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Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative

Kuemmerle-Deschner, Jasmin B. and Hansmann, Sandra and Wulffraat, Nico M. and Vastert, Sebastiaan J. and Hens, Kristien and Anton, Jordi and Avcin, Tadej and Martini, Alberto and Koné-Paut, Isabelle and Uziel, Yosef and Ravelli, Angelo and Wouters, Carine and Shaw, David and Özen, Seza and Eikelberg, Andreas and Prakken, Berent J. and Ruperto, Nicolino and Horneff, Gerd and Constantin, Tamas and Beresford, Michael W. and Sikken, Marijn and Foster, Helen E. and Haug, Iris and Schuller, Sabrina and Jägle, Christine and Benseler, Susanne M.. (2018) Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative. Annals of the rheumatic diseases, 77. pp. 319-327.

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Official URL: http://edoc.unibas.ch/58066/

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Abstract

Innovative 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.
Faculties and Departments:08 Cross-disciplinary Subjects > Ethik > Institut für Bio- und Medizinethik > Bio- und Medizinethik (Elger)
03 Faculty of Medicine > Departement Public Health > Ethik in der Medizin > Bio- und Medizinethik (Elger)
UniBasel Contributors:Shaw, David
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:British Medical Association
ISSN:0003-4967
e-ISSN:1468-2060
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:17 May 2018 15:10
Deposited On:17 May 2018 15:10

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