The AIDS Support Organisation (TASO) in collaboration with the Uganda National Council for Science and Technology (UNCST) and Makerere University College of Health Sciences (MUKCHS) - School of Biomedical Sciences (SBS) REC, is implementing a three-year project funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) titled, “Strengthening Community Structures in Clinical Research to Improve Oversight Role of National Ethics Regulatory Bodies in Uganda (SCINE-U)”. The SCINE-U project aims to understand the current operations of the CABs through a situational analysis of the existing community structures for clinical trials, develop national guidelines for CABs, strengthen community structures through capacity building, and to monitor their performance to improve research ethics and administration of clinical trials in Uganda.
As the number of clinical trials being conducted in sub Saharan Africa increase, protection of the rights and welfare for Clinical trial participants becomes very critical. Establishment of community engagement structures mainly through the Community Advisory Boards (CABs) is currently one of the requirements for funding clinical trials. Community Advisory Boards are formed to play a big role in the designing, implementation and dissemination of findings for clinical trials. As they participate in the different trial processes, their major aim is to ensure that clinical trial participants’ rights are protected and that communities benefit from research.
In Uganda, establishment and functionality of the Community Advisory Boards has been solely left to the principal investigators with most of them being guided by international community engagement guidelines. Community Advisory Boards play a supplementary role to the National regulatory systems at community level; however the current design of these structures has created limited interaction between the National Ethics Regulatory bodies and the CABs. Secondly considering the diversity in in the African society, there is need to design guidelines that will fit the African context.
1. Conduct a situation analysis of the existing community engagement structures in clinical trials.
2. Develop policies and guidelines to enhance the standardization and functionality of CABs required for clinical trials in Uganda.
3. Build the capacity of existing CABs for effective performance of their roles in clinical trials.
4. Develop a monitoring and evaluation framework for tracking the functionality of CABs.
We envisage that the developed monitoring and evaluation framework for tracking functionality of CABs will contribute to a meaningful and active involvement of communities in design, implementation and monitoring of clinical trials. The SCINE-U project will further enhance the oversight function of UNCST and other regulatory structures in clinical research in Uganda.
The project intends to develop a large network of CABs that are able to guide researchers and institutions in ethical aspects involved in community engagement so that participants are equal partners in the clinical research enterprise.
SCINE-U project aims at creating both immediate and sustainable change in the role of CABs to strengthen the regulatory ethical oversight through knowledge reach to communities and long term collaboration within the local and national ethics communities
The study Team
Dr. Mastula Nanfuka
Winfred Bandanga Naziiwa
Dr. Joseph Ochieng
Dr. Levicatus Mugenyi, PhD
Andrew Ojok Mijumbi
Irene Ssemakula Seryazi
The AIDS Support Organization (TASO)
Mulago Hospital Complex
P O Box 10443, Kampala-Uganda
External links: http://www.edctp.org/ethics-and-regulatory-capacities-2018/