Project: Zimbabwe Ethics and Regulatory Capacity Project

Acronym	ZERCaP (Reference Number: CSA2018ERC-2336)
Duration	01/10/2019 - 30/09/2022
Project Topic	The Zimbabwe Ethics and Regulatory Capacity Project (ZERCaP) will be implemented to strengthen ethics and regulatory functions of the Medical Research Council of Zimbabwe (MRCZ). After many years of inadequate funding from the state and donors, the country's health system, including oversight mechanisms for regulating research, have suffered neglect. Nevertheless, MRCZ has been limited by funding and challenges associated with an unstable economic environment. Today, Zimbabwe is changing, and in the near future, resources will become more available for regulatory institutions to fully implement their functions. The MRCZ secretariat is stabilising as a result, and staff attrition which characterised the last few years has stopped. MRCZ does not have a standardised and coordinated clinical trials and health research oversight system. For example, the current MRCZ mandate, which was enacted in 1974, requires review to align with the Health Act and Constitution. RECs are at various stages of developing Research Ethics Committees (RECs), and proposal submission systems remain manual. Tools used to develop proposals for ethical approval and for conducting monitoring site visits are not harmonised. With the current proposal, MRCZ seeks to strengthen ethical oversight capacity by: Ensuring that there is harmony in the policies and laws for health research and development oversight; updating and standardising tools for proposal development, ethical review, monitoring and oversight. This will entail closer collaboration between MRCZ and key institutions, such as the Medicines Control Authority of Zimbabwe (MCAZ) and key RECs at institutions of higher learning. Strengthening of a work programme for the new staff to better support RECs. This project will set the tone for MRCZ's modus operandi with RECs, which will lead to the establishment of at least three centres of excellence at REC level.    Establishing an electronic system for receiving, reviewing and approving clinical trials and other proposals for ethical review. This system will improve access to information on clinical trials, health research and development by ensuring that relevant aspects of studies are available on a searchable database. This linked database will be developed in liaison with MCAZ and RECs and feed a clearing house and online platform for sharing health research information. The proposed project will provide short term support needed to reinvigorate MRCZ to respond to both national and international challenges on clinical trials and health research oversight. The link with  MCAZ  who have  pharmacovigilance systems oversight, will ensure that researchers operate in a harmonised setting.
Network	EDCTP2
Call	Ethics and regulatory capacities 2018

Project partner

Number	Name	Role	Country
1	Medical Research Council of Zimbabwe	Coordinator	Zimbawe
2	Bindura University of Science Education	Partner	Zimbawe
3	Biomedical Research and Training Institute	Partner	Zimbawe
4	University of Zimbabwe	Partner	Zimbawe