Data Sharing Under the General Data Protection Regulation: Time to Harmonize Law and Research Ethics?

ABSTRACT: The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions base

SUBMITTER: Vlahou A 

PROVIDER: S-EPMC7968961 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature