BACKGROUND: Communicating results to research participants is an issue frequently discussed in terms of ethics. It has specific features when involving large-scale paediatric cohorts. High-throughput biological explorations reveal also incidental findings of medical relevance. This work analyses existing frameworks for managing such issues and proposes a policy grounded in the experience acquired in the FP7 EU project MeDALL-Mechanisms of the Development of ALLergy. METHODS: A bibliographical analysis was performed using law, ethics and academic documentation. Empirical data were acquired through informed consent forms from 9 of the 13 cohorts used in MeDALL and from replies to a general questionnaire (n = 10) on ethical issues sent to consortium members. Group discussions and expert consultations were conducted during project meetings. RESULTS: The notions of research results and incidental findings remain ambiguous as no agreed definition exists. The most appropriate terms are communication of results and disclosure of incidental findings. No legal norm and no specific guidance govern these issues in paediatric research at European level. Relevant policies depend on decisions in each cohort or project. The policy proposed states that these issues should be discussed during the informed consent process, with due attention to involvement of children, and a balance of interests between children, parents and society. A moral duty for researchers to communicate such information only applies if certain medical and social criteria are met. CONCLUSIONS: As there is no consensus within European Birth cohorts how to deal with results and incidental findings, we propose a general policy.
BACKGROUND: Communicating results to research participants is an issue frequently discussed in terms of ethics. It has specific features when involving large-scale paediatric cohorts. High-throughput biological explorations reveal also incidental findings of medical relevance. This work analyses existing frameworks for managing such issues and proposes a policy grounded in the experience acquired in the FP7 EU project MeDALL-Mechanisms of the Development of ALLergy. METHODS: A bibliographical analysis was performed using law, ethics and academic documentation. Empirical data were acquired through informed consent forms from 9 of the 13 cohorts used in MeDALL and from replies to a general questionnaire (n = 10) on ethical issues sent to consortium members. Group discussions and expert consultations were conducted during project meetings. RESULTS: The notions of research results and incidental findings remain ambiguous as no agreed definition exists. The most appropriate terms are communication of results and disclosure of incidental findings. No legal norm and no specific guidance govern these issues in paediatric research at European level. Relevant policies depend on decisions in each cohort or project. The policy proposed states that these issues should be discussed during the informed consent process, with due attention to involvement of children, and a balance of interests between children, parents and society. A moral duty for researchers to communicate such information only applies if certain medical and social criteria are met. CONCLUSIONS: As there is no consensus within European Birth cohorts how to deal with results and incidental findings, we propose a general policy.
Authors: Susan M Wolf; Rebecca Branum; Barbara A Koenig; Gloria M Petersen; Susan A Berry; Laura M Beskow; Mary B Daly; Conrad V Fernandez; Robert C Green; Bonnie S LeRoy; Noralane M Lindor; P Pearl O'Rourke; Carmen Radecki Breitkopf; Mark A Rothstein; Brian Van Ness; Benjamin S Wilfond Journal: J Law Med Ethics Date: 2015 Impact factor: 1.718
Authors: Jody M Shoemaker; Caitlin Cole; Linda E Petree; Deborah L Helitzer; Mark T Holdsworth; John P Gluck; John P Phillips Journal: Brain Behav Date: 2016-02-08 Impact factor: 2.708
Authors: Kiley B Vander Wyst; Micah L Olson; Smita S Bailey; Ana Martinez Valencia; Armando Peña; Jeffrey Miller; Mitchell Shub; Lee Seabrooke; Janiel Pimentel; Kiri Olsen; Robert B Rosenberg; Gabriel Q Shaibi Journal: BMC Med Res Methodol Date: 2021-12-05 Impact factor: 4.612
Authors: J Bousquet; J M Anto; M Akdis; C Auffray; T Keil; I Momas; D S Postma; R Valenta; M Wickman; A Cambon-Thomsen; T Haahtela; B N Lambrecht; K C Lodrup Carlsen; G H Koppelman; J Sunyer; T Zuberbier; I Annesi-Maesano; A Arno; C Bindslev-Jensen; G De Carlo; F Forastiere; J Heinrich; M L Kowalski; D Maier; E Melén; S Palkonen; H A Smit; M Standl; J Wright; A Asarnoj; M Benet; N Ballardini; J Garcia-Aymerich; U Gehring; S Guerra; C Hohman; I Kull; C Lupinek; M Pinart; I Skrindo; M Westman; D Smagghe; C Akdis; R Albang; V Anastasova; N Anderson; C Bachert; S Ballereau; F Ballester; X Basagana; A Bedbrook; A Bergstrom; A von Berg; B Brunekreef; E Burte; K H Carlsen; L Chatzi; J M Coquet; M Curin; P Demoly; E Eller; M P Fantini; B Gerhard; H Hammad; L von Hertzen; V Hovland; B Jacquemin; J Just; T Keller; M Kerkhof; R Kiss; M Kogevinas; S Koletzko; S Lau; I Lehmann; N Lemonnier; R McEachan; M Mäkelä; J Mestres; E Minina; P Mowinckel; R Nadif; M Nawijn; S Oddie; J Pellet; I Pin; D Porta; F Rancière; A Rial-Sebbag; Y Saeys; M J Schuijs; V Siroux; C G Tischer; M Torrent; R Varraso; J De Vocht; K Wenger; S Wieser; C Xu Journal: Allergy Date: 2016-08-23 Impact factor: 13.146