The report describes relevant regulations, procedures, and actors in Kenya with regard to ethical standards in clinical trials involving human beings. It is based on the review of official documents and secondary information and on interviews with representatives from research institutes, pharmaceutical companies, civil society and others. As main ethical issues, respondents emphasized fair benefits for participants, post-trial treatment access and informed consent. Ethical aspects of all research protocols must be approved by the National Council of Science and Technology (NCST) or one of the three national research institutes with a standing NCST clearance and institutional Ethics Review Committee (ERC). Although in theory the application and clearance process is clear, limited coordination and communication among the NCST, individual research institutes, and different Ministries might cause substantial variation in review procedures. Furthermore, various respondents raised doubts about institutional capacity for ethical reviews. Some ERC members are also responsible for research programmes and may therefore experience conflicts of interest.