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.
- juvenile idiopathic arthritis
- gene polymorphism
- multidisciplinary team-care
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JBK-D and SH contributed equally.
Handling editor Tore K Kvien
Contributors All authors made substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data. All authors were involved in drafting the work or revising it critically for important intellectual content. There was final approval of the version published by all authors. All authors gave agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding SHARE was funded by the European Agency for Health and Consumers (EAHC), No. 2011 1202.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.