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首页> 外文期刊>Biopreservation and biobanking >Review of the Italian current legislation on research biobanking activities on the eve of the participation of national biobanks' network in the legal consortium BBMRI-ERIC
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Review of the Italian current legislation on research biobanking activities on the eve of the participation of national biobanks' network in the legal consortium BBMRI-ERIC

机译：在国家生物库网络参与法律联盟BBMRI-ERIC的前夕，审查意大利现行的研究生物库活动立法

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摘要

The ethical-legal framework of research biobanking activities is still scarcely defined in Italy, and this constitutes a major obstacle to exploit the potential benefits of existing bioresource patrimony at the national and international levels. Biobanking and Biomolecular Resources Research Infrastructure (BBMRI), which aims to become a major interface between biological samples and data and top-level biological and medical research, is undertaking the crucial transformation to the ERIC (European Research Infrastructure Consortium) legal entity. In this scenario, there is a need to address the national legal and ethical concerns that are strictly correlated with the use of human biosources in research across European countries participating (and not) in BBMRI. In this perspective, this article aims to review the legal framework applying to research biobanking in Italy, including both "soft" nonbinding instruments and binding regulations. Since ethical and societal aspects impact biobanking research activities, the article discusses both the critical ethical and legal open issues that need to be implemented at the national level.
机译：在意大利，关于研究生物库活动的伦理法律框架仍然很少定义，这构成了在国家和国际层面上利用现有生物资源遗产的潜在利益的主要障碍。生物银行和生物分子资源研究基础设施（BBMRI）旨在成为生物样本和数据与顶级生物和医学研究之间的主要接口，目前正朝着ERIC（欧洲研究基础设施联盟）法人实体的关键转型。在这种情况下，有必要解决与（或不参与）BBMRI的欧洲国家的研究中与使用人类生物资源严格相关的国家法律和道德问题。从这个角度出发，本文旨在回顾适用于意大利研究型生物银行的法律框架，包括“软性”非约束性文书和约束性法规。由于道德和社会方面影响生物银行研究活动，因此本文讨论了需要在国家层面实施的重要的道德和法律公开问题。

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