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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 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. 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.
Emergency medicine --- Patients --- Physician and patient --- Law and Legislation --- Moral and ethical aspects. --- Legal status, laws, etc. --- Moral and ethical aspects --- Doctor and patient --- Doctor-patient relationships --- Patient and doctor --- Patient and physician --- Patient-doctor relationships --- Patient-physician relationships --- Patients and doctors --- Patients and physicians --- Physician-patient relationships --- Physicians and patients --- Interpersonal relations --- Fear of doctors --- Narrative medicine --- Persons --- Sick --- Medicine, Emergency --- Medicine --- Critical care medicine --- Disaster medicine --- Medical emergencies --- Selfish studies --- Standardize --- Conformity with the Basic Law --- Arzneimittel --- Arzt --- Einwilligungsfähigkeit --- Gesetzlicher Vertreter (Deutschland) --- Grundgesetz für die Bundesrepublik Deutschland --- Klinische Studie --- Patient --- Strafgesetzbuch (Deutschland)
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This open access book presents a topical, comprehensive and differentiated analysis of Germany’s public administration and reforms. It provides an overview on key elements of German public administration at the federal, Länder and local levels of government as well as on current reform activities of the public sector. It examines the key institutional features of German public administration; the changing relationships between public administration, society and the private sector; the administrative reforms at different levels of the federal system and numerous sectors; and new challenges and modernization approaches like digitalization, Open Government and Better Regulation. Each chapter offers a combination of descriptive information and problem-oriented analysis, presenting key topical issues in Germany which are relevant to an international readership. Sabine Kuhlmann is Professor of Political Science, Public Administration and Organization at Potsdam University, Germany, Vice President of the IIAS for Western Europe, and Vice-Chair of the National Regulatory Control Council of the German Federal Government. Isabella Proeller is Professor for Public and Nonprofit Management at the University of Potsdam, Germany. Dieter Schimanke is former Professor of Public Administration at the Helmut-Schmidt-University in Hamburg, Germany. He became Secretary of State in a state in East Germany after unification and since his retirement, he is Senior Expert in projects of GIZ on reforms of Public Administration (mainly in Eastern Europe and Asia). Jan Ziekow is Professor of Public Law and the Director of the German Research Institute for Public Administration, Germany, Vice-President and former President of the German Section of IIAS.
Public policy. --- Public administration. --- Political science. --- Public Policy. --- Public Administration. --- Governance and Government. --- Administration --- Civil government --- Commonwealth, The --- Government --- Political theory --- Political thought --- Politics --- Science, Political --- Social sciences --- State, The --- Administration, Public --- Delivery of government services --- Government services, Delivery of --- Public management --- Public sector management --- Political science --- Administrative law --- Decentralization in government --- Local government --- Public officers --- Public Policy --- Public Administration --- Governance and Government --- Policy Implementation --- Open Access --- German public administration --- federal administration --- social security --- Administrative federalism --- institutions --- reforms --- governance --- German administrative system --- decentralisation --- self-government --- multilevel governance --- Federal Constitutional Court --- the German Constitution --- the German federal architecture --- European Union (EU) --- the Basic Law --- the Federal Ministry of the Interior (BMI) --- the Länder --- Political structure & processes
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