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dc.contributor.authorde Lange, Dylan W.en_US
dc.contributor.authorGuidet, Bertrand R.en_US
dc.contributor.authorAndersen, Finn Husøyen_US
dc.contributor.authorArtigas, Antonioen_US
dc.contributor.authorBertolini, Guidoen_US
dc.contributor.authorMoreno, Ruien_US
dc.contributor.authorChristensen, Steffenen_US
dc.contributor.authorCecconi, Maurizioen_US
dc.contributor.authorAgvald-Öhman, Christinaen_US
dc.contributor.authorGradišek, Primožen_US
dc.contributor.authorJung, Christianen_US
dc.contributor.authorMarsh, Brian J.en_US
dc.contributor.authorOeyen, Sandraen_US
dc.contributor.authorBollen Pinto, Bernardoen_US
dc.contributor.authorSzczeklik, Wojciechen_US
dc.contributor.authorWatson, Ximenaen_US
dc.contributor.authorZafeiridis, Tilemachosen_US
dc.contributor.authorFlaatten, Hansen_US
dc.date.accessioned2019-11-12T15:33:29Z
dc.date.available2019-11-12T15:33:29Z
dc.date.issued2019-06-03
dc.Publishedde Lange DW, Guidet BR, Andersen FH, Artigas A, Bertolini G, Moreno R, Christensen S, Cecconi M, Agvald-Öhman, Gradišek, Jung C, Marsh, Oeyen S, Bollen Pinto B, Szczeklik W, Watson X, Zafeiridis T, Flaatten H. Huge variation in obtaining ethical permission for a non-interventional observational study in Europe. BMC Medical Ethics. 2019;20:39:1-7eng
dc.identifier.issn1472-6939
dc.identifier.urihttps://hdl.handle.net/1956/20991
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.en_US
dc.language.isoengeng
dc.publisherBMCeng
dc.rightsAttribution CC BYeng
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/eng
dc.titleHuge variation in obtaining ethical permission for a non-interventional observational study in Europeen_US
dc.typePeer reviewed
dc.typeJournal article
dc.date.updated2019-09-25T08:01:33Z
dc.description.versionpublishedVersionen_US
dc.rights.holderCopyright The Author(s) 2019
dc.identifier.doihttps://doi.org/10.1186/s12910-019-0373-y
dc.identifier.cristin1715955
dc.source.journalBMC Medical Ethics


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