Project: Strengthening Community Structures in Clinical Research to Improve Oversight Role of National Ethics Regulatory Bodies in Uganda (SCINE-U)

Acronym	SCINE-U (Reference Number: CSA2018ERC-2318)
Duration	01/09/2019 - 31/08/2021
Project Topic	With an increasing number of clinical trials being conducted in sub Saharan Africa, there is need to strengthen national ethics regulation and coordination to ensure protection of the rights and welfare of study participants.  Although the capacity of the Uganda National Council for Science and Technology (UNCST) and the institutional Research Ethics Committee (REC) in identifying and addressing ethical issues that arise from clinical trials has improved, there is still a gap in the community engagement by these bodies. The current national guidelines for research ethics provides limited guidance on community engagement and the community advisory boards. This role has been entirely left to the researcher which undermines the independence and power of the community advisory boards in research ethics. Community Advisory boards CAB) are continuously interacting with the communities and play a critical role in ensuring that the rights and welfare of trial participants are protected thus are key in strengthening the regulatory oversight role for UNCST. The major objective of this proposal is to strengthen community structures in clinical research to improve the oversight role of national ethics regulatory bodies in Uganda. The specific aims include conducting a situational analysis of the community engagement structures in clinical trials in Uganda, developing guidelines and operations manuals for CABS in Uganda, Capacity Building CABs in research ethics and developing a monitoring and evaluation framework for the operations of CABs in Uganda.  We shall use a mixed research methods to collect and analyse data from the CAB members, REC members, investigators, national ethics regulators and trial participants for the situation analysis. Guidelines will be informed by findings from the situation analysis, review of international guidelines and conducting consultative meetings with different stakeholders. Capacity building will include development of a curriculum and training manuals, training of CAB members and mentorship sessions. An online management information system for monitoring the operations of the CABs in Uganda by UNCST will be developed by closely working with experts in systems development and stakeholder consultative meetings. Strengthening the capacity of community advisory boards in research ethics and establishment of a formal link among the CABs, RECs and National Ethics Committees further strengthens the oversight and coordinating role of the NECs.
Network	EDCTP2
Call	Ethics and regulatory capacities 2018

Project partner

Number	Name	Role	Country
1	The AIDS Support Organisation	Coordinator	Uganda
2	Makerere University	Partner	Uganda
3	Uganda National Council for Science and Technology	Partner	Uganda