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

  1. 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.
  2. Enable  pharmacovigilence reporting mechanism at PPB   to review or assess safety data from  clinical trials in real time.
  3. Build the capacity of Institutional Ethics Review Committees (IERC) , NACOSTI, and PPB  for  regulation/ethics review, research administration and pharmacovigilance
  4. Stimulate pubic engagement, community and stake holder literacy in bioethics and research  particularly in clinical trials.
Hatua KENYA

Pharmacy and Poisons Board

PPB will provide guidance with
respect to clinical trials.

IntelliSOFT Consulting

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

National Commission For Science, Technology & Innovation

Will provide strategic direction for
implementation of the project.

Synergy Informatics Ltd

Will develop an online platform for registration of research institutions and researchers: the Researchers and Institutions Registration System (RIRS)

Council on Health Research for Development

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.

Bioethics Society of Kenya

Will develop and implement appropriate
workshops targeting those providing administrative support to IERCs and building
capacity for NACOSTI, PPB and the IERC.

CONTACT INFORMATION

Phone: +254737041739
Email: hatua@rctp.or.kehatuakenya18@gmail.com