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

Antonia Vlahou1, Dara Hallinan2, Rolf Apweiler3

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The General Data Protection Regulation (GDPR) presents challenges for biomedical research data sharing. Clarifications are needed for consent, harmonization, and secondary data use to facilitate transnational research.

Keywords:
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Area of Science:

  • Biomedical research
  • Data privacy law
  • European Union regulations

Background:

  • The General Data Protection Regulation (GDPR) harmonizes data protection in the EU.
  • GDPR impacts personal data processing, including biomedical research.
  • Biomedical researchers face practical issues with data and biological sample sharing under GDPR.

Purpose of the Study:

  • Highlight practical issues in data and biological sample sharing for biomedical researchers.
  • Specify how GDPR addresses these issues, based on expert consultation.
  • Identify areas needing GDPR clarification, especially participant consent.

Main Methods:

  • Consultation with ethics and legal experts.
  • Analysis of GDPR provisions concerning biomedical research.
  • Identification of specific areas requiring clarification and amendment.

Main Results:

  • GDPR presents challenges for data and biological sample sharing in biomedical research.
  • Areas needing clarification include consent requirements and secondary data use.
  • Proposed amendments focus on harmonizing exceptions, confirming broad consent, and defining secondary use roadmaps.

Conclusions:

  • Optimizing GDPR interpretation is crucial for harmonized transnational biomedical research.
  • Learned societies should lead in providing GDPR guidance for researchers.
  • Public engagement and education on data privacy issues are critical for progress.