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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
  1. Jasmin B Kuemmerle-Deschner1,
  2. Sandra Hansmann1,
  3. Nico M Wulffraat2,
  4. Sebastiaan J Vastert2,
  5. Kristien Hens3,
  6. Jordi Anton4,
  7. Tadej Avcin5,
  8. Alberto Martini6,
  9. Isabelle Koné-Paut7,
  10. Yosef Uziel8,9,
  11. Angelo Ravelli6,
  12. Carine Wouters10,
  13. David Shaw11,12,
  14. Seza Özen13,
  15. Andreas Eikelberg1,
  16. Berent J Prakken14,
  17. Nicolino Ruperto6,
  18. Gerd Horneff15,
  19. Tamas Constantin16,
  20. Michael W Beresford17,
  21. Marijn Sikken18,
  22. Helen E Foster19,
  23. Iris Haug1,
  24. Sabrina Schuller1,
  25. Christine Jägle1,
  26. Susanne M Benseler1,20
  1. 1 Division of Rheumatology, Department of Pediatrics, University Hospital Tuebingen, Tübingen, Germany
  2. 2 Paediatric Rheumatology, Wilhelmina Children’s Hospital, University Medical Center, Utrecht, The Netherlands
  3. 3 Department of Philosophy, University of Antwerp, Antwerp, Belgium
  4. 4 Pediatric Rheumatology, Hospital Sant Joan de Déu, Barcelona, Spain
  5. 5 Departments of Allergy, Rheumatology and Clinical Immunology, University Children’s Hospital, University Medical Centre Ljubljana, Ljubljana, Slovenia
  6. 6 Department of Paediatrics, University of Genoa, Gaslini Children’s Hospital, G. Gaslini Research Institute, Genoa, Italy
  7. 7 Department of Paediatric Rheumatology and Haematology, CEREMAI, GHU Paris-Sud - Hôpital de Bicêtre, APHP, Le Kremlin-Bicêtre, France
  8. 8 Pediatric Rheumatology Unit, Department of Pediatrics, Meir Medical Center, Kfar-Saba, Kfar Saba, Israel
  9. 9 Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel
  10. 10 Department of Microbiology and Immunology, Laboratory Paediatric Immunology, UZ Leuven Hospital, Leuven, Belgium
  11. 11 Department of Health, Ethics and Society, CAPHRI Research Institute, Maastricht University, Maastricht, The Netherlands
  12. 12 Institute for Biomedical Ethics, University of Basel, Basel, Switzerland
  13. 13 Department of Pediatrics, Hacettepe University, Ankara, Turkey
  14. 14 Paediatric Rheumatology, Wilhelmina Children’s Hospital, University Medical Center, Utrecht, The Netherlands
  15. 15 Department of General Pediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany
  16. 16 Reumatológia, Immunológia, Gyermekgyógyászati Klinika, Budapest, Hungary
  17. 17 Department of Paediatric Rheumatology, Institute for Translational Medicine, University of Liverpool, Alder Hey Children’s NHS Foundation Trust, Liverpool, UK
  18. 18 JIA Patient Council, Department of Paediatric Rheumatology, University Medical Center Utrecht, Wilhelmina Children’s Hospital, Utrecht, The Netherlands
  19. 19 Department of Paediatric Rheumatology, Great North Children’s Hospital, Institute of Cellular Medicine Musculoskeletal Research Group, Newcastle University, Newcastle upon Tyne, UK
  20. 20 Alberta Children’s Hospital Research Institute, Calgary, Alberta, Canada
  1. Correspondence to Susanne M Benseler, Rheumatology, Department of Pediatrics, Alberta Children’s Hospital, University of Calgary, Calgary, AB T3B6A8, Canada; Susanne.Benseler{at}albertahealthservices.ca

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.

  • juvenile idiopathic arthritis
  • gene polymorphism
  • treatment
  • multidisciplinary team-care

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Footnotes

  • 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.

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