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).

Hatua Kenya endeavors to:-

  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.
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This project is part of the EDCTP2 programme supported by the European Union.