Strengthening Clinical Trial Regulatory and Ethical Review Oversight in East Africa

The document is a comprehensive educational resource developed under the ACCESSAFRICA 2 project. It aims to strengthen the ethical review capacity of Research Ethics Committees (RECs) across Africa. Structured into six detailed modules, the manual covers foundational concepts of research ethics, ethical principles and theories, the roles and responsibilities of RECs, the ethical review process for research proposals, specific ethical issues in research (including transnational studies, adaptive trials, and decentralized trials), and the importance of continuing education and networking among REC members. Each module includes learning objectives, practical examples, case studies, and discussion questions to foster critical thinking and ethical reasoning. The manual emphasizes the importance of informed consent, protection of vulnerable populations, data privacy, and community engagement. It also addresses emerging ethical challenges such as the use of artificial intelligence, gene editing, and global health research. Designed for both trainees and trainers, the manual serves as a dynamic tool to promote principled decision-making, ethical oversight, and a culture of integrity in health-related research across the continent.