title: Personalized assent for pediatric biobanks.
abstract: Pediatric biobanking is considered important for generating biomedical knowledge and improving (pediatric) health care. However, the inclusion of children's samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure. We suggest that children should be involved through a personalized assent procedure, which means that both the content and the process of assent are adjusted to the individual child. In this paper we provide guidance on how to put personalized assent into pediatric biobanking practice and consider both the content and process of personalized assent. In the discussion we argue that the assent procedure itself is formative. Investing in the procedure should be a requirement for pediatric biobank research. Although personalized assent will require certain efforts, the pediatric (biobank) community must be aware of its importance. The investment and trust earned can result in ongoing engagement, important longitudinal information, and stability in/for the research infrastructure, as well as increased knowledge among its participants about research activity. Implementing personalized assent will both respect the child and support biobank research.
authors.affiliation: Department of Medical Humanities, Division Julius Center, University Medical Center Utrecht, Office Stratenum 6.131, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands. n.giesbertz@umcutrecht.nl.|Department of Genetics, Division Biomedical Genetics, University Medical Center Utrecht, KC.04.084.2, P.O. Box 85090, 3508 AB, Utrecht, The Netherlands. n.giesbertz@umcutrecht.nl.
authors.forename: Noor A A
authors.initials: NA
authors.lastname: Giesbertz
authors.affiliation: Clinical Trials & Research Governance (CTRG) University of Oxford Joint Research Office, Block 60, Churchill Hospital, Headington, Oxford, OX3 7LE, United Kingdom.
authors.forename: Karen
authors.initials: K
authors.lastname: Melham
authors.affiliation: Nuffield Department of Population Health, HeLEX-Centre for Health, Law and Emerging Technologies at Oxford, University of Oxford, Ewert House, Ewert Place, Banbury Road, Summertown, Oxford, OX2 7DD, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Kaye
authors.affiliation: Department of Medical Humanities, Division Julius Center, University Medical Center Utrecht, Office Stratenum 6.131, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
authors.forename: Johannes J M
authors.initials: JJ
authors.lastname: van Delden
authors.affiliation: Department of Medical Humanities, Division Julius Center, University Medical Center Utrecht, Office Stratenum 6.131, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
authors.forename: Annelien L
authors.initials: AL
authors.lastname: Bredenoord
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D003657:Decision Making / Q000941:ethics*; D006801:Humans; D057828:Informed Consent By Minors / Q000941:ethics*
keywords: Assent; Biological samples; Children; Consent; Pediatric biobank; Research ethics