title: [Legal aspects of consent in children (Part 1)].
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.
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; D005060:Europe; D005602:France; D006801:Humans; D033282:Parental Consent / Q000941:ethics / Q000331:legislation & jurisprudence*; D010372:Pediatrics / Q000941:ethics / Q000331:legislation & jurisprudence*; D010817:Physician-Patient Relations / Q000941:ethics