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

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.