Pragmatic trials aim to directly inform health care decision-making through the collection of so-called ‘real world data’ from observations of comparative treatment effects in clinical practice. In order to ensure the applicability and feasibility of a pragmatic trial, design features may be necessary that deviate from standard research ethics requirements. Examples are traditional requirements to seek written informed consent and to perform extensive data and safety monitoring. Proposals for deviations from standard research ethics practice have resulted in controversy about their (...) ethical acceptability. One of the justifications for altered procedures is the allegedly high social value of pragmatic trials. In order to properly operationalize the concept in the ethical assessment of pragmatic trial designs, specification is warranted. We identified three determinants from common claims about a pragmatic trial's social value: the extent to which the research question has real world relevance, the trial design's ability to generate a real world answer and the probability of direct uptake of the results by decision-makers in practice. Subsequently, we discuss how these determinants should be applied to the practice of pragmatic trials, and to what extent they might be applicable to explanatory trials. (shrink)

An important approach to understand how the brain gives rise to consciousness is to probe the depth of unconscious processing, thus to define the key features that cause conscious awareness. Here, we investigate the possibility for subliminal stimuli to shape the context for unconscious processing. Context effects have generally been assumed to require consciousness. In the present experiment, unconscious context processing was investigated by looking at the impact of the context on the response activation elicited by a subliminal prime. We (...) compared the effects of the same subliminal prime on target processing when the prime was embedded in different unconscious contexts. Results showed that the same prime can evoke opposite responses depending on the unconscious context in which it is presented. Taken together, the results of this study show that context effects can be unconscious. (shrink)

‘Stakeholder’ and related notions have been coined to enhance managerial practice in mainstream corporations. Currently, these notions are abundantly present in all kinds of discourses, especially those on ‘socially responsible investing’. But what kind of stakeholder management are these socially responsible investors promoting and what might be reasonable expectations about outcomes? We find that they promote an approach that has shareholder value as motivation and legitimisation and that they nowhere promote sharing of governance with stakeholders other than shareholders. We explain (...) why this might reasonably be expected. Besides mainstream investors and corporations, investing through co-operatively structured corporations differs regarding stakeholder positions with respect to the position of at least one stakeholder group, whether this be consumers, employees or producers. What are the implications thereof and are these investments then superior from a socially responsible perspective on investment? We find that co-operative investors meet their own set of difficulties in implementing stakeholder management. Our questions and findings enable us to formulate some critical remarks on the stakeholder-notion in both discourses and in general. We suggest that its use, if not halted altogether, should at least be restricted and substituted by the use of more specific notions. (shrink)

Cohen Kadosh, Tzelgov, and Henik [Cohen Kadosh, R., Tzelgov, J., and Henik, A. (2008). A synesthetic walk on the number line: The size effect. Cognition, 106, 548-557] present a new paradigm to probe properties of the mental number line. They describe two experiments which they argue to be inconsistent with the exact small number model proposed by Verguts, Fias, and Stevens [Verguts, T., Fias, W., Stevens, M. (2005). A model of exact small-number representation. Psychonomic Bulletin and Review, 12, 66-80]. We (...) discuss the data, assumptions, and conclusions of Cohen Kadosh et al.'s paper in relation to existing models of numerical cognition. (shrink)

The nature of unconscious information processing is a heavily debated issue in cognitive science, and neuroscience. Traditionally, it has been thought that unconscious cognitive processing is restricted to knowledge that is strongly prepared by conscious processes. In three experiments, we show that the task that is performed consciously can also be applied unconsciously to items outside the current task set. We found that a same–different judgment of two target stimuli was also performed on two subliminally presented prime stimuli. This was (...) true for target and prime stimuli from entirely different categories, as well as for prime and target stimuli at different levels of abstraction. These results reveal that unconscious processing can generalize more widely than previously accepted. (shrink)

Introduction International sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a ‘social license’ is identifying the views patients and the public may hold with regard to data sharing for health research. Methods We performed a narrative review of the empirical (...) evidence addressing patients’ and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed, Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients’ and public attitudes were extracted from selected references and thematically categorised. Results Twenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread—though conditional—support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability. Conclusions Our results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests. (shrink)

BackgroundThe rise of Big Data-driven health research challenges the assumed contribution of medical research to the public good, raising questions about whether the status of such research as a common good should be taken for granted, and how public trust can be preserved. Scandals arising out of sharing data during medical research have pointed out that going beyond the requirements of law may be necessary for sustaining trust in data-intensive health research. We propose building upon the use of a social (...) licence for achieving such ethical governance.Main textWe performed a narrative review of the social licence as presented in the biomedical literature. We used a systematic search and selection process, followed by a critical conceptual analysis. The systematic search resulted in nine publications. Our conceptual analysis aims to clarify how societal permission can be granted to health research projects which rely upon the reuse and/or linkage of health data. These activities may be morally demanding. For these types of activities, a moral legitimation, beyond the limits of law, may need to be sought in order to preserve trust. Our analysis indicates that a social licence encourages us to recognise a broad range of stakeholder interests and perspectives in data-intensive health research. This is especially true for patients contributing data. Incorporating such a practice paves the way towards an ethical governance, based upon trust. Public engagement that involves patients from the start is called for to strengthen this social licence.ConclusionsThere are several merits to using the concept of social licence as a guideline for ethical governance. Firstly, it fits the novel scale of data-related risks; secondly, it focuses attention on trustworthiness; and finally, it offers co-creation as a way forward. Greater trust can be achieved in the governance of data-intensive health research by highlighting strategic dialogue with both patients contributing the data, and the public in general. This should ultimately contribute to a more ethical practice of governance. (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)

Name der Zeitschrift: Byzantinische Zeitschrift Jahrgang: 108 Heft: 2 Seiten: 771-796.

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)

BackgroundIn this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants.DiscussionWe first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then (...) elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials.ConclusionThe fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished. (shrink)

The Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain.

The Dutch law states that a physician may perform euthanasia according to a written advance euthanasia directive when a patient is incompetent as long as all legal criteria of due care are met. This may also hold for patients with advanced dementia. We investigated the differing opinions of physicians and members of the general public on the acceptability of euthanasia in patients with advanced dementia.

Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing. Despite the recent adoption of the EU General Data Protection Regulation, the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of an ethical governance framework, we (...) set out to explore relevant ethical principles and norms. We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research. We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement. However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used. While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust. (shrink)

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, (...) RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task. (shrink)

BackgroundThe Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain.MethodsWe did an electronic search of seven Dutch national newspapers between January 2009 and May 2010 and conducted a content analysis.ResultsOf the 284 articles containing the term ‘euthanasia’, 24% referred to practices outside the scope of the law, mostly relating to (...) the forgoing of life-prolonging treatments and assistance in suicide by others than physicians. Of the articles with euthanasia as the main topic, 36% described euthanasia in the context of a terminally ill patient, 24% for older persons, 16% for persons with dementia, and 9% for persons with a psychiatric disorder. The most frequent arguments for euthanasia included the importance of self-determination and the fact that euthanasia contributes to a good death. The most frequent arguments opposing euthanasia were that suffering should instead be alleviated by better care, that providing euthanasia can be disturbing, and that society should protect the vulnerable.ConclusionsOf the newspaper articles, 24% uses the term ‘euthanasia’ for practices that are outside the scope of the euthanasia law. Typically, the more unusual cases are discussed. This might lead to misunderstandings between citizens and physicians. Despite the Dutch legalisation of euthanasia, the debate about its acceptability and boundaries is ongoing and both sides of the debate are clearly represented. (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)

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)

Disputations were a fixture of Martin Luther’s academic career. Luther participated regularly in disputations. It was an important communicative vehicle through which he developed and expressed his theology. The well-known 95 theses are a case in point. Luther’s career as a disputator was impressive. Several of his most influential disputations were explicitly intended for consideration by his academic and ecclesiastical colleagues, but the majority of his disputations took place as a curricular exercise at the University of Wittenberg. The purpose of (...) these disputations was pedagogical and polemical. Luther deployed the same tools for his defence of proper doctrine that were at the centre of the Protestant reformation in the face of objections. The disputatio de homine is a systematic summary of Luther’s anthropology. It incorporates the doctrine of justification as the theological definition of man. It treats the subject within the context of the relationship between theology and philosophy, and reflects upon the new language of theology. The disputatio de homine provides an essential resource for the study of Luther’s anthropology and the doctrine of justification. (shrink)

Considering Pragma-Dialectics honors the monumental contributions of one of the foremost international figures in current argumentation scholarship: Frans van Eemeren. The volume presents the research efforts of his colleagues and addresses how their work relates to the pragma-dialectical theory of argumentation with which van Eemeren’s name is so intimately connected. This tribute serves to highlight the varied approaches to the study of argumentation and is destined to inspire researchers to advance scholarship in the field far into the future. Replete with (...) contributions from highly-esteemed academics in argumentation study, chapters in this volume address such topics as: *Pragma-dialectic versus epistemic theories of arguing and arguments; *Pragma-dialectics and self-advocacy in physician-patient interactions; *The pragma-dialectical analysis of the ad hominem family; *Rhetoric, dialectic, and the functions of argument; and *The semantics of reasonableness. As an exceptional volume and a fitting tribute, this work will be of interest to all argumentation scholars considering the astute insights and scholarly legacy of Frans van Eemeren. (shrink)

A number of philosophers have recently found it congenial to talk in terms of grounding. Grounding discourse features grounding sentences that are answers to questions about what grounds what. The goal of this article is to explore and defend a counterpart-theoretic interpretation of grounding discourse. We are familiar with David Lewis's applications of the method of counterpart theory to de re modal discourse. Counterpart-theoretic interpretations of de re modal idioms and grounding sentences share similar motivations, mechanisms, and applications. I shall (...) explain my motivations and describe two applications of a counterpart theory for grounding discourse. But, in this article, my main focus is on counterpart-theoretic mechanisms. (shrink)

Die Festschrift Gnostica et Manichaica ehrt den am 13. Juli 1952 geborenen Religionshistoriker, Turkologen, Iranisten und Wissenschaftsgeschichtler Alois van Tongerloo. Sein vielseitiges und vielgestaltiges Wirken spiegelt sich in den 19 Beitragen von Kollegen, Freunden und Schulern, die so unterschiedliche Felder wie Religionsgeschichte, Manichaologie, Kirchengeschichte, Wissenschaftsgeschichte, Turkologie, Sinologie und Iranistik abdecken.Aus dem Inhalt : L. Cirillo, Mani: Apostle of Jesus Christ and Paraclete, in the Manichean primitive tradition and in the criticism of St. AugustinePaul Mirecki, Manichaeism, scribal magic and Papyrus Kellis (...) 35Zekine Ozertural, Uber eine orthographische Besonderheit der manichaisch-uigurischen TexteAntonio Panaino, The three Magi, the Stone of Christ and the Christian origin of the Mazdeam fire cultRomolo Perrotta, Wie entsteht eine "Haresie"? Eine phanomenologische PerspektiveCardinal Julien Ries, Le Manicheisme - une religion dualiste, gnostique et syncretisteJurgen Tubach, Die manichaische Hierarchie: die Zahlen 12, 72 und 360Roland van Vliet, Adoptianismus in der manichaischen Christologi. (shrink)

Psillos has recently argued that van Fraassen’s arguments against abduction fail. Moreover, he claimed that, if successful, these arguments would equally undermine van Fraassen’s own constructive empiricism, for, Psillos thinks, it is only by appeal to abduction that constructive empiricism can be saved from issuing in a bald scepticism. We show that Psillos’ criticisms are misguided, and that they are mostly based on misinterpretations of van Fraassen’s arguments. Furthermore, we argue that Psillos’ arguments for his claim that constructive empiricism itself (...) needs abduction point up to his failure to recognize the importance of van Fraassen’s broader epistemology for constructive empiricism. Towards the end of our paper we discuss the suspected relationship between constructive empiricism and scepticism in the light of this broader epistemology, and from a somewhat more general perspective. (shrink)