Project Summary

Health research is critical in addressing current and future global health needs. All health research involving human study participants must be conducted responsibly, by ensuring all study procedures and processes protects the safety and interests of study participants. Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) are critical in ensuring all research is conducted responsibly and that research projects involving human participants respect the dignity, welfare, safety, and well-being of those involved in the research.

Since 1978, the health research ethics review in the Gambia has been conducted by the independent Gambia Government/MRCG Joint Research Ethics Committee (EC), that consider the ethical and scientific merits of all biomedical research conducted in The Gambia to promote the rights of all study participants and communities. The Medicines and Related Products Act, 2014 requires that the Medicine Control Agency (MCA) authorises all clinical trials and that an ethical clearance issued by the EC should be submitted to the MCA together with the proposal. The Medicines and Related Products Act also stipulates how the EC and the MCA are supposed to work together in coordinating and regulating clinical trials.

Other than the existing Medicines and Related Products Act, 2014, there is currently no regulatory framework for Research Ethics that exist in The Gambia. As a result, the coordination of health research ethics is fragmented. Against this background, The Gambia Ethics and Regulatory Capacities (ERC) Project aim to build a robust ethics and regulatory governing framework with a view to enhancing the ethics and regulatory capacity of The Gambia, establish institutional research ethics committees and ensure optimum protection of research participants.

The Gambia ERC project aims to focus on a few key areas, including:

1. Undertaking an assessment of the enablers and inhibitors of ethics and regulatory capacity development in the Gambia

2. Undertaking a knowledge and skills ethics capacity building/enhancement

3. Strengthening medicines regulatory capacity

4. Building and/or strengthening Information and Technology capacity in the ethics review process

5. Collate clinical trials information and synthesis it to inform policy and practice

6. Developing a project sustainability mechanism

Successful completion of these six key areas will ensure the Gambia has robust ethics and regulatory capacity for effective management and coordination of clinical trials. Ultimately, this will improve the efficiency of EC and MCA and enhance the quality of ethics review in the Gambia.

This project is funded by the EDCTP. The consortium partners are EthiXPERT, Pharmalys, COHRED, Medical Research Council UNIT and Medicines Control Agency Gambia.

Expected Key Deliverables

At the end of this project, the following deliverables will have been achieved:

7. Ethics and regulatory skills and policy gap assessment report-This report will detail the gaps identified and the strategic actions that need to be taken to ensure the Gambia has a robust ethics review system.

8. National research ethics review framework-Through a consultative process, a national ethics review framework will be developed and presented to the Ministry of Health for adoption

9. National research ethics regulatory and coordination framework-A framework to guide the accreditation and coordination of institutional RECs will be developed and adopted

10. National Ethics Committee (NEC)-This project will ensure a National Ethics Committee (NEC) is established to play an oversight role in the coordination of research ethics, including the management and day to day supervision of institutional RECs, as shall be stipulated by the National research ethics regulatory and coordination framework

11. Accredited institutional Research Ethics Committees- Following the adoption of the national research ethics regulatory and coordination framework and establishment of the NEC, institutions that meet the criteria will be accredited and allowed to conduct ethics review.

12. RHInnO Ethics platform- RHInnO Ethics platform will be installed in institutions that will be selected and be configured into a low-cost package to enhance sustainability.

13. Online clinical trials database-An online database for clinical trials will be established as users continue using the RHInnO Ethics platform.

14. Build capacity in clinical trial oversight and pharmacovigilance monitoring.

15. Sustainability approach-An approach that guarantees the sustainability of the project beyond the project lifetime will be developed and adopted.

16. Meta-analysis-Through the integration of RHInnO Ethics and HRWeb, anonymised data transmitted to HRWeb from RHInnO Ethics will be analysed and used to generate trends and inform policy and practices on clinical trials.

For more information on this project, contact:

Francis Kombe

CEO EthiXPERT

kombe@ethixpert.org.za