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生物样本库的法律框架:德国的经验

A legal framework for biobanking: the German experience.

作者信息

Simon Jürgen, Paslack Rainer, Robienski Jürgen, Cooper David N, Goebel Jürgen W, Krawczak Michael

机构信息

Institut für Rechtswissenschaften, Universität Lüneburg, Lüneburg, Germany.

出版信息

Eur J Hum Genet. 2007 May;15(5):528-32. doi: 10.1038/sj.ejhg.5201810. Epub 2007 Mar 14.

Abstract

Although biobanks are vital for modern medical research, serious concerns have been raised about the legal basis and framework of such endeavours. This led the German 'Telematics Platform for Medical Research Networks' ('Telematikplattform für Medizinische Forschungsnetze', TMF) to initiate a project in 2004 that was designed to place German biobanks on a sound legal footing. This project involved the planning, writing and evaluation of an expert report that addresses in great detail the legal issues concerning property rights, medical professional regulations, general liability insurance, resource continuity and research secrecy. Here, we provide a brief summary of the major results of this project.

摘要

尽管生物样本库对现代医学研究至关重要,但人们对这类活动的法律基础和框架提出了严重关切。这促使德国“医学研究网络远程信息处理平台”(TMF)在2004年启动了一个项目,旨在为德国生物样本库奠定坚实的法律基础。该项目包括一份专家报告的规划、撰写和评估,该报告详细阐述了有关产权、医学专业法规、一般责任保险、资源连续性和研究保密性的法律问题。在此,我们简要总结该项目的主要成果。

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