Project: HATUA - Enabling Compliance And Building Capacity And Community For Clinical Research In Kenya

Acronym	HATUA-KENYA (Reference Number: CSA2016ERC-1418)
Duration	01/04/2018 - 31/03/2022
Project Topic	Healthcare research remains a fundamental global need. Within the context of new and re- emerging infections, environmental degradation and changes in life style and diet, the determination of causes of disease or ill health is important. Innovation for management of poor health and improving health outcomes is core for biomedical, social and behavioural research for health. Regulation of clinical trials at National and institutional levels vary greatly in Low and Middle income Countries (LMIC) like Kenya. Without adequate systems and infrastructure, such systems could be prone to abuse or manipulation, prove bureaucratic and inflexible, or be inadequate to meet the research needs for the volume and complexity of research proposals submitted. To improve the Kenyan National regulatory systems to handle the increasing volume of research, this project will increase the technical capacity of support for the Kenyan regulatory bodies and selected high volume accredited Institutional Research Ethics Committees (IRECs). The goal is to improve the oversight function at both the National level, improve competence at the institutional level, and facilitate communication between regulators and the IRECs and lastly to provide opportunity for sharing of best practices and networking by building a community of support and learning. This project can be described by 3 C’s: Compliance (improving functions for oversight of clinical trials), Capacity (building technical capacity through training in bioethics, pharmacovigilance, clinical monitoring and research administration) and Community (build a network for sharing and a community of best practices through seminars conferences and online consultation). COMPLIANCE: A capacity needs assessment was conducted to inform development of an online based system at both national and institutional level. Plans are underway to install PvERS and CTR systems at PPB. This will allow for effective communication and data sharing between PPB as the clinical trial regulators and accredited IERCs to ensure achievement of compliance. Installation of RIRS at NACOSTI will allow for registration of all researchers and research institutions in Kenya. This will provide the opportunity to regulate research and minimise the possibility of unregistered institutions or those who do not seek research clearance. The RHInn0 Ethics system is an online based protocol submission and review system that will be installed at both institutional and national level. This system will increase efficiency within IERCs and improve communication with the national regulators. The three electronic systems at both national and institutional level will improve research regulatory oversight. CAPACITY: To build technical capacity at national and institutional level, the project is currently supporting six students pursuing online training in Master’s in Bioethics. Two of the students at Trinity International University are both committee members for the KEMRI Scientific and Ethics Review Unit. Four students are at Anahuac University Mexico, all of whom have ERCs at their institutions. In addition to the long term training, we are developing a short term curriculum targeting research administrators and the IERC secretariat to equip them with skills and knowledge for efficiency support of IERC offices. COMMUNITY: BSK in collaboration with the HATUA project held a workshop on 9 - 10 November 2018. The theme for the workshop was “The Ethics of Universal Healthcare”. The 3rd Annual BSK conference was held on the 15 and 16 March 2019. The conference theme was “Contemporary ethical challenges”. In addition, HATUA Project in collaboration with BSK also held three Bioethics cafes in three different institutions in Kenya including; Pwani University, Egerton University and Technical university of Mombasa aimed at increasing awareness in bioethics.
Network	EDCTP2
Call	Ethics and regulatory capacities 2016

Project partner

Number	Name	Role	Country
1	Kenya Medical Research Institute	Coordinator	Kenya
3	Council on Health Research for Development	Partner	Switzerland
4	IntelliSOFT Consulting Limited	Partner	Kenya
5	National Commission for Science, Technology and Innovation	Partner	Kenya
6	Pharmacy and Poisons Board	Partner	Kenya
7	Synergy Informatics Ltd	Partner	Kenya