title: Statement of principles on the return of research results and incidental findings in paediatric research: a multi-site consultative process.
abstract: This paper proposes a set of recommendations for the return of research results and incidental findings in paediatrics. The Network of Applied Genetic Medicine of Quebec spearheaded the initiative to develop the Statement of Principles on the Return of Research Results and Incidental Findings, which was the result of a consultation process with clinical and research experts in the field. To formulate the Statement of Principles, the authors (i) reviewed empirical and grey literature on the return of research results and incidental findings in Europe and Canada, (ii) conducted a qualitative study of stakeholder groups, (iii) developed, and (iv) validated the recommendations through consultations with the stakeholder groups. The Statement of Principles provides a useful disclosure tool for deciding when, and under what circumstances to return research results and incidental findings. It addresses the issue of return of results in genetic research generally, and has also specific principles for various research contexts, including paediatric research. It delineates ethical issues unique to paediatric research, and provides a framework to guide research ethics committees as well as the research community in addressing these issues.
authors.affiliation: a Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University, 740, avenue Dr. Penfield, #5202 Montreal, QC H3A 0G1, Canada.
authors.forename: Karine
authors.initials: K
authors.lastname: Sénécal
authors.affiliation: b Centre of Genomics and Policy, Faculty of Medicine, Department of Family Medicine, McGill University, 740, avenue Dr. Penfield, #5203, Montreal, QC H3A 0G1, Canada.
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Rahimzadeh
authors.affiliation: c Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University, Canada Research Chair in Law and Medicine, 740, avenue Dr. Penfield, #5214, Montreal, QC H3A 0G1, Canada.
authors.forename: Bartha M
authors.initials: BM
authors.lastname: Knoppers
authors.affiliation: d IWK Health Centre, Department of Pediatrics, Dalhousie University, 5850 University Avenue, P.O. Box 9700, Halifax, NS B3K 6R8, Canada.
authors.forename: Conrad V
authors.initials: CV
authors.lastname: Fernandez
authors.affiliation: a Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University, 740, avenue Dr. Penfield, #5202 Montreal, QC H3A 0G1, Canada.
authors.forename: Denise
authors.initials: D
authors.lastname: Avard
authors.affiliation: e Sainte-Justine University Health Center, Research Center, Department of Pediatrics, University of Montreal, 3175 Chemin de la Côte Sainte-Catherine, Montreal, QC H3T 1C5, Canada.
authors.forename: Daniel
authors.initials: D
authors.lastname: Sinnett
mesh_terms: D005817:Genetic Counseling / Q000941:ethics / Q000592:standards; D036281:Genetic Research / Q000941:ethics*; D015894:Genome, Human; D023281:Genomics / Q000941:ethics / Q000379:methods / Q000592:standards; D017408:Guidelines as Topic; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans; D033162:Incidental Findings; D015201:Meta-Analysis as Topic; D010372:Pediatrics / Q000941:ethics* / Q000592:standards; D014342:Truth Disclosure / Q000941:ethics*
keywords: communication des résultats; découvertes fortuites; ethics; genetic/genomic research; incidental findings; paediatrics; pédiatrie; recherche génétique/génomique; return of results; éthique