Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without direct benefit (...) that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent. (shrink)

In the debate surrounding the introduction of non-invasive prenatal testing in prenatal screening programmes, the concept of routinisation is often used to refer to concerns and potential negative consequences of the test. A literature analysis shows that routinisation has many different meanings, which can be distinguished in three major versions of the concept. Each of these versions comprises several inter-related fears and concerns regarding prenatal screening and particularly regarding NIPT in three areas: informed choice, freedom to choose and consequences for (...) people with a disability. Three of the strongest arguments raised under the flag of routinisation are assessed for their validity: the threat that NIPT poses to informed choice, the potential increase in uptake of first-trimester prenatal screening and its consequences for social pressure to participate in screening or terminate affected pregnancies, and the negative consequences for disabled people. These routinisation arguments lack empirical or normative ground. However, the results of this analysis do not imply that no attention should be paid to possible problems surrounding the introduction of NIPT. At least two problems remain and should be addressed: there should be an ongoing debate about the requirements of informed choice, particularly related to an expanded scope of prenatal screening. Also, reproductive autonomy can only be achieved when expecting parents’ options are variegated, real and valuable, so that they can continue to choose whether or not to screen or to terminate a pregnancy. (shrink)

Informed consent is a key condition for prenatal screening programmes to reach their aim of promoting reproductive autonomy. Reaching this aim is currently being challenged with the introduction of non-invasive prenatal testing (NIPT) in first-trimester prenatal screening programmes: amongst others its procedural ease—it only requires a blood draw and reaches high levels of reliability—might hinder women’s understanding that they should make a personal, informed decision about screening. We offer arguments for a renewed recognition and use of informed consent compared to (...) informed choice, and for a focus on value-consistent choices and personalized informational preferences. We argue for a three-step counselling model in which three decision moments are distinguished and differently addressed: (1) professionals explore women’s values concerning whether and why they wish to know whether their baby has a genetic disorder; (2) women receive layered medical-technical information and are asked to make a decision about screening; (3) during post-test counselling, women are supported in decision-making about the continuation or termination of their pregnancy. This model might also be applicable in other fields of genetic (pre-test) counselling, where techniques for expanding genome analysis and burdensome test-outcomes challenge counselling of patients. (shrink)

Studie over de morele toelaatbaarheid van medische experimenten met mensen.

The central idea of this “article” is that certain developments such as extreme simplification, the politicisation of medical ethics, the “normative industry” and “empirethics”, may seriously threaten the (future) practice of medical ethics.

The introduction of non-invasive prenatal testing in healthcare systems around the world offers an opportunity to reconsider funding policies for prenatal screening. In some countries with universal access healthcare systems, pregnant women and their partners are asked to pay for NIPT. In this paper, we discuss two important rationales for charging women for NIPT: to prevent increased uptake of NIPT and to promote informed choice. First, given the aim of prenatal screening, high or low uptake rates are not intrinsically desirable (...) or undesirable. Using funding policies to negatively affect uptake, however, is at odds with the aim of screening. Furthermore, copayment disproportionally affects those of lower socioeconomic status, which conflicts with justice requirements and impedes equal access to prenatal screening. Second, we argue that although payment models may influence pregnant women’s choice behaviours and perceptions of the relevance of NIPT, the copayment requirement does not necessarily lead to better-informed choices. On the contrary, external influences on women’s personal choices for or against prenatal screening should ideally be avoided. To improve informed decision-making, healthcare systems should instead invest in adequate non-directive, value-focused pretest counselling. This paper concludes that requiring copayments for NIPT in universal access healthcare systems fails to promote reproductive autonomy and is unfair. (shrink)

As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers’ practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication of (...) incidental findings in imaging research. We conducted an interview study with a purposive sample of researchers at research facilities across the Netherlands. Based on a qualitative analysis of these interviews and on existing guidelines found in the literature, we developed a prototype ethical framework, which was critically assessed and fine-tuned during a two-day international expert meeting with bioethicists and representatives from large population-based imaging studies from the United Kingdom, Germany, Sweden and Belgium. Practices and policies for the handling of incidental findings vary strongly across the Netherlands, ranging from no review of research scans and limited feedback to research participants, to routine review of scans and the arrangement of clinical follow-up. Respondents felt that researchers do not have a duty to actively look for incidental findings, but they do have a duty to act on findings, when detected. The principle of reciprocity featured prominently in our interviews and expert meeting. We present an ethical framework that may guide researchers and research ethics committees in the design and/or evaluation of appropriate pathways for the handling of incidental findings in imaging studies. The framework consists of seven steps: anticipation of findings, information provision and informed consent, scan acquisition, review of scans, consultation on detected abnormalities, communication of the finding, and further clinical management and follow-up of the research participant. Each of these steps represents a key decision to be made by researchers, which should be justified not only with reference to costs and/or logistical considerations, but also with reference to researchers’ moral obligations and the principle of reciprocity. (shrink)

This interview study investigates the short- and long-term implications of incidental findings detected through brain imaging on research participants’ lives and their surroundings. For this study, nine participants of the Rotterdam Scan Study with an incidental finding were approached and interviewed. When examining research participants’ narratives on the impact of the disclosure of incidental findings, the authors identified five sets of tensions with regard to motivations for and expectations of research participation, preferences regarding disclosure, short- and long-term impacts and impacts (...) on self and others. The paper shows: that the impact of incidental findings may be greater than participants at first let on; incidental findings can have significant effects on participants’ social environment; and participants may not feel prepared for disclosure even if incidental findings have been discussed during the informed consent process. The authors call for investigators to be aware of research participants’ experiences and these short- and long-term impacts when designing suitable courses of action for the detection and management of incidental findings in research settings. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 29-31, June 2011.

Given the plethora of weight loss interventions, Devine and Barnhill rightly propose to also investigate unintended consequences. I agree. Some questions need to be raised: unintended consequences is a messy concept. How to distinguish between surprises and pseudo-unintended consequences? How to make sure that such research is not a box-ticking formality? And will results be implemented?

© 2016 Regents of the University of California.The Review summarizes much of particle physics and cosmology. Using data from previous editions, plus 3,062 new measurements from 721 papers, we list, evaluate, and average measured properties of gauge bosons and the recently discovered Higgs boson, leptons, quarks, mesons, and baryons. We summarize searches for hypothetical particles such as supersymmetric particles, heavy bosons, axions, dark photons, etc. All the particle properties and search limits are listed in Summary Tables. We also give numerous (...) tables, figures, formulae, and reviews of topics such as Higgs Boson Physics, Supersymmetry, Grand Unified Theories, Neutrino Mixing, Dark Energy, Dark Matter, Cosmology, Particle Detectors, Colliders, Probability and Statistics. Among the 117 reviews are many that are new or heavily revised, including those on Pentaquarks and Inflation. The complete Review is published online in a journal and on the website of the Particle Data Group. The printed PDG Book contains the Summary Tables and all review articles but no longer includes the detailed tables from the Particle Listings. A Booklet with the Summary Tables and abbreviated versions of some of the review articles is also available. (shrink)

It is usually assumed that Apuleius gave one of his characters the name ‘Thrasyllus’ because of its etymological connection with θρασ. Indeed it is singularly appropriate and Apuleius himself draws attention to the fact: Thrasyllus, praeceps alioquin et de ipso nomine temerarius… . However, it does not follow that a name with such an etymological significance can have no other connotations: in this note I suggest that there is a further frame of reference behind ‘Thrasyllus’ and that Apuleius may have (...) expected his readers to realize this. (shrink)

El texto que presentamos recoge las principales conclusiones que han derivado de los estudios sobre la Colección de documentos árabes del Archivo Histórico Provincial de Granada. Compuesta principalmente por documentos de carácter jurídico, el análisis del contenido de cada uno de ellos en relación con la materialidad del soporte y las tintas así como la coincidencia en el diseño y planificación de la página revelan el uso de idénticos protocolos de ejecución. Esta investigación nos está permitiendo, además, establecer coincidencias relevantes (...) relacionadas con los procesos de elaboración del papel entre los últimos años de permanencia de los árabes en la Península Ibérica y los primeros tras la incorporación del territorio a la Corona de Castilla y, sobre todo, con el modo de ejecutar el documento de archivo en sus formas externa e interna. (shrink)

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) uses the conceptualization of psychopathology to make psychiatric diagnoses operational. The use of explicit operational criteria appears to be based on an implicit neo-positivist epistemology. Operationalism involves an excessive focus on quantitative descriptions of behavior manifestations, contesting that psychopathology is understood as a deviation from the normal or the average in a given population. Consequently, the normal and the psychopathological become homogeneous. Our analysis investigates if this neo-positivist epistemology narrows (...) psychopathology conceptualization and endanger integration with the hybrid biopsychosocial model of psychiatry. Based on Georges Canguilhem’s theorization of a qualitative approach to the individual organism who is in a state of morbidity, we show that the (psychiatric) pathology also contains differences in quality. Moreover, that humans are norm-producing organisms that actively respond to changes in their internal and external environment. In this regard, the operationalization of mental disorders could include the normativity in humans, i.e., the ability to produce norms. We argue this will mitigate the one-sided psychopathology conceptualization and strengthen the relationship between psychiatric nosology and psychiatry’s hybrid biopsychosocial model. (shrink)

The majority of Dutch physicians feel pressure when dealing with a request for euthanasia or physician-assisted suicide. This study aimed to explore the content of this pressure as experienced by general practitioners. We conducted semistructured in-depth interviews with 15 Dutch GPs, focusing on actual cases. The interviews were transcribed and analysed with use of the framework method. Six categories of pressure GPs experienced in dealing with EAS requests were revealed: emotional blackmail, control and direction by others, doubts about fulfilling the (...) criteria, counterpressure by patient’s relatives, time pressure around referred patients and organisational pressure. We conclude that the pressure can be attributable to the patient–physician relationship and/or the relationship between the physician and the patient’s relative, the inherent complexity of the decision itself and the circumstances under which the decision has to be made. To prevent physicians to cross their personal boundaries in dealing with EAS request all these different sources of pressure will have to be taken into account. (shrink)

Building on the long-standing tradition of challenging oppression and questioning whose interests are being served in the field of language education, we report on a study that involved a group of U.S.-based graduate students who collaborated with a ninth-grade English teacher in Nepal. The study comes out of a larger project that sought to internationalize the curriculum of a graduate educational linguistics course at a U.S. university. At the heart of this internationalizing curriculum endeavour was a commitment to expose graduate (...) students in the U.S. to the issues of language teaching outside of the U.S. This was done through co-designing of a unit of lessons, with six graduate students meeting virtually with their teacher partner, Ditya, in Nepal over the course of a semester. The graduate students and Ditya constitute our research participants. The graduate student participants learned about the need to develop pedagogical materials that were relevant to the local context in Nepali classroom, and not attempt to transplant a Western-centric curriculum onto the Nepali classroom. In keeping with recent calls to decolonize higher education, we illustrate how critical theory in general and decolonizing pedagogy in particular can be infused into a U.S. graduate curriculum by drawing on the rich, indigenous knowledge and resources of a teacher collaborator from the Global South. We do this by reporting how this critical, decolonizing goal was realized through collaborative professionalism, which is characterized by the sharing of knowledge, skills, and experience to improve student achievement, reflection, dialogue and collective responsibility. (shrink)

Evolutionary developmental biology (evo-devo) has undergone dramatic transformations since its emergence as a distinct discipline. This paper aims to highlight the scope, power, and future promise of evo-devo to transform and unify diverse aspects of biology. We articulate key questions at the core of eleven biological disciplines—from Evolution, Development, Paleontology, and Neurobiology to Cellular and Molecular Biology, Quantitative Genetics, Human Diseases, Ecology, Agriculture and Science Education, and lastly, Evolutionary Developmental Biology itself—and discuss why evo-devo is uniquely situated to substantially improve (...) our ability to find meaningful answers to these fundamental questions. We posit that the tools, concepts, and ways of thinking developed by evo-devo have profound potential to advance, integrate, and unify biological sciences as well as inform policy decisions and illuminate science education. We look to the next generation of evolutionary developmental biologists to help shape this process as we confront the scientific challenges of the 21st century. (shrink)

El texto que presentamos recoge las principales conclusiones que han derivado de los estudios sobre la Colección de documentos árabes del Archivo Histórico Provincial de Granada. Compuesta principalmente por documentos de carácter jurídico, el análisis del contenido de cada uno de ellos en relación con la materialidad del soporte y las tintas así como la coincidencia en el diseño y planificación de la página revelan el uso de idénticos protocolos de ejecución. Esta investigación nos está permitiendo, además, establecer coincidencias relevantes (...) relacionadas con los procesos de elaboración del papel entre los últimos años de permanencia de los árabes en la Península Ibérica y los primeros tras la incorporación del territorio a la Corona de Castilla y, sobre todo, con el modo de ejecutar el documento de archivo en sus formas externa e interna. (shrink)

Dans cette contribution, nous présentons la base CLAPI développée au laboratoire ICAR dans le contexte de l’évolution des bases de données de langues parlées en France au cours des trente dernières années. Nous détaillons les deux composantes de CLAPI, l’archive de corpus de langue parlée en interaction audio et vidéo enregistrés dans des situations sociales naturelles variées, et la plateforme d’outils.L’usage et l’apport de CLAPI sont illustrés par deux études. L’une décrit comment la base peut être utilisée pour des travaux (...) de linguistique interactionnelle intégrant la multimodalité (« oh là là ») ; l’autre concerne une recherche combinant données et métadonnées (« trop »). L’article est aussi l’occasion d’un bilan plus général. La mise en perspective montre en effet qu’après la période des questions est venue celle des dilemmes. La période des questions, choix et décisions à toutes sortes de niveaux a accompagné la mise en place des bases de données. L’expérience permet maintenant de mesurer leurs indéniables apports en termes non seulement de quantité de données disponibles (et traitables grâce aux outils), mais aussi de qualité (comme conséquence des exigences de standardisation liées au partage des données). La période des dilemmes nous conduit à nous interroger sur les meilleurs choix à opérer aujourd’hui dans les relations entre la poursuite des recherches sur des corpus variés (et parfois sensibles) et les exigences des bases de données ouvertes. (shrink)

Om Blandt andet kampen mod bahāʼī i Iran, og om fundamentalismens tankegange, som er bange for kvinder, hvis de ikke er det svage og det tredje køn i samfundet, derfor undertrykker de dem og begrænser deres rettigheder.

I. Tijdperk vam Cartesius tot Kant -- II. De strijd tussen idealisme en naturalisme in de negentiende eeuw.

Here are the 18 guidance points contained in the UNAIDS document on Ethical Considerations in HIV Preventive Vaccine Research, reproduced by kind permission of the Joint United Nations Programme on HIV/AIDS.

In De Partibus Animalium I Aristotle sets out his philosophy of biology, discussing cause, necessity, soul, genus, and species, definition by logical division, and general methodology. In De Generatione Animalium I he applies his hylomorphic philosophy to the problem of animal reproduction. The translation is close, and includes passages from De Generatione Animalium II which complete Aristotle's theory of reproduction. The notes interpret Aristotle's arguments and discuss his views on major issues such as natural teleology. The original edition was published (...) in 1972. (shrink)