TY - JOUR
T1 - Recommendations for collaborative paediatric research including biobanking in Europe
T2 - A Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative
AU - Kuemmerle-Deschner, Jasmin B.
AU - Hansmann, Sandra
AU - Wulffraat, Nico M.
AU - Vastert, Sebastiaan J.
AU - Hens, Kristien
AU - Anton, Jordi
AU - Avcin, Tadej
AU - Martini, Alberto
AU - Koné-Paut, Isabelle
AU - Uziel, Yosef
AU - Ravelli, Angelo
AU - Wouters, Carine
AU - Shaw, David
AU - Özen, Seza
AU - Eikelberg, Andreas
AU - Prakken, Berent J.
AU - Ruperto, Nicolino
AU - Horneff, Gerd
AU - Constantin, Tamas
AU - Beresford, Michael W.
AU - Sikken, Marijn
AU - Foster, Helen E.
AU - Haug, Iris
AU - Schuller, Sabrina
AU - Jägle, Christine
AU - Benseler, Susanne M.
N1 - Publisher Copyright:
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved.
PY - 2018/3/1
Y1 - 2018/3/1
N2 - 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.
AB - 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.
KW - gene polymorphism
KW - juvenile idiopathic arthritis
KW - multidisciplinary team-care
KW - treatment
UR - https://www.scopus.com/pages/publications/85041173692
U2 - 10.1136/annrheumdis-2017-211904
DO - 10.1136/annrheumdis-2017-211904
M3 - Article
C2 - 29021237
AN - SCOPUS:85041173692
SN - 0003-4967
VL - 77
SP - 319
EP - 327
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 3
ER -