Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative

Autor: Nicolino Ruperto, Nico M Wulffraat, Michael W. Beresford, Christine Jägle, Gerd Horneff, Carine Wouters, Tadej Avcin, Alberto Martini, Seza Ozen, Berent J. Prakken, Sabrina Schuller, Marijn Sikken, Angelo Ravelli, Kristien Hens, Iris Haug, Andreas Eikelberg, Susanne M. Benseler, Sandra Hansmann, David Shaw, Sebastiaan J. Vastert, Isabelle Koné-Paut, Jordi Anton, Helen E. Foster, Tamás Constantin, Yosef Uziel, Jasmin B Kuemmerle-Deschner
Jazyk: angličtina
Rok vydání: 2018
Předmět:
0301 basic medicine
Pediatrics
Biomedical Research
CHILDREN
030105 genetics & heredity
GUIDELINES
Biochemistry
Informed consent
gene polymorphism
Nominal group technique
Medicine
Immunology and Allergy
Child
Intersectoral Collaboration
media_common
Biological Specimen Banks
INFORMED-CONSENT
treatment
Biobank
Europe
Systematic review
TISSUE-BANKING
Practice Guidelines as Topic
gene polymorphism
juvenile idiopathic arthritis
multidisciplinary team-care
treatment
HEALTH
multidisciplinary team-care
Inclusion (education)
GENETIC RESEARCH
medicine.medical_specialty
Consensus
PROFESSIONALS
Best practice
Immunology
General Biochemistry
Genetics and Molecular Biology
Ethics
Research
03 medical and health sciences
Rheumatology
Rheumatic Diseases
MANAGEMENT
Journal Article
media_common.cataloged_instance
Humans
European union
juvenile idiopathic arthritis
STANDARDIZED OPERATING PROCEDURES
Medical education
Research ethics
business.industry
Biochemistry
Genetics and Molecular Biology(all)
Philosophy
Human medicine
business
ETHICS
Genetics and Molecular Biology(all)
Zdroj: ANNALS OF THE RHEUMATIC DISEASES
r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
instname
Annals of the Rheumatic Diseases, 77(3), 319. BMJ Publishing Group
r-FSJD: Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
Fundació Sant Joan de Déu
Annals of the rheumatic diseases
ISSN: 0003-4967
Popis: 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.
Databáze: OpenAIRE
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