Monitor Prawniczy
no. 8/2025
Personal data of clinical trial participants and their protection under the Act on Clinical Trials of Medicinal Products for Human Use
DOI: 10.32027/MOP.25.8.16
Autorka jest doktorem nauk prawnych, asystentem w Katedrze Prawa Informatycznego WPIA UKSW, wykładowcą i autorką opracowań z problematyki ochrony danych osobowych
Abstract
The article focuses on analysing the basis for processing personal data of clinical trial participants. The analysis of the legal provisions concerning clinical trials, both EU and national, as well as the opinion of the European Data Protection Board allows for the formulation of conclusions according to which the consent of a person for processing their personal data in such projects should no longer be used as the main legal basis for processing personal data of clinical trial participants.
Keywords
personal data, consent, clinical trials, GDPR, basis for personal data processing
Literature
Ogólne rozporządzenie o ochronie danych osobowych. Komentarz, pod red. M. Sakowskiej-Baryły, Warszawa 2022, Legalis/el 2018; Ustawa o badaniach klinicznych produktów leczniczych stosowanych u ludzi. Komentarz, pod red. E. Wasilewskiej, Warszawa 2024, Legalis/el 2024.
