Project: Strengthening research ethics review and oversight in Kenya

Acronym	STREK (Reference Number: CSA2017ERC-1857)
Duration	01/11/2018 - 31/10/2021
Project Topic	The National Commission for Science, Technology and Innovation (NACOSTI), which accredits research ethics committees (RECs) in Kenya, through its National Bioethics Committee (NBC) to date have to date accredited 25 RECs, up from 5 in 2009. This means that most RECs are new and lack the necessary training and experience to efficiently carry out their duties. Here, we propose to support NACOSTI to establish systems to enable it to provide the necessary research ethics oversight, and to train and provide mentorship for to REC members to efficiently review research proposals for better protection of research participants in Kenya. Our aims in this regard will be to: 1) Improve the efficiency of NBC in providing research ethics oversight in Kenya; and 2) Strengthen the capacity of NBC and REC members in ethical review and oversight of health research. To improve the efficiency of NBC we will assist it to develop its strategic plan with clear strategic objectives and deliverables to streamlining its operations, and review its standard operating procedures (SOPs) and guidelines to improve efficiency. We will also upgrade NBC ICT infrastructure for efficient reporting, consultations and supervision of RECs and create a web database of REC members, for networking and consultation among them. To improve the capacity of NBC and REC members in ethical review and oversight in health research, we will develop a research ethics training package and use it to train at least 120 members by the end of the grant period; and establish a structured mentorship programme for REC members consisting of practicums at mentorship sites. At the end of the grant period, 22 REC members will have undergone the mentorship programme. In the last year of the grant, NACOSTI will organize a research ethics conference to facilitate networking between established and newer RECs for benchmarking, experience sharing and learning. Invitations will be extended to other National Bioethics Committees in the Eastern Africa Region and its members, and at least one EU-member state. The aims of our proposal are in line with the objectives of EDCTP2 of strengthening scientific capacity for clinical trials in endemic countries, which has research ethics as one of its component. This will enhance the conduct of phase 2 and 3 clinical trials in multicentre and multinational sites required due to the large number of study participants needed. The proposal also supports EDCTP2 requirements that clinical trials be carried out in full compliance with internationally recognised ethical principles.
Network	EDCTP2
Call	Ethics and regulatory capacities 2017

Project partner

Number	Name	Role	Country
1	University of Nairobi	Coordinator	Kenya
2	National Commission for Science, Technology and Innovation	Partner	Kenya