Communication of results and disclosure of incidental findings in longitudinal paediatric research

Authors

  • Velizara Anastasova,

    1. Inserm, UMR1027, Epidemiology and analyses in Public Health, Toulouse, France
    2. Université de Toulouse III – Paul Sabatier, UMR 1027, Toulouse, France
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  • Aurélie Mahalatchimy,

    1. Inserm, UMR1027, Epidemiology and analyses in Public Health, Toulouse, France
    2. Université de Toulouse III – Paul Sabatier, UMR 1027, Toulouse, France
    3. IRDEIC, Université Toulouse 1 Capitole, Manufacture des Tabacs, Toulouse, France
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  • Emmanuelle Rial-Sebbag,

    1. Inserm, UMR1027, Epidemiology and analyses in Public Health, Toulouse, France
    2. Université de Toulouse III – Paul Sabatier, UMR 1027, Toulouse, France
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  • Josep Maria Antó Boqué,

    1. Centre for Research in Environmental Epidemiology (CREAL), Barcelona, Spain
    2. Hospital del Research Institute (IMIM), Barcelona, Spain
    3. CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
    4. Department of Experimental and Health Sciences, University of Pompeu Fabra (UPF), Barcelona, Spain
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  • Thomas Keil,

    1. Charité – Universitätsmedizin Berlin, Berlin, Germany
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  • Jordi Sunyer,

    1. Centre for Research in Environmental Epidemiology (CREAL), Barcelona, Spain
    2. Hospital del Research Institute (IMIM), Barcelona, Spain
    3. CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
    4. Department of Experimental and Health Sciences, University of Pompeu Fabra (UPF), Barcelona, Spain
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  • Jean Bousquet,

    1. Inserm, U 1018, Centre for Research in Epidemiology and Population Health CESP, Paris, France
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  • Anne Cambon-Thomsen

    Corresponding author
    1. Université de Toulouse III – Paul Sabatier, UMR 1027, Toulouse, France
    • Inserm, UMR1027, Epidemiology and analyses in Public Health, Toulouse, France
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Correspondence

Anne Cambon-Thomsen, Inserm UMR 1027, Université Toulouse III - Paul Sabatier, Faculté de Médecine, Département d'épidémiologie et de santé publique, 37 allées Jules Guesde Toulouse, 31062, Cedex 9, France.

Tel.: +33 05 61 14 59 59

Fax: +33 05 61 14 56 23

E-mail: anne.cambon-thomsen@univ-tlse3.fr

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.

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