Calzolari Alessia, Napolitano Mariarosaria, Bravo Elena
Biopreserv Biobank. 2013 Apr;11(2):124-8. doi: 10.1089/bio.2012.0058.
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.
在意大利，生物样本库研究活动的伦理 - 法律框架仍鲜有明确界定，这成为在国家和国际层面利用现有生物资源遗产潜在益处的重大障碍。旨在成为生物样本与数据以及顶级生物医学研究之间主要接口的生物样本库和生物分子资源研究基础设施（BBMRI），正在向欧洲研究基础设施联盟（ERIC）法律实体进行关键转型。在这种情况下，有必要解决与参与（或未参与）BBMRI的欧洲国家研究中使用人类生物资源密切相关的国家法律和伦理问题。从这个角度来看，本文旨在审视适用于意大利生物样本库研究的法律框架，包括“软”性的非约束性文书和约束性法规。由于伦理和社会层面会影响生物样本库研究活动，本文还讨论了需要在国家层面实施的关键伦理和法律开放性问题。
