Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...) 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

Contents: Foreword. Wolfgang BALZER and C. ULISES MOULINES: Introduction. José A. DÍEZ CALZADA: Structuralist Analysis of Theories of Fundamental Measurement. Adolfo GARCÍA DE LA SIENRA and Pedro REYES: The Theory of Finite Games in Extensive Form. Hans Joachim BURSCHEID und Horst STRUVE: The Theory of Stochastic Fairness - its Historical Development, Formulation and Justification. Wolfgang BALZER and Richard MATTESSICH: Formalizing the Basis of Accounting. Werner DIEDERICH: A Reconstruction of Marxian Economics. Bert HAMMINGA and Wolfgang BALZER: The Basic Structure of (...) Neoclassical General Equilibrium Theory. Klaus MANHART: Balance Theories: Two Reconstructions and the Problem of Intended Applications. Rainer WESTERMANN: Festinger's Theory of Cognitive Dissonance: A Structuralist Theory-Net. Rainer REISENZEIN: Wundt's Three-Dimensional Theory of Emotion. Pablo LORENZANO: Classical Genetics and the Theory-Net of Genetics. Hinne HETTEMA and Theo A.F. KUIPERS: The Formalisation of the Periodic Table. C. ULISES MOULINES: The Basic Core of Simple Equilibrium Thermodynamics. Thomas BARTELBORTH: An Axiomatization of Classical Electrodynamics. Author's Index. Subject Index. (shrink)

A general practice research project on ethics is underway at the University of New South Wales, funded by GPEP. Ethical issues, as defined and explored by general practitioners and consumers, are being examined across four areas of Sydney.So far, telephone interviews have been conducted with a random sample of general practitioners. Face-to-face interviews have been conducted with 107 consumers, randomly sampled using ABS collection district information. Focus groups have been formed to discuss acceptable solutions to GP and consumer identified ethical (...) issues. This report will report on some preliminary findings to date and will explore professional and consumer roles in the formation of ethical solutions. (shrink)

A general practice research project on ethics is underway at the University of New South Wales, funded by GPEP (General Practice Evaluation Program, Commonwealth Department of Human Services and Health, GPEP 386). Ethical issues, as defined and explored by general practitioners and consumers, are being examined across four areas of Sydney.So far, telephone interviews have been conducted (64% response rate) with a random sample of general practitioners (GPs). Face-to-face interviews have been conducted with 107 consumers, randomly sampled using ABS collection (...) district information. Focus groups have been formed to discuss acceptable solutions to GP and consumer identified ethical issues. This report will report on some preliminary findings to date and will explore professional and consumer roles in the formation of ethical solutions. (shrink)

(1941). A survey of the growth of knowledge about certain parts of the foetal cardio-vascular apparatus, and about the foetal circulation, in Man and some other mammals. Part I: Galen to Harvey. Annals of Science: Vol. 5, No. 1, pp. 57-89.