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  • https://doi.org/10.1201/9781003475927-2Copy DOI Icon

Emerging Issues in Transnational Biomedical Research

  • Oct 24, 2025
  • Francesca Incardona
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Abstract

The chapter describes how the initiative to bring bio-medical and medical-data scientists together with law scholars, was conceived. The EuCARE project is a research initiative funded by the European Union, focusing on the study of the SARS-CoV-2 pandemic. It involves nearly 30 partners worldwide and faced numerous legal and ethical issues, thus serving as a test-bed for the European legal framework for the use of personal health data. EuCARE is based on cohorts of patients, healthcare workers, and students, with activities encompassing a laboratory network, artificial intelligence, and organizational management. The projects’ cahiers de doleances regarding ethical and legal issues regards specifically data reuse, the lack of regulatory uniformity across European countries, international data sharing and studies involving minors. Data reuse, essential for the project, clashes with varying interpretations of the GDPR among countries. The fragmentation of regulations has created difficulties in conducting multicentr studies. Data sharing with international organizations and non-EU countries has required careful consideration of data protection regulations. Studies involving minors have highlighted how the need for careful ethical evaluation, with differing approval regulations among countries, could hamper these studies.

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