Article
Recommendations for collaborative paediatric research including biobanking in Europe – A Single HUB and Access Point for Paediatric Rheumatology in Europe (SHARE) Initiative
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Authors
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Sandra Hansmann
- Universitätsklinikum Tübingen, Klinik für Kinder- und Jugendmedizin, Ambulanz für Autoimmunerkrankungen, Tübingen
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Jasmin Kümmerle-Deschner
- Universitätskinderklinik Tuebingen, Rheumatologie, Tübingen
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Nico Wulffraat
- University Medical Centre Utrecht, Wilhelmina Children's Hospital, Department of Pediatric Immunology, Utrecht, The Netherlands
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Susanne Benseler
- Alberta Children's Hospital, Calgary, Kanada
| Published: | September 4, 2017 |
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Outline
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Background: Innovative research in childhood rare diseases mandates international collaborations. However, researchers struggle with the dramatic regulatory heterogeneity. An EU-wide framework enabling collaborative paediatric research is missing. The aims of the study were to systematically review the evidence for best practice in collaborative paediatric research and to establish recommendations for research in childhood rare diseases.
Methods: The paediatric rheumatology SHARE project enabled a scoping review and expert discussion, which informed the systematic literature review. Published evidence was synthesized; recommendations were drafted. An iterative process refined recommendations including consultations with Ethics Committees and European experts for ethical and legal aspects of paediatric research. The SHARE expert committee and patient representatives vetted the proposed recommendations at a face-to-face consensus meeting using Nominal Group Technique. Agreement of 80% was mandatory for inclusion.
Results: The systematic literature review returned 1319 records. A total of 223 full-text publications plus 22 international normative documents were reviewed; of which 85 publications and 16 normative documents were included. A total of 21 recommendations were proposed including distinct themes of general principles (1-3), ethics (4-7), paediatric principles (8 and 9), consent to paediatric research (10 -14), paediatric data- and biobanks (15 and 16), sharing of data and samples (17 - 19) and commercialization and third parties (20 and 21). The refined recommendations resulted in an agreement of >80% for all 21 recommendations at the final consensus conference.
Conclusion: The SHARE initiative enabled the development of the first recommendations for paediatric collaborative research including data- and biobanking and sharing across borders. These recommendations provide strong support for an urgently needed European legislative framework and evidence-based guidance for its implementation. Children with rare diseases should no longer be left behind when life-changing discoveries can be made.
Funding: SHARE was funded by the European Agency for Health and Consumers (EAHC), No. 2011 1202.
