Title
Medical research in emergency research in the European Union member states : tensions between theory and practice Medical research in emergency research in the European Union member states : tensions between theory and practice
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
New york :Springer ,
Subject
Human medicine
Source (journal)
Intensive care medicine
Volume/pages
40(2014) :4 , p. 496-503
ISSN
0342-4642
ISI
000334074400003
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
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.
E-info
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