KEMRI’s Streamlined Research Regulation Pathway Ensures Safety & Compliance.

The pathway for the approval and oversight of human health research in Kenya follows a linear process, ensuring thorough review and compliance at multiple levels. At the forefront of this process is the Kenya Medical Research Institute (KEMRI), where the journey begins with the Center Scientific Committees (CSCs). Following the initial review by the CSCs, research proposals are then evaluated by the Scientific and Ethics Review Unit (SERU). For studies involving animals, the Animal Care and Use Committee (ACUC) steps in to ensure ethical standards are met. Clinical trials are subject to additional scrutiny by the Pharmacy and Poisons Board (PPB).

Subsequent to these evaluations, the National Commission for Science, Technology and Innovation (NACOSTI) provides further oversight, ensuring that all scientific and ethical standards are upheld. Finally, county approvals or approvals from specific institutions are obtained to complete the process. It is important to note that the review turnaround time (TAT) and approval timelines can vary significantly depending on the level of review and the specific institution involved. This comprehensive and multi-layered approach ensures that all human health research conducted in Kenya adheres to rigorous ethical and scientific standards.

The following diagram illustrate the sequential nature of research approval and oversight in Kenya:

1. Center Scientific Committee
   Most research centers in KEMRI have established Center Scientific Committees that review and approve research proposals prior to ethical clearances. This is an important step in the improvement of the quality of research. At the center, which serves as a peer review system, a research protocol receives the scientific rigor it deserves due to the availability of subject matter experts. All investigators intending to carry out research must submit and get approval at the CSC before onward transmission to SERU. The KEMRI SERU continues to receive proposals from the CSCs domiciled in the following centers: Centre for Global Health Research (CGHR), Center for Infectious & Parasitic Diseases Control Research (CIPDCR), Centre for Geographic Medicines Research-Coast (CGMRC), Centre for Vector Diseases Control (CVDC), Centre for Clinical Research (CCR), Centre for Biotechnology Research & Development (CBRD), Center for Virus Research (CVR), Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC), Center for Traditional Medicine & Drugs Research (CTMDR), Center for Public Health Research (CPHR), Center for Respiratory Diseases Research (CRDR), and Center for Microbiology Research (CMR). The upcoming centers like Center for Disease Control and Surveillance (CDCS) in Mandera, Center for Community Driven Research (CCDR) in Kirinyaga, Sports Science Research Center (SSRC) in Eldoret are encouraged to submit research proposals for review at SERU for ethical clearance once the process of CSC establishment is completed.

2. Animal Care and Use Committee.
   The One Health approach focuses on the interaction between humans, animal and environment. The intention is to address diseases, particularly the ones that are spread from animals to humans. Animal Care and Use Committee (ACUC) undertakes review of protocols involving animals prior. Researchers are required to submit a protocol (involving animals) to the KEMRI ACUC before submitting it to SERU for further review. Approval letter from KEMRI ACUC should be obtained before the application is submitted to SERU.

3. Scientific and Ethical Clearance.
   The KEMRI’s Scientific and Ethics Review Unit (SERU) Committee operates in full compliance with the Kenyan National Commission for Science, Technology and Innovation (NACOSTI/NBC/AC/0112, Valid until 14th March 2027) policies and as outlined in KEMRI’s research policy. The KEMRI SERU Committee also fulfils the US Food and Drug Administration (FDA) regulations for the protection of research participants as defined in 45 CFR (Code of Federation Regulations) part 46 for US federal funded studies only. The KEMRI SERU’s federal wide assurance number are as follows: (FWA00002066- Valid until 1st November 2029 and IORG0006771 Valid until 30th June 2025). As an active applicant for research, research-training, or research related grants or cooperative agreements under the United States Public Health Service (USPHS) Act, KEMRI maintains misconduct in science assurance with the US Office of Research Integrity (ORI). The purpose of the KEMRI SERU is to facilitate research with human participants and to protect their interests, rights and welfare. It was inaugurated in April 2014 after the culmination of a restructuring journey that begun in 2010. SERU reviews research submissions from KEMRI and non -KEMRI researchers interested in conducting human health research in Kenya. The KEMRI SERU ensures that all proposals adhere to scientific and ethical principles that are fundamental to the conduct of research involving human participants. The SERU is composed of a secretariat and three distinct review committee A, B and C. Each committee meets monthly to review, discuss and approve or disapprove proposals submitted.

4. Pharmacy and Poisons Board Clearance.
   As the National Medicines Regulatory Authority for Kenya, Pharmacy and Poisons Board (PPB) has the responsibility of regulating all clinical trials taking place in the country. This is done through Expert Committee on Clinical Trials (ECCT). Clinical Trials are important in the process new medicines discovery. Such medicines could be for diagnosis, treatment, management or prevention of diseases and conditions affecting humans. Clinical trials are also helpful in determining dosage, indications, or even the age group of medications. The PPB through the ECCT reviews the protocol and provides continuous oversight of approved clinical trials. Clinical Trial Applications (CTAs) are submitted, and clearances received online.

5. Research Licensing at NACOSTI.
   Section (12) of the Science, Technology and Innovation (STI) Act, No. 28 of 2013, Revised in 2014 provides the requirement for license to undertake research in Kenya. Specifically, section 12 (1) states that subject to the provisions of any other law, a person shall not undertake scientific research in Kenya without obtaining a license under this Act. Consequently, after obtaining ethical clearance from an accredited Institutional Scientific and Ethics Review Committee, all researchers are required to obtain a research license from the NACOSTI. The license is valid for one (1) year from the date of issuance. Application for a Research License is submitted and received online.

6. Counties and Institutions
   The Constitution of Kenya (2010) established forty-seven (47) county governments. County Health Departments in some counties provide approvals before any research can be conducted within their geographical boundaries. Researchers are also expected to obtain authorization to access institutions where they will conduct their studies. Institutions like hospitals, learning institutions, and correctional facilities will require authorizations.

Important links for more information:

1. KEMRI SERU webpage: https://www.kemri.go.ke/scientific-ethics-review-unit-seru/#1570435256840-7e2fb50a-b1f8
2. PPB, Online Clinical Trials System: https://ctr.pharmacyboardkenya.org/
3. NACOSTI Research Information Management System: https://research-portal.nacosti.go.ke/