Biomedical research increasingly depends on the responsible collection, management, and reuse of large datasets and biological samples.

This course introduces the principles and practices of data and sample governance to ensure that biomedical resources are managed ethically, legally, and effectively, while enabling their reuse for future research and innovation. Good governance is essential for building and maintaining trust in data and sample reuse through ensuring that research participants’ expectations are respected, that resources are used responsibly, and that researchers and institutions can collaborate with confidence. Strong governance frameworks are foundational to building trust in AI for biomedical research, ensuring transparency, accountability, and integrity in how data and samples are used and interpreted.

Developed jointly by ESCMID and ECRAID, in collaboration with CERCLE, CoMeCT, IDDO, MORU, and The Global Health Network, tthe course provides a hands-on introduction to data governance frameworks, ethical and legal requirements, and practical approaches to managing biomedical research data and samples in alignment withregulatory principles and ethical guidance. Participants who complete all modules will receive a Certificate of Completion, issued by ESCMID.

Course Contents

Objectives

By the end of this course, participants will be able to:

• Understand the key concepts and frameworks that underpin biomedical data and sample governance
• Design or strengthen institutional governance frameworks for responsible biomedical data and sample reuse
• Identify and navigate ethical, legal, and practical challenges in data and sample sharing
• Apply principles of transparency, accountability, and trust to governance processes
• Recognize the importance of governance in supporting responsible and equitable AI applications in biomedical research

Target Audience

This course is intended for:

• Biomedical researchers and data managers working with clinical, genomic, or public health data
• Data stewards and research administrators responsible for governance and compliance
• Biobank or sample collection managers and ethics officers involved in human sample management
• Professionals seeking to align institutional data governance with emerging European and global frameworks

No prior experience in data or sample governance is required.

Format

The course comprises four discovery learning modules released monthly between November 2025 and February 2026. Each module includes short expert lectures, infographics, case studies, and interactive materials.

An end-of-course live Q&A session, defined by course participant preferences, will allow participants to engage directly with international experts and reflect on how to apply what they have learned in their own institutional contexts.

Course contents

Acknowledgements

Course Coordinator

Lauren Maxwell - Heidelberg University's Institute for Global Health, Germany

Organisers

ECRAID-Base (European Clinical Research Alliance for Infectious Diseases)
CERCLE (Coalition for Equitable Research in Low-Resource Settings)
The Global Health Network

Funding

The Biomedical Data and Sample Governance Course was developed as part of the European Clinical Research Alliance for Infectious Diseases (ECRAID) Base project which receives funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement 965313.x

Your feedback is greatly appreciated; please take a couple of minutes to tell us your thoughts on this course

Take the survey