Informed Consent in GDPR and in Research on Human Subjects

FORMAT | Presented paper

LANGUAGE | English

HOW TO CITE| SANDU, Antonio, & Unguru (Gafton), E. (2019). Informed Consent in GDPR and in Research on Human Subjects – A Comparative Perspective. Prezentat în cadrul 12th LUMEN International Scientific Conference Rethinking Social Action. Core Values in Practice | RSACVP 2019 | 15-17 May 2019 | Iasi – Romania.

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ABSTRACT:

Applying informed consent to medicine is not limited to research on human subjects, but academic research is one of the most sensitive areas of action regulated by the new European legislative framework on personal data protection. We will analyze the validity of informed consent in research from the perspective of GDPR imperatives, IC as a process, not as a procedure, and the manner in which the IC process reflects the respect for the right of autonomy of the subjects involved in research, including the right to refuse data processing, as compliance with patient rights may sometimes be seen as contradicting the freedom of science. Broad consent, dynamic consent, IC in the case of vulnerable persons are concepts that have been widely debated in academic literature regarding research on human subjects, but under the impact of the new European Regulation on GDPR, there are a number of nuances that require a comparative analysis of the content of these concepts before and after the entry into force of the European Regulation (EU) 2016/679.

KEYWORDS:

Informed Consent, GDPR, Research on Human Subjects.