In the context of clinical research, the Data Protection Impact Assessment (DPIA), as required by Article 35 of the GDPR 2016/679, is an essential tool to ensure the compliant and responsible processing of personal data, particularly health and genetic data. The adoption of the DPIA addresses the need to safeguard the fundamental rights and freedoms of data subjects in high-risk scenarios, such as multicenter studies and the use of innovative technologies. This article analyzes the ethical, regulatory, and organizational value of the DPIA in clinical trials, highlighting operational challenges such as lack of resources, insufficient training, interpretative ambiguities, and weak integration with ethics committees. A multidisciplinary approach is proposed that sees the DPIA not merely as a regulatory obligation but as a strategic lever to enhance transparency and quality in research. In conclusion, the importance of clarifying roles and responsibilities is emphasized, while promoting a culture of data protection from the earliest stages.
Sotto la lente della valutazione d’impatto privacy: la ricerca clinica fra trasparenza e sfide regolatorie
Cagnazzo, Celeste
2025-01-01
Abstract
In the context of clinical research, the Data Protection Impact Assessment (DPIA), as required by Article 35 of the GDPR 2016/679, is an essential tool to ensure the compliant and responsible processing of personal data, particularly health and genetic data. The adoption of the DPIA addresses the need to safeguard the fundamental rights and freedoms of data subjects in high-risk scenarios, such as multicenter studies and the use of innovative technologies. This article analyzes the ethical, regulatory, and organizational value of the DPIA in clinical trials, highlighting operational challenges such as lack of resources, insufficient training, interpretative ambiguities, and weak integration with ethics committees. A multidisciplinary approach is proposed that sees the DPIA not merely as a regulatory obligation but as a strategic lever to enhance transparency and quality in research. In conclusion, the importance of clarifying roles and responsibilities is emphasized, while promoting a culture of data protection from the earliest stages.
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