One in three university students experiences mental health problems during their study. A similar percentage leaves higher education without obtaining the degree for which they enrolled. Research suggests that both mental health problems and academic underperformance could be caused by students lacking control and purpose while they are adjusting to tertiary education. Currently, universities are not designed to cater to all the personal needs and mental health problems of large numbers of students at the start of their studies. Within the (...) literature aimed at preventing mental health problems among students (e.g., anxiety or depression), digital forms of therapy recently have been suggested as potentially scalable solutions to address these problems. Integrative psychological artificial intelligence (AI) in the form of a chatbot, for example, shows great potential as an evidence-based solution. At the same time, within the literature aimed at improving academic success, the online life-crafting intervention in which students write about values and passions, goals, and goal-attainment plans has shown to improve the academic performance and retention rates of students. Because the life-crafting intervention is delivered through the curriculum and doesn’t bear the stigma that is associated with therapy, it can reach larger populations of students. But life-crafting lacks the means for follow-up or the interactiveness that online AI-guided therapy can offer. In this paper, we propose to integrate the current literature on chatbot interventions aimed at the mental health of students with research about a life-crafting intervention that uses an inclusive curriculum-wide approach. When a chatbot asks students to prioritize both academic as well as social and health-related goals and provides personalized follow-up coaching, this can prevent -often interrelated- academic and mental health problems. Right on-time delivery, and personalized follow-up questions enhance the effects of both -originally separated- intervention types. Research on this new combination of interventions should use design principles that increase user-friendliness and monitor the technology acceptance of its participants. (shrink)

Negative disjunctivists like Mike Martin and Bill Fish understand hallucinations in purely epistemic terms, and do not attribute phenomenal character to these visual misfires. However, the approaches by Martin and Fish are importantly different, and there has been little systematic work on how negative disjunctivism is motivated. In this paper, I argue for a version of negative disjunctivism that centers on the idea that perception involves the exercise of a fallible self-conscious capacity. I claim that this at once explains hallucinations (...) in purely negative terms that are close to Martin’s approach, while at the same time providing negative disjunctivism with an explanatory basis that Fish attempts to provide and Martin’s view lacks. (shrink)

### ­ In Who shall go first? A multicriteria approach to patient selection for first clinical trials of cardiac xenotransplantation, Kögel et al recommend the inclusion of patients who (1) have a (high) medical need for an allograft, (2) have the capacity to benefit from a xenograft, (3) have a ‘real’ choice between enrolment in a first-in-human clinical trial and an alternative life-sustaining treatment option and (4) have no clear record of previous non-compliance.1 As the authors discuss, patient selection must (...) promote the goal of gaining reliable and valid knowledge about the risks and benefits of cardiac xenotransplantation. While the four criteria outlined above certainly promote this goal, we argue it is crucial to add a fifth criterion emphasising the need to include diverse populations, particularly regarding sex, age, ethnicity and socioeconomic background.i In this commentary, we present two arguments for our claim and discuss the impact of neglecting diversity from the first trials on. ### The scientific rationale for including diverse populations First, including diverse populations in the first clinical trials of cardiac xenotransplantation enhances the scientific value of the data by assessing safety and efficacy among various populations. Treatment response can differ among patient (sub)groups as a result of genetic, physiological and socioeconomic factors.2 By including diverse populations from the first trials on, researchers can identify these …. (shrink)

Dealing with soldier enhancement can be challenging for military physicians. As research on the ethics of soldier enhancement is mostly theoretical, this study aims to gain insights into the actual moral issues military physicians encounter, or expect to encounter. To that end, we carried out a qualitative study involving six focus groups of Dutch military physicians (n = 28) in operational roles. The participants voiced their concerns about moral issues concerning soldier enhancement. Based on the group discussions, and using inductive (...) thematic analysis, we ascertained three major themes: (1) Doing no harm in soldier enhancement: uncertainty and high stakes; (2) Dependency relationships and conflicting moral responsibilities; and (3) The risk of ethical slippery slopes. Our findings illustrate that dealing with these moral responsibilities requires considerable skill and acuity to weigh up for all the situated complexities and dependency relationships that go beyond abstract rules or moral principles. A care-ethical approach that acknowledges the contextual and relational aspects of moral complexities along with peer consultation and joint reflective dialogue on moral issues can help military physicians deal with soldier enhancement responsibly. (shrink)

Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric (...) oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes. (shrink)

In their article, Luchtenberg and colleagues give voice to the opinions of young people on participation in clinical trials (Luchtenberg et al. 2015). Over time, it has become indisputable that chi...

Background Genuine uncertainty on superiority of one intervention over the other is called equipoise. Physician-investigators in randomized controlled trials need equipoise at least in studies with more than minimal risks. Ideally, this equipoise is also present in patient-participants. In pediatrics, data on equipoise are lacking. We hypothesize that 1) lack of equipoise at enrolment among parents may reduce recruitment; 2) lack of equipoise during participation may reduce retention in patients assigned to a less favoured treatment-strategy. Methods We compared preferences of (...) parents/patients at enrolment, documented by a questionnaire, with preferences developed during follow-up by an interview-study to investigate equipoise of child-participants and parents in the BeSt-for-Kids-study. This trial in new-onset Juvenile Idiopathic Arthritis-patients consists of three strategies. One strategy comprises initial treatment with a biological disease-modifying-antirheumatic-drug, currently not standard-of-care. Semi-structured interviews were conducted with 23 parents and 7 patients, median 11 months after enrolment. Results Initially most parents and children were not in equipoise. Parents/patients who refused participation, regularly declined due to specific preferences. Many participating families preferred the biological-first-strategy. They participated to have a chance for this initial treatment, and would even consider stopping trial-participation when not randomized for it. Their conviction of superiority of the biological-first strategy was based on knowledge from internet and close relations. According to four parents, the physician-investigator preferred the biological-first-strategy, but the majority stated that she had no preferred strategy. In phase 2, preferences tended to change to the treatment actually received. Conclusions Lack of equipoise during enrolment did not reduce study recruitment, mainly due to the fact that preferred treatment was only available within the study. Still, when developing a trial it is important to evaluate whether the physicians’ research question is in line with preferences of the patient-group. By exploring so-called ‘informed patient-group’-equipoise, successful recruitment may be enhanced and bias avoided. In our study, lack of equipoise during trial-participation did not reduce retention in those assigned to a less favoured option. We observed a change for preference towards treatment actually received, possibly explained by comparable outcomes in all three arms. (shrink)

Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. We present a (...) case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects. (shrink)

BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 (...) years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives.DiscussionAlthough assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad.SummaryPrevious research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated. (shrink)

Contemporary epidemiological methods testing the associations between green space and psychological well-being treat all vegetation cover as equal. However, there is very good reason to expect that variations in ecological "quality" (number of species, integrity of ecological processes) may influence the link between access to green space and benefits to human health and well-being. We test the relationship between green space quality and restorative benefit in an inner city urban population in Bradford, UK. We selected 12 urban parks for study (...) where we carried out botanical and faunal surveys to quantify biodiversity and assessed the site facilities of the green space (cleanliness, provision of amenities). We also conducted 128 surveys with park users to quantify psychological restoration based on four self-reported measure of general restoration, attention-grabbing distractions, being away from everyday life, and site preference. We present three key results. First, there is a positive association between site facilities and biodiversity. Second, restorative benefit is predicted by biodiversity, which explained 43% of the variance in restorative benefit across the parks, with minimal input from other variables. Third, the benefits accrued through access to green space were unrelated to age, gender, and ethnic background. The results add to a small but growing body of evidence that emphasise the role of nature in contributing to the well-being of urban populations and, hence, the need to consider biodiversity in the design of landscapes that enhance multiple ecosystem services. (shrink)

For decades, the discussion on children’s competence to consent to medical issues has concentrated around normative concerns, with little progress in clinical practices. Decision-making competence is an important condition in the informed consent model. In pediatrics, clinicians need to strike a proper balance in order to both protect children’s interests when they are not fully able to do so themselves and to respect their autonomy when they are. Children’s competence to consent, however, is currently not assessed in a standardized way. (...) Moreover, the correlation between competence to give informed consent and age in children has never been systematically investigated, nor do we know which factors exactly contribute to children’s competence. (shrink)

Dans cet article nous étudions le Trattato della sfera de Galilée, écrit avant 1600. C’est un traité d’astronomie géocentrique qui suit la structure du Tractatus de sphæra de Johannes de Sacrobosco. Nous analysons quelques particularités du traité, en le comparant à d’autres travaux astronomiques du xvie siècle, et nous discutons ses sources probables. Nous soutenons que l’influence du commentaire de Christoph Clavius sur la Sphæra de Sacrobosco ne peut pas être considérée comme son influence unique ou principale. Le traité de (...) Galilée était probablement inspiré par la Sfera del mondo de Piccolomini, un travail qui anticipait plusieurs particularités du Trattato della sfera. Cette influence est établie par de nombreuses annotations de Galilée trouvées dans un exemplaire du livre de Piccolomini. (shrink)

Experimental studies have suggested that variables such as aptness or conventionality are predictors of people’s preference for expressing a particular topic–vehicle pair as either a metaphor or a simile. In the present study, we investigated if such variables would also be predictive within a more naturalistic context, where other variables, such as the intention to include an explanation, may also influence people’s decision. Specifically, we investigated the production of metaphor and simile expressions on the Internet via the Google search engine (...) and checked for accompanying explanations, as well as the properties they expressed, to examine whether ratings such as aptness, conventionality, as well as participants’ own stated preference or the intention to produce an explanation, would predict which topic–vehicle pairs appeared more often as metaphor. We found that participants’ stated preference predicted metaphor dominance on the Internet, and that apt topic–vehicles occurred more often as metaphors. The explanations collected, however, occurred 82% of the time after similes, and familiar expressions were the most explained. Finally, comparing the properties expressed in these explanations to normed property lists, we found that simile explanations typically expressed a novel conception of the topic–vehicle relationship. Therefore, we found that Internet posters use metaphors to convey an apt relationship, as found in previous laboratory studies, but prefer using a simile frame when they want to express a relationship that readers will find novel. (shrink)

The review by De Bie et al. (2023) provides an overview of the current ethical literature on artificial womb technology (AWT). Two characteristics stand out, and provide the basis for our commentar...

Compiled by an archaeologist and philosopher of science, Science at the Frontiers: Perspectives on the History and Philosophy of Science supplements current literature in the history and philosophy of science with essays approaching the traditional problems of the field from new perspectives and highlighting disciplines usually overlooked by the canon. William H. Krieger brings together scientists from a number of disciplines to answer these questions and more in a volume appropriate for both students and academics in the field.

BackgroundFunctional changes after spinal cord injury are related to changes in cortical plasticity. These changes can be measured with electroencephalography and has potential to be used as a clinical biomarker.MethodIn this longitudinal study participants underwent a total of 30 sessions of robotic-assisted gait training over a course of 6 weeks. The duration of each session was 30 min. Resting state EEG was recorded before and after 30-session rehabilitation therapy. To measure gait, we used the Walking Index for Spinal Cord Injury (...) Scale, 10-Meter- Walking Test, Timed-Up-and-Go, and 6-Min-Walking Test. Balance was measured using Berg Balance Scale.ResultsFifteen participants with incomplete SCI who had AIS C or D injuries based on American Spinal Cord Injury Association Impairment Scale classification were included in this study. Mean age was 35.7 years and the mean time since injury was 17.08 months. All participants showed clinical improvement with the rehabilitation program. EEG data revealed that high beta EEG activity in the central area had a negative correlation with gait and balance measured at baseline, in a way that greater high beta EEG power was related to worse clinical function at baseline. Moreover, improvement in gait and balance had negative correlations with the change in alpha/theta ratio in the parietal area.ConclusionIn SCI, functional impairment and subsequent improvement following rehabilitation therapy with RAGT correlated with the change in cortical activity measured by EEG. Our results suggest that EEG alpha/theta ratio may be a potential surrogate marker of functional improvement during rehabilitation. Future studies are necessary to improve and validate these findings as a neurophysiological biomarker for SCI rehabilitation. (shrink)

Research question The secondary use of clinical data for research and learning activities has the potential to significantly improve medical knowledge and clinical care. To realize this potential, an ethical and legal basis for data use is needed, preferably in the form of patient consent. This raises the question: Do patients have a moral duty to provide their clinical data for research and learning activities? Methods On the basis of an ethical approach that we call “caring liberalism,” we evaluate plausibility (...) and moral weight of the following arguments in favor of a duty on patients to provide their clinical data for research and learning activities: the general duty to help; solidarity; the duty to act in the public interest; the free-rider argument; transgenerational justice; the principle of giving back; the do-not-harm principle; freedom of research and the value of science. Results The general duty to help and the duty to act in the public interest are strong reasons for a moral duty of patients to provide their clinical data for research and learning activities. Transgenerational justice and the principle of giving back are ethically weak reasons for such a duty but might be motivational factors. The other reasons are not appropriate to justify a duty. The results are relevant in several respects: for patients who are asked to consent to the secondary use of their clinical data; for the ethical discussion of the question whether and to what extent deviations from the classical specific consent are ethically justifiable under certain conditions; for the legal discussion of the conditions for a proportionate secondary use of clinical data for research and learning activities. (shrink)

Die sekundäre Forschungsnutzung von Behandlungsdaten hat großes Potenzial, biomedizinisches Wissen zu erweitern und die Patientenversorgung zu verbessern. Gleichzeitig sind für eine bessere Ausschöpfung dieses Potenzials diverse Herausforderungen zu bewältigen. Dies gilt insbesondere in Deutschland, wo im Vergleich zu anderen Ländern, wie z.B. Dänemark oder Finnland, die sekundäre Forschungsnutzung von Behandlungsdaten unterentwickelt ist. Die Intensivierung der Nutzung der Daten aus Diagnose und Therapie von Patienten und die Entwicklung der dafür notwendigen Strukturen in Deutschland ist ethisch und politisch geboten: für die Verbesserung (...) der Gesundheitsversorgung durch neue Erkenntnisse, Therapien und Qualitätssicherung. Aus diesem Grund fordern die Autor:innen alle Akteure des Gesundheitssystems, von der Bundes- und den Landesregierungen über die Krankenkassen, Kliniken, Ärzt:innen und Patient:innen dazu auf, einen Beitrag dazu leisten, eine Kultur der sekundären Forschungsnutzung von Behandlungsdaten zu etablieren. Basierend auf den Ergebnissen eines dreijährigen Verbundprojekts beantworten die Autor:innen aus den Bereichen Medizin, Rechtswissenschaften, Ethik und Sozialwissenschaften die Frage was notwendig ist, damit in Deutschland die Daten von Patient:innen systematisch für medizinische Forschung und die Analyse der klinischen Versorgungsqualität verwendet werden können und wirklich auch verwendet werden. Sie nennen zehn zentrale Forderungen und legen eine Liste von 23 Empfehlungen mit konkreten Maßnahmen vor, welche von den genannten Akteuren umgesetzt werden sollten. (shrink)

Research question The secondary research use of treatment data has the potential to expand medical knowledge and improve patient care. Hospitals play an important role in systematic secondary research use: they generate large amounts of treatment data and are supposed to establish the necessary structures for their use in research. This raises the ethical question: do hospitals have a moral duty to support secondary research use of treatment data by establishing and operating the necessary resources and infrastructure? Procedure Our aim (...) is to outline a conceptual framework to discuss the question and to propose a first normative position. Building on insights from business and organizational ethics, we develop a conceptual framework in which we view hospitals as moral actors. Our normative-ethical analysis is based on a reconstructive stakeholder approach, in which we identify the following general duties of hospitals: orientation towards patient wellbeing; cost efficiency; enabling employees to act in accordance with professional ethical standards; supporting public health and research. We examine whether these general duties provide reasons for a specific duty of hospitals to support secondary research use of treatment data. We discuss potential objections to such a duty arising from other, potentially conflicting general duties of hospitals (e.g., data protection), from practice (e.g., costs/resources), or related discourses (data ownership). Conclusion Certain general duties (orientation towards patient wellbeing, cost efficiency, support of public health) justify a duty of hospitals to support secondary research use of treatment data. The duty to enable employees to act in accordance with professional ethical standards is only an indirect reason; the duty to support research applies solely to university hospitals. Potential objections apply to a certain extent but can be mitigated through targeted measures. (shrink)

Research question The secondary research use of treatment data has the potential to expand medical knowledge and improve patient care. Hospitals play an important role in systematic secondary research use: they generate large amounts of treatment data and are supposed to establish the necessary structures for their use in research. This raises the ethical question: do hospitals have a moral duty to support secondary research use of treatment data by establishing and operating the necessary resources and infrastructure? Procedure Our aim (...) is to outline a conceptual framework to discuss the question and to propose a first normative position. Building on insights from business and organizational ethics, we develop a conceptual framework in which we view hospitals as moral actors. Our normative-ethical analysis is based on a reconstructive stakeholder approach, in which we identify the following general duties of hospitals: orientation towards patient wellbeing; cost efficiency; enabling employees to act in accordance with professional ethical standards; supporting public health and research. We examine whether these general duties provide reasons for a specific duty of hospitals to support secondary research use of treatment data. We discuss potential objections to such a duty arising from other, potentially conflicting general duties of hospitals (e.g., data protection), from practice (e.g., costs/resources), or related discourses (data ownership). Conclusion Certain general duties (orientation towards patient wellbeing, cost efficiency, support of public health) justify a duty of hospitals to support secondary research use of treatment data. The duty to enable employees to act in accordance with professional ethical standards is only an indirect reason; the duty to support research applies solely to university hospitals. Potential objections apply to a certain extent but can be mitigated through targeted measures. (shrink)