Summary
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
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
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/101145732 |
| Start date: | 01-06-2024 |
| End date: | 31-05-2027 |
| Total budget - Public funding: | 1 000 000,00 Euro - 1 000 000,00 Euro |
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Original description
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
Status
SIGNEDCall topic
HORIZON-JU-GH-EDCTP3-2023-01-05Update Date
20-09-2024
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