CECABI II

The challenge

Although Côte d’Ivoire has a moderately developed health research system, it has ambitions to increase the number of clinical research projects conducted in the country (Phase II to Phase IV). To achieve this goal, the country needs to strengthen its research ethics review and regulatory systems to ensure that studies are conducted to the highest ethical standards.

The CECABI I project, funded through the EDCTP2 programme, helped to build research oversight capacity in Côte d’Ivoire, for example, by supporting the creation of two new institutional review boards, to complement the national research ethics committee, the Comité National d’Éthique des Sciences de la Vie et de la Santé (CNESVS, National Ethics Committee of Life and Health Sciences). However, capacity remains limited, with little follow-up on projects after approval, and the work of CNESVS and Côte d’Ivoire’s national regulatory authority, l’Autorité Ivoirienne de Régulation Pharmaceutique (AIRP), is poorly coordinated.

The project

The activities of the CECABI I project, and the relationships developed during the project, have provided a springboard for further strengthening of the Côte d’Ivoire research oversight system through the CECABI II project.

Additional training will be organised to extend and expand the skills base in Côte d’Ivoire. The project is developing a clinical research management and oversight framework for Côte d’Ivoire, which will guide the training of research ethics committee members and at least 12% of the 1,000 researchers in the country who conduct clinical research.

To assure high standards in ethical review, Senegal’s national research ethics committee (Comité National d’Ethique pour la Recherche en Santé, CNERS) will engage with the CNESVS, rigorously assess its quality assurance and control management systems, and help to develop a pathway towards ISO certification. 

To support monitoring of approved projects, CECABI II will facilitate the adoption by both the CNESVS and the AIRP of the clinical trials inspection guide and checklist for Good Clinical Practice (GCP) inspections developed by the African Vaccine Regulatory Forum (AVAREF).

Additionally, the project will support at least five more institutions to establish research ethics committees. This will be an opportunity to test a new registration and accreditation framework developed in the CECABI I project.

These new committees will be provided with the RHInnO Ethics digital platform, ensuring a consistent approach is adopted across all of Côte d’Ivoire’s research ethics committees. Furthermore, a new RHInnO Ethics module is being developed that will create a seamless integration between the research ethics and regulatory approval systems, for example, enabling proposals submitted to research ethics committees to be automatically shared with the national regulatory agency.

The integration of RHInnO Ethics will also enable Côte d’Ivoire to share information with HRWeb Africa, so that it can contribute to an important database on regional clinical research activities.

Impact

The CECABI II project will significantly strengthen the research oversight system in Côte d’Ivoire. It will:

• Expand the number of research ethics committees in the country.
• Ensure that more clinical researchers in Côte d’Ivoire are aware of and trained in the essentials of ethics review.
• Strengthen coordination between the CNESVS and the AIRP, reducing duplication and improving efficiency.
• Improve the quality of clinical trials management and enhance research participants' protection.
• Establish systems for monitoring clinical research projects following approval.

Collectively, these advances will create stronger systems for clinical research governance in Côte d’Ivoire, ensuring better protection for research participants, helping to build trust in clinical research activities, and providing a foundation for expanding its portfolio of clinical research studies.