This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. (...) This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines. (shrink)
Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research (...) participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required. (shrink)
Congdon (2017), Giladi (2018), and McConkey (2004) challenge feminist epistemologists and recognition theorists to come together to analyze epistemic injustice. I take up this challenge by highlighting the failure of recognition in cases of testimonial and hermeneutical injustice experienced by victims of sexual harassment and sexual assault. I offer the #MeToo movement as a case study to demonstrate how the process of mutual recognition makes visible and helps overcome the epistemic injustice suffered by victims of sexual harassment and sexual assault. (...) I argue that in declaring “me too,” the epistemic subject emerges in the context of a polyphonic symphony of victims claiming their status as agents who are able to make sense of their own social experiences and able to convey their knowledge to others. (shrink)
Physician strikes in the United States have been relatively rare, although this has not been the case in other countries nor with other members of the healthcare community, such as nurses. This situation, however, could change. More physicians are either joining unions or seriously discussing doing so. The National Guild for Medical Providers, for example, is actively trying to expand its membership of 11,000 doctors in Michigan, Pennsylvania, and New Hampshire into Illinois, California, New Jersey, Colorado, Texas, and South Carolina. (...) The Federation of Physicians and Dentists, with 2,500 members in Florida and Connecticut, is trying to establish itself in Seattle, Las Vegas, Tucson, and Philadelphia. Although unions are neither necessary nor sufficient conditions for strikes, if physician unions do become more prevalent, the potential for collective work actions, including strikes, increases. (shrink)
Emerging genomic technologies promise more efficient infectious disease control. Whole genome sequencing is increasingly being used in tuberculosis diagnosis, surveillance, and epidemiology. However, while the use of WGS by public health agencies may raise ethical, legal, and socio-political concerns, these challenges are poorly understood. Between November 2017 and April 2018, we conducted semi-structured interviews with 22 key stakeholders across the fields of governance and policy, public health, and laboratory sciences representing the major jurisdictions currently using WGS in national TB programs. (...) Thematic analysis of the interviews was conducted using NVivo 11. Respondents identified several ethical and practical challenges associated with WGS in TB care and surveillance, all related to issues of trust, including: 1) the power of public health; 2) data sharing and profits derived from surveillance efforts; and 3) concerns regarding who has access to, and can benefit from, the technology. Additional challenges included: the potential utility that WGS adds to a public health program, the risks associated with linking necessary epidemiological metadata to the genomic data, and challenges associated with jurisdictional capacity to implement the technology. Successful implementation of WGS is dependent on fostering relationships of trust between those working with genomics technology and those directly impacted by it, including clinicians. Building trust between the public and the public health agencies and within public health agencies themselves is critical due to the inherent complexity of WGS and its implementation for communicable disease control purposes. (shrink)
Primary salt welds form at the base of minibasins in response to complete evacuation of autochthonous salt. Analytical and numerical models suggest it is difficult to completely remove salt from a weld by viscous flow alone, which is especially true in multilayered evaporites, within which flow is likely heterogeneous due to lithologically controlled viscosity variations. Welds are important in the hydrocarbon industry because they may provide a hydrodynamic seal and trap hydrocarbons, or may allow transmission of fluids from source to (...) reservoir rocks. Few papers document the subsurface expression of welds, principally because they have not been penetrated by wells or because the associated data are proprietary. We use 3D seismic and borehole data from the Santos Basin, offshore Brazil to characterize the geological and geophysical expression of a primary weld associated with flow of Aptian salt. The seismic data that we evaluated suggested that, locally, presalt and postsalt rocks are in contact at the base of an Upper Cretaceous minibasin, implying that several apparent welds, separated by low-relief salt pillows, are present. However, borehole data indicated that 22 m of anhydrite, carbonate, and sandstone are present in one of the welds, indicating that this and other welds may be incomplete. We find that seismic data may be unable to discriminate between a complete and incomplete weld, and we suggested that, during the subsurface analysis of welds, the term apparent weld is used until borehole data unequivocally proves the absence of salt. Furthermore, we speculate that preferential expulsion of halite and potash salt from the autochthonous layer during viscous flow and welding resulted in the formation of an incomplete weld, which, when compared with the initial autochthonous layer, is volumetrically enriched in nonevaporite lithologies and relatively viscous evaporite lithologies. The composition and stratigraphy of the autochthonous layer may thus dictate weld thickness and seal potential. (shrink)
Improving the informed consent process is a common theme in literature regarding biomedical human subjects research. Standards for appropriate language and required information have undergone scrutiny and evolved over time. One response to the call for improvement is the provision and use of informed consent templates to ensure that documents have a standardized format and quality of content. Little is known, however, about the prevalence of such ICTs or their effectiveness. This article discusses the rationale for creating and using templates, (...) describes the prevalence of and commonalities between templates, and identifies the need for an evaluation of their effectiveness in terms of their ethical and practical implications. The websites of 144 Association of American Medical Colleges -accredited institutions in the United States, 21 institutes in the National Institutes of Health, and the World Health Organization were searched for the presence of ICTs. A total of 105 medical schools, 3 NIH institutes, and the WHO had at least one ICT publicly available on their websites. The templates varied in format, length, style, language, and sections included. The prevalence of ICTs, variability in their content, and lack of published research regarding their effectiveness suggest that ICTs are available, but more research into their effectiveness and standardization of their development are needed. (shrink)
We use the Newell Test as a basis for evaluating ACT-R as an effective architecture for cognitive engineering. Of the 12 functional criteria discussed by Anderson & Lebiere (A&L), we discuss the strengths and weaknesses of ACT-R on the six that we postulate are the most relevant to cognitive engineering.
Desire in René Girard and Jesus presents a comprehensive analysis of René Girard’s work on the origins of culture and the depths of human desire. Girard’s hypothesis of mimesis discloses the lack of originality in human desire even as it offers a scientific method for handling religion after two centuries of its absence in the social science.
Post-modernist thought represents the latest skeptical turn in a revolution going back to the overthrow of speculative thought in and after Hegel's time, whose principal phases are traced from its dogmatic origins in 19c scientism and absolutism, through the 20c. schools of meta-philosophy, to the explicitly post-philosophical positions of Derrida, Rorty and others who would finally abandon or suspend all engagement with the tradition of philosophical reason. The progress toward this denouement has brought with it progressive distortion of the understanding (...) of classical philosophical arguments on their own terms, an understanding which now needs to be recovered from a standpoint that takes account of the legacy of the ultra-philosophical critique but now knows it as itself limited. (shrink)
The emplacement of igneous intrusions into sedimentary basins mechanically deforms the host rocks and causes hydrocarbon maturation. Existing models of host-rock deformation are investigated using high-quality 3D seismic and industry well data in the western Møre Basin offshore mid-Norway. The models include synemplacement and postemplacement mechanisms. We use the seismic interpretations of five horizons in the Cretaceous-Paleogene sequence to analyze the host rock deformation induced by the emplacement of the underlying saucer-shaped Tulipan sill. The results show that the sill, emplaced (...) between 55.8 and 54.9 Ma, is responsible for the overlying dome structure observed in the seismic data. Isochron maps of the deformed sediments, as well as deformation of the younger postemplacement sediments, document a good match between the spatial distribution of the dome and the periphery of the sill. The thickness [Formula: see text] of the Tulipan is less than 100 m, whereas the amplitude [Formula: see text] of the overlying dome ranges between 30 and 70 m. Spectral decomposition maps highlight the distribution of fractures in the upper part of the dome. These fractures are observed in between hydrothermal vent complexes in the outer parts of the dome structure. The 3D seismic horizon interpretation and volume rendering visualization of the Tulipan sill reveal fingers and an overall saucer-shaped geometry. We conclude that a combination of different mechanisms of overburden deformation, including elastic bending, shear failure, and differential compaction, is responsible for the synemplacement formation and the postemplacement modification of the observed dome structure in the Tulipan area. (shrink)
Igneous sills emplaced at shallow levels in sedimentary basins commonly uplift the overburden and free surface. Uplift produces dome-shaped forced folds that may host economic hydrocarbon accumulations. These intrusion-induced forced folds are typically assumed to develop instantaneously, whereby the oldest onlapping strata constrain the age of sill emplacement, and accommodate the entire volume of intruded magma. However, several studies demonstrate that forced folds may grow over geologic timescales, with additional space-making mechanisms partly accommodating the magma volume. It is thus critical (...) to understand when forced fold traps form and how they evolve in relation to the timing of source rock maturation and migration. We analyze two forced folds imaged in 2D seismic reflection data from offshore northwest Australia. Analyzing the seismic stratigraphy of the forced fold overburden allows us to recognize several distinct phases of fold growth. Subhorizontal reflections onlapping onto the lower portion of the forced folds at a high angle indicate that the first phase of sill emplacement and fold development occurred rapidly, facilitated by normal faulting, prior to the deposition of overlying strata during a period of magmatic quiescence and regional hydrocarbon maturation in the Early Cretaceous. Renewed magmatic activity resulted in a final, protracted phase of doming, which is recorded by a package of onlapping growth strata that was incrementally deformed by successive intrusive pulses. We also demonstrate that in addition to folding and faulting, the magma volume was likely accommodated by porosity reduction within the folded strata. Our observations imply that the age of the lowermost onlapping reflections only constrain the onset of sill emplacement and not the duration of magmatic activity. Constraining the dynamic evolution of intrusion-induced forced folds from the structure of onlapping reflections during hydrocarbon exploration can thus provide critical insights into the potential volume and charge history of any hydrocarbon accumulations. (shrink)
J.L. Schellenberg argues that divine hiddenness provides an argument for the conclusion that God does not exist, for if God existed he would not allow non-resistant non-belief to occur, but non-resistant non-belief does occur, so God does not exist. In this paper, I argue that the stakes involved in theistic considerations put pressure on Schellenberg’s premise that non-resistant non-belief occurs. First, I specify conditions for someone’s being a resistant non-believer. Then, I argue that many people fulfill these conditions because, given (...) some plausible assumptions, there is a very good pragmatic reason to be a theist rather than an atheist. I assume it is more likely that theists go to heaven than atheists, and I argue there is a non-zero probability that one can receive infinite utility and a method of comparing outcomes with infinite utilities in which the probability of each outcome affects the final expected values. Then, I show how this argument entails there is no good reason to think that there are very many non-resistant non-believers. (shrink)
Later reprinted by Deborah Charles Publications (and not available from Amazon), this book expounds and comments on the application of Greimasian semiotics to a legal text, as found in the article by Greimas and Landowski in Greimas, Sémiotique et Sciences Sociales (1976), compares this with the semiotic presuppositions of Hart, Dworkin, MacCormick and Kelsen, and offers my own analysis of the implications of such semiotic analysis for legal theory, including some more recent radical non-positivist accounts.
Introduction While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand. Methods Enrolment procedures included an informed consent comprehension quiz. An informed consent survey followed. Results 525 participants completed the informed consent survey (Heng County, China=255, Xinjiang, China=229, Chiang Mai, Thailand=41). Mean age was (...) 33 and mean educational level was 8 yrs. While quizzing was felt to be a good way to determine if a person understands the nature of clinical trial participation (97%) and participants did not generally find the quiz to be problematic, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded (5%); and did not find the questions easy (13%). In multivariate analysis, lower educational level was associated with not minding the quizzing (6–10 yrs vs 0–5 yrs: OR=0.27, p=0.03; more than 11 yrs vs 0–5 yrs: OR=0.18, p=0.03). There were also site differences (Heng County vs Xinjiang) in feeling anxious (OR=0.07; p=<0.01), not minding (OR=0.26; p=0.03), being bored (OR=0.25; p=0.01) and not finding the questions easy (OR=0.10; p=<0.01). Conclusions Quizzing during the informed consent process can be problematic for a minority of participants. These problems may be associated with the setting in which research takes place and educational level. Further research is needed to develop, test and implement alternative methods of ensuring comprehension of informed consent. Trial Registration clinicaltrials.gov number NCT00270257. (shrink)