Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...) 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

Inleiding in het denken van drie vroeg-christelijke auteurs, zoals dat zich ontwikkelde tijdens de confrontatie van het christendom met het jodendom en de hellenistische filosofie.

BackgroundResuscitation and treatment of critically ill newborn infants is associated with relatively high mortality, morbidity and cost. Guidelines relating to resuscitation have traditionally focused on the best interests of infants. There are, however, limited resources available in the neonatal intensive care unit, meaning that difficult decisions sometimes need to be made. This study explores the intuitions of lay people regarding resource allocation decisions in the NICU.MethodsThe study design was a cross-sectional quantitative survey, consisting of 20 hypothetical rationing scenarios. There were (...) 119 respondents who entered the questionnaire, and 109 who completed it. The respondents were adult US and Indian participants of the online crowdsourcing platform Mechanical Turk. Respondents were asked to decide which of two infants to treat in a situation of scarce resources. Demographic characteristics, personality traits and political views were recorded. Respondents were also asked to respond to a widely cited thought experiment involving rationing.ResultsThe majority of respondents, in all except one scenario, chose the utilitarian option of directing treatment to the infant with the higher chance of survival, higher life expectancy, less severe disability, and less expensive treatment. As discrepancy between outcomes decreased, however, there was a statistically significant increase in egalitarian responses and decrease in utilitarian responses in scenarios involving chance of survival, life expectancy, and cost of treatment. In the classic ‘lifeboat’ scenario, all but two respondents were utilitarian.ConclusionsThis survey suggests that in situations of scarcity and equal clinical need, non-health professionals support rationing of life-saving treatment based on probability of survival, duration of survival, cost of treatment or quality of life. However, where the difference in prognosis or cost is very small, non-health professionals preferred to give infants an equal chance of receiving treatment. (shrink)

The use of platelet rich plasma as a novel treatment is discussed in the context of a qualitative research study comprising 38 interviews with sports medicine practitioners and other stakeholders working within the English Premier League during the 2013–16 seasons. Analysis of the data produced several overarching themes: conservatism versus experimentalism in medical attitudes; therapy perspectives divergence; conflicting versions of appropriate evidence; subcultures; community beliefs/practices; and negotiation of medical decision-making. The contested evidence base for the efficacy of PRP is presented (...) in the context of a broader professional shift towards evidence based medicine within sports medicine. Many of the participants while accepting this shift are still committed to casuistic practices where clinical judgment is flexible and does not recognize a context-free hierarchy of evidentiary standards to ethically justifiable practice. We also discuss a tendency in the data collected to consider the use of deceptive, placebo-like, practices among the clinician participants that challenge dominant understandings of informed consent in medical ethics. We conclude that the complex relation between evidence and ethics requires greater critical scrutiny for this emerging specialism within the medical community. (shrink)

Experiments are described, using electroencephalography (EEG) and simple tests of performance, which support the hypothesis that collapse of a quantum field is of importance to the functioning of the brain. The theoretical basis of our experiments is derived from Penrose (1989) who suggested that conscious decision-making is a manifestation of the outcome of quantum computation in the brain involving collapse of some relevant wave function. He also proposed that collapse of any wave function depends on a gravitational criterion. As different (...) brain areas are known to subserve different functions, we argue that `Penrose collapse' must occur in a particular brain area when performing a task that uses it. Further, taking an EEG from the area should amplify the gravitational prerequisite for collapse, so affecting task performance. There are no non-quantum theories which could lead one to expect that taking an EEG could directly affect task performance by subjects. The results of both pilot and main experiments indicated that task performance was indeed influenced by taking an EEG from relevant brain areas. Control experiments suggested that the influence was quantum mechanical in origin, and was not due to any experimental artefact. The results are statistically significant and merit attempts at replication in an independent laboratory, preferably with more sophisticated equipment than was available to us. (shrink)

Undercover filming is a method commonly used by animal activist groups to expose animal cruelty and it is important to consider the effects of publically releasing video footage of cruel practices on the viewers’ mental health. Previously, we reported that members of the Australian public were emotionally distressed soon after viewing media broadcasts of cruelty to Australian cattle exported for slaughter in Indonesia in 2011. To explore if there were any long term impacts from exposure to media on this issue, (...) a self-selecting group of 15 people who were exposed to a documentary exposé of the cruelty were re-interviewed 12 months later. Nearly all recalled their strong initial reaction to the footage. Approximately one half of the respondents who initially had had a strong emotional reaction to the footage reported negative reactions that were still strong even after this period of time. They reported potential triggers for these feelings. Of the rest, some managed to internalise their feelings. Approximately one half of respondents were unaware of continued live export exposés, suggesting less prominent media coverage. Despite the aversion and repulsion reported after viewing the initial coverage, most respondents said they would choose to watch another broadcast of animal cruelty and nearly all supported undercover investigations as a means of revealing cruelty to animals. We conclude that many people viewing footage of cruelty to animals will have long term memory of this, but that they would prefer to be informed about the issues and not be protected from them. (shrink)

Since the 1970s, estrogen have sometimes been used in adolescent girls to reduce very tall adult expected height. Worries about long-term effects have led to a proposal to link treatment data with cancer registers. How should one deal with informed consent for such a study? We designed a qualitative study with semi-structured telephone interviews. From 1200 women who were to be followed-up in cancer registers, we randomly selected 22 women. Major themes were a wish to be involved and a positive (...) attitude to the proposed register research. The women did not express worry after reading the study protocol, but did convey considerable frustration that this research had not been initiated earlier. Active consent was not seen as crucial. We found strong interest in a high participation rate and a concern over missing data. The selection of information and consent or the decision to go ahead without consent in register follow-up is a delicate balancing act. Study participants wish to be contacted, but acknowledge the primary goal of answering important questions. Our study provides support for safeguarding privacy in epidemiological linkage studies and in follow-up of medical treatment without losing the scientific value by requesting for informed consent. (shrink)

The development of gene expression profiling and next-generation sequencing technologies have steered oncogenomics to the forefront of precision medicine. This created a need for harmonious cooperation between clinicians and researchers to increase access to precision oncology, despite multiple implementation challenges being encountered. The aim is to apply personalised treatment strategies early in cancer management, targeting tumour subtypes and actionable gene variants within the individual’s broader clinical risk profile and wellbeing. A knowledge-generating database linked to the South African Medical Research Council’s (...) Genomic Centre has been created for the application of personalised medicine, using an integrated service and research approach. Insights gained from patient experiences related to tumour heterogeneity, access to targeted therapies and incidental findings of pathogenic germline variants in tumour DNA, provided practice-changing evidence for the implementation of a cost-minimisation pathology-supported genetic testing strategy. Integrating clinical care with genomic research through data sharing advances personalised medicine and maximises precision oncology benefits. (shrink)

Publication de deux poèmes byzantins du 12ème s. attribués à Théodore Prodomos, qui fournissent un certain nombre de renseignements sur les tentes des camps d'hiver des Comnène, et en particulier sur celle de la maison d'Irène la Sevastokratorissa. Cette étude mène l'auteur à un commentaire historico-artistique des éléments décrits: il compare d'abord ceux-ci avec l'art des 11ème et et 12ème s., et particulièrement avec l'art profane, puis il s'interroge sur l'authenticité des descriptions par rapport aux figures de rhétorique employées dans (...) ces textes. (shrink)

Through discourse with international groups of physicians, we conducted a cross-cultural analysis of the types of ethical dilemmas physicians face. Qualitative analysis was used to categorise the dilemmas into seven themes, which we compared among the physicians by country of practice. These themes were a-theoretically-driven and grounded heavily within the text. We then subjected the dilemmas to an analysis of moral intensity, which represents an important theoretical perspective of ethical decision making. These constructs represent salient determinants of ethical behaviour and (...) our cross-cultural sample afforded us the opportunity to consider both the pragmatic aspects of culture, as they are perceived by physicians, as well as the theory-driven concept of moral intensity. By examining both culture and moral intensity, we hope to better elucidate the complexities of ethical decision-making determinants among physicians in their daily practice. Doing so may potentially have practical implications for ethics training of medical students and foreign physicians. (shrink)

This collective paper on radicalization and violent extremism part of the ‘Philosophy of education in a new key’ initiative by Educational Philosophy and Theory brings together some of the leading contemporary scholars writing on the most pressing epistemological, ethical, political and educational issues facing post-9/11 scholarship on radicalization and violent extremism. Its overall aim is to move beyond the ‘conventional wisdom’ associated with this area of scholarly research best represented by its many slogans, metaphors and other thought-terminating clichés. By providing (...) conceptual lenses on issues previously compartmentalized primarily [or even exclusively] in security and intelligence studies or at the fringes of scholarly interest, radicalization and violent extremism turn out to be much more complex than ‘radicalization studies’ has been eager to acknowledge. (shrink)