Kranendonk Elcke J, Ploem M Corrette, Hennekam Raoul C M
Department of Public Health, AMC, University of Amsterdam, Amsterdam, The Netherlands.
Departments of Paediatrics and Translational Genetics, AMC, University of Amsterdam, Amsterdam, The Netherlands.
Eur J Hum Genet. 2016 Jan;24(1):30-6. doi: 10.1038/ejhg.2015.59. Epub 2015 Apr 15.
Many current paediatric studies concern relationships between genes and environment and discuss aetiology, treatment and prevention of Mendelian and multifactorial diseases. Many of these studies depend on collection and long-term storage of data and biological material from affected children in biobanks. Stored material is a source of personal information of the donor and his family and could be used in an undesirable context, potentially leading to discrimination and interfering with a child's right to an open future. Here, we address the normative framework regarding biobanking with residual tissue of children, protecting the privacy interests of young biobank donors (0-12 years). We analyse relevant legal documents concerning storage and use of children's material for research purposes. We explore the views of 17 Dutch experts involved in paediatric biobank research and focus on informed consent for donation of leftover tissue as well as disclosure of individual research findings resulting from biobank research. The results of this analysis show that experts have no clear consensus about the appropriate rules for storage of and research with children's material in biobanks. Development of a framework that provides a fair balance between fundamental paediatric research and privacy protection is necessary.
当前许多儿科研究关注基因与环境之间的关系，并探讨孟德尔疾病和多因素疾病的病因、治疗与预防。其中许多研究依赖于在生物样本库中收集和长期存储患病儿童的数据及生物材料。所存储的材料是捐赠者及其家人个人信息的来源，可能会被用于不良目的，从而可能导致歧视并侵犯儿童拥有开放未来的权利。在此，我们探讨关于利用儿童剩余组织建立生物样本库的规范框架，以保护年轻生物样本库捐赠者（0至12岁）的隐私权益。我们分析了有关为研究目的存储和使用儿童材料的相关法律文件。我们探究了17位参与儿科生物样本库研究的荷兰专家的观点，重点关注对剩余组织捐赠的知情同意以及生物样本库研究所得个体研究结果的披露。该分析结果表明，专家们对于生物样本库中儿童材料的存储及研究的适当规则尚无明确共识。制定一个在基础儿科研究与隐私保护之间实现公平平衡的框架很有必要。
