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)

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)

In the Netherlands, the legalization of assisted suicide for persons with a death wish without severe illness, often referred to as persons with “completed life” or “tiredness of life,” is intensel...

A recurrent issue in the vast amount of literature on reasoning models in ethics is the role and nature of moral intuitions. In this paper, we start from the view that people who work and live in a certain moral practice usually possess specific moral wisdom. If we manage to incorporate their moral intuitions in ethical reasoning, we can arrive at judgements and (modest) theories that grasp a moral experience that generally cannot be found outside the practice. Reflective equilibrium (RE) (...) provides a framework for balancing moral intuitions, ethical principles and general theories. Nevertheless, persisting problems associated with the use of intuitions need to be addressed. One is the objection that moral intuitions lack the credibility necessary to guide moral reasoning. Ethicists have tried to solve this problem by formulating criteria to separate the “bad” intuitions from the “good” ones at the beginning of the reasoning process. We call this the credible input-justified outcome strategy. An example is the appeal to the common morality by Beauchamp and Childress. We think this approach is unsuccessful. As an alternative, we outline the good reasoning-justified outcome strategy. It connects to a variant of RE in which intuitions from different sources are incorporated. We argue that the elements of RE have different levels of justificatory power at the start of reasoning. In our strategy, each element can gain or lose justificatory power when it is tested in a reasoning process that meets several criteria. (shrink)

A short dictionary of quotations from Kierkegaard, Jaspers, Marcel, Heidegger, Sartre and de Beauvoir provides the reader with some idea of peculiarly existentialist understandings of standard philosophical terms as well as of terms which are more especially associated with existential thought. At times the selection seems rather arbitrary in some cases.--J. M. W.

An authorized, eminently readable translation of a work first published in German in 1957. Martin leads his reader into the problems of metaphysics by tracing the development of Plato's thought and Aristotle's criticism of Plato, focusing throughout on the question, "What is unity?" Although the book is introductory in intent and tone, it offers its own interpretation of Plato and Aristotle.--J. M. W.

Dicke discusses the metamorphosis of Hegelianism in Feuerbach and Marx through an examination of the concept of identity in the three philosophers. He demonstrates the persistence of this concept as a decisive theme in both Feuerbach and Marx, and shows how Hegel's doctrine of identity is transformed and adulterated in the process of adaptation. A primary consequence of Marx's modification of this doctrine is the philosophical sacrifice of the individual to the collective, which has its practical consequences in contemporary communist (...) states.--J. M. W. (shrink)

A richly detailed history of French secular thought in the seventeenth and early eighteenth centuries. A wealth of material is introduced from unpublished manuscripts. Spink's stress on the clandestine spread of the enlightenment, in spite of official suppression, is interesting and sobering.--J. M. W.

A new and simplified edition of Myers' major work, originally published in 1903. Previous editions had relegated all illustrative case material to cumbersome appendices. The editor of this edition has abridged this material and integrated it into the body of the text. The result is a more manageable and readable volume.--J. M. W.

The author regards faith as a restless quest for that which can save man from his self-destructive tendencies and allow him to actualize most completely his constructive potentialities. Wieman critically examines several answers to this quest of faith, including those of Dewey, Tillich, and Barth. In contrast he develops the view of "liberal religion," which finds the answer in a divine creativity fostered by communication, and is productive of fresh insights which transform human ideals.--J. M. W.

A revised edition of this translation which was first published in 1934. Silber has added a vigorous and provocative essay focusing attention on the importance of the Religion for understanding Kant's ethics.--J. M. W.

Miles traces the transmission of the Platonic tradition from the Florentine Platonists to Colet. Although he finds Colet more guarded than Ficino and Mirandola in his assimilation of Platonism to Christianity, he shows that Platonic and Neoplatonic themes pervade almost every aspect of Colet's thought. This is the first of a projected series of three volumes on the relations of the Oxford Reformers to the Platonic tradition.--J. M. W.

A thoughtful Christian counter-offensive on the popular interpretation of Marxism as the absolute antithesis of all that is Christian and democratic. The author's explicit intention is to break down the barrier to understanding and communication constituted by that image. He examines the Judeo-Christian heritage of Marxism and traces the influences which led to Marx's estrangement from that heritage. Elements of the heritage which survived the estrangement are then elucidated and the author concludes with an eminently reasonable appraisal of the legitimate (...) points of contact and conflict between the two doctrines.--J. M. W. (shrink)

Combining an appreciation of recent analyses of "types" of scientific explanation with a detailed knowledge of contemporary biological investigations, Goudge examines the theory of evolution since Darwin. He argues that twentieth century evolutionary theory gives rise to philosophical questions whose importance rivals anything that physics has to offer. After showing how "modern selectionist theory" differs from Darwin's view of evolution, he asks: "Has evolutionary theory metaphysical implications?" The answer--a tentative "yes"--is so carefully qualified that one wonders whether new contributions to (...) the theory of evolution have the philosophic import that Goudge claims for them.--J. M. W. (shrink)

In this brief work of modest pretensions, the author brings together Islamic texts relevant to freedom from a great variety of sources. He ventures very little analysis or interpretation. Each chapter is copiously footnoted. Given its purely scholarly intentions and limitations, the work should provide a valuable aid for those interested in the study of this field.--J. M. W.

Bahm surveys three types of intuition and three corresponding types of conflicting theories of intuition. He argues for an organic theory which views intuition as a dialectical synthesis of the oppositions discussed.--J. M. W.

This eighth volume of the Collected Works of Jung comprises a collection of essays in which Jung struggles with the basic theoretical problems of his psychology. He brings an impressive erudition to his search for concepts, models and explanatory principles adequate to the refractory psychic phenomena with which he deals. In keeping with Jung's conviction that the psyche is "a thing of such infinite complexity that it can be observed and studied from a great many sides," the essays exhibit a (...) variety of approaches, from the relatively empirical to the frankly speculative. The essays span some forty years of Jung's reflection and, thanks to their arrangement in thematic groupings by the editors, present an interesting study in the refinement of his thought and statement.--J. M. W. (shrink)

Worries about safety of approved drugs have pushed post registration research to become the fastest growing drug research phase. Until recently, phase IV studies were mainly conducted for marketing purposes and run much like a phase III trial—at institutions with experienced investigators and a list of inclusion and exclusion criteria. Innovative phase IV studies involve ordinary physicians in research naïve communities. This brings ethical issues familiar to medical research into clinical practice. As a consequence, individual physicians are challenged to protect (...) scientific integrity and to secure the ethical conduct of research. Several ethical issues need to be addressed in the process of developing a scientifically sound and ethically high principled practice of phase IV research.PHASE IVEssential to phase IV research is the focus on how drugs work in the real world. The research goal may be to explore a specific pharmacological effect, to establish the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. They may also be designed to establish a new clinical indication for a drug.1 Subjects may or may not be randomised, and the studies typically involve large numbers of patient-subjects and physicians.Doubts concerning the scientific rigor and clinical value have put postmarketing research in a poor light. However, high quality phase IV research is badly needed to further pharmaceutical science. First, because it can provide reliable data on the effectiveness, safety and optimal use of a drug in treated populations.2 3 In pre-registration clinical trials , a pharmaceutical product is studied under unrealistic circumstances. Under-representation of women and elderly are common and the concomitant use of medicines is usually extremely restrictive in these trials.4 Second, phase IV can provide much needed data for evidence-based …. (shrink)

"This book contains ideas to develop interdisciplinary and transdisciplinary views on economy and society. It aims to disseminate heterodox ideas on various subjects related to economics and global society. The book is organised in six parts. Part 1 contains the key lectures of Backhaus on the concept of state sciences and of Klamer on the importance of culture for economics. Parts 2- 6 contain successively contributions in the areas of economic paradigms and theories, population and society, corporate issues, environment, and (...) international relations. Examples of the content are: - the changes of family life cycles due to the rise of non-traditional households; - subjective and objective inflation rates after the introduction of the Euro; - the economics of genetic engineering; - the contribution of foreign direct investment to the economic development of host countries; - the inaccuracy of economic models applied in places characterized by extreme income disparities; - the improvement of political and corporate governance; - evolutionary thinking and emission trading; - freedom and order in the European Union; - the reform of social policy in Europe. The book provides interesting creative multi-disciplinary ideas with respect to various topical issues concerning the contemporary global society. It is highly recommended for economists and social scientists in search of broad views on social science and society.". (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)

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)

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)

OBJECTIVE: To report and analyse the pattern of end-of-life decision making for terminal Chinese cancer patients. DESIGN: Retrospective descriptive study. SETTING: A cancer clinical trials unit in a large teaching hospital. PATIENTS: From April 1992 to August 1997, 177 consecutive deaths of cancer clinical trial patients were studied. MAIN MEASUREMENT: Basic demographic data, patient status at the time of signing a DNR consent, or at the moment of returning home to die are documented, and circumstances surrounding these events evaluated. RESULTS: (...) DNR orders were written for 64.4% of patients. Patients in pain (odds ratio 0.45, 95% CI 0.22-0.89), especially if requiring opioid analgesia (odds ratio 0.40, 95% CI 0.21-0.77), were factors associated with a higher probability of such an order. Thirty-five patients were taken home to die, a more likely occurrence if the patient was over 75 years (odds ratio 0.12, 95% CI 0.04-0.34), had children (odds ratio 0.14, 95% CI 0.02-0.79), had Taiwanese as a first language (odds ratio 6.74, 95% CI 3.04-14.93), or was unable to intake orally (odds ratio 2.73, 95% CI 1.26-5.92). CPR was performed in 30 patients, none survived to discharge. CONCLUSIONS: DNR orders are instituted in a large proportion of dying Chinese cancer patients in a cancer centre, however, the order is seldom signed by the patient personally. This study also illustrates that as many as 20% of dying patients are taken home to die, in accordance with local custom. (shrink)

Heuristics of evolutionary biology dictate that phylogenetically older processes are inherently more stable and resilient to disruption than younger processes. On the grounds that non-declarative behaviour emerged long before declarative behaviour, Reber argues that implicit learning is supported by neural processes that are evolutionarily older than those supporting explicit learning. Reber suggested that implicit learning thus leads to performance that is more robust than explicit learning. Applying this evolutionary framework to motor performance, we examined whether implicit motor learning, relative to (...) explicit motor learning, conferred motor output that was resilient to physiological fatigue and durable over time. In Part One of the study a fatigued state was induced by a double Wingate Anaerobic test protocol. Fatigue had no affect on performance of participants in the implicit condition; whereas, performance of participants in the explicit condition deteriorated significantly. In Part Two of the study a convenience sample of participants was recalled following a one-year hiatus. In both the implicit and the explicit condition retention of performance was seen and, contrary to the findings in Part One, so was resilience to fatigue. The resilient performance in the explicit condition after one year may have resulted from forgetting or from consolidation of declarative knowledge as implicit memories. In either case, implicit processes were left to more effectively support motor performance. (shrink)

Pure Type Systems, PTSs, were introduced as a generalization of the type systems of Barendregt's lambda cube and were designed to provide a foundation for actual proof assistants which will verify proofs. Systems of illative combinatory logic or lambda calculus, ICLs, were introduced by Curry and Church as a foundation for logic and mathematics. In an earlier paper we considered two changes to the rules of the PTSs which made these rules more like ICL rules. This led to four kinds (...) of PTSs. Most importantly PTSs are about statements of the form M:A, where M is a term and A a type. In ICLs there are no explicit types and the statements are terms. In this paper we show that for each of the four forms of PTS there is an equivalent form of ICL, sometimes if certain conditions hold. (shrink)

Physical pain has always been part of human experience, and throughout history it is recorded that doctors and wise men and women have sought to ease pain. The attitudes of those suffering pain, however, have varied from stoical acceptance to sullen endurance. Today, most people consciously seek to avoid pain or to have their pain eased, although they do not always expect what in fact appears to be possible. This study of 13 patients with protracted pain was carried out at (...) The London Hospital by a professional group to see how patients regarded their own pain and the efforts of doctors and nurses to relieve it. The attitudes of the doctors and nurses were also studied, and the results, despite the limitations of the survey, suggest that: [List: see text]. (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)