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Project Topic
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The conduct of research on humans should be in accordance with basic principles of ethics, respect for persons, beneficence and justice. The ever-increasing amount and complexity of health research being conducted in sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region, in particular reviews related to conducting complex clinical trials. While structures for ethical review of health research have been established in several sub-Saharan countries, implementation may still be lagging behind due to a combined set of reasons, such as poor infrastructure, lack of secretarial support, lack of training or not enough experience reviewing research of greater regulatory complexity. The overall aim of this project is to build capacity for ethical review process for clinical trials in Ethiopia, including the implementation of relevant, appropriate and ethical clinical trial research, strengthen institutional capacity to achieve and sustain the overall review of health research in the country. The specific aims are: (i) to conduct a needs assessment of the clinical trial ethics review process; (ii) to strengthen institutional capacity for the clinical trial ethical review process, including the design of appropriate training programmes/curricula, maintain continued education in ethics review, provide advanced Master’s-level education, improve the efficiency of research protocol review using an online platform, facilitate accreditation by SIDCER, strengthen monitoring and evaluation, conduct operations research, and explore innovative strategies for sustainability, and (iii) to strengthen collaboration and networking in clinical trial research ethics. The project will be implemented by the National Ethical Review Committee, in concert with the National Regulatory Authority (NRA) in collaboration with preeminent research institutions in Ethiopia as well as institutions working in ethics review programmes in other African countries. The impact of the project entails the overall research ethics review system, long-term engagement and sustainability as well as policy framework of the ethical review system in Ethiopia. In the current reporting period spanning between 1 June 2018 and 30 May 2019 only few activities have been implemented. The main reason for the delay in the project emanated from the re-organisation of the coordinating institution from the Ministry of Science and Technology (MoST) to the newly established Ministry of Science and Higher Education (MoSHE). Nonetheless, we have conducted several SteRN Steering Committee meetings as well developed terms-of-reference (ToR) for the steering committee. In addition, the action plan for conducting the baseline survey of the current status of clinical trials in Ethiopia was developed and survey tools are in preparation. Publication of the SOP document is also done. As part of the dissemination and communication work package activity (WP3), the Coordinator attended the EDCTP Forum 2018 in Lisbon, Portugal, and this created a platform for networking and dissemination. The outcome of this project may have major policy implications as the project presents a concept that could enhance capability of the ethical review process for clinical trials being undertaken in Ethiopia. Overall conducting clinical research should improve public health practice with overarching impacts for national, regional and global preventive and disease management programmes.
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