Biobank Ethics and Governance Training Course

Biobank Ethics and Governance Training Course

Introduction

Biobanks play a critical role in advancing precision medicine, genomic research, population health, and translational science. As repositories of human biological materials, health data, and genetic information, biobanks raise complex ethical, legal, and governance challenges related to informed consent, privacy protection, data ownership, benefit sharing, and public trust. Effective biobank governance frameworks are essential to ensure ethical integrity, regulatory compliance, transparency, and accountability across the lifecycle of biospecimen and data management.

Biobank Ethics and Governance Training Course provides a comprehensive understanding of international ethical standards, governance models, regulatory frameworks, and best practices guiding biobank operations. Participants will explore real-world case studies, emerging ethical dilemmas, data-sharing models, AI integration, cross-border research, and community engagement strategies. The course emphasizes responsible research conduct, risk mitigation, stakeholder trust, and sustainable governance aligned with global norms such as GDPR, CIOMS, OECD, and UNESCO bioethics principles.

Course Duration

5 days

Course Objectives

1. Understand ethical foundations of biobanking
2. Apply informed consent models in biobank research
3. Analyze data protection and privacy-by-design
4. Interpret global biobank regulations and compliance
5. Strengthen governance and oversight mechanisms
6. Address genomic data ethics and AI governance
7. Manage data sharing and access governance
8. Mitigate ethical risks in cross-border research
9. Promote equity, inclusion, and benefit sharing
10. Enhance public trust and stakeholder engagement
11. Implement ethical review and audit frameworks
12. Resolve ethical conflicts and governance dilemmas
13. Support sustainable and transparent biobank operations

Target Audience

1. Biobank managers and coordinators
2. Researchers and principal investigators
3. Ethics committee and IRB members
4. Data protection and compliance officers
5. Genomic scientists and bioinformaticians
6. Healthcare administrators and policymakers
7. Legal professionals in health research
8. Public health and life science professionals

Course Modules

Module 1: Foundations of Biobank Ethics

• Ethical principles
• Historical evolution of biobanking ethics
• Human subject protection frameworks
• Ethical risk identification
• Case Study: Ethical failures in early biobank models

Module 2: Informed Consent Models

• Broad vs dynamic consent
• Digital and e-consent systems
• Withdrawal and re-consent mechanisms
• Vulnerable populations
• Case Study: Consent challenges in genomic biobanks

Module 3: Governance Frameworks

• Governance structures and roles
• Accountability and transparency models
• Policy development and SOPs
• Oversight committees
• Case Study: Successful national biobank governance

Module 4: Data Privacy and Protection

• GDPR and global data protection laws
• De-identification and anonymization
• Cybersecurity and risk management
• Data access controls
• Case Study: Data breach response in biobanks

Module 5: Data Sharing and Access

• Controlled vs open access models
• FAIR data principles
• Material Transfer Agreements (MTAs)
• Secondary use of data
• Case Study: International data-sharing disputes

Module 6: Genomics, AI, and Emerging Technologies

• Ethical use of AI in biobanks
• Algorithmic bias and fairness
• Big data governance
• Predictive analytics ethics
• Case Study: AI-driven genomic research ethics

Module 7: Equity, Benefit Sharing, and Community Engagement

• Inclusive biobanking practices
• Indigenous and community rights
• Benefit-sharing models
• Public engagement strategies
• Case Study: Community-led biobank initiatives

Module 8: Future Challenges and Sustainable Governance

• Cross-border regulatory harmonization
• Long-term sustainability models
• Ethical innovation governance
• Crisis and conflict management
• Case Study: Ethical governance during pandemics

Training Methodology

This course employs a participatory and hands-on approach to ensure practical learning, including:

• Interactive lectures and presentations.
• Group discussions and brainstorming sessions.
• Hands-on exercises using real-world datasets.
• Role-playing and scenario-based simulations.
• Analysis of case studies to bridge theory and practice.
• Peer-to-peer learning and networking.
• Expert-led Q&A sessions.
• Continuous feedback and personalized guidance.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.