Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. 8 ethics (...) committees were located at university medical schools and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required .Results: The duration of the ERP ranged from 1 to 176 days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities and 8 of 10 at medical chambers charged a median fee of €162 . The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval .Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country. (shrink)
The generalized second law of thermodynamics states that entropy always increases when all event horizons are attributed with an entropy proportional to their area. We test the generalized second law by investigating the change in entropy when dust, radiation and black holes cross a cosmological event horizon. We generalize for flat, open and closed Friedmann–Robertson–Walker universes by using numerical calculations to determine the cosmological horizon evolution. In most cases, the loss of entropy from within the cosmological horizon is more than (...) balanced by an increase in cosmological event horizon entropy, maintaining the validity of the generalized second law of thermodynamics. However, an intriguing set of open universe models shows an apparent entropy decrease when black holes disappear over the cosmological event horizon. We anticipate that this apparent violation of the generalized second law will disappear when solutions are available for black holes embedded in arbitrary backgrounds. (shrink)
A theory of the joint measurement of quantum mechanical observables is generalized in order to make it applicable to the measurement of the local observables of field theory. Subsequently, the property of local commutativity, which is usually introduced as a postulate, is derived by means of the theory of measurement from a requirement of mutual nondisturbance, which, for local observables performed at a spacelike distance from each other, is interpreted as a requirement of macrocausality. Alternative attempts at establishing a deductive (...) relationship between relativistic causality and local commutativity are reviewed, but found wanting, either because of the assumption of an unwarranted objectivity of the object system (algebraic approach) or because of the use of a projection postulate (operational approach). Finally, the quantum mechanical nonobjectivity is related to certain features of nonlocality which are present in the formalism of quantum mechanics. (shrink)
Building on a well-developed philosophy of language, Shibles proposes a theory of metaphor. Whereas one philosophy of language may regard metaphor as an inadequate or fallacious form of reasoning, another may consider it to be the very foundation of language. Shibles’ views lie in the latter direction, and he employs Wilbur Urban’s philosophy of language, presented in his Language and Reality, to develop his theory. Urban’s importance lies in his avoidance of reducing the philosophy of language to symbolic logic and (...) recognition of the importance of metaphor, symbol, and analogy. Also significant for a theory of metaphor is the fact that Urban saw a "high evaluation" of language as being more adequate than a "low evaluation" of language. (shrink)
Introduction: The decision of “do not attempt resuscitation” in the event of cardiopulmonary arrest is usually made when the patients are critically ill and cannot make an informed choice. Although, various professional bodies have published guidelines, little is know about the patients’ own views regarding DNAR discussion.Aim: The aim of this study was to determine patients’ attitudes regarding discussing DNAR before they are critically ill.Methods: A prospective study was performed in a general out patients department. A questionnaire was distributed to (...) consecutive outpatients along with an explanatory leaflet in the adult outpatient clinic.Results: 364 patients completed the questionnaire . 90% of respondents wanted all patients to be asked regarding DNAR decision at some point during a hospital admission. The majority would not find a DNAR discussion distressing. Only 10% would find it upsetting, however, 48% of these still wanted a discussion. 37% of respondents wanted to discuss DNAR decisions on admission; 32% in outpatients; 17% at consent for surgery, 14% when they are critically ill. 87% of respondents would not object to their relatives being involved in making decisions about their resuscitation status. However, only 12% of the subjects in the study had been involved in discussing the resuscitation status of a relative and 21% would not be comfortable to discuss a relative’s resuscitation status. Although 33% of patients preferred their resuscitation status to simply be documented within their clinical notes, 77% wanted it to be more easily accessible.Conclusions: This study suggests that contrary to current practice most patients want to discuss their DNAR status prior to becoming critically ill. This includes half of the small number that find it distressing to discuss. Although most patients are comfortable with relatives being involved in discussing DNAR, a significant proportion do not want their relatives to be asked. Furthermore, once a decision has been made, the majority of patients want it to be more accessible than current practice allows. (shrink)
