Statement of principles on the return of research results and incidental findings in paediatric research: a multi-site consultative process

Genome. 2015 Dec;58(12):541-8. doi: 10.1139/gen-2015-0092. Epub 2015 Nov 10.

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.

Keywords: communication des résultats; découvertes fortuites; ethics; genetic/genomic research; incidental findings; paediatrics; pédiatrie; recherche génétique/génomique; return of results; éthique.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Genetic Counseling / ethics
  • Genetic Counseling / standards
  • Genetic Research / ethics*
  • Genome, Human
  • Genomics / ethics
  • Genomics / methods
  • Genomics / standards
  • Guidelines as Topic
  • High-Throughput Nucleotide Sequencing
  • Humans
  • Incidental Findings*
  • Meta-Analysis as Topic
  • Pediatrics / ethics*
  • Pediatrics / standards
  • Truth Disclosure / ethics*