In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews and document (...) analysis to study how and why 11 US institutions have set up their monitoring programmes. Although these programmes varied considerably, we were able to distinguish two general types. ‘Compliance’ programmes on the one hand were part of the institutional review board office and set up to ensure compliance with regulations. Investigators’ participation was mandatory. Monitors focused on documentation. Investigators could be disciplined, and could be obliged to take corrective actions. ‘Quality-improvement’ programmes on the other hand were part of a separate office. Investigators requested to be monitored. Monitors focused more on actual research conduct. Investigators and other parties received feedback on how to improve the research process. Although both types of programmes have their drawbacks and advantages, we argue that if institutions want to set up monitoring programmes, quality improvement is the better choice: it can help foster an atmosphere of trust between investigators and the institutional review board, and can help raise the standards for the protection of human subjects. (shrink)

An increasing number of research teams are investigating the efficacy of brain-computer interface (BCI)-mediated interventions for promoting motor recovery following stroke. A growing body of evidence suggests that of the various BCI designs, most effective are those that deliver functional electrical stimulation (FES) of upper extremity (UE) muscles contingent on movement intent. More specifically, BCI-FES interventions utilize algorithms that isolate motor signals—user-generated intent-to-move neural activity recorded from cerebral cortical motor areas—to drive electrical stimulation of individual muscles or muscle synergies. BCI-FES (...) interventions aim to recover sensorimotor function of an impaired extremity by facilitating and/or inducing long-term motor learning-related neuroplastic changes in appropriate control circuitry. We developed a non-invasive, electroencephalogram (EEG)-based BCI-FES system that delivers closed-loop neural activity-triggered electrical stimulation of targeted distal muscles while providing the user with multimodal sensory feedback. This BCI-FES system consists of three components: (1) EEG acquisition and signal processing to extract real-time volitional and task-dependent neural command signals from cerebral cortical motor areas, (2) FES of muscles of the impaired hand contingent on the motor cortical neural command signals, and (3) multimodal sensory feedback associated with performance of the behavioral task, including visual information, linked activation of somatosensory afferents through intact sensorimotor circuits, and electro-tactile stimulation of the tongue. In this report, we describe device parameters and intervention protocols of our BCI-FES system which, combined with standard physical rehabilitation approaches, has proven efficacious in treating UE motor impairment in stroke survivors, regardless of level of impairment and chronicity. (shrink)

Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children’s consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children’s competence to consent to clinical research and to what extent they explain the variation in competence judgments.

Background: Issues concerning legislation and regulation with respect to the role of nurses in euthanasia and physician-assisted suicide gave the Minister for Health reason to commission a study of the role of nurses in medical end-of-life decisions in hospitals, home care and nursing homes.Aim: This paper reports the findings of a study of the role of nurses in euthanasia and physician-assisted suicide, conducted as part of a study of the role of nurses in medical end-of-life decisions. The findings for hospitals, (...) home care and nursing homes are described and compared.Method: A questionnaire was sent to 1509 nurses, employed in 73 hospitals, 55 home care organisations and 63 nursing homes. 1179 responses were suitable for analysis. The questionnaire was pilot-tested among 106 nurses, with a response rate of 85%.Results: In 37.0% of cases, the nurse was the first person with whom patients discussed their request for euthanasia or physician-assisted suicide. Consultation between physicians and nurses during the decision-making process took place quite often in hospitals and nursing homes and less frequently in home care situations . In some cases , nurses administered the euthanatics.Conclusions: The results show substantial differences between the intramural sector and the extramural sector , which are probably linked to the organisational structure of the institutions. Consultation between physicians and nurses during the decision-making process needs improvement, particularly in home care. Some nurses had administered euthanatics, although this task is by law exclusively reserved to physicians. (shrink)

This book represents the text of six lectures delivered by Canon Van Steenberghen in the Queen’s University, Belfast in May 1953, under the auspices of the Department of Scholastic Philosophy. As an introduction to the evolution of philosophical thought in the thirteenth century, it could hardly be bettered. It not merely states conclusions; it communicates the excitement of intellectual enquiry and discovery. It is a report of work in progress, with the challenge of work still remaining to be done. It (...) makes the reader participant of an absorbing debate, in which the author joins issue with eminent medieval scholars in elucidating some central problems of the history of scholasticism and their relevance to contemporary Thomism. The debate continues; but on many points the reader will have no doubt that Professor Van Steenberghen’s theses are définitivement acquises. (shrink)

This article reports the findings of a study into the role of Dutch nurses in the alleviation of pain and symptoms with a life-shortening intention, conducted as part of a study into the role of nurses in medical end-of-life decisions. A questionnaire survey was carried out using a population of 1509 nurses who were employed in hospitals, home care organizations and nursing homes. The response rate was 82.0%; 78.1% were suitable for analysis. The results show that in about half of (...) the cases nurses were involved in the decision making by the physician and that nurses were frequently involved in administering the medication. The authors' conclusion is that alleviation of pain and symptoms with a life-shortening intention represents a `grey' area, in which physicians and nurses act on the basis of personal ethical norms rather than legal rules, professional guidelines or shared moral values. (shrink)

This article reports the findings of a study into the role of Dutch nurses in the alleviation of pain and symptoms with a life-shortening intention, conducted as part of a study into the role of nurses in medical end-of-life decisions. A questionnaire survey was carried out using a population of 1509 nurses who were employed in hospitals, home care organizations and nursing homes. The response rate was 82.0%; 78.1% (1179) were suitable for analysis. The results show that in about half (...) of the cases (55.8%) nurses were involved in the decision making by the physician and that nurses were frequently (81.5%) involved in administering the medication. The authors' conclusion is that alleviation of pain and symptoms with a life-shortening intention represents a `grey' area, in which physicians and nurses act on the basis of personal ethical norms rather than legal rules, professional guidelines or shared moral values. (shrink)

Sections R1 to R3 attempt to take the sting out of hostile commentaries. Sections R4 to R5 engage Berlin and Kay and the World Color Survey to correct the record. Section R6 begins the formulation of a new theory of colour as an engineering project with a technological developmental trajectory. It is recommended that the colour space be abandoned.

In this target article the following hypotheses are discussed: (1) Colour is autonomous: a perceptuolinguistic and behavioural universal. (2) It is completely described by three independent attributes: hue, brightness, and saturation: (3) Phenomenologically and psychophysically there are four unique hues: red, green, blue, and yellow; (4) The unique hues are underpinned by two opponent psychophysical and/or neuronal channels: red/green, blue/yellow. The relevant literature is reviewed. We conclude: (i) Psychophysics and neurophysiology fail to set nontrivial constraints on colour categorization. (ii) Linguistic (...) evidence provides no grounds for the universality of basic colour categories. (iii) Neither the opponent hues red/green, blue/yellow nor hue, brightness, and saturation are intrinsic to a universal concept of colour. (iv) Colour is not autonomous. (shrink)

Argumentation as the public exchange of reasons is widely thought to enhance deliberative interactions that generate and justify reasonable public policies. Adopting an argumentation-theoretic perspective, we survey the norms that should govern public argumentation and address some of the complexities that scholarly treatments have identified. Our focus is on norms associated with the ideals of correctness and participation as sources of a politically legitimate deliberative outcome. In principle, both ideals are mutually coherent. If the information needed for a correct deliberative (...) outcome is distributed among agents, then maximising participation increases information diversity. But both ideals can also be in tension. If participants lack competence or are prone to biases, a correct deliberative outcome requires limiting participation. The central question for public argumentation, therefore, is how to strike a balance between both ideals. Rather than advocating a preferred normative framework, our main purpose is to illustrate the complexity of this theme. (shrink)

: According to a consensus of psycho-physiological and philosophical theories, color sensations (or qualia) are generated in a cerebral "space" fed from photon-photoreceptor interaction (producing "metamers") in the retina of the eye. The resulting "space" has three dimensions: hue (or chroma), saturation (or "purity"), and brightness (lightness, value or intensity) and (in some versions) is further structured by primitive or landmark "colors"—usually four, or six (when white and black are added to red, yellow, green and blue). It has also been (...) proposed that there are eleven semantic universals—labeling the previous six plus the "intermediaries" of orange, pink, brown, purple, and gray. There are many versions of this consensus, but they all aim to provide ontological, epistemological and semantic blueprints for the brute fact of the reality of color ordained by Nature (evolution). In contrast to this consensus, we have argued that "seeing color" is not a matter of light waves impacting on our eyes, producing sensations to be categorized and labeled in the "color space" in the brain. While electrochemical events may unproblematically be regarded as the causal precondition for seeing color, the reception of sensations in "the color space" as semantically labeled natural categories, kinds, or information, is a "just so" story: it is Wittgenstein's beetle in a box. In contrast we consider that the authority of this consensus might better be regarded not as the result of the truth-tracking of nature, but as the sociohistorical outcome of philosophical presuppositions, scientific theories, experimental practices, technological apparatus, and their feed forward into the lifeworld. The question we shall therefore explore is whether, or to what extent, we ourselves are changed, as the conditions of production of color science change. Thus we are doing a kind of anthropology at two levels: of color science itself (and its effect on our own lifeworld), and of those studied by the "anthropology of color". As befits this stance we are agnostic about the theoretical entities of color science (cf. van Fraassen 2001), and within this new context, we propose to cross-cut object-and-subject, organism-and-environment (the bedrock of color science) in socio-historical ways. Our approach is in part inspired by, but not the same as, that of Gibson, in that we wish to pursue the notion of "social affordances" (Burmudez 1995). We suggest that color has become a naturalization through science-based technologies, which, through praxes and materializations, have become the perceptual and cultural entities that structure experience and understanding in the lifeworld. It is this naturalization that we shall refer to and characterize as "the historically inflected exosomatic organ". Consequently we shall explore the historical ontology of "color" without assuming an underlying biological constant (Dupré 2001). In part 1 we show the flimsiness of the evidence for the three dimensions of color, borrowed from physics, and fine-tuned to a "standard observer" (a "spectral creature" with a phenomenal "color space"). In part 2 we address the structuring of hue through the development of color circles and color spaces. This is followed by a review of the evidence for unique hues. Again the evidence is shown to be flimsy. We then show that an isolated domain of color is a particular kind of model, not a "natural given". In part 3, after reviewing what is referred to as "the isomorphy thesis," we discuss the exemplary case study of Berlin and Kay (1969). This illustrates the pull of stadial models presupposed by their evolutionary theory of color language. The Berlin and Kay paradigm proposes that American English color terms are incorrigible and can provide the universal metalanguage. We conclude by presenting an alternative account, namely that we ourselves are changed as the conditions of production of color science change. We argue that it is better to regard "seeing-color" as a historically inflected exosomatic organ that provides social affordances for those trained to grasp them. (shrink)

Recent results have shown that the relative activation of muscles is different for isometric contractions and for movements. These results exclude an explanation of muscle activation patterns by a combination ofreciprocal and coactivation commands. These results also indicate that joint stiffness is not uniquely determined and that it may be different for isometric contractions and movements.

In reply to Wierzbicka's advocacy of semantic primitives we argue that talk of the semantic primitives repeats the fallacies addressed in the target article at a higher level. In reply to Malcolm's plea for a Wittgensteinian grammar of colour words, we argue that he uses words like “we” and “us” too easily, falling into the trap of “silly relativism.” In reply to McManus's science of word counts, we reiterate the nineteenth-century criticism that this method is based on an illegitimate application (...) of seemingly rigorous statistical methods. (shrink)

BackgroundPreprint usage is growing rapidly in the life sciences; however, questions remain on the relative quality of preprints when compared to published articles. An objective dimension of quality that is readily measurable is completeness of reporting, as transparency can improve the reader’s ability to independently interpret data and reproduce findings.MethodsIn this observational study, we initially compared independent samples of articles published in bioRxiv and in PubMed-indexed journals in 2016 using a quality of reporting questionnaire. After that, we performed paired comparisons (...) between preprints from bioRxiv to their own peer-reviewed versions in journals.ResultsPeer-reviewed articles had, on average, higher quality of reporting than preprints, although the difference was small, with absolute differences of 5.0% [95% CI 1.4, 8.6] and 4.7% [95% CI 2.4, 7.0] of reported items in the independent samples and paired sample comparison, respectively. There were larger differences favoring peer-reviewed articles in subjective ratings of how clearly titles and abstracts presented the main findings and how easy it was to locate relevant reporting information. Changes in reporting from preprints to peer-reviewed versions did not correlate with the impact factor of the publication venue or with the time lag from bioRxiv to journal publication.ConclusionsOur results suggest that, on average, publication in a peer-reviewed journal is associated with improvement in quality of reporting. They also show that quality of reporting in preprints in the life sciences is within a similar range as that of peer-reviewed articles, albeit slightly lower on average, supporting the idea that preprints should be considered valid scientific contributions. (shrink)

The COVID-19 pandemic has forced developmental researchers to rethink their traditional research practices. The growing need to study infant development at a distance has shifted our research paradigm to online and digital monitoring of infants and families, using electronic devices, such as smartphones. In this practical guide, we introduce the Experience Sampling Method – a research method to collect data, in the moment, on multiple occasions over time – for examining infant development at a distance. ESM is highly suited for (...) assessing dynamic processes of infant development and family dynamics, such as parent-infant interactions and parenting practices. It can also be used to track highly fluctuating family dynamics and routines. The aim of the current paper was to provide an overview by explaining what ESM is and for what types of research ESM is best suited. Next, we provide a brief step-by-step guide on how to start and run an ESM study, including preregistration, development of a questionnaire, using wearables and other hardware, planning and design considerations, and examples of possible analysis techniques. Finally, we discuss common pitfalls of ESM research and how to avoid them. (shrink)