撤销同意在生物医学研究中处理个人资料

IF 2.6 4区 社会学 Q1 LAW
Marcu Florea
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引用次数: 0

摘要

在生物医学研究方面,同意既是合法处理个人数据的基础,也是参与科学研究项目的生物伦理要求。虽然在法律和生物伦理文献中广泛讨论了获得有效同意的条件,但撤回同意受到的关注却少得多。根据欧盟通用数据保护条例(GDPR),数据主体有权随时撤回其同意,但在条例文本中没有明确定义处理个人数据的实体的责任。根据GDPR第7条,撤销“不影响基于撤销前同意的处理的合法性”,但没有明确规定在此之后会发生什么。本文的基本假设是,参与者对个人数据的收集和处理表示了有效的同意,并在研究生命周期的某一时刻决定撤回她/他的同意。从表面上看,这一决定将导致数据控制者有义务停止处理数据。然而,当更仔细地检查时,有实际的、法律的和道德的原因,为什么这可能并不总是最佳的解决方案。在收到撤回请求后停止处理并不是绝对的命令。根据GDPR,同意是一个关键点
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Withdrawal of consent for processing personal data in biomedical research
In the context of biomedical research, consent is both a ground for the lawful processing of personal data and a bioethical requirement for participation in scientific research projects. While the conditions for obtaining valid consent are extensively discussed in legal and bioethical literature, withdrawal of consent has received considerably less attention. According to the EU General Data Protection Regulation (GDPR), that data subjects have the right to withdraw their consent at any time, but the duties of the entities processing personal data are not clearly defined in the text of the Regulation. Pursuant to Article 7 GDPR, withdrawal ‘shall not affect the lawfulness of processing based on consent before its withdrawal’, but there is no clear specification of the rules governing what happens after this moment. The assumption underlying this article is that a participant expresses a valid consent for the collection and processing of personal data and, at a certain point during the research life-cycle, decides to withdraw her/his consent. This decision would, prima facie, result in an obligation of the data controller to cease processing the data. However, when more closely examined, there are practical, legal, and ethical reasons for why this might not always be the optimal solution. Stopping the processing after receiving a withdrawal request is not an absolute mandate. Pursuant to the GDPR, consent is one Key Points
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来源期刊
CiteScore
4.70
自引率
9.50%
发文量
20
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