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Titlebook: Liability for and Insurability of Biomedical Research with Human Subjects in a Comparative Perspecti; Jos Dute,Michael G. Faure,Helmut Koz

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Swedensubjects for that matter. The general healthcare legislation is often applicable to situations related to biomedical research and there are special acts on clinical testing of drugs and medical-technical equipment, taking biological material for research purposes and protection of sensitive informat
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Switzerlandied by analogy in most clinical studies refers, among others, to Directives 93/42/EEC and 90/385/EEC which both state that clinical investigation must be carried out in accordance with the Declaration of Helsinki. There is also reference to the Declaration of Helsinki in the Guidelines on experiment
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International Aspectscal research. This resulted in several treaties, resolutions, guidelinses and other international documents containing prvoisions, which aimed at protecting either directly or indirectly the position of the human test subject.
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Alternatives to Full Proof of Causation the harm, there is quite some disparity when it comes to finetune the requirement of causation, particularly in certain cases where the .-requirement. appears to bring about unsatisfactory results. Even the application of the test itself is not always uniform — the range of possible variations goes
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Summaries of the Country Reportsls should be carried out.. While the Helsinki Declaration therefore might appear to be formally binding due to that reference, the Belgian reporters warn not to overestimate the consequences thereof, which are already limited in light of the restricted overall scope of said Decree., Even without suc
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Germanye in weiten Teilen völlig umgestaltet und auch das Medizinproduktegesetz sowie die Strahlenschutzverordnung wurden maßgeblich reformiert. Hinzugetreten sind zum 1. August 2002 weitere maßgebliche Änderungen im Schadensersatzrecht und im Arzneimittelgesetz. Der nachfolgende Bericht beruht auf dem Gesetzes- und Literaturstand vom 1. August 2002.
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