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

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. Key words: genetic/genomic research, paediatrics, return of results, incidental findings, ethics. Cet article propose une serie de recommandations au sujet de la communication des resultats de recherche et des decouvertes fortuites en pediatrie. Le Reseau de Medecine Genetique Appliquee (RMGA) du Quebec a supervise et endosse l'Enonce de principes sur la communication des resultats de recherche et des decouvertes fortuites, lequel est le fruit d'un processus de consultation mene aupres d'experts cliniques et en recherche dans ce domaine. Pour formuler cet Enonce de principes, les auteurs ont (i) passe en revue la litterature empirique et grise sur le sujet de la communication des resultats de recherche et des decouvertes fortuites en Europe et au Canada, (ii) realise une etude qualitative aupres de parties prenantes, (iii) developpe et (iv) valide les recommandations via des consultations impliquant des parties prenantes. L'Enonce de principes apporte un outil de divulgation utile pour decider quand et dans quelles circonstances il convient de communiquer les resultats d'aide a la decision de recherche et les decouvertes fortuites. Il aborde la question de la communication des resultats de la recherche genetique de maniere generale et apporte egalement des principes specifiques pour differents contextes de recherche, dont la recherche en pediatrie. Il cerne les enjeux ethiques qui sont uniques a la recherche pediatrique et fournit un cadre pour guider les comites d'ethique en recherche ainsi que la communaute scientifique en ce qui a trait a ces enjeux. [Traduit par la Redaction] Mots-cles: recherche genetique/genomique, pediatrie, communication des resultats, decouvertes fortuites, ethique.
Introduction Rapid advances in research and clinical sequencing underscores the immediacy of national and international consensus regarding the return of research results and incidental findings. Although a number of professional [...]