Communication of results and disclosure of incidental findings in longitudinal paediatric research
Article first published online: 21 MAY 2013
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Pediatric Allergy and Immunology
Volume 24, Issue 4, pages 389–394, June 2013
How to Cite
Communication of results and disclosure of incidental findings in longitudinal paediatric research. Pediatr Allergy Immunol 2013: 24: 389–394., , , , , , , .
- Issue published online: 21 MAY 2013
- Article first published online: 21 MAY 2013
- Manuscript Accepted: 20 APR 2013
- MeDALL project. Grant Number: 261357
- European Commission Seventh Framework Programme
- incidental findings;
- individual results;
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.
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.
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.
As there is no consensus within European Birth cohorts how to deal with results and incidental findings, we propose a general policy.