The logical fallacies of the legal bases for data processing in and beyond clinical trials†
The logical fallacies of the legal bases for data processing in and beyond clinical trials†
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DOI：
10.1093/idpl/ipac003
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发表时间：
2022-02-11
影响因子：
2.1
通讯作者：
Pormeister, Kart
中科院分区：
文献类型：
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作者：
Pormeister, Kart
人体临床试验是一种医学研究形式，旨在最终开发供人类使用的医药产品。因此，它们不可避免地涉及评估药品安全性和有效性所需的健康、遗传和其他类型（可能高度敏感）的个人数据的处理。这意味着数据保护是一个不可避免的话题，在临床试验的特定领域也需要关注。事实上，临床试验已经得到了欧洲数据保护委员会（EDPB）的关注1，其形式是关于《通用数据保护条例》（GDPR）2和关于人用药品临床试验的法规（EU）536/2014 [临床试验法规（CTR）]之间相互作用的意见。4不幸的是，EDPB的这一意见包含逻辑谬误，即同意作为临床试验中处理个人数据的法律的依据，以及在进一步研究中（包括临床试验以外）对此类数据的二次使用。关于“特殊类别”个人数据的研究使用，GDPR将其交由成员国或其他欧盟法律监管。5目前，CTR似乎是欧盟立法中唯一一项可能包含关于同意数据处理以用于（特殊类别）个人数据的二次研究用途的具体规则。然而，这一声明确立了问题的关键：EDPB坚决声称CTR在任何程度上都不规范数据处理的同意，而
Clinical trials on humans are a form of medical research aimed at ultimately developing medicinal products for human use. As such, they inevitably involve the processing of health, genetic and other types of (possibly highly sensitive) personal data that are needed to assess the safety and efficacy of a medicinal product. This means that data protection is an unavoidable topic that needs attention in the specific realm of clinical trials as well. And clinical trials have, in fact, received such attention from the European Data Protection Board1 (EDPB) in the form of an opinion concerning the interplay between the General Data Protection Regulation2 (GDPR) and regulation (EU) 536/2014 on clinical trials on medicinal products for human use3 [Clinical Trials Regulation (CTR)]. 4 Unfortunately, this opinion of the EDPB contains logical fallacies regarding consent as a legal basis for the processing of personal data in clinical trials, and the secondary use of such data in further research, including beyond clinical trials.Regarding the research use of ‘special categories’ of personal data, the GDPR leaves this to be regulated either in national Member State or other EU law. 5 Currently, the CTR seems to be the one piece of EU legislation that may arguably contain a specific rule on consent to data processing for the secondary research use of (special categories of) personal data. However, this very statement establishes the crux of the matter: the EDPB firmly claims that the CTR does not to any extent regulate consent to data processing, whereas a