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[生物样本库运营与使用的现行法律框架条件:第3部分:所有权与使用权]

[Current legal framework conditions for running and utilization of biobanks: Part 3: ownership and rights of use].

作者信息

Haier J

机构信息

Comprehensive Cancer Center Münster, Universitätsklinikum Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Deutschland,

出版信息

Chirurg. 2014 Oct;85(10):918-28. doi: 10.1007/s00104-014-2813-z.

Abstract

The organizing institution of a biobank can be of public or private law in nature and the form can be freely selected. Biomaterials must be legally valued as objects whereby inalienable personality rights are still valid even if ownership is transferred. The treating physician does not automatically acquire a comprehensive right of ownership or utilization for the materials taken during the treatment. The biobank acquires tangible property and user rights on the samples by a legal agreement between the donor and the biobank. Reutilization clauses in submission contracts should not be used due to the danger of a formularization development and surprise clauses. During the processing of biomaterials within the biobank substantially new characteristics can appear which have an effect on ownership and commercialization rights. The donor does not have a utilization right in the sense of a patent or copyright. If there are changes in the legal form and the use by third parties, the declaration of consent by the donor remains fully effective. There are special risks for the donor if the biobank transfers these biomaterials. This must be clarified before finalizing the agreement on sample transference and utilization in the sense of an informed decision.

摘要

生物样本库的组织机构在性质上可以是公法或私法性质的,其形式可以自由选择。生物材料必须在法律上被视为物品,即使所有权转移,不可剥夺的人格权仍然有效。治疗医生并不会自动获得对治疗期间所采集材料的全面所有权或使用权。生物样本库通过捐赠者与生物样本库之间的法律协议获得样本的有形财产权和使用权。由于存在格式化发展和意外条款的风险,提交合同中的再利用条款不应被使用。在生物样本库对生物材料进行处理的过程中,可能会出现对所有权和商业化权利有影响的全新特征。捐赠者不具有专利或版权意义上的使用权。如果法律形式和第三方使用发生变化,捐赠者的同意声明仍然完全有效。如果生物样本库转移这些生物材料,捐赠者会面临特殊风险。在就样本转移和使用达成最终协议之前,必须从知情决策的角度对此进行澄清。

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