title: [Consent in children: Practical situations (part 2)].
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.
authors.affiliation: CIC 005 pédiatrie, hôpital Pellegrin enfants, CHU de Bordeaux, 33076 Bordeaux, France.
authors.forename: F
authors.initials: F
authors.lastname: Nacka
authors.affiliation: CIC 1426, pharmacologie pédiatrique et pharmacogénétique, hôpital Robert-Debré, 48, boulevard Sérurier, 75019 Paris, France.
authors.forename: L
authors.initials: L
authors.lastname: Benadjaoud
authors.affiliation: CIC 005 pédiatrie, hôpital Pellegrin enfants, CHU de Bordeaux, 33076 Bordeaux, France.
authors.forename: M
authors.initials: M
authors.lastname: Fayon
authors.affiliation: CIC 1426, pharmacologie pédiatrique et pharmacogénétique, hôpital Robert-Debré, 48, boulevard Sérurier, 75019 Paris, France. Electronic address: evelyne.jacqzaigrain@gmail.com.
authors.forename: E
authors.initials: E
authors.lastname: Jacqz-Aigrain
authors.forename: J-P
authors.initials: JP
authors.lastname: Demarez
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D002648:Child; D005602:France; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D007872:Legal Guardians; D010372:Pediatrics / Q000941:ethics*