HATUA – KENYA
HATUA – ENABLING COMPLIANCE AND BUILDING CAPACITY AND COMMUNITY FOR CLINICAL RESEARCH IN KENYA (HATUA – KENYA)
HATUA is a project funded by European & Developing countries Clinical Trials Partnership (EDCTP). The core institutions engaged in undertaking this project include: the Kenya Medical Research Institute (KEMRI), the National Commission for Science, Technology and Innovation (NACOSTI), the Pharmacy and Poisons Board (PPB), Synergy Informatics, intelliSOFT Consulting and the Council of Health Research for Development (COHRED). In addition, the
Project will engage local private and public universities and the Bioethics Society of Kenya (BSK).
The HATUA Project focuses on improving the 3 C’s in research namely: 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).
GOALS to be achieved through HATUA
- Support the registration of all researching institutions and create a database of individuals engaged in research in accordance with the law – STI Act No. 28 of 2013.
- Enable pharmacovigilence reporting mechanism at PPB to review or assess safety data from clinical trials in real time.
- Build the capacity of Institutional Ethics Review Committees (IERC) , NACOSTI, and PPB for regulation/ethics review, research administration and pharmacovigilance
- Stimulate pubic engagement, community and stake holder literacy in bioethics and research particularly in clinical trials.
PPB will provide guidance with
respect to clinical trials.
i. Develop the platform that facilitates communication between the IREC and the PPB when clinical trials are approved.
ii. Develop online submission system for adverse events for ongoing clinical trials
Will provide strategic direction for
implementation of the project.
Will develop an online platform for registration of research institutions and researchers: the Researchers and Institutions Registration System (RIRS)
Will provide technical support to implement the RHInnO Ethics (online based submission and review system) at both theNational Bioethics Committee (NBC) and the IERC levels.
Will develop and implement appropriate
workshops targeting those providing administrative support to IERCs and building
capacity for NACOSTI, PPB and the IERC.