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dc.contributor.authorde Lange, Dylan W.
dc.contributor.authorGuidet, Bertrand R.
dc.contributor.authorAndersen, Finn Husøy
dc.contributor.authorArtigas, Antonio
dc.contributor.authorBertolini, Guido
dc.contributor.authorMoreno, Rui
dc.contributor.authorChristensen, Steffen
dc.contributor.authorCecconi, Maurizio
dc.contributor.authorAgvald-Öhman, Christina
dc.contributor.authorGradišek, Primož
dc.contributor.authorJung, Christian
dc.contributor.authorMarsh, Brian J.
dc.contributor.authorOeyen, Sandra
dc.contributor.authorBollen Pinto, Bernardo
dc.contributor.authorSzczeklik, Wojciech
dc.contributor.authorWatson, Ximena
dc.contributor.authorZafeiridis, Tilemachos
dc.contributor.authorFlaatten, Hans
dc.date.accessioned2019-09-26T07:28:53Z
dc.date.available2019-09-26T07:28:53Z
dc.date.created2019-08-14T14:52:38Z
dc.date.issued2019
dc.identifier.citationBMC Medical Ethics. 2019, 20:39 1-7.nb_NO
dc.identifier.issn1472-6939
dc.identifier.urihttp://hdl.handle.net/11250/2618851
dc.description.abstractBackground Ethical approval (EA) must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. Methods Sixteen European national coordinators (NCs) of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. Results N = 8/16 of the NCs could apply at one single national ethical committee (EC), while the others had to apply to various regional ECs and/or individual hospital institutional research boards (IRBs). The time between applying for EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were (very) unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. Discussion Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies. Conclusion Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries.nb_NO
dc.language.isoengnb_NO
dc.publisherBMC (part of Springer Nature)nb_NO
dc.rightsNavngivelse 4.0 Internasjonal*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/deed.no*
dc.titleHuge variation in obtaining ethical permission for a non-interventional observational study in Europenb_NO
dc.typeJournal articlenb_NO
dc.typePeer reviewednb_NO
dc.description.versionpublishedVersionnb_NO
dc.source.pagenumber1-7nb_NO
dc.source.volume20:39nb_NO
dc.source.journalBMC Medical Ethicsnb_NO
dc.identifier.doi10.1186/s12910-019-0373-y
dc.identifier.cristin1715955
dc.description.localcode© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/)nb_NO
cristin.unitcode194,65,25,0
cristin.unitnameInstitutt for sirkulasjon og bildediagnostikk
cristin.ispublishedtrue
cristin.fulltextoriginal
cristin.qualitycode1


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Navngivelse 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse 4.0 Internasjonal