Data Sharing Under the General Data Protection Regulation

The General Data Protection Regulation (GDPR) became binding law in the European Union Member States 2018, as a step toward harmonizing personal data protection legislation Union. governs almost all types of processing, hence, also, those pertaining to biomedical research. purpose this article is highlight main practical issues related and biological sample sharing that researchers face regularly, specify how these are addressed context GDPR, after consulting with ethics/legal experts. We identify areas which clarifications GDPR needed, particularly consent requirements by study participants. Amendments should target following: (1) restricting exceptions based on national laws increasing harmonization, (2) confirming concept broad consent, (3) defining roadmap for secondary use data. These changes will be achieved acknowledged learned societies field taking lead preparing document giving guidance optimal interpretation finalized following period commenting multistakeholder audience. In parallel, promoting engagement education public relevant (such different or residual risk re-identification), both local/national international levels, considered critical advancement. hope open discussion involving major stakeholders, optimizing allowing harmonized transnational research approach.