The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonise the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity and inconsistency remains due to disparate interpretation by EU member states. Critical care research has been particularly impacted due to variable and often restrictive consenting procedures for incapacitated subjects, with some countries requiring a court-appointed representative, while others recognise consent from family members and occasionally professional representatives. Furthermore, the absence of (...) a waiver of consent threatened to put an end to emergency research in Europe and was met with varied responses. Approval procedures by ethics committees are equally inconsistent, particularly those relating to provision of a single opinion for multi-centre trials. Although evidence is somewhat mixed, this complexity as well as a general increase in administrative and financial burden following the Directive has been shown to cause a reduction in clinical trial activity in Europe, particularly academic trials. We aim to clarify some of these inconsistent procedures, particularly those relating to informed consent of incapacitated subjects, as well as discussing some general weaknesses and possible improvements of the Directive ahead of its planned revision in 2011. (shrink)

Forty‐nine subjects judged the relevancy of sentence parts of a word problem (the Allsports problem). Patterns of subjects' judgments suggest three problem‐solving heuristics: a SETS heuristic, a TIME heuristic, and a QUESTION heuristic. Presentation of the question before the problem tends to suppress SETS and TIME heuristics. A computer program (ATTEND) is presented to simulate subjects' behavior on the Allsports problem. The program is context‐sensitive in that it can change a relevance judgment upon the acquisition of further information. Averaged subject (...) judgments and ATTEND judgments agree for 87% of the items. (shrink)

Objective: To develop an approach for seeking informed consent to examine tissues retained from a previous study of sudden infant death syndrome as part of a study on asthma, and to document responses and participation rate.Design: Pilot open-ended approach to 10 volunteer SIDS parents, followed by staged approach to seek consent from the target SIDS families for the asthma study.Participants: Parents of SIDS infants known to SIDS and Kids Victoria and parents of SIDS infants from the 1991–2 SIDS in Victoria (...) case–control study.Main outcomes: Qualitative responses of the piloted parents and study parents, and participation rates.Results: The pilot group responses were used to refine the written material to be provided. Of the 72 families for which contact details were available, 45 gave verbal consent for contact by the Victorian Institute of Forensic Medicine regarding the asthma study, three refused and 24 did not respond to two letters. Thirty-three completed consent forms, all positive for participation in the asthma study, giving a positive response rate of 73% .Conclusions: The use of postmortem tissue for research is acceptable to the next of kin when an approach is sensitive to their concerns and needs and is made by experienced counsellors from a familiar organisation. Despite the painful memories evoked by the approach of the research group, the acceptance rate among those who could be contacted was high. (shrink)

Purpose – To review and discuss Luciano Floridi’s 2019 book The Logic of Information: A Theory of Philosophy as Conceptual Design, the latest instalment in his philosophy of information (PI) tetralogy, particularly with respect to its implications for library and information studies (LIS). Design/methodology/approach – Nine scholars with research interests in philosophy and LIS read and responded to the book, raising critical and heuristic questions in the spirit of scholarly dialogue. Floridi responded to these questions. Findings – Floridi’s PI, including (...) this latest publication, is of interest to LIS scholars, and much insight can be gained by exploring this connection. It seems also that LIS has the potential to contribute to PI’s further development in some respects. Research implications – Floridi’s PI work is technical philosophy for which many LIS scholars do not have the training or patience to engage with, yet doing so is rewarding. This suggests a role for translational work between philosophy and LIS. Originality/value – The book symposium format, not yet seen in LIS, provides forum for sustained, multifaceted and generative dialogue around ideas. (shrink)

Short-term limb immobilization results in skeletal muscle decline, but the underlying mechanisms are incompletely understood. This study aimed to determine the neurophysiologic basis of immobilization-induced skeletal muscle decline, and whether repetitive Transcranial Magnetic Stimulation could prevent any decline. Twenty-four healthy young males underwent unilateral limb immobilization for 72 h. Subjects were randomized between daily rTMS using six 20 Hz pulse trains of 1.5 s duration with a 60 s inter-train-interval delivered at 90% resting Motor Threshold, or Sham rTMS throughout immobilization. (...) Maximal grip strength, EMG activity, arm volume, and composition were determined at 0 and 72 h. Motor Evoked Potentials were determined daily throughout immobilization to index motor excitability. Immobilization induced a significant reduction in motor excitability across time. The rTMS intervention increased motor excitability at 0 h. Despite daily rTMS treatment, there was still a significant reduction in motor excitability, loss in EMG activity, and a loss of maximal grip strength after immobilization. Interestingly, the increase in biceps and posterior forearm skinfold thickness with immobilization in Sham treatment was not observed following rTMS treatment. Reduced MEPs drive the loss of strength with immobilization. Repetitive Transcranial Magnetic Stimulation cannot prevent this loss of strength but further investigation and optimization of neuroplasticity protocols may have therapeutic benefit. (shrink)

ABSTRACTNegative feedback has paradoxical features to it. This form of feedback can have informational value under some circumstances, but it can also threaten the ego, potentially upsetting behaviour as a result. To investigate possible consequences of the latter type, two experiments presented positive or negative feedback within a sequence-prediction task that could not be solved. Following feedback, participants had to control their behaviours as effectively as possible in a motor control task. Relative to positive feedback, negative feedback undermined control in (...) a manner suggesting emotional upset. These reactions lasted for at least three seconds and were especially pronounced among people reporting that they typically lose control in the context of their negative emotions. The findings document a novel form of behavioural dysregulation that occurs in response to negative feedback while also highlighting the utility of motor control perspectives on self... (shrink)

This book is a collection of secondary essays on America's most important philosophic thinkers—statesmen, judges, writers, educators, and activists—from the colonial period to the present. Each essay is a comprehensive introduction to the thought of a noted American on the fundamental meaning of the American regime.

Objective: To assess the adequacy of the process of informed consent for surgical patients at the University Hospital of the West Indies. Method: The study is a prospective, cross-sectional, descriptive study. 210 patients at the University Hospital of the West Indies were interviewed using a standardised investigator-administered questionnaire, developed by the authors, after obtaining witnessed, informed consent for participation in the study. Data were analysed using SPSS V.12 for Windows. Results: Of the patients, 39.4% were male. Of the surgical procedures, (...) 68.6% were scheduled, 7.6% urgent and 23.8% emergency, 35.2% were minor and 64.8% major. Information imparted/received was acceptable in 40% of cases, good in 24% and inadequate (unacceptable) in 36% of cases. Almost all (97.6%) patients stated that they understood why an operation was planned and 93.3% thought that they had given informed consent. Most (95.2%) thought that they had free choice and made up their own mind. A quarter (25.2%) of all patients were told that it was mandatory for them to sign the form. There was a discussion of possible side effects and complications in 56.7% of patients. Conclusions: This study clearly indicates that surgical patients at the University Hospital of the West Indies feel that they have given informed consent. However, it also suggests that more information should be given to patients for consent to be truly informed. (shrink)

This long-awaited new edition contains eight of the dialogues of Plato, and is the first in a new five-volume complete edition of his works in the OCT series.

The assumption of materialism Howard Robinson believes is false.

In editing Plato's Sophist for the new OCT vol. I, ed. E. A. Duke, W. F. Hicken, W. S. M. Nicoll, D. B. Robinson, and J. C. G. Strachan , there was less chance of giving novel information about W = Vind. Supp. Gr. 7 for this dialogue than for others in the volume, since Apelt's edition of 1897 was used by Burnet in 1900 and was based on Apelt's own collation of W. The result was better than the (...) somewhat confused information printed by Burnet, even in his 1905 reprint, for W for the other dialogues in vol. I. But in the Sophist as elsewhere in vol. I collations largely due to Dr W. S. M. Nicoll added new facts about all of BDTWP and their correctors, and the search for testimonia largely carried out by Dr E. A. Duke added new facts in that area. A reviewer counts 66 changes in our text of the Sophist, which may perhaps be a slight over-estimate. Classification of changes as substantive or as falling into different groups is sometimes difficult, but I think plausible figures are as follows. We have in 25 places made a different choice of readings from the primary mss. and testimonia. We have printed conjectures where Burnet kept a ms. reading in 17 places, but conversely we have reverted to a ms. reading where Burnet had a conjecture in 8 places. We have printed alternative conjectures to conjectures adopted by Burnet in 6 places. So we have actually departed from the primary sources on at most 9 more occasions overall than Burnet. What must be noted is that Burnet had already printed conjectures on something like 87 occasions , so our percentage addition to Burnet's departures from the primary sources is modest. Moreover Burnet printed about 25 readings from testimonia; we have followed him in 20 or so of these cases, and this in turn implies that the primary mss. are in error at these further 20 places. It needs to be underlined that though Burnet undoubtedly deserved to be regarded as a safe and cautious editor, nevertheless he departed from the primary mss. on average about twice per Stephanus page in this dialogue. Sometimes, of course, testimonia showed him right to do this, but testimonia cover only a quite small part of this dialogue. Otherwise Burnet accepted almost 90 conjectures. For the Politicus the figures are fairly similar; Burnet accepted 22 Byzantine conjectures and 35–40 more modern ones. The new OCT there adds 15 or so more conjectures. (shrink)

Emphasis placed on the search for new theoretical and methodological foundations for conducting modern social and political research. As the latter, it proposed to consider the leading propositions of the new version of the theory of social development by American researchers D.Acemoglu and J.Robinson, presented in their monograph «Narrow Corridor. States, Societies, and the Fate of Liberty» (2019).In the context of achieving the specified goal, the following tasks solved:– the content of the theory of social development by D.Acemoglu and (...) D.Robinson («narrow corridor»);– the main ideas of the concept are compared with other theoretical constructions of social development proposed by leading Western researchers – R.Dahrendorf, S.Lipset, R.Englgart and. Habermas;– the strategy of applying the concept of «narrow corridor» in relation to the research of the leading elements of socio-political reality is determined.As a result, the following conclusions are drawn: firstly, this conceptual construction of D.Acemoglu and D.Robinson can be considered as a certain theoretical construction, claiming the level of a new version of the theory of social development; secondly, its structure is made up of leading provisions capable of interpreting both the static aspect of the existence of social and political reality (civil society – the state) and the dynamic one – the mechanism of its constant development (the struggle between the elites and the state, on the one hand, and the masses and civil society, on the other hand); thirdly, its heuristic potential for social and political research can be realized through the following research strategy: choosing a research subject; justification of the group of variables that can characterize it; determination of the set of factors that led to its occurrence; determination of the set of factors affecting its further development; consideration of the context of functioning and development of this subject of research – on the one hand, from the standpoint of civil society development, and, on the other – from the standpoint of further state building. (shrink)