Ethical management in the constitution of a European database for leukodystrophies rare diseases.

Nathalie Duchange 1, * Sylviane Darquy 1 Diane D'Audiffret 1 Ingrid Callies 1 Anne-Sophie Lapointe 1 Boris Loeve 1 Odile Boespflug-Tanguy 2, 3 Grégoire Moutel 4
* Auteur correspondant
1 EA 4569 - Laboratoire Ethique Politique et Santé
2 Centre de référence des leucodystrophies
3 Service de neurologie pédiatrique et maladies métaboliques
4 Unité de Médecine Sociale
Abstract : BACKGROUND: The EU LeukoTreat program aims to connect, enlarge and improve existing national databases for leukodystrophies (LDs) and other genetic diseases affecting the white matter of the brain. Ethical issues have been placed high on the agenda by pairing the participating LD expert research teams with experts in medical ethics and LD patient families and associations. The overarching goal is to apply core ethics principles to specific project needs and ensure patient rights and protection in research addressing the context of these rare diseases. AIM: This paper looks at how ethical issues were identified and handled at project management level when setting up an ethics committee. METHODS: Through a work performed as a co-construction between health professionals, ethics experts, and patient representatives, we expose the major ethical issues identified. RESULTS: The committee acts as the forum for tackling specific issues tied to data sharing and patient participation: the thin line between care and research, the need for a charter establishing the commitments binding health professionals and the information items to be delivered. Ongoing feedback on the database, including delivering global results in a broad-audience format, emerged as a key recommendation. Information should be available to all patients in the partner countries developing the database and should be scaled to different patient profiles. CONCLUSION: This work led to a number of recommendations for ensuring transparency and optimizing the partnership between scientists and patients.
Keywords : ethical management health database ethics committee rare disease leukodystrophy
Type de document :
Article dans une revue
European Journal of Paediatric Neurology, Elsevier, 2014, 18 (5), pp.597-603. 〈10.1016/j.ejpn.2014.04.002〉
Liste complète des métadonnées

Littérature citée [26 références]  Voir  Masquer  Télécharger
http://www.hal.inserm.fr/inserm-00995366
Contributeur : Nathalie Duchange <>
Soumis le : vendredi 23 mai 2014 - 11:13:26
Dernière modification le : vendredi 22 juin 2018 - 14:39:03
Document(s) archivé(s) le : samedi 23 août 2014 - 11:30:24

Fichier

Duchange_et_al_EJPN_2014.pdf
Fichiers produits par l'(les) auteur(s)

Identifiants

Collections

ETHIQUE | UNIV-PARIS5 | USPC

Citation

Nathalie Duchange, Sylviane Darquy, Diane D'Audiffret, Ingrid Callies, Anne-Sophie Lapointe, et al.. Ethical management in the constitution of a European database for leukodystrophies rare diseases.. European Journal of Paediatric Neurology, Elsevier, 2014, 18 (5), pp.597-603. 〈10.1016/j.ejpn.2014.04.002〉. 〈inserm-00995366〉

Exporter

BibTeX TEI DC DCterms EndNote

Partager

Métriques

Consultations de la notice

853

Téléchargements de fichiers

312

Contact

support.ccsd.cnrs.fr
hal.support@ccsd.cnrs.fr
Logo CCSD