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SHR Neuro Krebs Kardio Lipid

Zenz, W; Klobassa, DS; Sonnleitner, A; Binder, A; Sellner, A; Sperl, M; Wintergerst, U; Huemer, C; Ausserer, B; Stelzl, W; Kaulfersch, W; Grigorow, I; Biebl, A; Wimmer, A; Ortner, D; Emhofer, J; Birnbacher, R; Mostafa, G; Ihm, U; Keck, B; Farr, S; Jaros, Z; Zaunschirm, HA; Weingarten, C; Glennie, L; van Leeuwen, E; Levin, M.
Genetic research in Austrian children. Balancing act between milestones in medicine and millstones in bureaucracy
MONATSSCHR KINDERH. 2014; 162(12): 1110-1116.
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Autor/innen der Med Uni Graz:
Biebl Ariane
Binder Alexander
Kohlfürst Daniela
Sellner Andrea
Sonnleitner Astrid
Sperl Matthias
Zenz Werner

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Austria's reputation as a research incubator is directly dependent on the feasibility of conducting medical studies on humans. Institutional ethics approval is a prerequisite for these undertakings. We describe the administrative burden required to obtain institutional ethics approval for the Austrian part of the multinational FP7 project European Union childhood life-threatening infectious diseases study (EUCLIDS) which was established to untangle the genetic background of severe infectious bacterial diseases in children. The Austrian study centre at the Medical University of Graz coordinates 22 Austrian pediatric hospitals. For inclusion of these hospitals in the EUCLIDS project, a total of 11 ethical approvals from 9 different ethical committees using 5 different consent forms were necessary. Each ethical approval obtained has to be extended on a yearly basis throughout the entire duration of the project. This project is further hampered by the fact that the Austrian legal situation does not provide the explicit possibility to obtain deferred consent for genetic studies in children. Austrian legislation concerning genetic diagnostic studies in children is in major need of reform. Besides administrative simplifications we suggest the introduction of a lead ethics committee for multicentre genetic diagnostic studies, the establishment of the legal condition to ask for deferred consent in children and the consideration of new genetic techniques, such as genome-wide association screening and next generation sequencing.

Find related publications in this database (Keywords)
Ethics committees
Next generation sequencing
Genome-wide association study
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