Kenya Profile Updated

The Kenya profile in ClinRegs has been reviewed and updated with the following information: 

• Updates to the National Guidelines for Ethical Conduct of Biomedical Research Involving Human Participants in Kenya (See Submission Content, and the Ethics Committee and Informed Consent topics)  

• Updates and clarifications provided by the Kenya Pharmacy and Poisons Board (See Submission Process, Safety Reporting, and IMP/IND Quality Requirements) 

Sources Added During this Update: 

(Guidance) Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards (G-WHO-DSMB) (2005) 
World Health Organization 

(Not Available Online) NIAID Communication with Pharmacy and Poisons Board (December 2021) (KEN-37) 

Sources Revised During this Update: 

(Guidance) National Guidelines for Ethical Conduct of Biomedical Research Involving Human Participants in Kenya (G-ECBiomedRes) (January 2020) 
National Commission for Science, Technology and Innovation