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On-Demand Course

Data Governance Course

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Course Summary

In a rapidly evolving biomedical research landscape, managing and governing data and biological samples are essential for ensuring their ethical use, long-term value, and security. To address these needs, Ecraid Foundation and ESCMID, in collaboration with CERCLE and TGHN, are offering a free online course on Data and Sample Governance for Biomedical Research. 

Participants will engage in four free discovery learning modules that include real-world scenarios, case studies, and interactive exercises to build their understanding of data and sample governance frameworks, policies, and ethical and legal considerations. In addition, we will host end-of-course discussions with experts on the topics that course participants would like to explore in more detail.

The data and sample governance course is financed by the EU-funded ECRAID-Base project, which receives funding from the European Union’s Horizon 2020 Research and Innovation Programme (grant agreement 965313).

Release day: TBD
Length: 10 hours
Language: English

Course Coordinator:
Lauren Maxwell, Heidelberg University's Institute for Global Health, Germany

Registration: Free

 

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Course Structure

This module covers the following topics on Data Governance:

  1. What is Health Data Governance
  2. The Aims of Data Governance Frameworks
  3. Why are Health Data Frameworks Important?
  4. The Data Governance Act
  5. The European Health Data Space
  6. F.A.I.R. Data Tools for Global Collaboration in Outbreak Research
  7. Case Study - Researcher Journey in the Swiss Personal Health Network (SPHN)

 

By the end of this module, learners would be able to:

  • Understand the core principles and frameworks governing biomedical data management and reuse.
  • Identify key ethical, legal, and practical considerations in health data governance.
  • Review major international guidelines and policies shaping biomedical data sharing.
  • Analyse case studies of successful data reuse in infectious diseases and other health research areas.

By the end of the module, learners would be able to:

  • Define the goals and essential components of a robust data governance framework.
  • Recognize best practices for Data Access Committees (DACs) and their role in governance.
  • Understand different data access mechanisms (e.g., direct download, virtual research environments, federated reuse).
  • Evaluate governance approaches suitable for epidemic response and large-scale data sharing.
  • Apply practical tools and strategies to develop and assess data governance frameworks.

By the end of the module, learners would be able to:

  • Identify key ethical issues including broad consent, benefit sharing, and engagement with data producers.
  • Understand legal frameworks and agreements necessary for compliant data and sample sharing.
  • Differentiate between various consent models and legal controls supporting data reuse.
  • Integrate considerations of data protection, privacy, and AI ethics into governance.
  • Understand intellectual property issues in academic-industry partnerships.
  • Plan budgeting and cost recovery for FAIR data and data preservation.

By the end of the module, learners would be able to:

  • Compare governance structures for biomedical data and sample reuse.
  • Understand local and international legislation affecting sample sharing, including the Nagoya Protocol.
  • Identify best practices for managing sample metadata and biobank governance.
  • Recognize special ethical considerations for pediatric and living biobanks.
  • Assess cost recovery and budgeting for sample storage and sharing.
  • Make informed decisions on sample preservation and commercial use.

Intended Audience

Researchers, data stewards, and anyone involved in biomedical data or sample management, governance, or reuse will benefit from this training. No prior knowledge of data or sample governance is required.

Learning outcomes

  • Understanding and implementing the FAIR principles.
  • Constructing and implementing data and sample governance frameworks.
  • Navigating ethical, legal, and regulatory concerns, including European biomedical data reuse legislation and the Nagoya Protocol.
  • Ensuring data and metadata quality for effective reuse.
  • Choosing trusted repositories and metadata catalogues for biomedical data and samples.

Registration fees

There is no fee for this course.

If you register before the course start date, you will receive and email when the course launches.

Course Coordinator

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)
TGHN (The Global Health Network)
 

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