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dc.contributor.authorKuemmerle-Deschner, Jasmin B; ; ; JFA; CORA; ;
dc.contributor.authorHansmann, Sandra; ; ; ; ; ;
dc.contributor.authorWulffraat, Nico M; ; ; ; ; ;
dc.contributor.authorVastert, Sebastiaan J; ; ; ; ; ;
dc.contributor.authorHens, Kristien; U0055263; ; ; ; ;
dc.contributor.authorAnton, Jordi; ; ; ; ; ;
dc.contributor.authorAvcin, Tadej; ; ; ; ; ;
dc.contributor.authorMartini, Alberto; ; ; ; ; ;
dc.contributor.authorKoné-Paut, Isabelle; ; ; ; ; ;
dc.contributor.authorUziel, Yosef; ; ; ; ; ;
dc.contributor.authorRavelli, Angelo; ; ; ; ; ;
dc.contributor.authorWouters, Carine; U0034203; ; ; ; ;
dc.contributor.authorShaw, David; ; ; ; ; ;
dc.contributor.authorÖzen, Seza; ; ; ; ; ;
dc.contributor.authorEikelberg, Andreas; ; ; ; ; ;
dc.contributor.authorPrakken, Berent J; ; ; ; ; ;
dc.contributor.authorRuperto, Nicolino; ; ; ; ; ;
dc.contributor.authorHorneff, Gerd; ; ; ; ; ;
dc.contributor.authorConstantin, Tamas; ; ; ; ; ;
dc.contributor.authorBeresford, Michael W; ; ; ; ; ;
dc.contributor.authorSikken, Marijn; ; ; ; ; ;
dc.contributor.authorFoster, Helen E; ; ; ; ; ;
dc.contributor.authorHaug, Iris; ; ; ; ; ;
dc.contributor.authorSchuller, Sabrina; ; ; ; ; ;
dc.contributor.authorJägle, Christine; ; ; ; ; ;
dc.contributor.authorBenseler, Susanne M; ; ; ; ; JLA;
dc.date.accessioned2019-10-26T06:51:12Z
dc.date.available2019-10-26T06:51:12Z
dc.date.created2017-10-28 23:09
dc.date.issued2017-10
dc.identifieroai:lirias.kuleuven.be:123456789/596482
dc.identifierhttps://lirias.kuleuven.be/handle/123456789/596482
dc.identifier0003-4967
dc.identifierhttp://ard.bmj.com/cgi/pmidlookup?view=long&pmid=29021237
dc.identifier1468-2060
dc.identifier472754;https://lirias.kuleuven.be/bitstream/123456789/596482/1//Kuemmerle-Deschner+et+al.pdf
dc.identifier.urihttp://hdl.handle.net/20.500.12424/1647095
dc.description.abstractInnovative research in childhood rheumatic diseases mandates international collaborations. However, researchers struggle with significant regulatory heterogeneity; an enabling European Union (EU)-wide framework is missing. The aims of the study were to systematically review the evidence for best practice and to establish recommendations for collaborative research. The Paediatric Rheumatology European Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) project enabled a scoping review and expert discussion, which then informed the systematic literature review. Published evidence was synthesised; recommendations were drafted. An iterative review process and consultations with Ethics Committees and European experts for ethical and legal aspects of paediatric research refined the recommendations. SHARE experts and patient representatives vetted the proposed recommendations at a consensus meeting using Nominal Group Technique. Agreement of 80% was mandatory for inclusion. The systematic literature review returned 1319 records. A total of 223 full-text publications plus 22 international normative documents were reviewed; 85 publications and 16 normative documents were included. A total of 21 recommendations were established including general principles (1-3), ethics (4-7), paediatric principles (8 and 9), consent to paediatric research (10-14), paediatric databank and biobank (15 and 16), sharing of data and samples (17-19), and commercialisation and third parties (20 and 21). The refined recommendations resulted in an agreement of >80% for all recommendations. The SHARE initiative established the first recommendations for Paediatric Rheumatology collaborative research across borders in Europe. These provide strong support for an urgently needed European framework and evidence-based guidance for its implementation. Such changes will promote research in children with rheumatic diseases.
dc.description.abstractstatus: accepted
dc.format.medium796772 bytes
dc.languageen
dc.language.isoeng
dc.publisherH.K. Lewis
dc.relation.ispartofAnnals of the Rheumatic Diseases vol:Ahead of print
dc.rights472754;intranet
dc.titleRecommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative
dc.typeArticle
ge.collectioncodeOAIDATA
ge.dataimportlabelOAI metadata object
ge.identifier.legacyglobethics:11828321
ge.identifier.permalinkhttps://www.globethics.net/gel/11828321
ge.lastmodificationdate2017-10-28 23:09
ge.lastmodificationuseradmin@pointsoftware.ch (import)
ge.submissions0
ge.oai.exportid148650
ge.oai.repositoryid1370
ge.oai.setnameInterfaculty Centre for Biomedial Ethics and Law
ge.oai.setnameLaboratory of Immunobiology (Rega Institute)
ge.oai.setnameBiomedical Sciences Group
ge.oai.setnameDepartment of Public Health and Primary Care
ge.oai.setnameImmunology
ge.oai.setnameKU Leuven
ge.oai.setspechdl_123456789_6700
ge.oai.setspechdl_123456789_6709
ge.oai.setspechdl_123456789_6
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ge.setnameGlobeEthicsLib
ge.setspecglobeethicslib
ge.linkhttps://lirias.kuleuven.be/handle/123456789/596482
ge.linkhttp://ard.bmj.com/cgi/pmidlookup?view=long&pmid=29021237


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