Skip to main content
European Commission logo
English English
CORDIS - EU research results
CORDIS
CORDIS Web 30th anniversary CORDIS Web 30th anniversary

Côte d'Ivoire Ethics Capacity Building Initiative (CECaBI II)

Project description

Strengthening clinical trial oversight in Côte d’Ivoire

As clinical trials proliferate in Africa, there is an urgent need for standardised protocols and effective oversight. Despite a push for national health research ethics committees over the past 20 years, many African countries, including Côte d'Ivoire, still face challenges in implementing robust frameworks for Phase II to IV trials. In Côte d'Ivoire, a 2020 presidential decree aimed to enhance trial regulation by integrating universities and institutional research ethics committees as key players. However, awareness and implementation of these bodies remain limited. In this context, the EU-funded CECABI II project will build regulatory and ethics capacity, enhancing quality assurance, and digitalising operations. CECABI II aims to elevate Côte d'Ivoire’s clinical trials to international standards.

Objective

The number of studies and experiments on humans is increasing in Africa. For the past two decades, the setting up of national health research ethics committees (NREC) in Africa, encouraged by the WHO, UNESCO and CIOMS, has resulted to a need for a framework to guide and standardise how Phase II to IV clinical trials in Africa are conducted. Additionally, NREC and National Regulatory Agency (NMRA) must proactively play their roles in managing and regulating clinical trials.

In Côte d'Ivoire, an important decree signed by the President of the Republic in April 2020 defines the regulation of clinical trials in the country. The decree positions Universities and the establishment of institutional research ethics committees (IRECs) as the third pillar for enhancing the conduct of clinical trials and other categories of health research. However, only a couple of institutional review committees exist, with a very small proportion of researchers being aware of these IRECs. Furthermore, knowledge about the existence and functions of NRA is estimated to be much lower comparative to NREC. The need for NREC, NMRA and IRECs to work in synergy is a critical prerequisite for raising the quality of clinical trials to international standards.

Funded by EDCTP II, the CECABI project (CSA2020ERC-3081), was instrumental in laying the foundation for building the regulatory and ethics capacity in Côte d'Ivoire. Important, it identified critical gaps that need urgent attention. The proposed CECABI II is a three years project that seeks to
1) Build capacity in clinical trials, GCP and research ethics for research practitioners
2) Enhance quality assurance through ISO certification of the NREC
3) Digitalise the operations and ongoing collaboration between the NREC and NRA
4) Support the domestication and digitalisation of AVAREF system
5) Monitor and evaluation to implementation of the project

Fields of science

CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.

Programme(s)

Coordinator

ETHIXPERT NPC
Net EU contribution
€ 350 000,00
Address
34 STANGER AVENUE, ELDORAIGNE X18
0157 PRETORIA
South Africa

See on map

SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Research Organisations
Links
Total cost
€ 350 000,00

Participants (4)