Name der Zeitschrift: Das Mittelalter Jahrgang: 19 Heft: 2 Seiten: 302-325.

This book investigates the relationships between gestures and artefacts theoretically and historically, by analyzing different phenomena stemming from a variety of fields such as robotics, archaeology, gesture studies, anthropology, philosophy, and gestural practices like choreography, music performance, and composition. It underlines how embodiment and technology change the interplay between maker and artefact over time and appeals to students and researchers in these fields. Its goal is to enable the reader to understand that the recurring topics and questions as well as (...) multi-level similarities are by no means accidental, but can best be understood if one pays attention to the intertwinements of materiality and cognition, praxis and techne. (shrink)

Transformative and mutually beneficial solutions require decision-makers to reconcile present- and future interests and to align them with those of other decision-makers. Despite the natural co-occurrence of intrapersonal and interpersonal conflicts in the transformation toward sustainability, both types of conflicts have been studied predominantly in isolation. In this conceptual article, we breathe new life into the traditional dialog between individual decision-making and negotiation research and address critical psychological barriers to the transformation toward sustainability. In particular, we argue that research on (...) intrapersonal and interpersonal conflicts should be tightly integrated to provide a richer understanding of the interplay between these conflicts. We propose a novel, unifying framework of interdependent conflicts that systematically structures this interplay, and we analyze how complex interdependencies between the social and temporal dimensions pose fundamental psychological barriers to mutually beneficial solutions. Since challenges to conflict resolution in the transformation toward sustainability emerge not only between individual decision-makers but also frequently between groups of decision-makers, we scale the framework up to the level of social groups and thereby provide an interdependent-conflicts perspective on the interplay between intra- and intergenerational conflicts. Overall, we propose simple, testable propositions, identify intervention approaches, and apply them to transition management. By analyzing the challenges faced by negotiating parties during interdependent conflicts and highlighting potential intervention approaches, we contribute to the transformation toward sustainability. Finally, we discuss implications of the framework and point to avenues for future research. (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)

As the capabilities of Artificial Intelligence (AI) have increased over recent years, so have the challenges of how to govern its usage. Consequently, prominent stakeholders across academia, government, industry, and civil society have called for states to devise and deploy principles, innovative policies, and best practices to regulate and oversee these increasingly powerful AI tools. Developing a robust AI governance system requires extensive collective efforts throughout the world. It also raises old questions of politics, democracy, and administration, but with the (...) new challenges posed by AI's growing influence on markets, governing structures, international relations, healthcare, science, and political activism. The Oxford Handbook of AI Governance delineates the scope of these issues and addresses the key questions of AI governance. Across forty-nine chapters, organized in nine major sections, the Handbook covers the theoretical and ethical foundations of AI governance, different frameworks for developing a governance structure for AI, practical perspectives on AI governance in different policy domains, economic analyses of AI governance, and concrete lessons about the impact of AI governance domestically and internationally. Chapter authors come from a wide set of disciplines, areas of study, and cultural backgrounds, providing a global perspective on AI governance. (shrink)

Perhaps, as Professor Battaglia remarks in his Introduction, the German people has the philosophical vocation: Si può persino dire, con una certa enfasi, che il popolo tedesco ha ‘la’ vocazione filosofica. Certainly it was a happy idea to invite distinguished German and Austrian philosophers to explain each his philosophical standpoint. The project was successfully carried out by the Institute of Philosophy in the University of Bologna. The list of contributors speaks for itself: Theodor W Adorno, Ernst Bloch, Leo Gabriel, Hans (...) G Gadamer, Romano Guardini, Dietrich von Hildebrand, Helmut Kuhn, Ludwig Landgrebe, Johannes Baptista Lotz, Karl Löwith, Friedrich Max Müller, Josef Pieper, Helmut Plessner, Fritz-Joachim von Rintelen, Amadeo Silva-Tarouca, Ernst Topitsch, and Carl F von Weizsäcker. The page or two of biography that precedes each essay is helpful; there are as many contrasts here as there are between the different philosophical perspectives outlined by the contributors; and there is one striking similarity in the interruption of the careers of so many of these men—all now in their sixties or older—by the Nazi period. Professor Felice Battaglia’s Introduzione deserves to stand with the other contributions; it is a summary that weaves together with considerable skill the strands of German philosophy represented by writers as various as Bloch and Guardini or Pieper and Plessner. German philosophy, he points out, has come a long way from the gnoseological problems of Kant or the absolutism of Hegel; it has unexpectedly found its way, via phenomenology and existentialism, back to a situation in which one can say: Teologia non spaventa molti pensatori tedeschi. (shrink)

The Remmelink Committee published its report on medical decisions at the end of life in the Netherlands in September 1991. As a result, the Dutch debate about physician aid‐in‐dying has been broadened to include life‐terminating acts that have not been explicitly requested by the patient.

Cocaine use disorder is associated with maladaptive decision-making behavior, which strongly contributes to the harmful consequences of chronic drug use. Prior research has shown that cocaine users exhibit impaired neuropsychological test performances, particularly with regard to attention, learning, and memory but also in executive functions such as decision-making and impulse control. However, to what extent cocaine users show impaired decision-making under risk without feedback has not yet been investigated systematically. Therefore, to examine risk-taking behavior, 31 chronic cocaine users and 26 (...) stimulant-naïve healthy controls who were part of the Zurich Cocaine Cognition Study, performed the Randomized Lottery Task (RALT) with winning lotteries consisting of an uncertain and a certain prospect. Results revealed that risky decisions were associated with male sex, increased cocaine use in the past year, higher cocaine concentrations in the hair, and younger age. In addition, higher levels of cocaine in the hair and cumulative lifetime consumption were associated with risky decisions, whereas potentially confounding factors including cognition and psychiatric symptoms had no significant effect. Taken together, our results indicate that cocaine users who increased their consumption over a period of 1 year show deficits in the processing of risky information accompanied with increased risk-taking. Future research should analyse whether risky decisions could potentially serve as a prognostic marker for cocaine use disorder. (shrink)

People who work and live in a certain moral practice usually possess a specific form of moral wisdom. If we manage to incorporate their moral intuitions in ethical reasoning, we can arrive at judgements and theories that grasp a moral experience that generally cannot be found outside the said practice. To achieve this goal, we need a legitimate way to balance moral intuitions, ethical principles and general theories. In the present contribution, we describe a version of the model of Reflective (...) Equilibrium, which we call the Normative-Empirical Reflective Equilibrium . RE provides a framework for ethical thinking that includes both moral experience and normative theory.After an outline of the model, we focus on the role of empirical research and illustrate how empirical data on moral intuitions can add to the comprehensiveness of the set of moral beliefs in NE-RE. Subsequently, we describe how coherence among the elements of an NE-RE can be understood and measured. Finally, we address an important question for any method of moral reasoning: what is the status of the outcome of the reasoning process? This is a matter of justification. We argue for a so-called good reasoning-justified outcome strategy in NE-RE. This strategy is built on a reasoning process in which the reason-giving force of each element is tested and weighed. The thinker has to work towards a coherent view in which only the elements with sufficient justificatory power are retained. If the thinker decides that the elements fit together into a coherent view, a reflective equilibrium is reached. NE-RE is an attempt to describe a model for moral reasoning that can profit from the moral wisdom present among experienced agents through the use of empirical research. (shrink)

Vorwort der Herausgeber mit Schriftenverzeichnis Albert Mues - H. SEubert: Transzendentalphilosophie und Metaphysik heute. EIne Skizze - M. SCherbaum: Philosophie als Lebensform - oder: Die Krise des Nihilismus und die Validitat transzendentaler Argumentation. SYstematische Reflexionen zu Letztbegrundung, Grenze und Bedeutung von Philosophie - M. GErten: Der Charakter der Transzendentalphilosophie als fundamentaler Geltungsreflexion. HIstorische und systematische uberlegungen mit besonderem Blick auf den spaten Fichte - L. MOckl: Zur logischen Position der Hypothese - I. RAdrizzani: Die Zeitfiguration in der Transzendentalphilosophie. REinhard Lauths (...) Appositionslehre als Aktualisierung von Fichtes Zeitmodell - K. POllok: Kants Begriff der Normativitat im Kontext der fruhneuzeitlichen Philosophie - C. LOtz: Gewissen und Widerstand - M. FUchs: "Freiheit, die sich Dasein gibt". INdividuum und Staat bei Platon und Hegel - B. DIeckmann: Reich der Freiheit und Kreuzestheologie. OPfer bei Johann Gottlieb Fichte - W. KLausnitzer: Christentum versus Islam. uBerlegungen zum Thema der Gewalt in beiden Religionen - M. FAmula: Zwischen Grenzenlosigkeit und Ausgrenzung. LIebe als Kultivierungsprozess in Adalbert Stifters Brigitta. (shrink)

BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus. In this manuscript, we attempted to do just that.MethodsWe extracted (...) the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus. Of the 12 clusters, Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences. (shrink)

Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond (...) its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials. (shrink)

Book Reviews in this Article: Rationing America's Medical Care: The Oregon Plan and Beyond, edited by Martin A. Strosberg, Joshua M. Wiener, Robert Baker and I. Alan Fein. Bad Medicine: The Prescription Drug Industry in the Third World, by Milton Silverman, Mia Lydecker and Philip R. Lee. Stanford Feminist Perspectives in Medical Ethics, edited by Helen Bequaert Holmes and Laura M. Purdy, Bloomington and Indianapolis: Indiana Choices in Health Care: A Report by the Government Committee on Choices in Health Care, (...) The Netherlands, 1992. (shrink)

This commentary introduces the notion of “technical alterity” in order to address the following questions: is it possible that technical objects can become “others” in analogy to Levinas’ ethics and can this relation provide solutions for the subject in the Anthropocene? According to Levinas, the human subject’s only break from having to be itself is in the consumption and enjoyment of things. Objects constitute thus an “other” that can be consumed, i.e., appropriated and be made one’s own. But, in times (...) of the Anthropocene, where the entanglement of human and non-human actors becomes increasingly obvious and intricate, and a question of survival for human beings in the face of the climate crisis, it is necessary to develop a relation with non-human actors that does not reduce them to mere means to an end. This ethical relation with technical objects relies upon an epistemic act, since technical objects precisely do not have a “face” in the Levinasian sense. Technical objects as “technical others” have therefore—in light of Simondon’s philosophy of technology—to be invented. (shrink)

In recent years, inverse spectra were investigated with imaging optics and a quantitative description with radiometric units was suggested. It could be shown that inverse spectra complement each other additively to a constant intensity level. Since optical intensity in radiometric units is a power area density, it can be expected that energy densities of inverse spectra also fulfill an inversion equation and complement each other. In this contribution we report findings on a measurement of the power area density of inverse (...) spectra for the near ultraviolet, visible and the infrared spectral range. They show the existence of corresponding spectral regions ultra-yellow and infra-cyan in the inverted spectrum and thereby present additional experimental evidence for equivalence of inverse spectra beyond the visible range. (shrink)

In this article, we discuss recent evidence from experimental economics on the impact of social preferences on workplace behavior. We focus on situations in which a single employer interacts with multiple employees. Traditionally, equity and efficiency have been seen as opposing aims in such work environments: individual pay-for-performance wage schemes maximize of efficiency but might lead to inequitable outcomes. We present findings from laboratory experiments that show under which circumstances partially incomplete contracts can create equitable work environments while at the (...) same time reaching surprisingly efficient outcomes. (shrink)

Late Medieval and Early Modern Fight Books offers insights into the cultural and historical transmission and practices of martial arts, based on the corpus of the Fight Books (Fechtbücher) in 14th- to 17th-century Europe. The first part of the book deals with methodological and specific issues for the studies of this emerging interdisciplinary field of research. The second section offers an overview of the corpus based on geographical areas. The final part offers some relevant case studies. This is the first (...) book proposing a comprehensive state of research and an overview of Historical European Martial Arts Studies. One of its major strengths lies in its association of interdisciplinary scholars with practitioners of martial arts. Contributors are Sydney Anglo, Matthias Johannes Bauer, Eric Burkart, Marco Cavina, Franck Cinato, John Clements, Timothy Dawson, Olivier Dupuis, Bert Gevaert, Dierk Hagedorn, Daniel Jaquet, Rachel E. Kellet, Jens Peter Kleinau, Ken Mondschein, Reinier van Noort, B. Ann Tlusty, Manuel Valle Ortiz, Karin Verelst, and Paul Wagner. (shrink)

Cognitive theories of emotion propose that the interpretation of emotion-eliciting situations crucially shapes affective responses. Implicit or automatic biases in these interpretations may hinder emotion regulation and thereby increase risk for the onset and maintenance of psychological disorders. In this study, participants were randomly assigned to a positive or negative interpretation bias training using ambiguous social scenarios. After the completion of the training, a stress task was administered and changes in positive and negative affect and self-esteem were assessed. The results (...) demonstrate that the interpretation bias training was successful in that participants exhibited a tendency to interpret novel scenarios in accordance with their training condition. Importantly, the positive training condition also had a protective effect on self-esteem. Participants in this condition did not exhibit a decrease in self-esteem after the stress task, whereas participants in the negative condition did. These results demonstrate that implicit cognitive biases can be trained and that this training affects self-esteem. Implications of these findings for research on psychopathology and emotion regulation are discussed. (shrink)

The topics of ethical conduct and governance in academic research in the business field have attracted scientific and public attention. The concern is that research misconduct in organizations such as business schools and universities might result in practitioners, policymakers, and researchers grounding their decisions on biased research results. This study addresses ethical research misconduct by investigating whether the ethical orientation of business researchers is related to the likelihood of research misconduct, such as selective reporting of research findings. We distinguish between (...) deontological and consequentialist ethical orientations and the competition between researchers and investigate the moderating role of their perceived autonomy. Based on global data collected from 1031 business scholars, we find that researchers with a strong deontological ethical orientation are less prone to misconduct. This effect is robust against different levels of perceived autonomy and competition. In contrast, researchers having a consequentialist ethical orientation is positively associated with misconduct in business research. High levels of competition in the research environment reinforce this effect. Our results reveal a potentially toxic combination comprising researchers with a strong consequentialist orientation who are embedded in highly competitive research environments. Our research calls for the development of ethical orientations grounded on maxims rather than anticipated consequences among researchers. We conclude that measures for ethical governance in business schools should consider the ethical orientation that underlies researchers’ decision-making and the organizational and institutional environment in which business researchers are embedded. (shrink)

The Remmelink Committee published its report on medical decisions at the end of life in the Netherlands in September 1991. As a result, the Dutch debate about physician aid‐in‐dying has been broadened to include life‐terminating acts that have not been explicitly requested by the patient.

During the last decade, Network Science has become one of the most active fields in applied physics and mathematics, since it allows the analysis of a diversity of social, biological and technological systems [24]. From the diversity of applications of Network Science, in this Opinion paper we are concerned about its potential to analyse one of the most extended group sports, Football (soccer in U.S. terminology) [29], since it allows addressing different aspects of the team organization and performance not captured (...) by classical analyses based on the performance of individual players. The reason behind relies on the complex nature of the game, which, paraphrasing the foundational paradigm of complexity sciences “can not be analysed by looking at its components (i.e., players) individually but, on the contrary, considering the system as a whole” or, in the classical words of after-match interviews “it’s not just me, it’s the team”. The recent ability of obtaining datasets of all events occurring during a match, including the position of the players and the interactions between them has opened the door to new kind of studies where it is possible to analyse and quantify the behaviour of a team as a whole, together with the role of a single player [17]. Under this framework, the organization of a team can be considered as the result of the interaction between its players, creating a network based on passes. In this way, we can create passing networks, which are directed (i.e.,... (shrink)

Setting out to understand the effects of positive moral emotions in leadership, this research examines the consequences of leaders’ expressions of gratitude and pride for their followers. In two experimental vignette studies and a field study, leaders’ gratitude expressions showed a positive effect and leaders’ pride expressions showed a negative effect on followers’ ascriptions of leader selfishness. Thereby, leaders’ gratitude expression indirectly led to higher follower satisfaction with and OCB towards the leader, while leaders’ pride expressions indirectly reduced satisfaction with (...) and OCB towards the leader. Furthermore, leaders’ expressions of gratitude indirectly reduced followers’ intentions to leave the leader, while leaders’ expressions of pride indirectly fuelled them. Although ascriptions of selfishness consistently influenced these leader outcomes more strongly than comparable organizational outcomes, results on organizational outcomes were mixed. While leaders’ expressions of gratitude led, as expected, to higher job satisfaction and lower turnover intentions, leaders’ expressions of pride showed positive relations with both OCB towards the organization and intentions to leave the organization. We discuss the theoretical implications of leaders’ expressions of positive moral emotions as signals of outcome attributions, as well as leaders’ selfishness and practical implications that help leaders build followers’ satisfaction and positive leader–follower relationships. (shrink)

The current German criticism of HUGO centers around the term ‘human dignity’; consenquentialist and autonomy-based arguments are used. The debate culminates in questioning the integrity of bioethics as a scholarly discipline and has created a heterogeneous coalition of disparate political and social groups that oppose any research that would facilitate genetic pre-selection of human characteristics.

Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we propose an alternative (...) approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of ‘mini-organs’ in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a ‘consent for governance’ model that contributes to responsible innovation and clinical translation in this exciting field. (shrink)

During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate . Current international research ethics guidelines contain a wide variety of standards for the standard of care—including the provision of the highest attainable, the best available, the best current, a proven , and an established effective treatment. In this article, (...) we systematically review the currently used standards and argue that none of the current standards is adequate to serve as a universal standard for the standard of care. Alex London has made a substantial proposal for a universal standard, but universally adopting his standard is problematic. In this article, we propose a revised version of London's standard. (shrink)

Based on a field study, this paper explores the differential role that perceived top management trustworthiness has on female and male employees’ negative emotions and turnover intentions in organizations. A theoretical model is established that explicates a negative indirect effect of perceived top management trustworthiness on employee turnover intentions through employee negative emotions. The results reveal that there is a negative relationship between perceived top management trustworthiness and employee negative emotions and resulting turnover intentions and that this effect is stronger (...) for female employees than for male employees. These results demonstrate the pivotal role played by top management trustworthiness, provide an explanation for the turnover gender gap, and highlight the subjectivity in reactions to trustworthiness perceptions. The implications for organizations are discussed in line with the need for top management to positively influence employees and particularly women, to retain them in their workforce. (shrink)

An increasing number of older patients have to decide on a treatment plan for advanced chronic kidney disease, involving dialysis or conservative care. Shared decision-making is recommended as the model for decision-making in such preference-sensitive decisions. The aim of SDM is to come to decisions that are consistent with the patient’s values and preferences and made by the patient and healthcare professional working together. In clinical practice, however, SDM appears to be not yet routine and needs further implementation. A shift (...) from a biomedical to a person-centered conception might help to make the process more shared. Shared should, therefore, be interpreted as two persons bringing two perspectives to the table, that both need to be explored during the decision-making process. Starting from the patient’s perspective will enable to determine the mutual goals of care first and, subsequently, determine the best way for achieving those goals. To perform such SDM, the healthcare professional needs to become a skilled companion, being part of the patient’s relational context, and start asking the right questions about what matters to the patient as person. In this article, we describe the need for a person-centered conception of SDM for the setting of older patients with advanced CKD. (shrink)

The authors of the paper ‘Advance euthanasia directives: a controversial case and its ethical implications’ articulate concerns and reasons with regard to the conduct of euthanasia in persons with dementia based on advance directives. While we agree on the conclusion that there needs to be more attention for such directives in the preparation phase, we disagree with the reasons provided by the authors to support their conclusions. We will outline two concerns with their reasoning by drawing on empirical research and (...) by providing reasons that contradict their assumptions about competence of people with dementia and the importance of happiness in reasoning about advance directives of people with dementia. We will draw attention to the important normative questions that have been overstepped in their paper, and we will outline why further research is required. (shrink)

It is often argued that clinical research should not violate the Kantian principle that people must not be used merely as a means for the purposes of others. At first sight, the practice of clinical research itself, however, seems to violate precisely this principle: clinical research is often beneficial to future people rather than to participants; even if participants benefit, all things considered, they are exposed to discomforts which are absent both in regular care for their diseases and in other (...) areas of daily life. Therefore, in this paper we will consider whether people are used merely as a means by being enrolled in clinical research. On the basis of recent studies of Kantian scholars we will argue that clinical research is compatible with the Kantian principle if the conditions of possible consent and end-sharing have been met. Participants are not used merely as a means if they have sufficient reasons to consent to being enrolled in clinical research and can share the ends of the researchers who use them. Moreover, we will claim that even if people are used merely as a means by participating in clinical research, it may not always be morally wrong to use them in this way. (shrink)

Therapeutic privilege is a defence that may be available to doctors who fail to disclose to the patient relevant information when seeking informed consent for treatment if they have a reasonable belief that providing that information would likely cause the patient concerned serious physical or mental harm. In a landmark judgement, the Singapore Court of Appeal introduced a novel interpretation of TP, identifying circumstances in which it might be used with patients who did not strictly lack capacity but might be (...) inclined to refuse recommended treatments. In this paper, we explore the conceptual and practical challenges of this novel interpretation of TP. We propose that more emphasis should be placed on forms of shared and supported decision-making that foster the autonomy of patients with compromised mental capacity while being mindful of the need to safeguard their well-being. The kind of privilege that doctors might need to invoke is one of time and supportive expertise to ensure a flexible, responsive approach calibrated to the individual patients’ needs. The provision of such service would extinguish the need for the novel TP proposed by the Singapore Court of Appeal. (shrink)

Monitoring and assistive technologies (MATs) are being used more frequently in healthcare. A central ethical concern is the compatibility of these systems with the moral preferences of their users—an issue especially relevant to participatory approaches within the ethics-by-design debate. However, users’ incapacity to communicate preferences or to participate in design processes, e.g., due to dementia, presents a hurdle for participatory ethics-by-design approaches. In this paper, we explore the question of how the value preferences of users in the field of dementia (...) care can be integrated into AI-based MATs. First, we briefly introduce different ethics-by-design approaches and explain the challenges they face in dementia care. Next, we introduce a novel approach for addressing these challenges. Through a qualitative content analysis of interviews with persons with dementia and their family caregivers (n = 27), we identified multiple ideal–typical value preference profiles. We then applied these profiles in a computer simulation, by which we also introduce the concept of ethical compliance quantification to scale the moral preferences of the interviewees for the simulation. Finally, we discuss study results, the advantages of using computer simulations, and general study limitations before drawing conclusions for further research. The study contributes to the ongoing debate on participatory ethics-by-design by defining on the basis of empirical data ideal–typical value preference frameworks that can be used to guide MAT actions and their outcomes. Going forward, MAT end-users with dementia and other communication-impaired persons could be enabled to choose a value profile that best fits their moral preferences. (shrink)

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and (...) vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

Modern medicine provides unprecedented opportunities in diagnostics and treatment. However, in some situations at the end of a patient’s life, many physicians refrain from using all possible measures to prolong life. We studied the incidence of different types of treatment withheld or withdrawn in 6 European countries and analyzed the main background characteristics.

In his paper, Fabrice Jotterand clearly illustrates the difficulties of applying the concept of human dignity in the context of emerging enhancement technologies. Unfortunately, however, Jotterand'...

BackgroundPregnant people have been overlooked or excluded from clinical research, resulting in a lack of scientific knowledge on medication safety and efficacy during pregnancy. Thus far, both the opportunities to generate evidence-based knowledge beyond clinical trials and the role of pregnant people in changing their status quo have not been discussed. Some scholars have argued that for rare disease patients, for whom, just like pregnant people, a poor evidence base exists regarding treatments, solidarity has played an important role in addressing (...) the evidence gap. This paper explores whether and how the enactment of solidarity among pregnant people can be stimulated to help address the poor evidence base on medications used during pregnancy.MethodWe use the concept of solidarity formulated by Prainsack and Buyx and enrich their concept by providing an account for stimulating the enactment of solidarity. Then we apply this account to the case of pregnant people who use medication.ResultsSolidarity means enacted commitment on the part of an individual to assisting others with whom the person recognizes a similarity in a relevant respect. Although solidarity cannot be imposed, we argue that the empowerment of people is a crucial concept in understanding how solidarity can be stimulated. Empowerment in the context of pregnant people means creating awareness about their status quo, explaining how scientific research can help close the knowledge gap, and how pregnant people can themselves contribute. In particular, how pregnant people can contribute to the collection of health data to strengthen the evidence base for medications used during pregnancy.ConclusionsWe conclude that acting in solidarity can help change the status quo for pregnant people. Furthermore, we argue that the empowerment of pregnant people and other relevant stakeholders is a way to stimulate the enactment of solidarity. The process of empowerment starts by raising awareness about the lack of evidence on medications used during prengnacy and by explaining to pregnant people how they can contribute to changing the way knowledge is being generated by, for example, sharing data on the health effects of medications. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...) Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...) of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

Human adults possess the extraordinary ability to produce mental imagery about a wide variety of non-occurrent events. We can, for example, simulate the perception of different places, different times, different possibilities, or others’ perspectives. Findings from cognitive psychology, neuropsychology, and cognitive neuroscience suggest that all of these capacities rely on the same neuro-cognitive mechanism: episodic simulation. This ability produces mental imagery by constructively recombining elements of past experiences to simulate event representations. However, if episodic simulation indeed produces mental imagery, it (...) remains unclear how the non-imagistic aspects of its outputs become cognitively determined. In this article, I argue that there are (at least) four such non-imagistic ‘dimensions’ of episodic simulation: specificity, temporal orientation, subjectivity, and factuality. Further, I propose an account of the mechanisms which might be responsible for determining where a given output of episodic simulation falls within this dimensional space. According to this view, episodic simulation relies on propositional ‘scope-operators’ either deployed as inputs to the simulation process itself or produced by post-hoc monitoring processes operating over its outputs. This view has consequences for how we should view the operation, development, and evolution of episodic simulation. (shrink)