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Intensive Care Medicine

Erschienen in:

01.04.2014 | Review

Medical research in emergency research in the European Union member states: tensions between theory and practice

verfasst von: Erwin J. O. Kompanje, Andrew I. R. Maas, David K. Menon, Jozef Kesecioglu

Erschienen in: Intensive Care Medicine | Ausgabe 4/2014

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Abstract

In almost all of the European Union member states, prior consent by a legal representative is used as a substitute for informed patient consent for non-urgent medical research. Deferred (patient and/or proxy) consent is accepted as a substitute in acute emergency research in approximately half of the member states. In 12 European Union member states emergency research is not mentioned in national law. Medical research in the European Union is covered by the Clinical Trial Directive 2001/20/EC. A proposal for a regulation by the European Commission is currently being examined by the European Parliament and the Council and will replace Directive 2001/20/EC. Deferred patient and/or proxy consent is allowed in the proposed regulation, but does not fit completely in the practice of emergency research. For example, deferred consent is only possible when legal representatives are not available. This criterion will delay inclusion of patients in acute life-threatening conditions in short time frames. As the regulation shall be binding in its entirety in all member states, emergency research in acute situations is still not possible as it should be.

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Titel: Medical research in emergency research in the European Union member states: tensions between theory and practice
verfasst von: Erwin J. O. Kompanje
Andrew I. R. Maas
David K. Menon
Jozef Kesecioglu
Publikationsdatum: 01.04.2014
Verlag: Springer Berlin Heidelberg
Erschienen in: Intensive Care Medicine / Ausgabe 4/2014
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-014-3243-6

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Medical research in emergency research in the European Union member states: tensions between theory and practice

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