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KEMRI, the Kenya Medical Research Institute, is Kenya’s national body for human-health research. It runs research through a network of named centres and thematic programmes, and it operates the Scientific and Ethics Review Unit (SERU) — the committee that reviews and approves health-research protocols, including protocols from researchers who have no KEMRI affiliation at all.
If you are an external collaborator, the two facts that matter most are these. First, SERU reviews non-KEMRI protocols, so it is a route open to you, not an internal-only committee. Second, SERU approval and a NACOSTI research permit are two different requirements and most external collaborators need both, in that order. This page covers the centre structure, the SERU route with its real fees and timelines, and how the two approvals fit together.
A note on the acronym: which SERU this is
“SERU” in this page always means KEMRI’s Scientific and Ethics Review Unit. There is an entirely unrelated SERU in scholarly publishing — NISO’s Shared Electronic Resource Understanding, a recommended practice for licensing electronic resources between libraries and publishers. The two have nothing to do with each other, and searching for one will surface the other. This page is about the Kenyan research-ethics body only.
One further wrinkle worth knowing before you go looking: KEMRI’s own site labels the unit inconsistently. The site navigation menu reads “Scientific Ethics Review Unit (SERU)” and the page URL is scientific-ethics-review-unit-seru, but the body text of that same page, the unit’s own letterhead and its postal address all read “Scientific and Ethics Review Unit”. The longer form with “and” is the one the unit uses for itself; the menu label simply drops the conjunction. Use the full form in correspondence and cite it that way in your protocol.
What KEMRI is, and the law behind it
KEMRI is a Kenyan State Corporation, not a university and not a government ministry. Its own account of its legal basis, given on both the institute homepage and the SERU pages, is:
- Established in 1979 through the Science and Technology (Amendment) Act, Cap 250 of the Laws of Kenya (the homepage describes this as the Science and Technology (Repealed) Act), as the national body responsible for carrying out research in human health in Kenya.
- That 1979 Act has since been superseded by the Science, Technology and Innovation Act, 2013 — the same statute that establishes NACOSTI.
- KEMRI states that it currently operates under Legal Notice No. 35 of March 2021.
That shared statutory parent is not a trivia point. Because KEMRI and NACOSTI both sit under the Science, Technology and Innovation Act 2013, the ethics-approval and research-permit tracks described below are two limbs of one national framework rather than two unrelated bureaucracies — which is exactly why you are expected to satisfy both.
KEMRI’s motto, in case you meet it in institutional correspondence, is “In Search of Better Health”.
KEMRI’s research centres
KEMRI organises its science through named centres, most of which carry a location and an acronym. Knowing which centre owns your disease area matters practically: your KEMRI collaborator will sit in one of them, the centre’s own scientific committee performs the first tier of review for KEMRI-led protocols, and SERU assigns compliance officers by centre.
The centres listed on KEMRI’s own site, accessed August 2026, are:
- Centre for Global Health Research (CGHR) — Kisumu
- Centre for Clinical Research (CCR) — Nairobi
- Centre for Traditional Medicine and Drug Research (CTMDR) — Nairobi
- Centre for Virus Research (CVR) — Nairobi
- Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC) — Nairobi
- Centre for Infectious and Parasitic Diseases Control Research (CIPDCR) — Busia
- Centre for Respiratory Diseases Research (CRDR) — Nairobi
- Centre for Microbiology Research (CMR) — Nairobi
- Centre for Community Driven Research — Kirinyaga
- Centre for Public Health Research (CPHR) — Nairobi
- Centre for Biotechnology Research and Development (CBRD) — Nairobi
- Centre for Disease Control and Surveillance — Mandera
- Centre for Vector Diseases Control — Kwale
- Sports Science Research Centre (SSRC)
One discrepancy to be aware of. KEMRI’s site footer lists its regional offices, and that list includes the Centre for Geographic Medicine Research, Coast (CGMRC) at Kilifi — the base of the long-running KEMRI–Wellcome Trust Research Programme — which does not appear in the centres navigation menu. We have not been able to establish from KEMRI’s own published pages whether CGMRC is currently constituted as a centre under a different heading, or simply omitted from that menu. If your work is Kilifi-based, confirm the current reporting line with the SERU secretariat rather than inferring it from the website.
KEMRI’s research programmes
Cutting across the geographic centres are thematic programmes. A protocol typically belongs to a centre for administration and to a programme for scientific framing. The programmes KEMRI lists are:
- Non-Communicable Diseases (NCD) Programme
- Natural Products Research and Drug Development (NAPREDA) Programme
- Public Health and Health Research Systems Programme
- One Health Programme
- Infectious and Parasitic Disease Programme
- Biotechnology Programme
- Sexual Reproductive, Adolescent and Child Health Programme
KEMRI also runs a Department of Epidemiology, Statistics and Informatics (DESI), which is the natural first contact for design, sampling and analysis support, and an internal research grants scheme for KEMRI staff. External collaborators cannot apply to the internal scheme; for Kenyan national funding, see CASRAI’s overview of the National Research Fund’s Kenyan funding streams.
SERU: what it is and how it is built
The Scientific and Ethics Review Unit was inaugurated in April 2014, completing a restructuring that began in 2010. Before that, KEMRI ran two separate bodies — a Scientific Steering Committee (SSC) and an Ethics Review Committee (ERC) — and a protocol had to clear each in turn. SERU merged those functions into what KEMRI describes as a one-stop shop carrying out both the scientific and the ethics approval.
This history is the reason older Kenyan protocols, published methods sections and consent forms carry “SSC number” references. If you are extending or re-analysing a study approved before 2014, expect an SSC protocol number rather than a SERU number, and expect the non-KEMRI shipment category to still be written as “NON-SSC/NON-SERU” in current guidance.
Structurally, SERU consists of a secretariat and four review committees. Each of the four committees meets monthly to approve or disapprove the proposals in front of it. Your submission is allocated to one committee; it is not reviewed by all four, and the monthly cadence is the single biggest driver of your calendar.
The two-tier review structure — and what changes if you are external
KEMRI operates what it calls a 2-tier research review system. The tiers are:
- Tier 1 — scientific peer review. For a KEMRI protocol, this is done by the relevant Centre Scientific Committee. For a non-KEMRI protocol, this tier is performed by your host institution, not by KEMRI.
- Tier 2 — simultaneous scientific and ethics review by one of SERU’s four committees.
That first tier is the step external collaborators most often miss. SERU does not run tier 1 for you. If you are an external investigator, you must arrive at SERU already carrying documented scientific review from your host institution — and note that this is a scientific review requirement, distinct from the separate rule (discussed below) that your home-country ethics approval will not substitute for Kenyan ethics approval.
SERU publishes separate submission forms for the two routes: a KEMRI Submission Form to SERU and a Non-KEMRI Submission Form to SERU, plus a dedicated Submission Checklist for Non-KEMRI Protocols. Use the non-KEMRI checklist as your actual pre-submission gate; it exists precisely because the external route has different documentation.
What SERU review costs
KEMRI publishes these figures in the SERU FAQ (accessed August 2026):
- Initial protocol review, non-KEMRI investigators: KSh 100,000
- Expedited review request: KSh 200,000
- Both are stated as a one-off fee for each study, not an annual or per-review charge.
Two things to note. First, KEMRI states these charges for non-KEMRI investigators; it does not publish an equivalent figure for KEMRI-internal protocols on that page, so do not assume the same number applies to a KEMRI-led study. Second, and counterintuitively, expedited review costs twice as much as standard review, not less. Budget accordingly — see the next section for why the word “expedited” is doing something other than what it appears to.
KEMRI maintains a “SERU Review Fee and Bank Details” page for payment instructions. We have deliberately not reproduced bank account details here, because payment details are exactly the kind of information that changes without notice and that is worth impersonating. Take them from KEMRI directly.
How long SERU review takes
- Standard review: approximately six weeks to a first response. KEMRI is explicit that this first response “can either be an approval or a request to the study investigators to make further revisions” — so six weeks is time-to-first-decision, not time-to-approval. If your protocol comes back with revisions, you re-enter a monthly committee cycle.
- Expedited review and quick turnaround: no longer than 10 working days.
Plan on the assumption that revisions are the normal outcome rather than the exception, and that each round is gated by a monthly committee meeting. A realistic external-collaborator timeline for a first-time, non-trivial protocol is therefore materially longer than six weeks.
“Expedited” does not mean “fast” — the trap in the terminology
KEMRI flags this itself, in an explicit note in its FAQ, and it is the single most commonly misread piece of SERU terminology. There are two distinct concepts:
- Quick Turn Around — a proposal qualifies because it requires a faster than usual review due to a major public health concern, an epidemic being KEMRI’s own example. This is the category that is genuinely about speed.
- Expedited review — a proposal qualifies because it is not more than minimal risk and involves only procedures in the set-out categories. KEMRI’s note reads: “Expedited review does not mean quick review of the proposal. It means the application will not be reviewed by a full committee because it involves minimal risk on the participants.”
In other words, “expedited” describes the review route, not the clock — it means not sent to a full committee. Requesting expedited review because you are in a hurry is a category error, and an expensive one at KSh 200,000. Request it because your study is genuinely minimal risk.
KEMRI defines a minimal risk study as one in which the likelihood of harm to participants is no greater than they would encounter in daily life or during routine medical or psychological care or examination — a definition that will be familiar to anyone who has worked with a US IRB. If the distinction between these committee types is new to you, CASRAI’s comparison of IRBs and ethics committees sets out the general vocabulary, and the dictionary entry for Independent Ethics Committee (IEC) covers the international term of art.
SERU approval and the NACOSTI permit: you almost certainly need both
This is where external collaborators most often get stuck, so it is worth being precise. These are two different requirements, issued by two different bodies, and neither substitutes for the other.
- SERU approval is ethics and scientific review of your protocol, issued by KEMRI. It says your study is scientifically sound and ethically acceptable.
- The NACOSTI research permit (also called a research licence) is national authorisation to conduct research in Kenya at all, issued by the National Commission for Science, Technology and Innovation. It says you are licensed to do research on Kenyan soil.
The ordering is what trips people up. NACOSTI requires ethical approval as an input to the permit application, not as a follow-up. Your protocol must already be approved by an ethics review committee accredited by NACOSTI — and a NACOSTI-accredited committee is normally one attached to a Kenyan university or research institution. KEMRI’s SERU is such a committee. An approval from your home institution abroad will not substitute. CASRAI’s guide to applying for the NACOSTI research permit, with the current fee table covers that application in full, and Kenya’s national research-ethics framework explains how NACOSTI accredits institutional committees in the first place.
So the practical sequence for a typical external collaborator is:
- Secure scientific review at your host institution (SERU tier 1 for non-KEMRI protocols).
- Submit to SERU using the non-KEMRI form and checklist; obtain ethics approval.
- Apply to NACOSTI for the research permit, attaching that approval.
- If your study involves an investigational drug, biologic or device, obtain Pharmacy and Poisons Board authorisation as well — a third, separate track covered in CASRAI’s guide to Kenya’s PPB clinical-trial authorisation pathway.
A budgeting observation that is easy to miss. The NACOSTI permit is inexpensive — its published fees run from KSh 100 for a student attachment to USD 500 for a non-African post-doctoral or individual researcher. SERU review at KSh 100,000 is therefore, for most external collaborators, an order of magnitude more expensive than the permit it is a prerequisite for. Teams that budget for “Kenyan research approvals” by looking only at the NACOSTI fee table will be badly short. Note also that the NACOSTI permit is valid for one year and must be renewed, whereas the SERU fee is one-off per study but carries the continuing-review obligations set out below.
If your work is a multi-country African trial, the regional layer is developing separately; see CASRAI’s guide to the African Medicines Agency and multi-country trials. For the practicalities of the NACOSTI portal itself, including its migration to eCitizen sign-in, see the NACOSTI login guide.
After approval: what SERU requires you to keep doing
SERU approval is not a one-time clearance. The unit publishes a defined set of post-approval submissions, each with its own form, and the reporting clocks are short:
- Amendments. Any change to an approved project — recruitment or data-collection procedures, research personnel, sponsor or funding agency, study site, study design, or any change to the informed consent — requires an amendment submission. There are separate KEMRI and non-KEMRI amendment forms and a SERU amendment checklist.
- Annual renewal. All active or open studies must be renewed, and KEMRI is explicit that this includes a study closed to accrual but still in follow-up, and a study where participant contact is complete and only analysis, report writing or manuscript preparation remain. Failure to submit an annual renewal on time requires the Principal Investigator to pause the study and file a protocol deviation. That is a real and avoidable consequence: a missed administrative deadline converts into a reportable compliance event.
- Protocol deviation. Any failure to adhere to the procedures or treatment plan in the approved protocol version. The PI must report within 7 working days of being notified of its occurrence.
- Protocol violation. Any planned or inadvertent change that may affect participant safety, data integrity, or participants’ willingness to continue.
- Serious adverse events. An occurrence leading to hospitalisation, death, permanent disability, or that is life-threatening. Report to SERU by email within 24 hours of the PI learning of it, with hard copies to follow within three working days.
- Urgent safety changes. A separate report where a protocol change is necessary to eliminate an apparent immediate danger or risk to participants.
- Close-out report. Filed when all study activities are complete and findings published, or when a study never started and the PI sees no reason to keep it open. KEMRI’s stated trigger for closure is that there is no further participant contact, the dataset has been closed, and the main findings have been published.
KEMRI adds a note that matters for multi-site work: investigators running multi-site studies reviewed by multiple IRBs must comply with all IRBs providing oversight. SERU approval does not release you from your home committee’s continuing-review requirements, and the reporting clocks above run in parallel with, not instead of, your sponsor’s and home institution’s. For the general framework, see CASRAI’s guide to Good Clinical Practice and the dictionary entry for ICH GCP.
Shipping biological samples out of Kenya
This is a distinct SERU function and a common source of delay, because the authority depends on whose study it is.
- SERU is the KEMRI-mandated unit that processes and approves applications to ship biological samples or specimens — but only for KEMRI-based studies.
- For non-KEMRI-affiliated studies (the category KEMRI still writes as NON-SSC/NON-SERU), shipment authority comes instead from the Head of the Department of Standards and Regulatory Services (DSRS), Ministry of Health, at Afya House, Cathedral Road, Nairobi. This is a different building and a different institution — if you are an external collaborator without KEMRI affiliation, SERU is not your shipping authority.
- Shipment is limited to analyses that cannot be carried out at KEMRI or at other institutions in Kenya. This is a substantive restriction on capacity-flight, not a formality: be prepared to justify why the assay cannot be run domestically.
- Sample types KEMRI names as commonly shipped include blood, saliva, breast milk, mosquito parts, biological cultures, tissue, hair, human stool and environmental samples used in human-health research.
- Two conditions must be satisfied in advance: the study must already be SERU-approved, and the approved protocol must itself contain a provision for shipment of samples. Retrofitting shipment onto a protocol that did not anticipate it means an amendment.
- For human samples, participants must have consented to shipment of their samples to overseas institutions. Your consent form has to have said so at the time of consent.
SERU also advises on importation of samples for research purposes under SERU-approved protocols. Because export of biological material almost always travels with a written agreement, see CASRAI’s guides to the material transfer agreement process and to access and benefit-sharing compliance for international MTAs, plus the dictionary entry for Material Transfer Agreement (MTA). For genomic work specifically, the governance model in H3Africa’s Data and Biospecimen Access Committee is the closest continental comparator.
How to contact SERU
SERU’s published contact point, as of August 2026, is [email protected]. The unit sits at House Number 8, KEMRI Headquarters, off Mbagathi Road, Nairobi, with a postal address of P.O. Box 54840–00200. KEMRI also lists an electronic submission route and a published SERU committee schedule — check that schedule before finalising your timeline, since the monthly meeting dates, not the postmark, determine when your protocol is actually seen.
What we could not verify
In keeping with CASRAI practice, the limits of this page are stated rather than papered over. All figures above are taken from KEMRI’s own published pages, accessed August 2026. The following we could not confirm from a primary source and you should check directly with the SERU secretariat:
- The review fee for KEMRI-internal protocols. KEMRI publishes the KSh 100,000 and KSh 200,000 figures explicitly for non-KEMRI investigators only.
- Whether the SERU fee is payable per submission or per approved study in edge cases such as a protocol withdrawn and resubmitted, or a study that fails review. KEMRI states it is one-off per study; it does not address these cases.
- The current status of the Centre for Geographic Medicine Research, Coast (Kilifi), which appears in KEMRI’s regional-office listing but not its centres menu, as noted above.
- Whether any of the fees above have changed since the pages were last updated. KEMRI does not date its fee page.
- Turnaround for amendments, renewals and shipment applications. KEMRI publishes timelines for initial and expedited review only.
Fees and timelines are the fields most likely to drift. Where a figure here is load-bearing for your budget or your grant timeline, confirm it against KEMRI’s SERU pages before you rely on it.
Frequently asked questions
What does KEMRI stand for?
Kenya Medical Research Institute. It is a Kenyan State Corporation established in 1979 and is the national body responsible for research in human health in Kenya.
Can a non-KEMRI researcher get approval from KEMRI SERU?
Yes. SERU explicitly reviews research submissions from both KEMRI and non-KEMRI researchers who intend to conduct research in Kenya, and publishes a separate non-KEMRI submission form and checklist. The difference is that for a non-KEMRI protocol, the first-tier scientific review is performed by your host institution rather than by a KEMRI Centre Scientific Committee.
How much does KEMRI SERU review cost?
KEMRI publishes KSh 100,000 for an initial protocol review by non-KEMRI investigators, and KSh 200,000 for an expedited review request. Both are stated as one-off per study. KEMRI does not publish an equivalent figure for KEMRI-internal protocols.
How long does KEMRI SERU approval take?
Approximately six weeks to a first response for standard review — but that response may be a request for revisions rather than an approval. Expedited review and quick turnaround are stated as no longer than 10 working days. Because each of SERU’s four committees meets monthly, a revision round adds a further cycle.
Why does expedited review cost more than standard review?
Because “expedited” at SERU denotes the review route, not the speed. KEMRI states plainly that expedited review does not mean quick review; it means the application will not go to a full committee, because the study is no more than minimal risk. The separate “Quick Turn Around” category is the one defined by urgency, such as an epidemic.
Do I need both SERU approval and a NACOSTI permit?
Most external collaborators need both. They are different things: SERU gives ethics and scientific approval of the protocol; NACOSTI issues the national research permit that licenses you to conduct research in Kenya. NACOSTI requires approval from an ethics committee it has accredited as an input to the permit application, and SERU is such a committee. An approval from your home institution abroad does not substitute.
Which comes first, SERU or NACOSTI?
SERU. Ethical approval is an input to the NACOSTI permit application, not a subsequent step. Applying to NACOSTI without it is the most common reason an application stalls.
Is KEMRI’s SERU the same as the SERU used in library licensing?
No. They are unrelated and share only an acronym. KEMRI’s SERU is the Scientific and Ethics Review Unit, a research-ethics body. NISO’s SERU is the Shared Electronic Resource Understanding, a recommended practice for electronic-resource licensing between libraries and publishers.
Can I ship samples out of Kenya after SERU approval?
Only if your approved protocol already provides for shipment, your participants consented to overseas shipment, and the analysis genuinely cannot be performed at KEMRI or another institution in Kenya. Also check whose authority applies: SERU processes shipment applications for KEMRI-based studies only, while non-KEMRI studies apply to the Head of the Department of Standards and Regulatory Services at the Ministry of Health.
What happens if I miss a SERU annual renewal?
KEMRI states that late submission of an annual renewal requires the Principal Investigator to pause the study and file a protocol deviation — so a missed administrative deadline becomes a reportable compliance event.
Related CASRAI resources
- NACOSTI Research Permit Kenya: Fees and How to Apply
- Kenya’s National Research-Ethics Framework: NACOSTI Accreditation and NCST Guidelines
- Kenya Clinical Trial Authorization: The Pharmacy and Poisons Board Pathway
- NRF Kenya (National Research Fund): Funding Overview
- What Is CUE? Kenya’s Commission for University Education
- KENET: Kenya’s Research and Education Network (NREN) Explained
- The African Medicines Agency and Multi-Country Clinical Trials in Africa
- H3Africa’s Data and Biospecimen Access Committee (DBAC)
- Access and Benefit-Sharing Compliance for International MTAs
- AESA: DELTAS Africa and Grand Challenges Africa Explained
- ARIN: Africa’s Research Integrity Network
- IRB vs. Ethics Committee: What’s the Difference?
- Grants Management & Research Funding — CASRAI’s cluster hub








