Project: Strengthening the Regulatory and Ethics Capacity in Ghana

Acronym	STREC-Ghana (Reference Number: CSA2018ERC-2334)
Duration	01/11/2019 - 31/10/2022
Project Topic	The last decade has seen an unprecedented increase in local and international clinical research initiatives. As a country that is situated only a few miles away from some of the countries hit by the recent Ebola outbreak, Ghana remains extremely vulnerable to the deadliest infectious disease in history. This calls for the need to strengthen the regulatory and ethics capacity of Ghana to optimise research participants’ protection and promote high-quality research. Ghana currently has 17 accredited Research Ethics Committees (RECs). The Council for Scientific and Industrial Research (CSIR-Ghana) is the body that is legally mandated to coordinate and regulate scientific research nationally. On the other hand, the Food and Drugs Authority (FDA) has the overall mandate to coordinate, approve and certify all clinical trials. (http://www.ccghr.ca/resources/harmonisation/ghana/ghana-research-ethics/). Although Ghana is reputed for having one of the best clinical trials regulatory systems in Africa, (in terms of legal framework, guidelines and human capacity) and designated as a Regional Centre of Regulatory Excellence (RCORE), there are still some gaps in regulation, which may probably be due to ineffective coordination between research institutions, Research Ethics Committees (RECs) and the FDA. There is therefore a need to strengthen coordination between the various stakeholders while enhancing capacity ie. continuous capacity building. STREC-Ghana consortium is a collaboration between CSIR-Ghana, FDA Ghana, Council on Health Research and Development (COHRED), Pharmalys and Pharma Ethics. The aim of STREC-Ghana is to strengthen the regulatory and ethics capacity of Ghana by carrying out a systematic assessment of the regulatory, ethics and structural capacity of Ghana to identify key gaps and come up with sustainable solutions for the gaps identified. An all-inclusive participatory approach, drawing on tested technological approaches will be used. Through this multidisciplinary partnership, we specifically hope to: Use a stakeholder participatory approach to review the existing regulatory and ethics capacity situation in Ghana in order to identify key gaps that need to be addressed Use the gaps identified to establish a responsive research and ethics regulatory system in the country with a view to strengthening the general ethics review system in the country Provide specialised and targeted-high level clinical trial review training to those involved in coordination, regulation and monitoring of clinical trials and Develop efficiency of the clinical trials portfolio by implementing a tested and proven online ethics review system in the country.
Network	EDCTP2
Call	Ethics and regulatory capacities 2018

Project partner

Number	Name	Role	Country
1	Council for Scientific and Industrial Research	Coordinator	Ghana
2	Council on Health Research for Development	Partner	Switzerland
3	Food and Drugs Authority Ghana	Partner	Zambia
4	Pharma-Ethics (Pty) Ltd	Partner	South Africa
5	Pharmalys SARL	Partner	Senegal