NSERS is Kenya’s national framework for the ethical oversight of research. It brings together the National Scientific and Ethics Committee (NSEC); a national advisory committee to NACOSTI and the network of Institutional Scientific and Ethics Review Committees (ISERCs) accredited by NACOSTI across the country.

NSEC is a national-level committee that advises NACOSTI on research ethics policy, provides expert review of ISERC accreditation applications, and reviews complex protocols referred to it. ISERCs are institution-level committees, accredited by NACOSTI, that conduct day-to-day ethics review of research protocols at their host institutions.

Institutions apply to NACOSTI through the accreditation process set out in the ISERC Accreditation Guidelines. This includes submission of an application form, the committee’s Standard Operating Procedures, member CVs and other supporting documents. Applications undergo pre-screening, a physical assessment visit, a mentorship period, and a review before accreditation is granted. See the Apply for Accreditation page for full details.

Clinical trials in Kenya require review by an ISERC specifically accredited for that purpose.  See the Directory of ISERCs Accredited for Clinical Trials. Clinical trials also require separate regulatory approval from the Pharmacy and Poisons Board (PPB).

Non-clinical research protocols are reviewed by any of the ISERCs accredited by NACOSTI. Researchers typically submit to the ISERC at their host institution. See the Directory of NACOSTI-Accredited ISERCs.

Timelines vary depending on the completeness of the application and the assessment cycle. Following submission, the application is pre-screened, an expert assessment committee is constituted and conducts a physical assessment visit, and a mentorship period follows before the accreditation decision. Institutions should plan for the process to extend across several months.

Fees are prescribed by the Commission and published in NACOSTI’s fee schedule. 

Accreditation is granted for a period of three years. Institutions must apply for renewal at least six months before expiry. The renewal process follows the same steps as initial accreditation.

Concerns may be reported in confidence to the NSEC Secretariat at nsec@nacosti.go.ke. NSEC takes all concerns seriously and follows up in line with NACOSTI’s institutional procedures.

NSEC does not review individual protocols by default, protocol review is the function of accredited ISERCs. NSEC may review protocols specifically referred to it by NACOSTI, typically for research raising novel ethical questions or where an ISERC is not yet available in the relevant area.