Published July 17, 2025 | Version v1
Project deliverable Open

Training Manual on Ethics Capacity

Contributors

  • 1. ROR icon University of Oslo
  • 2. ROR icon University of South-Eastern Norway

Description

This training manual was developed to strengthen the ethical oversight of clinical trials and health-related research in East Africa. It is designed as a comprehensive resource for Research Ethics Committee (REC) members, trainers, and stakeholders involved in the ethical review of research involving human participants.

Structured into six detailed modules, the manual covers foundational concepts in research ethics, ethical principles and theories, the roles and responsibilities of RECs, the ethical review process, specific ethical issues (including transnational research, adaptive trial designs, and data protection), and continuing education for REC members. It includes practical tools, case studies, and references to international guidelines such as the Declaration of Helsinki, CIOMS, and the Belmont Report.

The manual is intended to build capacity, promote ethical reflection, and support principled decision-making in diverse research contexts, particularly in low- and middle-income countries.

Files

D4.2. Training Manual on Ethics capacity.pdf

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Additional details

Funding

European Union
European & Developing Countries Clinical Trials Partnership