Regulating biobanking with children's tissue: a legal analysis and the experts' view

Area of Science:

• Paediatric biobanking
• Genetics and environmental research
• Medical ethics and privacy law

Background:

• Current paediatric studies increasingly rely on biobanks storing children's biological material for genetic and environmental research.
• Stored samples contain sensitive personal information, posing risks of discrimination and impacting a child's right to an open future.
• Existing normative frameworks for biobanking children's residual tissue require careful examination to protect young donors' privacy.

Purpose of the Study:

• To analyze the normative framework for biobanking residual tissue from children (0-12 years).
• To protect the privacy interests of young biobank donors.
• To explore expert consensus on informed consent and disclosure of research findings in paediatric biobanking.

Main Methods:

• Analysis of relevant legal documents concerning the storage and use of children's biological material for research.
• Exploration of views from 17 Dutch experts involved in paediatric biobank research.
• Focus on informed consent for leftover tissue donation and disclosure of individual research findings.

Main Results:

• Experts lack a clear consensus on appropriate regulations for storing and researching children's biological material in biobanks.
• Significant divergence exists regarding informed consent procedures for paediatric tissue donation.
• Disagreements were also noted concerning the disclosure of individual research findings to donors or families.

Conclusions:

• There is a pressing need for a robust framework balancing paediatric research requirements with robust privacy protection for young biobank donors.
• Developing clear guidelines for informed consent and data usage is crucial for ethical paediatric biobanking.
• Further deliberation among stakeholders is necessary to establish consensus on best practices.