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基于《通用数据保护条例》第40条制定生物样本库中个人数据处理行为准则的建议。

Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40.

作者信息

Krekora-Zając Dorota, Marciniak Błażej, Pawlikowski Jakub

机构信息

Department of Comparative Civil Law, Faculty of Law and Administration, University of Warsaw, Warsaw, Poland.

BBMRI.pl Consortium, Wroclaw, Poland.

出版信息

Front Genet. 2021 Nov 12;12:711614. doi: 10.3389/fgene.2021.711614. eCollection 2021.

Abstract

Personal data protection has become a fundamental normative challenge for biobankers and scientists researching human biological samples and associated data. The General Data Protection Regulation (GDPR) harmonises the law on protecting personal data throughout Europe and allows developing codes of conduct for processing personal data based on GDPR art. 40. Codes of conduct are a soft law measure to create protective standards for data processing adapted to the specific area, among others, to biobanking of human biological material. Challenges in this area were noticed by the European Data Protection Supervisor on data protection and Biobanking and BioMolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI.ERIC). They concern mainly the specification of the definitions of the GDPR and the determination of the appropriate legal basis for data processing, particularly for transferring data to other European countries. Recommendations indicated in the article, which are based on the GDPR, guidelines published by the authority and expert bodies, and our experiences regarding the creation of the Polish code of conduct, should help develop how a code of conduct for processing personal data in biobanks should be developed.

摘要

个人数据保护已成为生物样本库管理者以及研究人类生物样本及相关数据的科学家面临的一项基本规范性挑战。《通用数据保护条例》(GDPR)统一了全欧洲关于保护个人数据的法律,并允许根据GDPR第40条制定处理个人数据的行为准则。行为准则是一种软法措施,旨在为适应特定领域(包括人类生物材料生物样本库)的数据处理创建保护标准。欧洲数据保护监管机构以及生物样本库与生物分子资源研究基础设施——欧洲研究基础设施联盟(BBMRI.ERIC)注意到了该领域存在的挑战。这些挑战主要涉及GDPR定义的明确以及数据处理(特别是将数据传输到其他欧洲国家)的适当法律依据的确定。本文基于GDPR、监管机构和专家机构发布的指南以及我们在制定波兰行为准则方面的经验所提出的建议,应有助于制定生物样本库中个人数据处理行为准则的方式。

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