Project: Building Capacity for Research Ethics and Regulation in Zambia

Acronym	BUCARERZ (Reference Number: CSA2017ERC-1904)
Duration	01/09/2018 - 28/02/2021
Project Topic	Introduction: The capacity of Researchers, Research Institutions, Research Ethics Committees (RECs), and Institutional Review Boards (IRBs), in research ethics in general and in the conduct of clinical trials in particular is still weak in Zambia. The Zambia National Health Research Policy of 2010 identified capacity building in ethical conduct of research as a key priority and even proposed including research ethics in the training curricula of health workers. The overall health research regulatory body in Zambia is the National Health Research Authority (NHRA); under it is the National Health Research Ethics Board (NHREB) which regulates Research Ethics Committees (RECs) and Institutional Review Boards (IRBs). There are a number of RECs and IRBs in Zambia and some more are being formed. The capacity of the above regulatory bodies in ethical review remains inadequate. The NHRA, though managed by a team of experienced researchers, require most of its technical staff to be trained in research ethics and good clinical practice (GCP) in general. One of the key roles of the NHRA is to build the research capacity (including ethics) of researchers, research institutions, RECs, IRBs. It is therefore necessary that its technical staff be well trained in all aspects of research ethics. The NHREB is composed of members from various disciplines who have just received basic orientation to research ethics; these members need to undergo more intense training in research ethics in order to improve the quality of their ethical review and their oversight and supervision of various RECs and IRBs in the country. Overall Goal: To support Zambia to establish and develop robust national medicines regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies for use in humans. Methodology: NHRA proposes to undertake a number of capacity building activities in order to achieve this goal that include training of NHRA/NHREB and ZAMRA staff in regulations and quality assurance systems to serve as trainer of trainers. The capacity building program will include training of trainers locally and at an international site, training of researchers at selected institutions and RECs/IRBs, supportive supervision, mentorship as well as through networking events. NHRA will facilitate local and national networking meetings among RECs/IRBs and Researchers in order to enhance collaboration and strengthening of networking and sharing of good practices. NHRA will also facilitate transnational collaborations involving regional networking activities with partners such as the African Medicines Regulatory Harmonisation Programme (AMRH).
Network	EDCTP2
Call	Ethics and regulatory capacities 2017

Project partner

Number	Name	Role	Country
1	National Health Research Authority	Coordinator	Zambia