The Ivory Coast is located in West Africa. Its neighbours are Guinea, Liberia, Mali, Burkina Faso and Ghana, among others, and has a population of 25 million people. The life expectancy for males is 42 and 47 for females. Infant mortality is estimated at 118 of 1000 live births.
According to the World Health Organistion (WHO), the Ivory Coast has the 27th-highest maternal mortality rate and the 19th-highest HIV/AIDs rate among adults in the world. Furthermore, its proximity to Guinea and Liberia, which are among the countries that were worst hit by the 2014-2016 West Africa Ebola Virus outbreak, make it vulnerable to disease outbreak.
Despite this context, the Ivory Coast devotes only 0.13% of Gross Domestic Product (GDP) to Research Innovation and Development (RID). This RID investment has been linked to a myriad of challenges, including inadequate scientific equipment, fragmentation of research organisations and a failure to exploit and protect research results. For example, despite 63.8% of the 2012–2015 National Development Plan being devoted to wealth creation and social equity, only 1.2% was allocated to scientific research. This has affected not only the quality of health research but the overall ethics governance and regulatory practices in the country.
The national research ethics committee was established in 2001 to advise the Ministry of Health on how to promote protection of the dignity and rights of research participants and assess the ethical considerations of studies before they are implemented. Although the Ivory Coast’s research ethics and regulation remains fragile, under-developed and fragmented, it has received limited support for capacitating its national ethics and regulatory practices.
The Ivory Coast’s Ethics Building Initiative (CECaBI) is a consortium of different partners who plan to work together to transform the ethics and regulatory practices in the country by undertaking the following objectives:
- Undertake a comprehensive needs assessment and benchmarking to identify specific areas of improvement.
- Establish a vibrant research ethics committee secretariat to help the National Research Ethics Committee (NREC) to operate efficiently.
- Develop an ethics governance framework, to facilitate assessment of the capacity of academic institutions to conduct review process and develop guidelines for registering, accrediting and assessing Institutional Research Ethics Committees’ (IRECs) performance.
- Offer intensive advanced training in ethics review, Good Clinical Practice (GCP) and clinical research management training to equip members with skills to conduct high quality reviews.
- Digitalise the operations of the RECs through the introduction of a French online ethics review system and an online clinical trials database.
This project is funded by the EDCTP. The consortium partners are Comité National d’Ethique des Sciences de la Vie et de la Santé (CNESVS), Ivorian Authority for Pharmaceutical Regulation (AIRP), Centre Suisse de Recherche Scientifique (CSRS), EthiXPERT, Pharmalys, and COHRED
Expected Key Deliverables
At the end of this project, the following milestones will have been achieved:
- A needs and gap assessment report describing the research ethics and regulatory situation in the republic of the Ivory Coast and the key recommendations that should be implemented to ensure the country has a vibrant ethics and regulatory system that is able to carry out robust reviews and promote research subject protection.
- Based on the needs identified, the research ethics and regulatory framework may be reviewed or a new a framework may be developed that is sensitive to the context of the Ivory Coast.
- An advanced intensive one-week training in research ethics will be given to junior and senior members of the NECLHS and National Regulatory Authority (NRA) to build their capacity to carry out robust ethics review for a diverse range of scientific studies, and create a cohort of local experts who will be able to continue sharing the knowledge and skills they acquire to people who will be assigned to conduct such roles in the future. This will be followed by a refresher training course in year two.
- A one-week training course in GCP, will be offered to members of NECLHS and NRA and other stakeholders, including members of research and academic institutions, to enable them to understand the roles and responsibilities of each key player in the conduct of bio-medical research, especially when human participants are involved. A refresher will be conducted in year two, to refresh the participants on what was covered in year one and to allow them an opportunity to reflect and share any changes and challenges they may have experienced.
- A one-week training course on coordination and monitoring of clinical trials will be offered to junior and senior members of the NRA as well as the NECLHS and other institutions that review clinical trials.
- The NECLHS and NRA will be installed with a functional RHInnO Ethics platform, French version. In addition, at least three research and academic institutions with adequate human and technological capacity will be identified to receive platform installations and licences.
- RHInnO Ethics training over three days, on entry level, will be offered to members of the RECs identified as indicated above.
- An online database of clinical trials will be developed to ensure information about clinical trials, that is captured using the RHInnO Ethics platform, is automatically used to gradually update the online database that will have been developed by then.
- A sustainability framework will be developed in order to guide how the project will be supported to continue beyond the funding cycle.
- An end-of-project report will be developed to provide extensive information on the project, including the lessons learned.
- At least one manuscript will be developed and published in a peer reviewed free access journal in order to share the findings of the study.
- Have profound understanding of ethical and practical issues pertinent to life, health and clinical research.
- Have adequate knowledge about relevant players involved in life, health and clinical research to enable sound collaborative and complementary roles to be played without hindrances.
- Be knowledgeable about sociological, epidemiological, clinical and entomological regulatory review processes.
- Be familiar with fundamental ethical principles and be able to apply them in the field as they conduct research
- Have established their IRB within 2 years.
- Have members of their IRB sufficiently trained and qualified to provide efficient and timely feedback to research protocols prior to submission to CNESVS.
- Be required by CNESVS to assist them to provide timeous high-quality ethics review of research protocols through their IRB.
- In long term be independent to CNESVS and considered as institutional research ethics committee that are accredited and authorized by the States Authorities and National Regulatory Authorities to review protocols by providing efficient, timely and high-quality ethics review without compromising the safety and welfare of those involved.
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