Project Summary

The National Research Ethics Committee for Health (NRECH) is the authority that is responsible for monitoring health research in the Republic of Benin and is also responsible for reviewing research protocols. In addition, three other institutional research ethics committees are currently active in Benin. To successfully conduct research in Benin, researchers should apply for ethical approval from any of the research ethics committee that operates in Benin, which they deem relevant for their research. Applications for clinical trials must be reviewed by the National Research Ethics Committee for Health Research.

In February 2014, an outbreak of the Ebola Virus Disease (EVD) in Guinea was reported. The EVD has spread to Liberia, Mali, Nigeria, Senegal and Sierra Leone causing untold hardship and thousands of deaths in these countries. During the outbreak, Benin’s risk levels were considered extremely high due to its proximity to Nigeria-which was one of the countries affected by the EVD. Although there was no confirmed case of the EVD identified in the republic of Benin, the situation in Nigeria made Benin highly vulnerable and remained on high alert throughout the period.

It is evident that even before the COVID-19 pandemic outbreak, the republic of Benin’s ethics and regulatory capacity were already limited by the lack of a framework to regulate and accredit institutional ethics review committees. A manual paper-based system is in use which requires files of printed-research-applications to be submitted to the relevant REC, screened and dispatched to the REC members before convening a face-to-face meeting to discuss the proposals and conclude final decisions. The COVID-19 pandemic therefore exacerbated what was already a fragmented and fragile ethics and regulatory system by forcing the termination of physical meetings and by making the handling of physical files a potential “health hazard”. Furthermore, NRECH does not have any guidelines for rapid review of clinical trials, nor adequate capacity to conduct robust rapid and high-quality reviews of complex clinical trials.

With COVID-19, the committees reduced their activities to the bare minimum, although they still accepted to evaluate urgent procedures, especially protocol that were related to COVID-19. It is to be noted that, while COVID-19 made the situation worse, the challenges are not only unique to the COVID-19 pandemic but cut across all the routine operations of NRECH, BAPR and the rest of the institutional RECs in Benin and require urgent strategies to be addressed. The AMÉLIORER project aims to fill these gaps.

AMÉLIORER is a French word for improve. “AMÉLIORER” is used to denote that by the end of this project, the AMÉLIORER consortium will have improved and upgraded Benin’s ethics and regulatory landscape to international standards. Specifically, AMÉLIORER aims to

• Identify challenges associated with implementing the current regulatory framework

• Develop a responsive ethics review and regulatory framework for Benin

• Implement a dynamic and responsive digital platform for online ethics review

• Build advanced skills in clinical trials management for the NREC and NRA staff

• Develop a framework to ensure project sustainability

Achieving these objectives will transform Benin’s ethics and regulatory landscape.

This project is funded by the EDCTP. The consortium partners are The National Research Ethics Committee for Health, Benin (NRECH), The Beninese Agency for Pharmaceutical Regulation (BAPR),  EthiXPERT, Pharmalys, and COHRED

Expected Key Deliverables

At the end of this project, the following milestones will be achieved:

1. A report detailing the factors influencing the successful implementation of the current code of ethics and deontology for health research and a list of strategic actions for addressing the identified challenges.

2. An ethics review and regulatory framework detailing how institutional RECs operating in Benin will be coordinated, including guidelines for accreditation, SOPs for establishing institutional RECs and induction training for REC members.

3. A functional RHInnO Ethics platform installed at the NRECH, BAPR and the three institutional RECs currently operating in Benin.

4. A functional online clinical trials database, that is able to capture clinical trials information through the RHInnO Ethics platform and electronically, through entering the information directly.

5. A report showing which institutions were installed with the platform.

6. A report detailing the outcome of the RHInnO Ethics training for each of the RECs that have received RHInnO Ethics platform installations.

7. A report detailing the outcome of the RHInnO Ethics refresher training that will be conducted during the second year of the project.

8. A report of the intensive advanced training in clinical trials management, detailing the topics covered, the participants who attended the training and a post training assessment report of the skills and competence gained by the trained participants.

9. A report on the refresher training on the intensive advanced training in clinical trials management conducted during the second year of the project.

10. A report of the intensive training in research ethics, detailing the topics covered, the participants who attended the training and a post training assessment report of the skills and competence gained by the training participants.

11. A report on the refresher research ethics training conducted during the second year of the project.

12. A proposed project sustainability framework, detailing the preferred financial management approach to facilitate financial independence and project sustainability.

13. A mid-term and end-term monitoring and evaluation report, detailing ongoing monitoring strategies used, milestones achieved, challenges experienced, if any, and how they were addressed.

14. A functional HRWeb linkage that is integrated with RHInnO Ethics and able to collate data, synthesise it and perform a meta-analysis of anonymised data.

For more information on this project, contact:

Francis Kombe

CEO, EthiXPERT

kombe@ethixpert.org.za