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. 2015 Sep;22(9):989-95.
doi: 10.1016/j.arcped.2015.06.010. Epub 2015 Jul 27.

[Consent in children: Practical situations (part 2)]

[Article in French]
F Nacka  1 , L Benadjaoud  2 , M Fayon  1 , E Jacqz-Aigrain  3 ; \membres du réseau pédiatrique Inserm des centres d'investigations cliniques (CIC); J-P Demarez
Collaborators, Affiliations

[Consent in children: Practical situations (part 2)]

[Article in French]
F Nacka et al. Arch Pediatr. 2015 Sep.

Abstract

Ethical and regulatory documents frame informed consent in pediatric research; their application is obligatory but may be complex. In this specific context, pediatric investigators have a central ethical role to play to ensure the strict respect of regulatory and ethical requirements adapted to the French legal, social, and cultural context as well as good clinical practices. This article attempts to shed light on the considerations that can allow researchers to come to terms with industrial and institutional demands while responding to the needs of patients, particularly in the domain of pediatric research.

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