Kenya’s National Research-Ethics Framework: NACOSTI Accreditation and NCST Guidelines

Any institution conducting research on human participants in Kenya operates inside a national ethics-review system anchored by the National Commission for Science, Technology and Innovation (NACOSTI). NACOSTI does not review individual protocols itself. Instead, it accredits Institutional Scientific and Ethics Review Committees (ISERCs) at universities, research institutes, and hospitals, and those accredited committees carry out the actual ethical review before NACOSTI issues the research license or permit a study needs to proceed. This guide walks through how that system is built, where its founding ethics guidance comes from, and how the pieces fit together in practice.

The Legal Basis: NACOSTI and the Science, Technology and Innovation Act, 2013

NACOSTI’s authority to approve scientific research and accredit research institutions in Kenya comes from the Science, Technology and Innovation (ST&I) Act, 2013, section 6(1). Under this framework, any entity intending to establish or operate a research institute in Kenya must register with NACOSTI, and a registered institute is expected to maintain its own ethics review committee to oversee the ethical conduct of research carried out under its name. NACOSTI itself is Kenya’s national body responsible for regulating and assuring quality across the science, technology, and innovation sector and for advising government on related policy — accrediting ethics review committees and licensing research are two of the mechanisms through which it does that.

From NCST to NACOSTI: Where the Older Guidelines Come From

Kenya’s foundational human-participants research ethics document, the National Guidelines for Ethical Conduct of Biomedical Research Involving Human Participants, was issued in 2004 under the National Council for Science and Technology (NCST) — NACOSTI’s predecessor body. The ST&I Act, 2013 restructured Kenya’s national science governance and NACOSTI took on NCST’s regulatory functions, but the 2004 guidelines were not simply discarded: NACOSTI continues to host and reference them as part of the primary ethics guidance ISERCs and researchers are expected to apply, alongside the newer accreditation-specific guidance issued directly under NACOSTI. Anyone working from an older citation to “NCST guidelines” in a Kenyan ethics context is very likely referring to this 2004 document, now administered under NACOSTI rather than its original issuing body.

The National Science and Ethical Committee (NSEC)

Ethics-specific matters within NACOSTI are handled by the National Science and Ethical Committee (NSEC), which operates its own site at nsec.nacosti.go.ke. Per NSEC’s own published materials, its current mandate sits within NACOSTI’s broader goals of accrediting research institutions, approving scientific research, and assuring the quality and relevance of research programmes. NSEC’s stated functions include:

• Reviewing accreditation applications from institutions seeking to establish or renew an ISERC
• Conducting monitoring and evaluation of accredited ISERCs on an ongoing basis
• Reviewing protocols referred to it directly by NACOSTI
• Addressing ethical dilemmas that arise in the course of research
• Developing and periodically reviewing Kenya’s national research-ethics instruments and guidance documents
• Maintaining partnerships with other scientific and ethics bodies

NSEC’s own site material indicates its current structure and name date to a reorganization in November 2021, when an earlier, narrower biosafety-focused committee’s mandate was expanded into what is now NSEC. Institutions confirming committee history or governance detail for a specific submission should check NSEC’s own About Us and Mandate pages directly, since institutional-history detail like this is exactly the kind of thing that gets updated as committees evolve.

Institutional Scientific and Ethics Review Committees (ISERCs)

An ISERC is the Kenyan equivalent of what many other systems call an institutional review board (IRB) or research ethics committee (REC): a standing committee, based within a university, research institute, or hospital, that reviews research proposals involving human participants (or, depending on the institution, biomedical, biological, social-science, or environmental research more broadly) before that research can proceed. ISERCs review proposals for ethical clearance, and that clearance is a precondition for NACOSTI issuing the research license the study needs. In practical terms, an ISERC only has standing to issue that clearance if it is itself accredited by NACOSTI — an unaccredited institutional ethics committee’s approval does not substitute for the accredited-ISERC step in the national licensing chain.

How ISERC Accreditation Works

NACOSTI accredits ISERCs on the recommendation of NSEC, under the ST&I Act’s section 6(1) authority described above. Per NACOSTI’s own published accreditation page, the core requirements for an institution seeking initial accreditation or renewal are to:

• Submit the prescribed ISERC application form to NACOSTI
• Demonstrate adherence to NACOSTI’s Guidelines for Accreditation of Institutional Scientific Ethics Review Committees in Kenya, the accreditation-specific standards document NSEC maintains (available via nsec.nacosti.go.ke)

NACOSTI has also periodically published lists of assessment activity — for example, announcements of institutes and ISERCs it has recently assessed — on its own news pages, which gives a sense of accreditation as an ongoing, periodically renewed status rather than a one-time award. NACOSTI’s site also maintains a public list of currently accredited ISERCs. Because application forms, specific fee schedules, and processing timeframes are the kind of operational detail that changes without much notice, institutions preparing a submission should treat NACOSTI’s and NSEC’s own current web pages as the authoritative source rather than any static third-party summary, including this one.

The National Training Guide for Institutional Ethics Review Committees

Separately from the accreditation guidelines, NACOSTI hosts a National Training Guide for Institutional Ethics Review Committees, a resource aimed at building the review competence of ISERC members themselves — covering the kind of material a committee member needs to apply consistent ethical review standards once their committee is accredited. This sits alongside the 2004 National Guidelines for Ethical Conduct of Biomedical Research Involving Human Participants as part of the substantive ethics-guidance layer ISERCs are expected to apply, distinct from the accreditation-process layer that governs whether a committee is recognized to review at all.

How the Pieces Fit Together

Put together, a study involving human participants in Kenya typically has to clear review in this order:

1. The researcher’s home institution must have (or the researcher must otherwise access) an ISERC accredited by NACOSTI, which reviews the protocol against the National Guidelines for Ethical Conduct of Biomedical Research Involving Human Participants and any subject-specific guidance that applies.
2. The ISERC issues ethical clearance if the protocol meets those standards.
3. NACOSTI issues the national research license (or, for foreign researchers, a research permit), which depends on that prior ISERC clearance having been granted.

This two-layer structure — institutional ethics review, then national licensing — is the same basic shape used by many national research-governance systems, though the specific bodies and legal instruments involved are distinctly Kenyan. It is a separate track from Kenya’s medicines regulatory pathway: interventional clinical trials of pharmaceutical products in Kenya additionally require authorization from the Pharmacy and Poisons Board (PPB) under the Pharmacy and Poisons Act, which sits alongside, not instead of, the ISERC/NACOSTI ethics-and-licensing track. See CASRAI’s guide to Kenya Clinical Trial Authorization and the PPB Approval Pathway for how that second track works and how the two connect.

Practical Notes for Institutions and Researchers

• Confirm accreditation status before relying on a clearance. Because ISERC accreditation is periodically renewed rather than permanent, check NACOSTI’s current published list of accredited ISERCs rather than assuming a committee’s accreditation from a prior study is still active.
• Registration precedes review. A research institute generally needs to be registered with NACOSTI before it can establish and seek accreditation for its own ISERC.
• Foreign and collaborative research has extra steps. Non-Kenyan researchers and international collaborations should expect the national research-permit process to sit on top of, not replace, ISERC ethical clearance.
• Domain-specific committees are common. Larger institutions may run separate ISERCs (or ISERC subcommittees) for health/biomedical, social-science, and environmental research, since the ethical issues and required expertise differ meaningfully across those areas.

Frequently Asked Questions

Is NACOSTI the same body as the old NCST?

NACOSTI is the successor to the National Council for Science and Technology (NCST) following the Science, Technology and Innovation Act, 2013. Documents issued under NCST’s name, including the 2004 biomedical research ethics guidelines, remain part of the ethics framework NACOSTI now administers.

What is the difference between NSEC and an ISERC?

NSEC is a national committee within NACOSTI that sets accreditation standards, recommends which institutional committees should be accredited, and monitors them afterward. An ISERC is the institution-level committee — based at a specific university, research institute, or hospital — that actually reviews individual research protocols and issues ethical clearance.

Does ISERC ethical clearance replace the need for a NACOSTI research license?

No. ISERC clearance is a precondition NACOSTI expects to see before it issues the separate national research license or permit a study needs. They are sequential steps in the same overall process, not alternatives to each other.

Do the 2004 National Guidelines still apply, or has NACOSTI replaced them?

NACOSTI continues to host and reference the 2004 National Guidelines for Ethical Conduct of Biomedical Research Involving Human Participants as part of its current ethics guidance, alongside newer accreditation-specific guidelines issued directly under NACOSTI/NSEC. Institutions should check NACOSTI’s current document listings, since guidance documents of this kind are periodically reviewed and updated.

Where can I find the current list of NACOSTI-accredited ISERCs?

NACOSTI publishes and periodically updates a list of accredited ISERCs on its own website. Because accreditation is a renewed rather than permanent status, treat that current published list, not a cached or third-party copy, as the authoritative source.

Primary Sources

• National Commission for Science, Technology and Innovation — Accreditation of Institutional Scientific and Ethics Review Committees (ISERCs)
• NACOSTI — Accredited ISERCs in Kenya
• NACOSTI — National Training Guide for Institutional Ethics Review Committees (PDF)
• National Science and Ethical Committee — nsec.nacosti.go.ke, including its Mandate and Reports pages
• NSEC — Guidelines for Accreditation of Institutional Scientific Ethics Review Committees in Kenya (PDF)