Publicaties
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Between minimal standards and national variation: minimum harmonization of advertising rules KU Leuven
Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study KU Leuven
Background: The COVID-19 pandemic brought global disruption to health, society and economy, including to the conduct of clinical research. In the European Union (EU), the legal and ethical framework for research is complex and divergent. Many challenges exist in relation to the interplay of the various applicable rules, particularly with respect to compliance with the General Data Protection Regulation (GDPR). This study aimed to gain insights ...
Rethinking informed consent in the time of COVID-19: An exploratory survey KU Leuven
BACKGROUND: Owing to the infectious nature of COVID-19, alternative solutions, such as electronic informed consent (eIC), needed to be implemented to inform research participants about study-related information and to obtain their consent. This study aimed to investigate stakeholders' experiences with alternative consenting methods as well as their views on any regulatory or legal guidelines for eIC implementation in clinical research. Results ...