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Mind the gap with Europe. Why public interest cannot be a good reason to perform observational and epidemiological research?
Tumori Journal ( IF 1.9 ) Pub Date : 2023-08-07 , DOI: 10.1177/03008916231190956
Celeste Cagnazzo 1 , Bruno Ficara 1 , Federica Palermo 2 , Franca Fagioli 1
Affiliation  

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.

中文翻译:

注意与欧洲的差距。为什么公共利益不能成为进行观察和流行病学研究的充分理由?

意大利隐私立法的后果主要是在观察研究层面上感受到的,该立法代表了欧洲一般数据保护法规的非常严格的实施。在这一领域并不总是能够获得受试者的同意,并且就回顾性研究而言,目前尚不清楚应遵循哪种正确的监管程序。该法律实施的不确定性已经被多种解释所取代,因此很难在意大利找到一条统一的道路。然而,到目前为止的观察点可能是完全错误的,选择比同意不同的法律依据会更正确,既可以维护科学进步和集体伦理,又不失去对主体的保护。这种方法已经被其他欧洲国家所效仿,它可以使我们更接近欧洲其他国家,并使我们能够有竞争力地参与我们经常被隔绝的社区项目。
更新日期:2023-08-07
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