Project: Scaling up of capacity of Research Ethics Committees in Uganda

Acronym	SCRECU (Reference Number: CSA2018ERC-2315)
Duration	01/10/2019 - 30/09/2021
Project Topic	The overarching goal of this proposal is to scale up sustainable capacity for the clinical trials information management systems (CRIMS) for effective research ethics committee (REC) review process, facilitate multiple REC review, national registration and subsequent monitoring of approvals in Uganda. In Uganda complex clinical research is a growing phenomenon, but the capacity of the RECs to effectively use CRIMS to manage such research has lagged behind. As new medical drugs, interventions and devices are being studied, the emergence of new, re-emergence of once forgotten and persistence of neglected diseases all combine into a challenging alliance to the country’s capacity to regulate and monitor research appropriately. Over the last decade there are noticeable progressive impacts of the steady investments in research safety culture through the initiatives by the Uganda National Council for Science and Technology (UNCST) and its accredited and registered institutional RECs countrywide. These agencies need to be abreast with the bulk of research reviews, quality of review, as well as monitoring of research according to the stipulated research and ethics guidelines, locally and internationally. Furthermore, there is a growing problem of coordination of submission of research to multiple ethical regulatory authorities including RECs, UNCST, National Drug Authority and the Office of the President, especially for international research before they can commence their activities in Uganda. This process is usually slow, time consuming and therefore costly, much to the discouragement of not only researchers who often have tight deadlines to meet, but also to research development in the country. Furthermore, most researchers lack information on who should review protocols in Uganda. Through the Consortium for Clinical Research Regulation and Ethics Capacity Development in Uganda (CREDU) project funded in 2017 by the European & Developing Countries Clinical Trials Partnership [CSA2015ERC-863]; a need for CRIMS in Uganda was well supported by the needs assessment conducted across various levels of the regulatory chain in Uganda. However, the CREDU Project’s mandate is up to the CRIMS’ proof of concept. Through this application we therefore aim to build the capacity for RECs to effectively implement CRIMS so as to harmonise standards and improve on the quality of the in-country research approval process across all regulatory agencies via an online platform for review, registration and approval of clinical trials. Moreover, we have nested a study to evaluate effectiveness of CRIMS in these settings so as to inform guidelines on ethical processes in Uganda.
Network	EDCTP2
Call	Ethics and regulatory capacities 2018

Project partner

Number	Name	Role	Country
1	Uganda National Council for Science and Technology	Coordinator	Uganda
2	Busitema University	Partner	Uganda
3	Mbale Regional Referral Hospital	Partner	Uganda