title: Consent procedures in pediatric biobanks.
abstract: The inclusion of children's samples in biobanks brings forward specific ethical issues. Guidelines indicate that children should be involved in the consent procedure. It is, however, unclear how to allocate an appropriate role for children. Knowledge of current practice will be helpful in addressing this issue. Therefore, we conducted an international multiple-case study on the child's role in consent procedures in pediatric biobanks. Four biobanks were included: (1) LifeLines, (2) Prevention and Incidence of Asthma and Mite Allergy (PIAMA), (3) Young-HUNT3 and (4) the Oxford Radcliffe Biobank contribution to the Children's Cancer and Leukaemia Group tissue bank (ORB/CCLG). Four themes linked to the child's role in the consent procedure emerged from the multiple-case study: (1) motives to involve the child, (2) informing the child, (3) the role of dissent, assent and consent and (4) voluntariness of children to participate. We conclude that biobank characteristics influence the biobank's motives to include children in the consent procedure. Moreover, the motives to include children influence how the children are involved in the consent procedure, and the extent to which children are able to make voluntary decisions as part of the consent procedure. This insight is valuable when designing pediatric biobank governance.
authors.affiliation: Department of Medical Humanities, Julius Center, University Medical Center, Utrecht, The Netherlands.
authors.forename: Noor Aa
authors.initials: NA
authors.lastname: Giesbertz
authors.affiliation: Department of Medical Humanities, Julius Center, University Medical Center, Utrecht, The Netherlands.
authors.forename: Annelien L
authors.initials: AL
authors.lastname: Bredenoord
authors.affiliation: Department of Medical Humanities, Julius Center, University Medical Center, Utrecht, The Netherlands.
authors.forename: Johannes Jm
authors.initials: JJ
authors.lastname: van Delden
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D002648:Child; D003219:Confidentiality / Q000941:ethics* / Q000331:legislation & jurisprudence; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007391:International Cooperation; D008297:Male; D009042:Motivation / Q000941:ethics; D009426:Netherlands; D009664:Norway; D010287:Parent-Child Relations; D033282:Parental Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D010372:Pediatrics; D011795:Surveys and Questionnaires; D006113:United Kingdom