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INITIAL PROPOSAL

This is a new proposal that is going through the first review at the KEMRI/SERU.

  1. KEMRI Proposal Format
  2. KEMRI Proposal Submission Form to SERU
  3. KEMRI Proposal Checklist & Initial Submission to SERU

AMENDMENT

An amendment is shall be defined as any change to a SERU approved research project, such as:

Recruitment and data collection Procedures, Research Personnel, sponsor or funding agency, project study site, study design and or any change on the informed consent.

NB/= Investigators should consult the SERU office for more information on the amendment criteria.

  1. KEMRI Amendment Submission Form to SERU
  2. KEMRI SERU Checklist for Amendments

ANNUAL RENEWAL

This is an annual report provided detailing activities carried out within that specified reporting period. All active or open studies must be renewed including:

  1. A study that is closed to accrual of research participants but is in the follow-up phase.
  2. A study in which direct contact with study participants is complete but data analysis, report writing or manuscript preparation are the only ongoing activities.

Failure to submit an annual renewal on time requires the Principal Investigator to pause the study and file a protocol deviation.

  1. Checklist
  2. CRR submission form
  3. Protocol Deviation Form

NOTIFICATION

This is a report submitted when the change to a protocol is necessary to eliminate apparent immediate danger/risk to the research participants.

  1. Checklist

DEVIATION

It’s defined as any failure to adhere to the defined procedures or treatment plans outlined in the protocol version previously approved by the SERU. The P.I should report deviations within 7 working days after being notified of its occurrence.

  1. Protocol Deviation Form

VIOLATION

Any planned or inadvertent changes that may or may not impact safety of study participants, affect the integrity of study data, and/or affect study participants’ willingness to participate in the study previously approved by the SERU

  1. Checklist
  2. Protocol Deviation Form

SERIOUS ADVERSE EVENTS

It’s an occurrence that leads to the following: hospitalization, death, permanent disability or life threatening. It should be reported to SERU via email within 24 hours after the P.I learns of its occurrence and hard copies forwarded to SERU within three working days.

  1. SAE Submission Guidlines

STUDY CLOSEOUT

This is a final report on a study that has completed all study activities and published and the study now needs to close.

It’s also submitted when a study didn’t kick off and the P.I doesn’t see any need to keep it open due to various justifiable reasons.

  1. KEMRI SERU Study Closure Report Form

SHIPMENT

KEMRI Scientific and Ethics Review Unit (SERU) is the Unit mandated by KEMRI to process and approve applications for shipment of Biological samples or specimens. Shipment of samples is limited to analyses that cannot be carried out in KEMRI and other institutions in Kenya. Samples and specimens that are commonly shipped include but not limited to; blood samples, saliva, breast milk samples, mosquito parts samples, biological cultures, tissue and tissue samples, hair samples, human stool, environmental samples used in human health research; among other samples.

SERU also provides advisory on importation of samples for research purposes in SERU approved protocols.

SERU handles only shipment applications for KEMRI-based studies. The authority to ship biological samples or specimens from non-KEMRI affiliated studies (NON-SSC/NON-SERU category) should be obtained from the Head of the Department of Standards and Regulatory Services (DSRS), Ministry of Health, Afya House, Cathedral Road.

Investigators who intend to ship samples should ensure that their studies are approved by SERU and there is a provision of shipment of samples in the approved protocol. For samples from humans, the study participants must have consented to the shipment of their samples to overseas institutions for analysis.

Additionally the application should be accompanied by cover letter detailing the request , SERU Form for exportation of samples, Consent Documents, current SERU initial of continuing approval letter and a part of the protocol that indicates the need for shipment of samples (unless requested for a whole protocol).

  1. KEMRI SERU Shipment
  2. SERU Form for Exportation of samples

The Scientific and Ethics Review Unit ensures that all research proposals involving human subjects meet acceptable standards of scientific rigor, are feasible for implementation and protect research participants.

Hence, SERU requires all study investigators/researchers to adhere to guidelines that will enable protection of research participants when conducting research.

BASIC TRAINING.

All research scientist /study investigators planning to undertake research studies with human subjects are required to have ethics certification which includes CITI, TRREE,NIH, FHI 360.

CAPACITY BUILDING

The SERU offers training for: researchers, Research centres/ institutions and other scientific and ethics committees. The Unit conducts, promotes and facilitates training in research ethics and research methodology.

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