Boeckhout Martin, van Dijk Jet, Legemate Dink A
Universiteit van Amsterdam, afd. Wijsbegeerte, Amsterdam, the Netherlands.
Ned Tijdschr Geneeskd. 2011;155(26):A3557.
Ethical and legal aspects of biobanking continue to be a topic of concern. The String of Pearls Initiative (PSI) helped establish new norms for biobank governance in The Netherlands. This article gives an overview of issues that emerged from the medical-ethical review processes of PSI. The criteria applied to biobanking projects by Ethical Review Boards were derived from the legally prescribed criteria for medical research. However, these criteria were interpreted in radically diverging ways. Key issues included the legal status of prospective research-dedicated biobanks, informed consent, monitoring of the use of biobanks, and alignment of biobanking policies both within and between research departments. The article calls on all actors involved in biobanking to continue to strive for the harmonization of biobanking policies. A certain degree of central coordination is crucial in order to improve on collaborative biobanking initiatives.
生物样本库的伦理和法律问题仍然是一个备受关注的话题。“珍珠链计划”（PSI）有助于在荷兰建立生物样本库管理的新规范。本文概述了PSI医学伦理审查过程中出现的问题。伦理审查委员会应用于生物样本库项目的标准源自医学研究的法定标准。然而，这些标准的解释却大相径庭。关键问题包括前瞻性研究专用生物样本库的法律地位、知情同意、生物样本库使用情况的监测，以及研究部门内部和之间生物样本库政策的协调一致。本文呼吁参与生物样本库工作的所有各方继续努力实现生物样本库政策的统一。为了改进合作性生物样本库倡议，一定程度的中央协调至关重要。
