Personalized assent for pediatric biobanks

BMC Medical Ethics

Debate

Karen Melham¹  Johannes J. M. van Delden²  Annelien L. Bredenoord²  Noor A. A. Giesbertz³  Jane Kaye⁴ 

[1] Clinical Trials & Research Governance (CTRG) University of Oxford Joint Research Office, Block 60, Churchill Hospital, Headington, OX3 7LE, Oxford, United Kingdom;Department of Medical Humanities, Division Julius Center, University Medical Center Utrecht, P.O. Box 85500, Office Stratenum 6.131, 3508 GA, Utrecht, The Netherlands;Department of Medical Humanities, Division Julius Center, University Medical Center Utrecht, P.O. Box 85500, Office Stratenum 6.131, 3508 GA, Utrecht, The Netherlands;Department of Genetics, Division Biomedical Genetics, University Medical Center Utrecht, P.O. Box 85090, KC.04.084.2, 3508 AB, Utrecht, The Netherlands;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, OX2 7DD, Oxford, UK;

关键词: Research ethics;    Pediatric biobank;    Assent;    Consent;    Children;    Biological samples;   

DOI  :  10.1186/s12910-016-0142-0

 received in 2016-03-04, accepted in 2016-09-29,  发布年份 2016

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2016