Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study.

ABSTRACT:

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 into the experience of key clinical research stakeholders [investigators, ethics committees (ECs), and data protection officers (DPOs)/legal experts working with clinical research sponsors] across the EU and the UK on the main challenges related to data protection in clinical research before and during the pandemic.

Materials and methods

SUBMITTER: Lalova-Spinks T 

PROVIDER: S-EPMC9589288 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature