Paediatric biobanking: Dutch experts reflecting on appropriate legal standards for practice

Abstract

Large sets of data and human specimens, such as blood, tumour tissue and DNA, are deposited in biobanks for research purposes, preferably for long periods of time and with broadly defined research aims. Our research focuses on the retention of data and biological materials obtained from children. However important such paediatric biobanks may be, the privacy interests of the children involved and the related risks may not be ignored. The privacy issues arising from paediatric biobanks are the central focus of this article. We first review the international regulations that apply to biobanks and then summarise viewpoints expressed by experts in a round-table discussion. We confine ourselves here to two normative questions: (1) How much control should children’s parents or legal representatives, and later the children themselves, have over the stored materials and data? (2) What should be done if research findings emerge that have serious implications for a child’s health? Conclusion: On the basis of international legal standards and the views of experts, involved in paediatric biobanking, we argue that biological material of children may only be stored in a biobank for scientific purposes if parents provide their explicit consent, the child is re-contacted at 16 or 18 years of age to reconsider storage and use of its material, and the biobank maintains a limited policy in disclosure of individual research findings to the child’s parents. What is Known: • Increasingly, biological material of children is stored in biobanks for research purposes. • Clear standards on the conditions under which children’s cells or tissues may be stored and used are lacking. What is New: • According to experts, storage and use of children’s materials should only be allowed if performed in accordance with appropriate consent procedures and feedback policies. Electronic supplementary materialThe online version of this article (doi:10.1007/s00431-016-2810-y) contains supplementary material, which is available to authorized users.

Reconsenting paediatric research participants for use of identifying data

“…The United Nations Convention on the Rights of the Child states that ‘Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child’ 53. Moreover, the Organization for Economic Co-Operation and Development’s Guidelines on Human Biobanks and Genetic Research Databases ‘specifically state that consent for continued sample storage and use should be obtained from minors once they gain the capacity to decide according to applicable law or ethical principles’ 54 55. While such guidelines are not necessarily binding on courts or REBs, they stand as powerful statements of international norms that further buttress the conclusion that reconsent is required from children who obtain capacity.…”

“…53 Moreover, the Organization for Economic Co-Operation and Development’s Guidelines on Human Biobanks and Genetic Research Databases ‘specifically state that consent for continued sample storage and use should be obtained from minors once they gain the capacity to decide according to applicable law or ethical principles’. 54 55 While such guidelines are not necessarily binding on courts or REBs, they stand as powerful statements of international norms that further buttress the conclusion that reconsent is required from children who obtain capacity.…”

The general data protection regulation, the clinical trial regulation and some complex interplay in paediatric clinical trials

“…In Italy, for example, calls are being made for guarantors or curators of paediatric biobanks to develop procedures for contacting donors when they come of age, so they can inter alia confirm or rescind the consent, have the samples destroyed and/or have the information eliminated [11]. A similar appeal has been made in the Netherlands [12]. The (non-binding) OECD-Guidelines on Human Biobanks and Genetic Research Databases include a requirement (Annotation 32) to obtain the child's consent for ongoing storage and use of the material when the child reaches the age of majority [13].…”

Key Implications of Data Sharing in Pediatric Genomics

“…Recontacting children at the age of majority enables them to exercise this future capacity, 25 but the logistical challenges, scope of parental authority, and justification for recontact is widely debated in the literature. [26][27][28][29] Working group members considered the child's right to information and data withdrawal at the age of majority to be an ethically meaningful practice that should be strengthened when logistically possible. Members also emphasized how clinical contexts differ significantly from the research context in this regard.…”

“…Although parents or legal guardians consent on behalf of their children to share data, it is recommended that children make their own decisions regarding data sharing when their capacity is legally recognized. Recontacting children at the age of majority enables them to exercise this future capacity, but the logistical challenges, scope of parental authority, and justification for recontact is widely debated in the literature . Working group members considered the child’s right to information and data withdrawal at the age of majority to be an ethically meaningful practice that should be strengthened when logistically possible.…”