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Review
. 2015 Sep;22(9):983-8.
doi: 10.1016/j.arcped.2015.06.013. Epub 2015 Jul 27.

[Legal aspects of consent in children (Part 1)]

[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
Review

[Legal aspects of consent in children (Part 1)]

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

Abstract

In pediatric research, the patient is legally a minor and therefore protected by law. Research can only be conducted after parental consent and patient assent have been obtained. In this context, this review discusses the historical events and documents related to all ethical precautions and obligations. It also underlines that physicians shall respect all legal measures, but that individual involvement must comply with ethical standards while taking into account issues particular to pediatric research related to parental consent and child assent to clinical trials.

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