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The logical fallacies of the legal bases for data processing in and beyond clinical trials†
International Data Privacy Law ( IF 2.500 ) Pub Date : 2022-02-11 , DOI: 10.1093/idpl/ipac003
Kärt Pormeister

Key Points
  • The European Data Protection Board's opinion on the interplay between the General Data Protection Regulation and the Clinical Trials Regulation (CTR) contains logical fallacies.
  • The European Data Protection Board (EDPB) argues that consent is generally not an appropriate legal basis for the processing of personal data for primary research purposes in clinical trials due to a presumed imbalance of power between trial sponsor and participant, neglecting the fact that such an imbalance of power would render participation in the trial impossible in the first place.
  • The EDPB insists that the CTR does not regulate consent to data processing, but only consent to trial participation, whereas article 28(2) CTR could be argued to establish a notion of consent for the secondary research uses of the personal data obtained for and during clinical trials.


中文翻译:

临床试验内外数据处理的法律依据的逻辑谬误†

关键点
  • 欧洲数据保护委员会关于通用数据保护条例和临床试验条例 (CTR) 之间相互作用的意见包含逻辑谬误。
  • 欧洲数据保护委员会 (EDPB) 认为,由于假定试验发起人和参与者之间的权力不平衡,同意通常​​不是在临床试验中出于主要研究目的处理个人数据的适当法律依据,而忽略了这样一个事实:权力不平衡首先会导致无法参与审判。
  • EDP​​B 坚持认为,CTR 并不规范对数据处理的同意,而只是对参与试验的同意,而第 28 条第 2 款 CTR 可以被争论为建立一个同意的概念,即同意在为和期间获得的个人数据的二次研究使用临床试验。
更新日期:2022-02-11
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