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 challenges posed by chronic illness have pointed out to epidemiologists the multifactorial complex nature of disease causality. This notion has been referred to as a web of causality. This web extends theoretically beyond risk markers. It includes determinants of emergence/non-emergence of disease. This web of determinants is a form of complex system. Due to its complexity, the determinants within such system are not linked to each others in a linear, predictable manner only. Predictability is possible only on a short-term (...) basis, and unpredictability sets in over the long run. Understanding such a system of determinants calls for articulation and testing of complex models which synthesize our knowledge of multiple determinants at many scales, both biological and otherwise. Given the complexity of this web and existing knowledge about the nonlinearity of such systems, the following question is posed: Can the challenge of studying causality be adequately addressed if emphasis continues to be placed on using tools and methods that are geared towards looking at such system from a linear paradigm? Or is it time to add to the epidemiologic research agenda the notion of nonlinearity and its relevant form of analytical approaches that are being tested in other disciplines? Furthermore, the question posed here applies as well to the study of determinants of health. Addressing determinants of heath adds further complexity to our task. (shrink)

‘The authenticity of the ille ego lines fails on every count’ was the conclusion of an article by Professor R. G. Austin1 on the lines of the Aeneid preceding arma virumque cano. The aim of the following discussion is to suggest that perhaps, after all, Virgil did write the lines. To avoid unnecessary repetition I adhere as closely as possible to Prof. Austin's arrangement of the points to be considered. It is not always the arrangement that I should have chosen (...) myself but I have only had to deviate from it in as far as I have found it necessary to discuss part of the contents of section V ‘Conclusions’ along with section I ‘The Ancient Evidence’. 1t will be understood that only the reader with Prof. Austin's article to hand will find the following fully intelligible. (shrink)

The main interest of this book is to raise the very difficult question of the interrelation between technology and care. Its ambitious aim is to interpret technology and care as ….

Taking up the idea that sanity is a necessary condition for responsibility, Susan Wolf sets forth two criteria for determining whether an actor is sane. I argue that the second criterion is inappropriate for this determination since it invokes some hidden axiological standard. I reexamine a case study that Wolf describes and arrive at a different judgment about the responsibility of the actor. I argue that the foremost criterion for determining whether an actor is sane is functional rather than axiological. (...) The theory of responsibility, rather than the notion of sanity, must do the work of appraising the value of an actors’ behavior, and that must be done in light of the fact that responsible moral agents enjoy varying degrees of sanity. (shrink)

Rufus of Ephesus (fl.c.a.d.100) wrote a large body of works on a variety of medical topics. Generally speaking, the Arabic tradition is particularly important for the reconstruction of much of his œuvre. In the present article, I am going to present four new fragments of Rufus’On Melancholyand a fragment from an otherwise unknown monographOn Preferring Fresh Poppies. These new fragments provide fascinating new insights into Rufus’ approach to recording case histories.

In the contemporary period of history, so deeply contradictory and in many respects conflict ridden, eschatological themes, predictions of universal catastrophe and the ecological or nuclear destruction of mankind, and other motifs of the end of human history have become unprecedentedly widespread and greatly attractive. Despite the huge stores of scientific knowledge accumulated in the past few decades, many people are being drawn more and more into the stream of mystical monstrous visions and are beginning to connect the end of (...) the second millennium with implausible, obsessive apocalyptic presentiments with regard to the world as a whole as well as to our own Russian history. Soothsayers have appeared who have begun to link the phenomena of disintegration and decline and the destruction of political, ethical, and aesthetic criteria being manifested in our country in one way or another directly with the end of Russian history, with the final act of the Russian historical drama. In the sphere of concrete theoretical and philosophical-sociological knowledge, notions of the limit of historical progress, that history has fundamentally, in its essentials, run its course and that from now on the future will bring nothing essentially new, are being put forward and defended. (shrink)