Data Sharing for Biomedical Research

Provides practical guidance for sharing biomedical research data ethically, responsibly, and in compliance with regulatory requirements.

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About this Course

This course provides a practical approach to data sharing in biomedical research, with a focus on human subjects data and real-world implementation. Learners will explore how to apply ethical principles and regulatory requirements while preparing and sharing data in compliant and responsible ways. Emphasis is placed on protecting participant privacy, using appropriate standards and tools, and supporting effective collaboration across research settings.

Language Availability: English

Suggested Audiences: Biomedical Researchers, IRB Members, Students

Organizational Subscription Price: Included as part of an annual subscription to our Data Management and Sharing Series, which is available as part of an organizational subscription package or for $675 per year/per site as a subscription add-on for government and non-profit organizations; $750 per year/per site as a subscription add-on for for-profit organizations
Independent Learner Price: $99 per person


Course Content

Introduction to Human Subjects Data in Biomedical Research

This module introduces the foundational concepts of human subjects data in biomedical research, defining key data types and their role in advancing scientific knowledge. It highlights the value of data sharing, including its benefits and challenges, and situates these practices within a historical context and key milestones in the field. The module also provides examples of how data sharing has enabled impactful research discoveries.

Recommended Use: Required
ID (Language): 22456 (English)
Author(s): Leslie Howes, MPH, CIP - Harvard T.H. Chan School of Public Health

Ethical and Regulatory Frameworks

This module examines the ethical principles and regulatory frameworks that guide data sharing in biomedical research, including privacy, confidentiality, and respect for autonomy. It highlights applicable regulations, the role of funding mechanisms in shaping data ownership, and the responsibilities of Institutional Review Boards (IRBs) in reviewing data-sharing plans and informed consent processes. The module also addresses best practices such as de-identification, clear participant communication, and proper documentation, while introducing key roles that support compliant and responsible data sharing.

Recommended Use: Required
ID (Language): 22457 (English)
Author(s): Leslie Howes, MPH, CIP - Harvard T.H. Chan School of Public Health

Practical Considerations

This module focuses on the practical implementation of data sharing in biomedical research, including the use of data standards, repositories, and institutional infrastructure. It addresses collaboration across research settings, the use of agreements such as data use agreements and material transfer agreements, and strategies for managing data quality, integration, and compliance. The module also emphasizes data security practices and tools to support responsible and effective data sharing.

Recommended Use: Required
ID (Language): 22458 (English)
Author(s): Leslie Howes, MPH, CIP - Harvard T.H. Chan School of Public Health

Addressing Challenges and Future Directions

This module examines how to balance the benefits of data sharing with the protection of participant privacy and individual rights in biomedical research. It explores key challenges and disparities that can limit effective data sharing, highlights emerging innovations, and emphasizes the roles of funders, journals, and academic institutions in promoting transparency and accountability. This module concludes with a discussion of evolving technologies and policies shaping the future of data sharing.

Recommended Use: Required
ID (Language): 22459 (English)
Author(s): Leslie Howes, MPH, CIP - Harvard T.H. Chan School of Public Health


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