Commin Virginie
CNRS, Centre de Recherche, "Droit, Sciences et Techniques", UMR 810 - University of Paris I-CNRS.
J Int Bioethique. 2009 Sep;20(3):69-86, 149. doi: 10.3917/jib.203.0069.
The French law does not name them expressly under this word; nevertheless the legislator provided them recently with a relatively interconnected legal framework. On one hand, the technical specific rules related to the activities of biobanks (on which conditions a biobank can be established, on which conditions samples can be given thereto). On the other hand, there is an application to biobanks of the big principles of "French-style" bioethics: 'non property' principle, informed consent and data confidentiality principles. We shall show that in so doing, the French legislator grasped and answered the main part of the questions raised and so paved the way for a sustained acitivity of biobanks in France. In spite of this dense legal framework, the law has not anticipated at present all the questions arising from the practice of biobanks, notably the rights of the donors such as an on-going control on the use of biological material and associated data they gave for research purposes, as well as researchers' right to access biobanks and current issues related to ownership. We shall thus discover the French legal framework for biobanks used for research purposes. Then we shall try to clear issues remaining unresolved.
法国法律并未明确以这个词来命名它们；然而，立法者最近为它们提供了一个相对相互关联的法律框架。一方面，是与生物样本库活动相关的技术特定规则（生物样本库在哪些条件下可以建立，在哪些条件下可以向其提供样本）。另一方面，“法式”生物伦理的主要原则适用于生物样本库：“非财产”原则、知情同意原则和数据保密原则。我们将表明，法国立法者通过这样做，把握并回答了所提出问题的主要部分，从而为法国生物样本库的持续活动铺平了道路。尽管有这个严密的法律框架，但目前法律并未预见到生物样本库实践中产生的所有问题，特别是捐赠者的权利，比如对他们为研究目的提供的生物材料及相关数据使用情况的持续控制权，以及研究人员访问生物样本库的权利和与所有权相关的当前问题。因此，我们将探究用于研究目的的生物样本库的法国法律框架。然后我们将试图厘清仍未解决的问题。
