title: Communication of results and disclosure of incidental findings in longitudinal paediatric research.
abstract: 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.affiliation: Inserm, UMR1027, Epidemiology and analyses in Public Health, Toulouse, France.
authors.forename: Velizara
authors.initials: V
authors.lastname: Anastasova
authors.forename: Aurélie
authors.initials: A
authors.lastname: Mahalatchimy
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Rial-Sebbag
authors.forename: Josep Maria
authors.initials: JM
authors.lastname: Antó Boqué
authors.forename: Thomas
authors.initials: T
authors.lastname: Keil
authors.forename: Jordi
authors.initials: J
authors.lastname: Sunyer
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
authors.forename: Anne
authors.initials: A
authors.lastname: Cambon-Thomsen
mesh_terms: D000818:Animals; D003142:Communication; D030881:Disclosure; D032984:Ethics, Research; D005060:Europe; D006801:Humans; D006967:Hypersensitivity / Q000453:epidemiology*; D033162:Incidental Findings; D008137:Longitudinal Studies; D028681:Moral Obligations; D010372:Pediatrics / Q000941:ethics* / Q000331:legislation & jurisprudence; D011050:Policy Making