注意与欧洲的差距。为什么公众利益不能成为开展观察和流行病学研究的充分理由?

IF 2 4区 医学 Q3 ONCOLOGY Tumori Pub Date : 2024-02-01 Epub Date: 2023-08-07 DOI:10.1177/03008916231190956
Celeste Cagnazzo, Bruno Ficara, Federica Palermo, Franca Fagioli
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引用次数: 0

摘要

意大利的隐私法是对欧洲数据保护总条例的一种限制性执行,其后果主要体现在观察性研究方面。在这一领域,并非总能获得研究对象的同意,至于回顾性研究,目前尚不清楚应遵循哪种正确的监管程序。法律执行中的这种不确定性导致了多种解释,使意大利很难找到一条统一的道路。不过,也有可能迄今为止的观察点是完全错误的,更正确的做法是选择不同于同意的法律依据,既维护科学进步和集体伦理,又不失去对主体的保护。其他欧洲国家已经采用了这种方法,它可以拉近我们与欧洲其他国家的距离,使我们能够有竞争力地参与到我们经常被切断的社区项目中去。
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Mind the gap with Europe. Why public interest cannot be a good reason to perform observational and epidemiological research?

The consequences of the Italian privacy legislation, that represents a very restrictive implementation of the general European regulation on data protection, have mainly been felt at the level of observational research. In this field is not always possible to obtain the consent of subjects, and as for retrospective studies, it is not currently clear which is the correct regulatory procedure to follow. This uncertainty in the law's implementation has given way to multiple interpretations, making it difficult to obtain a homogeneous path in Italy. However, it is possible that the observation point has been totally wrong so far and that it would be more correct to choose a different legal bases than consent, both to preserve scientific progress and collective ethics, without losing the protection of the subject. This approach, which has already been followed by other European countries, could bring us closer to the rest of Europe and allow us to competitively participate in community projects that we are often cut off from.

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来源期刊
Tumori
Tumori 医学-肿瘤学
CiteScore
3.50
自引率
0.00%
发文量
58
审稿时长
6 months
期刊介绍: Tumori Journal covers all aspects of cancer science and clinical practice with a strong focus on prevention, translational medicine and clinically relevant reports. We invite the publication of randomized trials and reports on large, consecutive patient series that investigate the real impact of new techniques, drugs and devices inday-to-day clinical practice.
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