threshold elevations were attenuated by an antibody known to neutralize the binding of hcrt-1 to its receptors. Taken together, these observations suggest that Hrct-1 negatively regulates brain reward function in rats. Because Hrct-1 negatively regulates brain reward function, we hypothesized that it may attenuate the increased brain reward function usually observed after cocaine consumption, and thereby alter cocaine self-administration behavior. A daily injection of Hrct-1 (1 µg icv), for 4 consecutive days, slightly increased cocaine self-administration (0.25 mg/infusion) in rats. Overall, these data demonstrate that Hrct-1 negatively regulates brain reward function, and as such may indirectly alter cocaine self-administration. Given the well-established role of hypocretin neurons in regulating feeding behavior and sleep, we hypothesize that hypocretinergic regulation of brain reward function may provide a mechanism by which appropriate and competing behaviors (e.g. sleep or feeding) may be engaged to maintain energy homeostasis. (shrink)

E.O. Wright, using the labourtransfer and game theory approach of J. Roemer, provides a general framework for a comparative analysis of the different class systems, the historical variations of which are founded on the peculiar nature of the "asset" the dominant class appropriates.

MORRIS: But come back to that other kind of fiction, in which the author himself is involved with his works, not merely in writing something for other people but in writing what seems to be necessary to his conscious existence, to his sense of well-being. For such a writer, when he finished with something he finishes with it; he is not left with continuations that he can go on knitting until he runs out of yarn. This conceit reflects my own (...) experience as a writer, relying on the sap that keeps rising, the force that drives the flower, as Dylan Thomas put it. It is plantlike. We put it in the sun and when it doesn't grow, we take it and put it in another room. I don't think of repotting the plant. The plant must make its own way. BOOTH: I like the organic metaphor, but I keep wanting to come back to particular cases to see how you actually work, in literal detail. Even the organic novelist obviously still has the matter of collecting notes, starting a novel, having it fail to go. Let me put a simple question, and move out from there. How many actual novels, whether they ever reach fruition or not, do you have "growing" at a given time? MORRIS: You don't mean simultaneously? BOOTH: I mean actual notes that exist in some kind of manuscript form, starts on a novel, something you are actually working on. MORRIS: It is so unusual for me to have more than one or two things in mind at once that I don't find this a fruitful question. Wright Morris's work as a novelist, essayist, and photographer is examined by prominent critics in Conversations with Wright Morris; the collection, edited by Robert E. Knoll, was published in the spring of 1977 by the University of Nebraska Press. "The Writing of Organic Fiction" is a chapter in that book. Wayne C. Booth's other contributions to Critical Inquiry include "Kenneth Burke's Way of Knowing" ,"Irony and Pity Once Again: Thais Revisited" , "M.H. Abrams: Historian as Critic, Critic as Pluralist" , “'Preserving the Exemplar': Or, How Not to Dig our Own Graves" , "Notes and Exchanges" , "Metaphor as Rhetoric: The Problem of Evaluation" ,"Ten Literal 'Theses" , and, with Robert E. Streeter, W.J.T. Mitchell: "Sheldon Sacks 1930-1979". (shrink)

This article is part of a For-Discussion-Section of Methods of Information in Medicine about the paper "Biomedical Informatics: We Are What We Publish", written by Peter L. Elkin, Steven H. Brown, and Graham Wright. It is introduced by an editorial. This article contains the combined commentaries invited to independently comment on the Elkin et al. paper. In subsequent issues the discussion can continue through letters to the editor.

Centuries of scientific progress have been devoted to reducing uncertainty. Newtonian physics, introduced over 300 years ago, allowed for precise prediction of planetary and tidal motion, falling bodies and infinitely more, in addition to allowing the construction of the material world. The 20th century witnessed a revolution in our understanding of organ and cellular function and dysfunction, elucidation of pathways, mediators, receptors, and molecular interactions, and breakthroughs in the characterization of replication, transcription, and translation, all of which has been integral (...) to our understanding of human physiology and pathophysiology. Clinical epidemiology has had a revolutionary impact on our .. (shrink)

Background and objectives: Physicians are exposed to matters of existential character at work, but little is known about the personal impact of such issues. Methods: To explore how physicians experience and cope with existential aspects of their clinical work and how such experiences affect their professional identities, a qualitative study using individual semistructured interviews has analysed accounts of their experiences related to coping with such challenges. Analysis was by systematic text condensation. The purposeful sample comprised 10 physicians (including three women), (...) aged 33–66 years, residents or specialists in cardiology or cardiothoracic surgery, working in a university hospital with 24-hour emergency service and one general practitioner. Results: Participants described a process by which they were able to develop a capacity for coping with the existential challenges at work. After episodes perceived as shocking or horrible earlier in their career, they at present said that they could deal with death and mostly keep it at a distance. Vulnerability was closely linked to professional responsibility and identity, perceived as a burden to be handled. These demands were balanced by an experience of meaning related to their job, connected to making a difference in their patients’ lives. Belonging to a community of their fellows was a presupposition for coping with the loneliness and powerlessness related to their vulnerable professional position. Conclusions: Physicians’ vulnerability facing life and death has been underestimated. Belonging to caring communities may assist growth and coping on exposure to existential aspects of clinical work and developing a professional identity. (shrink)