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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 Vastert3,
  5. Kristien Hens4,
  6. Jordi Anton5,
  7. Tadej Avcin6,
  8. Alberto Martini7,
  9. Isabelle Koné-Paut8,
  10. Yosef Uziel9,10,
  11. Angelo Ravelli7,
  12. Carine Wouters11,
  13. David Shaw12,13,
  14. Seza Özen14,
  15. Andreas Eikelberg1,
  16. Berent J Prakken15,
  17. Nicolino Ruperto7,
  18. Gerd Horneff16,
  19. Tamas Constantin17,
  20. Michael W Beresford18,
  21. Marijn Sikken19,
  22. Helen E Foster20,
  23. Iris Haug1,
  24. Sabrina Schuller1,
  25. Christine Jägle1,
  26. Susanne M Benseler1,21
  1. 1Division of Rheumatology, Department of Pediatrics, University Hospital Tuebingen, Tübingen, Germany
  2. 2Paediatric Rheumatology, Wilhelmina Children’s Hospital, University Medical Center, Utrecht, The Netherlands
  3. 3Paediatric Rheumatology, Wilhelmina Children’s Hospital, University Medical Center, Utrecht, The Netherlands
  4. 4Department of Philosophy, University of Antwerp, Antwerp, Belgium
  5. 5Pediatric Rheumatology, Hospital Sant Joan de Déu, Barcelona, Spain
  6. 6Departments of Allergy, Rheumatology and Clinical Immunology, University Children’s Hospital, University Medical Centre Ljubljana, Ljubljana, Slovenia
  7. 7Department of Paediatrics, University of Genoa, Gaslini Children’s Hospital, G. Gaslini Research Institute, Genoa, Italy
  8. 8Department of Paediatric Rheumatology and Haematology, CEREMAI, GHU Paris-Sud - Hôpital de Bicêtre,APHP, Le Kremlin-Bicêtre, France
  9. 9Pediatric Rheumatology Unit, Department of Pediatrics, Meir Medical Center, Kfar-Saba, Kfar Saba, Israel
  10. 10Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel
  11. 11Department of Microbiology and Immunology, Laboratory Paediatric Immunology, UZ Leuven Hospital, Leuven, Belgium
  12. 12Department of Health, Ethics and Society, CAPHRI Research Institute, Maastricht University, Maastricht, The Netherlands
  13. 13Institute for Biomedical Ethics, University of Basel, Basel, Switzerland
  14. 14Department of Pediatrics, Hacettepe University, Ankara, Turkey
  15. 15Paediatric Rheumatology, Wilhelmina Children’s Hospital, University Medical Center, Utrecht, The Netherlands
  16. 16Department of General Pediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany
  17. 17Reumatológia, Immunológia, Gyermekgyógyászati Klinika, Budapest, Hungary
  18. 18Department of Paediatric Rheumatology, Institute for Translational Medicine, University of Liverpool, Alder Hey Children’s NHS Foundation Trust, Liverpool, UK
  19. 19JIA Patient Council, Department of Paediatric Rheumatology, University Medical Center Utrecht, Wilhelmina Children’s Hospital, Utrecht, The Netherlands
  20. 20Department of Paediatric Rheumatology, Great North Children’s Hospital, Institute of Cellular Medicine Musculoskeletal Research Group, Newcastle University, Newcastle upon Tyne, UK
  21. 21Alberta 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

  • 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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