Project: Enhancing the Regulatory and Ethics Capacities in Swaziland

Acronym	ERECIS (Reference Number: CSA2018ERC-2316)
Duration	01/09/2019 - 31/08/2022
Project Topic	The Kingdom of eSwatini, formerly known as Swaziland’s Ministry of Health, has been active in the area of research ethics through informal committees since 2006. The Ministry has over the years progressively developed capacity to review ethical and scientific soundness of research that involves human participants in the country. The capacity which is being referred to includes institutional structures, policies and guidelines for protecting human research participants. Policies and guidelines include the under-listed key guiding documents: a national research policy and strategic plan; national health research agenda; national guidelines for researchers and standard operating guidelines and currently developing guidelines for reviewers.While some progress has been made in establishing a culture and capacity to ensure the protection of human participants in health research in the country, there are still several areas of need. These areas include; lack of a dedicated budget for the Board, lack of national Health Research Ethics Framework, lack of legislation, lack of guidelines and capacity to review clinical trials protocols, lack of guidelines and capacity to monitor approved studies. There is also lack of training for the chairpersons and secretariat staff on administration of Review Board business. The capacity for academic institutions to conduct research ethics review has not been ascertained.Enhancing the Regulatory and Ethics Capacities in Swaziland (ERECIS) aims to build the operational and technical capacity of the National Health Research Review Board (NHRRB), the Medicine Regulatory Authority (MRA) and related institutions to ensure adequate protection of human research participants in the Kingdom of eSwatini. Specifically, ERECIS aims at: -Goal 1 - Building a robust and efficient operational and technical system for clinical research ethics regulatory and oversight in the kingdom of eSwatini, through developing responsive research regulatory and ethics review frameworks, policies and guidelines and equipping the NHRRB office with furniture and equipment, to enable it to function optimally.Goal 2 - Developing high-level clinical trial review capacity to ensure accredited IRECs will be able to rapidly review complex clinical trials and emerging epidemics.Goal 3 - Building high-level capacity to monitor approved clinical trials and ensure implementation of research studies in line with approved protocols by offering training in project and clinical trials management.   Goal 4 - Digitalising the regulatory and ethics review process in eSwatini by installing the RHInnO Ethics package at three Institutional Research Committees that review clinical trials and the NHRRB, in order to harmonise and enhance efficiency and quality of review.
Network	EDCTP2
Call	Ethics and regulatory capacities 2018

Project partner

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