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)

Systemic autoimmune diseases are characterized by the production of antibodies against a broad range of self-antigens. Recent evidence indicates that the majority of these autoantigens are modified in various ways during cell death. This has led to the hypothesis that the primary immune response in the development of autoimmunity is directed to components of the dying cell. In this article, we summarize data on the modification of autoantigens during cell death and the possible consequences of this for autoimmunity. BioEssays 22:627–636, (...) 2000. © 2000 John Wiley & Sons, Inc. (shrink)

This book deserves the attention of philosophers of religion. Tracy presents a monumental synthesis of philosophy and history within the context of a "revisionist" theological model. Part I attempts adequately to articulate a method of inquiry by outlining the sets of evaluative criteria, the uses of evidence, and the place of the various philosophical and historical methods within this model. Not only must the method be responsive to the historical tradition, but it also must heed the non-Christian scrutiny of what (...) Van A. Harvey calls the "morality of scientific knowledge," which demands a critical posture toward beliefs and tradition. Tracy’s model involves three steps: 1) phenomenology of the "religious dimension" of our "common experience and language," 2) an "historical and hermeneutical investigation" of the Christian tradition, and 3) "transcendental or metaphysical reflection" in order both to determine the "truth-status" of the previous steps and to effect a critical correlation of philosophy and hermeneutics. (shrink)

About one third of patients with epilepsy have seizures refractory to the medical treatment. Electrical stimulation mapping is the gold standard for the identification of “eloquent” areas prior to resection of epileptogenic tissue. However, it is time-consuming and may cause undesired side effects. Broadband gamma activity recorded with extraoperative electrocorticography during cognitive tasks may be an alternative to ESM but until now has not proven of definitive clinical value. Considering their role in cognition, the alpha and beta bands could further (...) improve the identification of eloquent cortex. We compared gamma, alpha and beta activity, and their combinations for the identification of eloquent cortical areas defined by ESM. Ten patients with intractable focal epilepsy participated in a delayed-match-to-sample task, where syllable sounds were compared to visually presented letters. We used a generalized linear model approach to find the optimal weighting of each band for predicting ESM-defined categories and estimated the diagnostic ability by calculating the area under the receiver operating characteristic curve. Gamma activity increased more in eloquent than in non-eloquent areas, whereas alpha and beta power decreased more in eloquent areas. Diagnostic ability of each band was close to 0.7 for all bands but depended on multiple factors including the time period of the cognitive task, the location of the electrodes and the patient’s degree of attention to the stimulus. We show that diagnostic ability can be increased by 3–5% by combining gamma and alpha and by 7.5–11% when gamma and beta were combined. We then show how ECoG power modulation from cognitive testing can be used to map the probability of eloquence in individual patients and how this probability map can be used in clinical settings to optimize ESM planning. We conclude that the combination of gamma and beta power modulation during cognitive testing can contribute to the identification of eloquent areas prior to ESM in patients with refractory focal epilepsy. (shrink)

Moral case deliberation (MCD) is a specific form of clinical ethics, aiming to stimulate ethical reflection in daily practice in order to improve the quality of care. This article focuses on the implementation of MCD in nursing homes and the questions how and where to organize MCD. The purpose of this study was to evaluate one way of organizing MCD in two Dutch nursing homes. In both of these nursing homes the MCD groups had a heterogeneous composition and were organized (...) apart from existing institutional communication structures. As part of a naturalistic evaluation, systematic observations, interviews and focus groups were completed. The findings indicate that the heterogeneous composition and MCD meetings separate from existing structures have benefits. However, the participants also reported negative experiences. This gives rise to the question whether a mixed MCD group which meets separately is an effective way to embed MCD as an instrument for reflection on moral issues in daily practice. We conclude that there is no single answer to that question. In the end, the two implementation strategies (i.e. within existing communication structures and a mixed MCD group) can be complementary to each other. (shrink)

The world is not on track to achieve Agenda 2030—the approach chosen in 2015 by all UN member states to engage multiple stakeholders for the common goal of sustainable development. The creation of the 17 Sustainable Development Goals (SDGs) arguably offered a new take on sustainable development by adopting hybrid and principle-based governance approaches, where public, private, not for profit and knowledge-institutions were invited to engage around achieving common medium-term targets. Cross-sector partnerships and multi-stakeholder engagement for sustainability have consequently taken (...) shape. But the call for collaboration has also come with fundamental challenges to meaningful engagement strategies—when private enterprises try to establish elaborate multi-stakeholder configurations. How can the purpose of businesses be mitigated through multi-stakeholder principle-based partnerships to effectively serve the purpose of a common sustainability agenda? In selecting nine scholarly contributions, this special issue aims at advancing this discourse. To stimulate further progress in business studies, this introductory essay, furthermore, identifies three pathways for research on multi-stakeholder engagement processes in support of the Decade of Action along three coupling lines: multi-sector alignment (relational coupling), operational perception alignment (cognitive coupling) and goal and strategic alignment (material coupling). (shrink)

In this article, an ethical analysis of an educational programme on renal replacement therapy options for patients and their social network is presented. The two main spearheads of this approach are: (1) offering an educational programme on all renal replacement therapy options ahead of treatment requirement and (2) a home-based approach involving the family and friends of the patient. Arguments are offered for the ethical justification of this approach by considering the viewpoint of the various stakeholders involved. Finally, reflecting on (...) these ethical considerations, essential conditions for carrying out such a programme are outlined. The goal is to develop an ethically justified and responsible educational programme. (shrink)

Our study presents an overview of the issues that were brought forward by participants of a moral case deliberation (MCD) project in two elderly care organizations. The overview was inductively derived from all case descriptions (N = 202) provided by participants of seven mixed MCD groups, consisting of care providers from various professional backgrounds, from nursing assistant to physician. The MCD groups were part of a larger MCD project within two care institutions (residential homes and nursing homes). Care providers are (...) confronted with a wide variety of largely everyday ethical issues. We distinguished three main categories: ‘resident’s behavior’, ‘divergent perspectives on good care’ and ‘organizational context’. The overview can be used for agendasetting when institutions wish to stimulate reflection and deliberation. It is important that an agenda is constructed from the bottom-up and open to a variety of issues. In addition, organizing reflection and deliberation requires effort to identify moral questions in practice whilst at the same time maintaining the connection with the organizational context and existing communication structures. Once care providers are used to dealing with divergent perspectives, inviting different perspectives (e.g. family members) to take part in the deliberation, might help to identify and address ethical ‘blind spots’. (shrink)

The EDPS Ethics Advisory Group (EAG) has carried out its work against the backdrop of two significant social-political moments: a growing interest in ethical issues, both in the public and in the private spheres and the imminent entry into force of the General Data Protection Regulation (GDPR) in May 2018. For some, this may nourish a perception that the work of the EAG represents a challenge to data protection professionals, particularly to lawyers in the field, as well as to companies (...) struggling to adapt their processes and routines to the requirements of the GDPR. What is the purpose of a report on digital ethics, if the GDPR already provides all regulatory requirements to protect European citizens with regard to the processing of their personal data? Does the existence of this EAG mean that a new normative ethics of data protection will be expected to fill regulatory gaps in data protection law with more flexible, and thus less easily enforceable ethical rules? Does the work of the EAG signal a weakening of the foundation of legal doctrine, such as the rule of law, the theory of justice, or the fundamental values supporting human rights, and a strengthening of a more cultural approach to data protection? Not at all. The reflections of the EAG contained in this report are not intended as the continuation of policy by other means. It neither supersedes nor supplements the law or the work of legal practitioners. Its aims and means are different. On the one hand, the report seeks to map and analyse current and future paradigm shifts which are characterised by a general shift from analogue experience of human life to a digital one. On the other hand, and in light of this shift, it seeks to re-evaluate our understanding of the fundamental values most crucial to the well-being of people, those taken for granted in a data-driven society and those most at risk. The objective of this report is thus not to generate definitive answers, nor to articulate new norms for present and future digital societies but to identify and describe the most crucial questions for the urgent conversation to come. This requires a conversation between legislators and data protection experts, but also society at large - because the issues identified in this report concern us all, not only as citizens but also as individuals. They concern us in our daily lives, whether at home or at work and there isn’t a place we could travel to where they would cease to concern us as members of the human species. (shrink)