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[null,"1.","Record Nr.",null,"UNINA9910135543403321"]
[null,null,"Autore",null,"Wehage Caterina"]
[null,null,"Titolo",null,"Klinische Prüfungen an Notfallpatienten / / Caterina Wehage"]
[null,null,"Pubbl/distr/stampa",null,"Universitätsverlag Göttingen, 2014"]
[{"$nulls":4},"[Göttingen] : , : Universitätsverlag Göttingen, , 2014"]
[{"$nulls":4},"©2014"]
[null,null,"ISBN",null,"9783863951771 (ebook)"]
[{"$nulls":4},"3863951778 (ebook)"]
[null,null,"Descrizione fisica",null,"1 online resource (xii, 227 pages) : illustrations; digital, PDF file(s)"]
[null,null,"Collana",null,"Göttinger Schriften zum Medizinrecht ; ; Band 18"]
[null,null,"Disciplina",null,"344.43041"]
[null,null,"Soggetti",null,"Emergency medicine - Law and Legislation - Germany"]
[{"$nulls":4},"Emergency medicine - Moral and ethical aspects"]
[{"$nulls":4},"Patients - Legal status, laws, etc - Germany"]
[{"$nulls":4},"Physician and patient - Germany"]
[{"$nulls":4},"Physician and patient - Moral and ethical aspects - Germany"]
[null,null,"Lingua di pubblicazione",null,"Tedesco"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Nota di bibliografia","Includes bibliographical references (pages [211]-227)"]
[null,null,null,"Sommario/riassunto","In the activity of each investigating physician, the protection of the individual patient and the interest of the physician coincide in gaining knowledge from the treatment for future patients. There is a tension between the protection of the individual patient and the research interest. For emergency patients, immediate treatment must always be in the foreground. However, only clinical trials in emergency patients may allow for medical advances in the treatment of such patients. The present study examines the extent to which clinical trials in emergency patients are permitted. One focus is on the delimitation between individual healing attempts, which is absolutely necessary for this examination. clinical examinations and non-interventional examinations, as well as between selfish and purely alien studies. The presentation of the admissibility requirements for self-employment studies in emergency patients in all areas of medicine is based on the respective relevant standards of the German Medicines Act, the Medical Devices Act and the Radiation and X-ray Protection Ordinance. These standards are checked for compatibility with the Basic Law and with the relevant European regulations. Finally, the present work addresses the "]
[{"$nulls":4},"question of whether purely alien studies on emergency patients are compatible with the applicable law de lege lata or de lege ferenda could be compatible."]
[{"$nulls":4},"In der Tätigkeit jedes forschenden Arztes treffen der Schutz des einzelnen Patienten und das Interesse des Arztes aufeinander, Erkenntnisse aus der Behandlung für künftige Patienten zu gewinnen. Es besteht ein Spannungsverhältnis zwischen dem Schutz des einzelnen Patienten und dem Forschungsinteresse. Bei Notfallpatienten muss die unverzügliche Behandlung stets im Vordergrund stehen. Nur klinische Prüfungen an Notfallpatienten können aber den medizinischen Fortschritt bei der Behandlung solcher Patienten ermöglichen. Die vorliegende Arbeit untersucht, inwieweit klinische Prüfungen an Notfallpatienten zulässig sind. Ein Schwerpunkt liegt dabei in der für diese Prüfung zwingend notwendigen Abgrenzung zwischen individuellem Heilversuch, klinischen Prüfungen und nichtinterventionellen Prüfungen sowie zwischen eigennützigen und rein fremdnützigen Studien. Die Darstellung der Zulässigkeitsvoraussetzungen eigennütziger Studien an Notfallpatienten in allen Bereichen der Medizin erfolgt dabei anhand der jeweils einschlägigen Normen des Arzneimittelgesetzes, des Medizinproduktegesetzes, der Strahlen- und Röntgenschutzverordnung. Diese Normen werden auf ihre Vereinbarkeit mit dem Grundgesetz und mit den maßgeblichen europäischen Regelungen überprüft. Schließlich geht die vorliegende Arbeit noch auf die Frage ein, ob rein fremdnützige Studien an Notfallpatienten mit geltendem Recht de lege lata vereinbar sind bzw. de lege ferenda vereinbar sein könnten."]