Project: Building the Regulatory and Ethics Capacities of Rwanda

Acronym BRECOR (Reference Number: CSA2018ERC-2317)
Duration 01/12/2019 - 01/05/2022
Project Topic Developing countries carry 90% of the global burden of communicable and Non-Communicable Diseases (NCD). Despite NCDs being largely preventable, their prevalence and incidence are expected to increase, with the majority of the increase occurring in low- and middle-income countries (LMICs) and particularly in Sub Saharan Africa. While research is essential for healthy development, less than 10% of the annual global expenditure on health research is allocated to addressing developing countries' problems. Poor countries must face this challenge seriously. It is essential that they nurture a conducive research environment with sound governing tools and enabling capacity in order to define priorities for the health research agenda; influence national, regional, and global health agendas; and lobby for a more equitable allocation of resources. An important aspect of regulatory and ethics capacity is ensuring that clinical research protocols are reviewed by competent review committee members. In Rwanda, researchers are required to submit their applications to Institutional Review Boards (IRBs) before submitting to the Rwanda National Ethics Committee (RNEC) for approval. Considering the complexity of the issues that have to be adjudicated by IRBs and the diversity of specialised expertise needed to judge study design, plan, and feasibility, it is important that IRBs have adequate capacity to conduct a robust review on all protocols submitted. The Building the Regulatory and Ethics Capacities of Rwanda (BRECOR) project brings together a number of competent partners with the aim of enhancing the available human and management infrastructural resources with a view to enabling them to effectively and meaningfully deliver its duties optimally. Overall, BRECOR aims at increasing the efficiency of the ethics and regulatory system in Rwanda. Specifically, BRECOR aims to: 1.    Strengthen the general ethics review system in Rwanda 2.    Develop strong clinical trial review capacity to ensure institutional ethics committees are able to carry out  high-quality review to emerging clinical trials efficiently 3.    Equip the NREC with an online ethics review system that will enable online submission, review and approval of the protocols 4.    Develop human and technical capacity for clinical trials inspection and monitoring through hands-on training of NREC and FDA inspectors by clinical quality assurance experts 5.    Establish a paperless information and document management system to ensure efficiency and effective management of RNEC through barcoding and digital archiving of all existing documents  6.    Strengthen the interaction, communication and information sharing between NREC, FDA and other ethics and regulatory stakeholders in Rwanda.
Network EDCTP2
Call Ethics and regulatory capacities 2018

Project partner

Number Name Role Country
1 Ministry of Health - Rwanda Coordinator Rwanda
2 Council on Health Research for Development Partner Switzerland
3 Pharma-Ethics (Pty) Ltd Partner South Africa
4 Pharmalys SARL Partner Senegal
5 Rwanda Biomedical Center Partner Rwanda