Clinical trials in Kenya are an essential mechanism for developing new medicines, vaccines, medical devices, and treatment protocols to address the health challenges facing Kenya and the broader African continent. Kenya’s strong research infrastructure, significant disease burden, and relatively experienced regulatory environment have attracted international sponsors seeking to conduct multi-centre trials in Africa, though the multi-body approval process, spanning ethics review, PPB authorisation, NACOSTI licensing, and county-level clearance, is more involved than sponsors accustomed to single-regulator jurisdictions often expect. Understanding the regulatory and ethical framework for clinical trials in Kenya is critical for sponsors, investigators, and research institutions involved in or planning to conduct clinical research in the country.
Clinical Trials in Kenya: The Regulatory Framework and Governing Bodies
Clinical trials in Kenya are regulated primarily by the Pharmacy and Poisons Board (PPB) under the Pharmacy and Poisons Act (Cap 244), which has jurisdiction over trials of medicinal products. The Kenya Medical Research Institute (KEMRI), established under the Science and Technology Act, is the primary national research institution and operates several research centres that conduct clinical trials in partnership with international sponsors. The Kenya National Commission for Science, Technology and Innovation (NACOSTI) provides overarching oversight of scientific research in Kenya. The Science, Technology and Innovation Act, No. 28 of 2013 requires all research involving human subjects to be licensed by NACOSTI. PPB and ethics committee review are sequential, not parallel: ethics committee approval must be secured first, and only then can the sponsor apply to the PPB for clinical trial authorisation. A common planning mistake is submitting to both bodies at once to save time, which does not work and can require the PPB application to be resubmitted once ethics approval is confirmed.
Ethical Review Requirements
No clinical trial involving human subjects may be conducted in Kenya without prior approval from a duly constituted ethics review committee. The principal ethics review bodies in Kenya include the KEMRI Scientific and Ethics Review Unit (SERU), the Kenyatta National Hospital/University of Nairobi Ethics and Research Committee (KNH/UoN-ERC), the Aga Khan University Hospital Research Ethics Committee, and various institutional review boards (IRBs) at accredited research institutions.
Ethics committees review clinical trial protocols for scientific merit, ethical soundness of the study design, adequacy of the informed consent process, protections for vulnerable populations such as children, pregnant women, and prisoners, and the appropriateness of the risk-benefit balance for trial participants. All ethics committees in Kenya must be registered with NACOSTI and operate under the Kenya National Research Ethics Framework.
PPB Clinical Trial Authorisation
For trials of medicinal products, including pharmaceuticals, biologics, and vaccines, the sponsor must submit an application for clinical trial authorisation to the Pharmacy and Poisons Board. The application includes the trial protocol, the investigator’s brochure, the proposed informed consent documents, the CV and qualifications of the principal investigator, details of the trial site and its facilities, safety monitoring arrangements, and evidence of ethics committee approval.
The PPB reviews the application and may request additional information or modifications to the protocol before granting authorisation. Conducting a clinical trial of a medicinal product without PPB authorisation is a serious offence under the Pharmacy and Poisons Act. The PPB monitors ongoing trials through interim safety reports, serious adverse event notifications, and periodic site inspections.
Site-level approvals are also required at the county level under Kenya’s devolved health system, since county health departments have their own authority over research conducted within health facilities they administer; sponsors planning a multi-site trial should map out county-level requirements for each site early, since these run in parallel with, not instead of, the national PPB and NACOSTI processes and are a common source of site start-up delay if left until after national approvals are secured.
Informed Consent
Informed consent is the cornerstone of ethical clinical research. In Kenya, the informed consent process must ensure that potential participants fully understand the nature of the trial, its risks and potential benefits, the voluntary nature of participation, and their right to withdraw at any time without consequence. The consent form must be available in the participant’s language and, where the participant is illiterate, must be read aloud with an independent witness present.
Special provisions apply for trials involving minors, parental or guardian consent is required in addition to the child’s assent where the child is of sufficient maturity, and for trials involving cognitively impaired participants where a legally authorised representative must provide consent on their behalf. For trials conducted in rural or community settings, Kenyan ethics committees frequently also expect evidence of prior community engagement, such as consultation with local administration or community health structures, in addition to individual informed consent, since a purely individual consent process can be seen as insufficient where the trial affects a community’s relationship with the health system more broadly.
Clinical Trial Agreements and Indemnification
International sponsors conducting trials at Kenyan sites must enter into clinical trial agreements with each site institution governing the sponsor’s obligations including supply of investigational products, payment of site costs, training of investigators, provision of insurance and indemnification for trial participants who suffer harm as a result of participation, and publication rights. Adequate insurance coverage and indemnification arrangements for trial-related injuries are an ethical and regulatory requirement, and the clinical trial agreement should specify clearly whether the sponsor’s indemnity covers only injuries directly caused by the investigational product or extends more broadly to procedural injuries arising from trial participation, since site institutions and sponsors frequently start from different assumptions on this point and it is better resolved in the contract than after an incident occurs.
Data Privacy in Clinical Research
Clinical trial data in Kenya is subject to the Data Protection Act 2019, covered in more depth in our guide to data protection compliance in Kenya. Research participants are data subjects whose personal health data is sensitive personal data under the Act. Sponsors and investigators must ensure that data collection, storage, transfer, and use comply with the DPA 2019, including the requirements for explicit consent, data minimisation, security safeguards, and international data transfer agreements where data is transferred offshore to the sponsor’s home country.
Information on the KEMRI Scientific and Ethics Review Unit and clinical research requirements is available from the Kenya Medical Research Institute.
For legal advice on clinical trial regulatory approvals, ethics committee submissions, clinical trial agreements, indemnification structures, and data protection compliance in Kenya, consult our life sciences and healthcare legal services team. Our regulatory and compliance advisory practice assists research sponsors and institutions from our offices at Nextgen Mall, Nairobi. The broader regulatory framework is covered in our guide to healthcare regulation in Kenya.
