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[Legal aspects of consent in children (Part 1)]
F Nacka1, L Benadjaoud2, M Fayon1
1CIC 005, pédiatrie, hôpital Pellegrin enfants, CHU de Bordeaux, 33076 Bordeaux, France.
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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