I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

Discussions of sexual ethics often focus on the wrong of treating another as a mere object instead of as a person worthy of respect. On this view, the task of sexual ethics becomes putting the other’s subjectivity above their status as erotic object so as to avoid the harms of objectification. Ward and Anderson argue that such a view disregards the crucial, moral role that erotic objecthood plays in sexual encounters. Important moral features of intimacy are disclosed through the experience (...) of being an erotic object for another, as well as in perceiving another as an erotic object. Drawing on phenomenology, especially the insights of Simone de Beauvoir, Ward and Anderson argue that erotic encounters are shaped by the human condition of ambiguity, where being an object for others is intertwined with bodily agency. Because sexual agency is complex in this way, theories of sexual ethics and responsibility must widen their focus beyond transparent communication and authoritative expressions of will. (shrink)

Autistic students are more likely to drop out of university, while facing both challenges and opportunities within university environments. This study compared the experiences of autistic and non-autistic current United Kingdom students, in terms of thoughts about dropping out, burnout, mental health and coping, during the COVID-19 pandemic. Burnout was of particular interest as this is a relatively unexamined phenomenon for autistic students. Seventy autistic and 315 non-autistic students, completed a mixed methods questionnaire with standardized measures of burnout, mental health, (...) and coping styles. We also included qualitative questions about dropping out and COVID-19 experiences. We found autistic participants experienced higher rates of burnout and mental health symptoms and were more likely to have thought about dropping out. Reasons given for thinking about dropping out, for both groups, focused on poor mental well-being, doubts about university, and academic challenges. For autistic participants, further analyses did not identify specific predictors of thinking about dropping out, but for non-autistic participants, this was predicted by maladaptive coping styles and academic burnout. Academic and personal burnout predicted one another for autistic students, and age, maladaptive coping, autistic characteristics, stress, and anxiety additionally predicted burnout for non-autistic students. Similarities in experiences during the pandemic were noted, with both groups experiencing negative social implications, difficulties adjusting to emergency online learning, and poorer psychological well-being. Moving forward from COVID-19, universities must find ways to enhance both academic and social support, to enable equal opportunity within Higher Education for autistic students. (shrink)

In his Experiments in Ethics, Appiah focuses mostly on the dimension of naturalism as a naturalism of deprivation - naturalism’s apparent robbing us of aspects of the world that we had held dear. The aim of this paper is to remind him of that naturalism has a dimension of plenitude as well - its capacity to enrich our conception of the world as well. With regard to character, we argue that scientific psychology can help provide a conception of character as (...) dynamic, in a way that may preserve many key aspects of eudaimonistic ethics from the situationists’ challenge. With regard to intuition, we address Appiah’s worry that naturalistic explanations of the sources of our intuitions may leave us feeling that those intuitions have been thereby debunked. We suggest that it may be that feeling of debunking that should itself be debunked. (shrink)

This article challenges Margaret E. Simons’s claim that Sartre forced himself on Beauvoir on October 15, 1929. We argue that Diary of a Philosophy Student: Volume 3, 1926–30 depicts the young Beauvoir struggling with conflicting feelings about marriage, sexual desire, and gender roles. Highlighting early reflections on “the woman in love,” we suggest that Beauvoir’s diary discloses gendered harm but not sexual violation. We name this harm erotic ambivalence and find it central to The Second Sex.

BackgroundTrial registration helps minimize publication and reporting bias. In leading medical journals, 96% of published trials are registered. The aim of this study was to determine the proportion of randomized controlled trials published in key nursing journals that met criteria for timely registration.MethodsWe reviewed all RCTs published in three (two general, one mental health) nursing journals between August 2011 and September 2016. We classified the included trials as: 1. Not registered, 2. Registered but not reported in manuscript, 3. Registered retrospectively, (...) 4. Registered prospectively (before the recruitment of the first subject into the trial). 5. Timely registration (as 4 but the trial identification number is reported in abstract).ResultsWe identified 135 trials published in the three included journals. The majority (n = 78, 58%) were not registered. Thirty-three (24%) were retrospectively registered. Of the 24 (18%) trials that were prospectively registered, 11 (8%) met the criteria for timely registration.ConclusionsThere is an unacceptable difference in rates of trial registration between leading medical and nursing journals. Concerted effort is required by nurse researchers, reviewers and journal editors to ensure that all trials are registered in a timely way. (shrink)

An expanding policy framework aimed at monitoring alcohol consumption during pregnancy has emerged. The primary justification is prevention of harm from what is termed ‘prenatal alcohol exposure’ (PAE), by enabling more extensive diagnosis of the disability labelled fetal alcohol spectrum disorder (FASD). Here we focus on proposals to include biomarkers as a PAE ‘screening tool’, specifically those found in meconium (the first newborn excrement), which are discussed as an ‘objective’ measure of PAE.We ask the overarching question, ‘Can routine screening of (...) meconium to establish PAE be ethically or legally justified’, and we answer, ‘No’. To reach this conclusion, we discuss three areas. First, we consider the reasons why meconium screening should not be deemed ‘typical’ within the scope of accepted screening tools. We argue that given the aim and necessary timing of the screen, it cannot achieve what it promises. Second, we outline why patient autonomy and consent are not properly accounted for and cannot be reconciled with the ‘routinisation’ of the proposed ‘screening’. Last, we outline why the benefit of such a screen is not clear, focusing on the significance of trust in healthcare professionals (HCP) for the best interests of the future child and pregnant woman.While recognising the adverse effects of heavy alcohol consumption during pregnancy, we emphasise the case for robust ethical, legal and social considerations and the central need for trust between HCP and patients in maternity care. We conclude the permissibility of meconium screening has not been proven, and it is not justified. (shrink)

Business Ethics: A European Review, EarlyView.

Individuals with autism spectrum disorders (ASD) are impaired not only in social competencies but also in sensory perception, particularly olfaction. The olfactory ability of individuals with ASD has been examined in several psychophysical studies, but the results have been highly variable, which might be primarily due to methodological difficulties in the control of odor stimuli (e.g., the problem of lingering scents). In addition, the neural correlates of olfactory specificities in individuals with ASD remain largely unknown. To date, only one study (...) has investigated this issue using functional magnetic resonance imaging (fMRI). The present study utilized a sophisticated method−a pulse ejection system−to present well-controlled odor stimuli to participants with ASD using an ASD-friendly application. With this advantageous system, we examined their odor detection, identification, and evaluation abilities and measured their brain activity evoked by odors using functional near-infrared spectroscopy (fNIRS). As the odor detection threshold (DT) of participants with ASD was highly variable, these participants were divided into two groups according to their DT: an ASD-Low DT group and an ASD-High DT group. Behavioral results showed that the ASD-High DT group had a significantly higher DT than the typically developing (control) group and the ASD-Low DT group, indicating their insensitivity to the tested odors. In addition, while there was no significant difference in the odor identification ability between groups, there was some discrepancy between the groups’ evaluations of odor pleasantness. The brain data identified, for the first time, that neural activity in the right dorsolateral prefrontal cortex (DLPFC) was significantly weaker in the ASD-High DT group than in the control group. Moreover, the strength of activity in the right DLPFC was negatively correlated with the DT. These findings suggest that participants with ASD have impairments in the higher-order function of olfactory processing, such as olfactory working memory and/or attention. (shrink)

In a case study of the growth of cognitive science, we analyzed the activities of the Cognitive Science Society with a particular emphasis on the multidisciplinary nature of the field. Analyses of departmental affiliations, training back‐grounds, research methodology, and paper citations suggest that the journal Cognitive Science and the Annual Meeting of the Cognitive Science Society are dominated by cognitive psychology and computer science, rather than being an equal division among the constituent disciplines of cognitive science. However, at many levels, (...) a growing percentage of work was found to involve a conjunction of multiple disciplines, such that approximately 30–50% of recent work in the Cognitive Science Society is multidisciplinary. In a questionnaire study of cognitive scientists involved in collaborative research, multidisciplinarity was found to shape the research process and affect the factors associated with successful research. (shrink)

Grammatical gender is independent of biological sex for the majority of animal names (e.g., any giraffe, be it male or female, is grammatically treated as feminine). However, there is apparent semantic motivation for grammatical gender classes, especially in mapping human terms to gender. This research investigated whether this motivation affects deductive inference in native German speakers. We compared German with Japanese speakers (a language without grammatical gender) when making inferences about sex-specific biological properties. We found that German speakers tended to (...) erroneously draw inferences when the sex in the premise and grammatical gender of the target animal agreed. An over-generalization of the grammar–semantics mapping was found even when the sex of the target was explicitly indicated. However, these effects occurred only when gender-marking articles accompanied the nouns. These results suggest that German speakers project sex-specific biological properties onto gender-marking articles but not onto conceptual representations of animals per se. (shrink)

Persons with visual impairments (hereafter PVI) detect and discover obstacles and road conditions by touching with a white cane when walking on the streets. In one training session, an Orientation and Mobility specialist (hereafter SPT) guided a PVI by grasping and moving the cane that the PVI was holding. We conducted a multimodal analysis of two instruction sequences, one a "proving and achieving" demonstration (Sacks in Lectures on conversation, Blackwell, 1992) and the other a "learnable" (Zemel and Koschmann, in Discourse (...) Stud 16:163–183, 2014) demonstration. The achieving demonstration proved the assessment of the PVI's performance. In the "learnable" demonstration, the PVI was able to receive and perform the most critical part of the "learnable" of the long contact touch without the aid of talk. Sharing a single cane touch is an efficient way for both the guiding SPT and the guided PVI to jointly experience and understand the environmental features. The SPT did not need to verbally confirm that the guided touch was accountable to the PVI and seemed confident that intersubjectivity with the PVI had been established. A unique form of being with others and achieving intersubjectivity in society was identified. In traditional learning instruction, it has been assumed that the learnable is presented and communicated visually and audibly. However, through guided touch learnable is presented and conveyed effectively in the cases of this paper. It seems that the sense of touch has been considered to be just for the occasion, but this is an example of something that is not just for the occasion but is consequential, that is, usable for further occasions. The data is in Japanese. (shrink)

While empathy is considered a critical determinant of the quality of medical care, growing evidence suggests it may be associated with both one’s own positive and negative moods among healthcare professionals. Meanwhile, sense of coherence plays an essential role in the improvement of both psychological and physical health. Reportedly, individual SOC reaches full stability after around age 30. The aim of this study was first to evaluate the mediatory role of SOC on the association between empathy and individual moods among (...) 114 healthcare professionals in a general hospital, and then to examine the moderating effect of age on this association. Participants completed a range of self-report demographic questionnaires, Empathy Process Scale, the 13-item Antonovsky’s SOC, and Profile of Mood States. Findings showed that SOC mediated the relations between empathy and both POMS-Vigor and POMS-Depression. Notably, moderated mediation analysis revealed that there was a significant interaction on self-vigor mood in healthcare professionals. The indirect effect of empathy on self-vigor mood through SOC was significant at over mean age “32.83.” Although there was no significant interaction with age regarding the indirect effect of empathy on self-depression mood, in the sub-category level analysis of empathy, we found a significant interaction item [age × empathy for other’s negative affect ] on SOC. This indirect effect was also significant at over mean age “32.83.” Taken, together, the current study highlighted the significant mediator of SOC on that empathy amplifies self-vigor mood and attenuates self-depression mood as a protective factor among the Japanese healthcare professionals. Some components of these processes may depend on the moderating role of age, indicating that we may need to consider the SOC development with age for more effective empathy performance interventions among healthcare professionals. (shrink)

ObjectiveNoisy galvanic vestibular stimulation (nGVS) is often used to improve postural stability in disorders, such as neurorehabilitation montage. For the safe use of nGVS, we investigated whether arterial pressure (AP) and heart rate vary during static supine and slow whole-body tilt with random nGVS (0.4 mA, 0.1–640 Hz, gaussian distribution) in a healthy elderly population.MethodsThis study was conducted with a double-blind, sham-controlled, cross-over design. Seventeen healthy older adults were recruited. They were asked to maintain a static supine position on a (...) bed for 10 min, and the bed was tilted up (TU) to 70 degrees within 30 s. After maintaining this position for 3 min, the bed was passively tilted down (TD) within 30 s. Real-nGVS or sham-nGVS was applied from 4 to 15 min. The time course of mean arterial pressure (MAP) and RR interval variability (RRIV) were analyzed to estimate the autonomic nervous activity.ResultnGVS and/or time, including pre-/post-event (nGVS-start, TU, and TD), had no impact on MAP and RRIV-related parameters. Further, there was no evidence supporting the argument that nGVS induces pain, vertigo/dizziness, and uncomfortable feeling.ConclusionnGVS may not affect the AP and RRIV during static position and whole-body tilting or cause pain, vertigo/dizziness, and discomfort in the elderly. (shrink)

Recent studies suggest that meta-learning may provide an original solution to an enduring puzzle about whether neural networks can explain compositionality – in particular, by raising the prospect that compositionality can be understood as an emergent property of an inner-loop learning algorithm. We elaborate on this hypothesis and consider its empirical predictions regarding the neural mechanisms and development of human compositionality.

ObjectiveMost young adults diagnosed with breast or gynecologic cancers experience adverse reproductive or sexual health outcomes due to cancer and its treatment. However, evidence-based interventions that specifically address the RSH concerns of young adult and/or LGBTQ+ survivor couples are lacking. Our goal is to develop a feasible and acceptable couple-based intervention to reduce reproductive and sexual distress experience by young adult breast and gynecologic cancer survivor couples with diverse backgrounds.MethodsWe systematically adapted an empirically supported, theoretically grounded couple-based intervention to address (...) the RSH concerns of young couples coping with breast or gynecologic cancer through integration of stakeholder perspectives. We interviewed 11 couples with a history of breast or gynecologic cancer to review and pretest intervention materials. Three of these couples were invited to review and comment on intervention modifications. Content experts in RSH and dyadic coping, clinicians, and community advisors participated throughout the adaptation process.ResultsFindings confirmed the need for an online, couple-based intervention to support young couples experiencing RSH concerns after breast or gynecologic cancer. Qualitative themes suggested intervention preferences for: A highly flexible intervention that can be tailored to couples’ specific RSH concerns; Active steps to help members of a dyad “get on the same page” in their relationship and family building plans; A specific focus on raising partners’ awareness about how cancer can affect body image and physical intimacy; and Accessible, evidence-based information about RSH for both partners. These results, along with feedback from stakeholders, informed adaptation and finalization of the intervention content and format. The resulting virtual intervention, Opening the Conversation, includes five weekly sessions offering training to couples in communication and dyadic coping skills for addressing RSH concerns.ConclusionThe systematic adaptation process yielded a theory-informed intervention for young adult couples facing breast and gynecological cancers, which will be evaluated in a randomized controlled trial. The long-term goal is to implement and disseminate Opening the Conversation broadly to reach young adult couples with diverse backgrounds who are experiencing RSH concerns in cancer survivorship. (shrink)

This article uses critical discourse analysis to investigate artificial intelligence (AI) generated images of aged care nurses and considers how perspectives and perceptions impact upon the recruitment and retention of nurses. The article demonstrates a recontextualization of aged care nursing, giving rise to hidden ideologies including harmful stereotypes which allow for discrimination and exploitation. It is argued that this may imply that nurses require fewer clinical skills in aged care, diminishing the value of working in this area. AI relies on (...) existing data sets, and thus represent existing stereotypes and biases. The discourse analysis has highlighted key issues which may further impact upon nursing recruitment and retention, and advocates for stronger ethical consideration, including the use of experts in data validation, for the way that aged care services and nurses are depicted and thus valued. (shrink)

There are two ways to understand any proposed properties of language-of-thoughts (LoTs): As diagnostic or constitutive. We argue that this choice is critical. If candidate properties are diagnostic, their homeostatic clustering requires explanation via an underlying homeostatic mechanism. If constitutive, there is no clustering, only the properties themselves. Whether deep neural networks (DNNs) are alternatives to LoTs or potential implementations turn on this choice.

Alexithymia, psychological distress, and posttraumatic stress disorder (PTSD) are highly related constructs. The ongoing debate about the nature and relationship between these constructs is perpetuated by an overreliance on cross-sectional research. We examined the longitudinal interactive relationship between alexithymia, psychological distress, and PTSD. We hypothesised that there is an interactive relationship between the three constructs. Military personnel (N = 1871) completed the Toronto Alexithymia Scale, the Kessler 10 and a PTSD Checklist (PCL-C) at pre-deployment, post-deployment, and at 3–4 years following (...) the post-deployment assessment. We initially tested whether psychological distress is either a moderator or mediator in the relationship between alexithymia and PTSD across the time points. General psychological distress was a partial mediator of total PTSD severity and hyperarousal symptomology at all three time points. Psychological distress fully mediated re-experiencing and avoidance symptomology at all three time points. Our results suggest that those with alexithymia are at longitudinal risk of developing more severe PTSD symptomology and experiencing hyperarousal irrespective of temporal proximity to traumatic exposure. Further, vulnerability to the emergence of re-experiencing and avoidance symptomology for those with alexithymia is increased when one experiences greater distress. Our results show that alexithymia is a persistent risk factor for PTSD symptomology. (shrink)

Alternative food networks, such as farmers’ markets and community-supported agricultural and fishery programs, often struggle to reach beyond a consumer base that is predominantly white and affluent. This case study explores seven inclusion strategies deployed by a community-supported fishery program (Fishadelphia, in Philadelphia, PA, USA) including discounting prices, accepting payment in multiple forms and schedules, offering a range of product types, communicating and recruiting through a variety of media (especially in person), and choosing local institutions and people of color (POC) (...) as pickup location hosts. Our analysis indicated that all of these strategies were associated with increased participation of customers of color and/or customers without a college degree. For Asian customers, accepting cash, offering whole fish, recruiting in-person, and POC-hosted pickup locations were key factors. For Black customers, discounted price, accepting cash, offering fillets, and communicating through means other than email were most important. Discounted price and communicating through means other than email were most important for customers without a college degree. Payment method, payment schedule and communication method were highly correlated with other strategies; we suggest that these strategies work in synergy to make the program attractive and feasible to these customers. We consider how Fishadelphia’s inclusion efforts have benefitted from both tactical approaches (i.e., programmatic features) and a structural approaches (i.e., the people and places represented within the project), and suggest that elements of both tactical and structural inclusion can be applied in other contexts. This work is crucial for increasing food access, and underscores the importance of relationships in recruiting diverse customers. (shrink)

The original Italian text has been reproduced in the back of the volume.

Recently Lafont [6] showed the finite model property for the multiplicative additive fragment of linear logic (MALL) and for affine logic (LLW), i.e., linear logic with weakening. In this paper, we shall prove the finite model property for intuitionistic versions of those, i.e. intuitionistic MALL (which we call IMALL), and intuitionistic LLW (which we call ILLW). In addition, we shall show the finite model property for contractive linear logic (LLC), i.e., linear logic with contraction, and for its intuitionistic version (ILLC). (...) The finite model property for related substructural logics also follow by our method. In particular, we shall show that the property holds for all of FL and GL - -systems except FL c and GL - c of Ono [11], that will settle the open problems stated in Ono [12]. (shrink)

Brute facts are facts that don't have explanations. They are instrumental in our attempts to give accounts of other facts or phenomena, and so they play a key role in many philosophers' views about the structure of the world. This volume explores neglected questions about the nature of brute facts and their explanatory role.

"The Liberty for which Patriot Patrick Henry was willing to die was more than a rhetorical flourish. The American Patriots and Founders based their ideas about Liberty upon almost 200 years of experience on their own as well as the heritage of English Common Law and even back to the natural order of Thomas Aquinas, not to mention the philosophy of Aristotle and the Biblical Exodus of the Israelites from Egypt. In over 50-years of scholarship Ellis Sandoz has researched, documented (...) and contemplated the governance of man throughout the ages. The erudition brought to bear in this compact tome reflects a depth and breadth of learning that illuminates the subject with dazzling insight. Yet, he always reminds us that principles of Liberty are readily comprehensible to the common man. Sandoz worries that the present day adherence to political correctness limits our response to obviously murderous terroristic movements. He attacks academia for ignoring the spiritual nature of existence and events. He even chastens "social dogoodism" when it is provided instead of, rather than as a reflection of, spiritual nourishment. The book revolves around the motivation and context of the American Founding and drives home its relevance to contemporary living. The Founders fought against tyranny that attempted to control their physical and spiritual lives. Unjust governance was deemed to be without authority. Aristocrats and commoners ultimately must answer to the Final Authority. These concepts are reflected in the Declaration of Independence: "all men are created equal and they are endowed by their Creator with certain unalienable rights -- that among these are life, liberty and the pursuit of happiness." Sandoz is not only a scholar, but a grandfather; his words will engender Liberty for future generations."--Publisher's website. (shrink)

We present some ideas on logical process descriptions, using relations from the DIO (Drug Interaction Ontology) as examples and explaining how these relations can be naturally decomposed in terms of more basic structured logical process descriptions using terms from linear logic. In our view, the process descriptions are able to clarify the usual relational descriptions of DIO. In particular, we discuss the use of logical process descriptions in proving linear logical theorems. Among the types of reasoning supported by DIO one (...) can distinguish both (1) basic reasoning about general structures in reality and (2) the domain-specific reasoning of experts. We here propose a clarification of this important distinction between (realist) reasoning on the basis of an ontology and rule-based inferences on the basis of an expert’s view. (shrink)

Scientific Essentialism defends the view that the fundamental laws of nature depend on the essential properties of the things on which they are said to operate, and are therefore not independent of them. These laws are not imposed upon the world by God, the forces of nature or anything else, but rather are immanent in the world. Ellis argues that ours is a dynamic world consisting of more or less transient objects which are constantly interacting with each other, and whose (...) identities depend on their roles in these processes. Natural objects must behave as they do, because to do otherwise would be contrary to their natures. The laws of nature are, therefore, metaphysically necessary, and consequently, there are necessary connections between events. Brian Ellis calls for the rejection of the theory of Humean Supervenience and an implementation of a new kind of realism in philosophical analysis. (shrink)