Background The European Union aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury, aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury. (...) Documents included detailed information on IRB procedures and the duration from IRB submission until approval. They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally or locally and primary IRB approval was obtained after one, two or three review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days and appeared to be shorter after submission to local IRBs compared to central IRBs. Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries. (shrink)

Introduction: The Dutch Euthanasia Act states that euthanasia is not punishable if the attending physician acts in accordance with the statutory due care criteria. These criteria hold that: there should be a voluntary and well-considered request, the patient’s suffering should be unbearable and hopeless, the patient should be informed about their situation, there are no reasonable alternatives, an independent physician should be consulted, and the method should be medically and technically appropriate. This study investigates whether physicians experience problems with these (...) criteria in medical practice.Methods: In 2006, questionnaires were sent to a random, stratified sample of 2100 Dutch physicians . Physicians were asked about problems in their decision-making related to requests for euthanasia or assisted suicide after enforcement of the 2002 Euthanasia Act.Results: Of all physicians who had received a request for euthanasia or assisted suicide , 25% had experienced problems in the decision-making with regard to at least one of the criteria of due care. Physicians who had experienced problems mostly indicated to have had problems related to evaluating whether or not the patient’s suffering was unbearable and hopeless and whether or not the patient’s request was voluntary or well considered .Discussion: Physicians in The Netherlands most frequently reported problems related to aspects in which they have to evaluate the patient’s subjective perspective. However, it can be questioned whether placing emphasis on these subjective aspects is an adequate fulfilment of the duties imposed on physicians, as laid down in the Dutch Euthanasia Act. (shrink)

The participation of vulnerable patients in clinical research poses apparent ethical dilemmas. Depending on the nature of the vulnerability, their participation may challenge the ethical principles of autonomy, non-maleficence, or justice. On the other hand, non-participation may preclude the building of a knowledge base that is a prerequisite for defining the optimal clinical management of vulnerable patients. Such clinical uncertainty may also incur substantial economic costs. We present the participation of pre-menopausal women with atrial fibrillation in trials of novel oral (...) anticoagulant drugs as a case study. Due to their non-participation in pivotal trials, it is uncertain whether for them, the risks that are associated with these drugs are outweighed by the advantages compared with conventional treatment. We addressed the question whether research of this new class of drugs in this subgroup would be appropriate from both, an ethical as well an economic perspective. We used the method of specifying norms as a wider framework to resolve the apparent ethical dilemma, while incorporating the question whether research of oral anticoagulants in premenopausal women with atrial fibrillation can be justified on economic grounds. For the latter, the results of a value-of-information analysis were used. Further clinical research on NOACs in premenopausal women with atrial fibrillation can be justified on both, ethical and economic grounds. Addressing apparent ethical dilemmas by invoking a method such as specifying norms can improve the quality of public practical reasoning. As such, the method should also prove valuable to committees that have formally been granted the authority to review trial protocols and proposals for scientific research. (shrink)

OBJECTIVES: To identify the factors that influence the assessment of reported cases of physician-assisted death by members of the public prosecution. DESIGN/SETTING: At the beginning of 1996, during verbal interviews, 12 short case-descriptions were presented to a representative group of 47 members of the public prosecution in the Netherlands. RESULTS: Assessment varied considerably between respondents. Some respondents made more "lenient" assessments than others. Characteristics of the respondents, such as function, personal-life philosophy and age, were not related to the assessment. Case (...) characteristics, i.e. the presence of an explicit request, life expectancy and the type of suffering, strongly influenced the assessment. Of these characteristics, the presence or absence of an explicit request was the most important determinant of the decision whether or not to hold an inquest. CONCLUSIONS: Although the presence of an explicit request, life expectancy and the type of suffering each influenced the assessment, each individual assessment was dependent on the assessor. The resulting danger of legal inequality and legal uncertainty, particularly in complicated cases, should be kept to a minimum by the introduction of some form of protocol and consultation in doubtful or boundary cases. The notification procedure already promotes a certain degree of uniformity in the prosecution policy. (shrink)

The use of do not resuscitate (DNR) orders in Dutch hospitals was studied as part of a nationwide study on medical decisions concerning the end of life. DNR decisions are made in 6 per cent of all admissions, and 61 per cent of all in-hospital deaths were preceded by a DNR decision. We found that in only 14 per cent of the cases had the patients been involved in the DNR decision (32 per cent of competent patients). The concept of (...) futility is analysed as these findings are discussed. We conclude that determining the effectiveness of resuscitation is a medical judgement whereas determining the proportionality (burden/benefit ratio) of it requires a discussion between doctor and patient (or his or her surrogates). Since the respondents in the cases without patient involvement gave many reasons for their decision that went beyond determining effectiveness, we conclude that more patient involvement would have been desirable. (shrink)

Even though integrity is widely considered to be an essential aspect of research, there is an ongoing debate on what actually constitutes research integrity. The understanding of integrity ranges from the minimal, only considering falsification, fabrication and plagiarism, to the maximum, blending into science ethics. Underneath these obvious contrasts, there are more subtle differences that are not as immediately evident. The debate about integrity is usually presented as a single, universal discussion, with shared concerns for researchers, policymakers and ‘the public’. (...) In this article, we show that it is not. There are substantial differences between the language of research integrity in the scientific arena and in the public domain. Notably, scientists and policymakers adopt different approaches to research integrity. Scientists tend to present integrity as a virtue that must be kindled, while policy documents and newspapers stress norm enforcement. Rather than performing a conceptual analysis through philosophical reasoning and discussion, we aimed to clarify the discourse of ‘scientific integrity’ by studying its usage in written documents. To this end, large numbers of scientific publications, policy documents and newspaper articles were analysed by means of scientometric and content analysis techniques. The texts were analysed on their usage of the term ‘integrity’ and of frequently co-occurring terms and concepts. A comparison was made between the usage in the various media, as well as between different periods in which they were published through co-word analysis, mapping co-occurrence networks of significant terms and themes. (shrink)

While attention to research integrity has been growing over the past decades, the processes of signalling and denouncing cases of research misconduct remain largely unstudied. In this article, we develop a theoretically and empirically informed understanding of the causes and consequences of reporting research misconduct in terms of power relations. We study the reporting process based on a multinational survey at eight European universities. Using qualitative data that witnesses of research misconduct or of questionable research practices provided, we aim to (...) examine actors’ rationales for reporting and not reporting misconduct, how they report it and the perceived consequences of reporting. In particular we study how research seniority, the temporality of work appointments, and gender could impact the likelihood of cases being reported and of reporting leading to constructive organisational changes. Our findings suggest that these aspects of power relations play a role in the reporting of research misconduct. Our analysis contributes to a better understanding of research misconduct in an academic context. Specifically, we elucidate the processes that affect researchers’ ability and willingness to report research misconduct, and the likelihood of universities taking action. Based on our findings, we outline specific propositions that future research can test as well as provide recommendations for policy improvement. (shrink)

When the Oxyrhynchus Papyri of Sophocles' 'ІΧνενταí gave the forms κννηγ[Έ]σω , 1. 44 in Fragmenta Tragica Papyracea, and ΈκκννηγΈσαι, 1. 75, it restored to light a verb which is not acknowledged in the Lexicons, but which had remained, though almost unnoticed, in Phrynichus, Soph. Propar. in Bekker's Anecdota I. p. 48, and Theognostus' Canons in Cramer's Anecdota Oxoniensia II. p. 143. The form could not come from κννηγετΕîν, nor from the Hellenistic verb κννηγεîν, and attention was first drawn to (...) these two authorities by P. Maas in Berl. Philol. Wochenschr. 1912, p. 1075, and by J. Stahl in Rhein. Mus. Vol. LXVIII. p. 307 . I owe these references to Mr. Stuart Jones. (shrink)

When the Oxyrhynchus Papyri of Sophocles' 'ІΧνενταí gave the forms κννηγ[Έ]σω, 1. 44 in Fragmenta Tragica Papyracea, and ΈκκννηγΈσαι, 1. 75, it restored to light a verb which is not acknowledged in the Lexicons, but which had remained, though almost unnoticed, in Phrynichus, Soph. Propar. in Bekker's Anecdota I. p. 48, and Theognostus' Canons in Cramer's Anecdota Oxoniensia II. p. 143. The form could not come from κννηγετΕîν, nor from the Hellenistic verb κννηγεîν, and attention was first drawn to these (...) two authorities by P. Maas in Berl. Philol. Wochenschr. 1912, p. 1075, and by J. Stahl in Rhein. Mus. Vol. LXVIII. p. 307. I owe these references to Mr. Stuart Jones. (shrink)

Human societies are extraordinarily cooperative compared to those of most other animals. In the vast majority of species, individuals live solitary lives, meeting to only to mate and, sometimes, raise their young. In social species, cooperation is limited to relatives and (maybe) small groups of reciprocators. After a brief period of maternal support, individuals acquire virtually all of the food that they eat. There is little division of labor, no trade, and no large scale conflict. Communication is limited to a (...) small repertoire of self-verifying signals. No one cares for the sick, or feeds the hungry or disabled. The strong take from the weak without fear of sanctions by third parties. Amend Hobbes to account for nepotism, and his picture of the state of nature is not so far off for most other animals. In contrast, people in even the simplest human societies regularly cooperate with many unrelated individuals. Human language allows low-cost honest communication of virtually unlimited complexity. The sick are cared for, and sharing leads to substantial flows of food from the middle aged to the young and old. Division of labor and trade are prominent features of every historically known human society, and archaeology indicates that they have a long history. Violent conflict among sizable groups is common. In every human society, social life is regulated by commonly held moral systems that specify the rights and duties of individuals enforced, albeit imperfectly, by third party sanctions. (shrink)

Peer review of journal submissions has become one of the most important pillars of quality management in academic publishing. Because of growing concerns with the quality and effectiveness of the system, a host of enthusiastic innovators has proposed and experimented with new procedures and technologies. However, little is known about whether these innovations manage to convince other journal editors. This paper will address open questions regarding the implementation of new review procedures, the occurrence rate of various peer review procedures and (...) their distribution over scientific disciplines or academic publishers, as well as the motivations for editors or publishers to engage in novel review procedures. It shows that in spite of enthusiastic innovation, the adoption of new peer review procedures is in fact very slow, with the exception of text similarity scanners. For now, peer review innovations appear to be restricted to specific niches in academic publishing. Analysing these niches, the article concludes with a reflection on the circumstances in which innovations might be more widely implemented. (shrink)

Between 1787, and the end of his life in 1832, Bentham turned his attention to the development and application of economic ideas and principles within the general structure of his legislative project. For seventeen years this interest was manifested through a number of books and pamphlets, most of which remained in manuscript form, that develop a distinctive approach to economic questions. Although Bentham was influenced by Adam Smith's An Inquiry into the Nature and Causes of the Wealth of Nations, he (...) neither adopted a Smithian vocabulary for addressing questions of economic principle and policy, nor did he accept many of the distinctive features of Smith's economic theory. One consequence of this was that Bentham played almost no part in the development of the emerging science of political economy in the early nineteenth century. The standard histories of economics all emphasize how little he contributed to the mainstream of late eighteenth and early nineteenth-century debate by concentrating attention on his utilitarianism and the psychology of hedonism on which it is premised. Others have argued that the calculating nature of his theory of practical reason reduced the whole legislative project to a crude attempt to apply economics to all aspects of social and political life. Put at its simplest this argument amounts to the erroneous claim that Bentham's science of legislation is reducible to the science of political economy. A different but equally dangerous error would be to argue that because Bentham's conception of the science of legislation comprehends all the basic forms of social relationships, there can be no science of political economy as there is no autonomous sphere of activity governed by the principles of economics. This approach is no doubt attractive from an historical point of view given that the major premise of this argument is true, and that many of Bentham's ‘economic’ arguments are couched in terms of his theory of legislation. Yet it fails to account for the undoubted importance of political economy within Bentham's writings, not just on finance, economic policy, colonies and preventive police, but also in other aspects of his utilitarian public policy such as prison reform, pauper management, and even constitutional reform. All of these works reflect a conception of political economy in its broadest terms. However, this conception of political economy differs in many respects from that of Bentham's contemporaries, and for this reason Bentham's distinctive approach to problems of economics and political economy has largely been misunderstood. (shrink)

It is the impression of neurologists who deal with cancer patients that the incidence of neurologic complications of cancer is increasing (Posner 1995). ...

This new edition offers expanded selections from the works of Kongzi, Mengzi, Zhuangzi, and Xunzi ; two new works, the dialogues _Robber Zhi_ and _White Horse_; a concise general introduction; brief introductions to, and selective bibliographies for, each work; and four appendices that shed light on important figures, periods, texts, and terms in Chinese thought.

In his paper ‘Has the Ontological Argument Been Refuted?’, 97–110) William F. Vallicella argues that my attempt to show that the Ontological Argument begs the question is unsuccessful. 1 I believe he is wrong about this, but before endeavouring to vindicate my position I must first make clear what precisely is the point at issue between us. The Ontological Argument is not a single argument, but a family of arguments. Newly devised formulations of the argument are frequently put forward by (...) philosophers in an effort to avoid difficulties that have been pointed out in previous versions. As a consequence there is no possibility of a conclusive proof that every form of the argument embodies the same fallacy. Nevertheless, one can, I believe, prove that all the standard versions of the argument embody a certain fallacy and that, given the nature of the argument, it is therefore unlikely that the argument can be formulated in such a way as to avoid this difficulty. What I tried to show in my paper is that the six best-known versions of the argument all beg the question and that they do so at the same point in the argument, namely when it is asserted that it is possible that an absolutely perfect being exists. It is difficult to see how an ontological argument could be formulated without including this claim as one of its premises, since the distinguishing badge of the argument is the inference from the possibility of an absolutely perfect being to its actuality. It must be unlikely then, if my criticism of these six versions is correct, that there is any way of formulating the argument that avoids this fallacy. (shrink)

Theism, according to David O'Connor, has in recent centuries been on trial for its life, the charge being that the existence of so much evil in the world is incompatible with belief in a benevolent creator. But this trial, he claims is incapable of producing a reasoned verdict.