Scientific and Ethics Review Unit (SERU)

The Scientific and Ethics Review Unit (SERU) is central to research in KEMRI. The Unit’s purpose is to facilitate research with human participants and to protect their 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 research in Kenya.

The Unit 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 four review committees.

Each committee meets monthly to review and approve or disapprove proposals submitted.

Kebenei Enock Kipchirchir

RESEARCH OFFICER-AG. HEAD SERU


Mr. Kebenei holds a Bachelors’ Degree in Information Sciences from Moi University. Currently, he is pursuing MSc Degree in Health Information Management from Kenyatta University. He has trained in ICT, Leadership & Management in Health, Geographic Information Systems, and Health Research Ethics. He is a member of Bioethics Society of Kenya.

He joined KEMRI on 1st February 2013 as a Data Clerk at the then Ethics Review Committee. Currently, he works at the Scientific and Ethics Review Unit (SERU) as an Assistant Research Officer. He serves as an Assistant Secretary in one of the SERU Committees.

Mr. Kebenei’s research interest is Health Research Data Management and Bioethics.

Caroline Kithinji

Research Officer


Caroline Kithinji is a Senior Research Officer at KEMRI SERU. Her duties include sourcing for funding for ERC initiatives to build capacity for the Ethics Review Committee and Secretariat; training research administrators, committee members, and clinical monitors in good clinical practice; and ethics review and ethics principles on an ongoing basis. She has also been the Lead Facilitator for regional seminars and teaching ethics at the KEMRI Graduate School.

Caroline has carried out research on informed consent and contributed two chapters to the Africa wide publication, “Research Ethics in Africa: A Resource for Research Ethics Committees.” Additionally, Caroline is a Certified IRB Professional and a member of the Programs Committee for the Maisha HIV and Aids Conference where she has provided technical support to the Kenya AIDS Strategic Framework 2014/2015 to 2018/2019.

Caroline holds a Master of Science in Medical Parasitology from London School of Hygiene and Tropical Medicine, as well as a Bachelor of Science from Nairobi University. In 2006 Caroline joined the Johns Hopkins School of Public Health under the Fogarty African Bioethics Training Program (FABTB) and received a certificate in ethics after completing a one year program

Gideon Cornel Msee

Assistant Research Officer


Mr. Msee holds a B.Sc. Biochemistry majors and is currently pursuing MSc. Medical Biochemistry.

He has trained in International Health Research Ethics (MOI-Indiana University) and other bioethics related courses including GCLP, Research Ethics Evaluation, and Informed Consent. Additionally he is a leader with a certificate in leadership and management in health.

He first joined KEMRI in 2013 as student on attachment performing basic laboratory work for various research activities at the KEMRI Centre for Global Health Research (CGHR) and later in 2014 proceeded to the Scientific and Ethics Review Unit (SERU) where he is currently employed as an Assistant Research Officer.

Gideon is tasked with assisting the SERU to ensure timely review of protocols to safeguard wellbeing of research participants and scientific compliance. He is the assistant secretary for the Ethics Review Committee (ERC). Msee’s aspiration is to be a lead health research scientist in biochemistry and bioethics

Kisienya Odhiambo Cyprian

Assistant Research Officer


MSc. Bioinformatics and Molecular Biology
BSc. Biotechnology

Work experience

Research Regulation/administration since 2014

Dr. Serah Gitome

Assistant Research Officer


Dr. Serah Gitome is a medical doctor and public health specialist with 9 years of extensive experience in HIV prevention and reproductive health-related research in Kenya. She obtained her MB Ch. B degree from the University of Nairobi in 2006 and MPH (Epidemiology) from the University of California, Berkeley in 2013.

Dr. Gitome’s main research interests are at the intersection of HIV prevention and reproductive health, particularly among young women and reproductive-age HIV sero-discordant couples. She collaborates with various scientists from the University of California, San Francisco, University of Michigan, AMREF, among other Institutions, to design and conduct clinical trials and non-experimental studies in the fields of HIV prevention and reproductive health in Kenya.

As a Certified IRB Professional and a member/Secretary of SERU Committee C, Dr. Gitome reviews scientific proposals and provides technical guidance on clinical and regulatory matters to SERU reviewers.

Geoffrey K. Ngasura

Assistant Research Officer


Mr. Geoffrey Ngasura is the compliance officer in charge of Shipment, ISO and administrative support at Scientific and Ethics Review Unit (SERU). He has been with the Scientific and Ethics Review Unit since 2014. Mr. Ngasura holds Bachelors in Business Information Technology from Mt. Kenya University. He has a certificate in International Research and Ethics from Indiana University.

Mr. Ngasura also has certificate in International Leadership and Management in Health from University of Washington. He has passion in Research Ethics and Regulation. Mr. Ngasura’s hobbies are Traveling, Nature walking, and Hiking. He is also a volunteer with Presidents Award Kenya as an assessor.

James Nguya Wanja

Compliance Officer


James Nguya Wanja is a SERU Compliance Officer at the SERU Secretariat. He joined KEMRI in October 2011 as an Assistant Research Officer (Research Ethics) at Scientific Steering Committee (SSC) and Ethics Research Committee (ERC) Secretariats before restructuring of the scientific and ethics review processes was done by KEMRI.

James was one of the research officers who carried the data collection that culminated with the restructuring of the review system to make a one stop shop Scientific and Ethics Review Unit (SERU) which carries out the functions that both SSC and ERC on research regulation (Scientific and Ethics approvals).

James is a Bachelor of Arts (Social Work) graduate from the University of Nairobi class of 2011. He also has a Research Ethics and Public Health Certificate obtained at the Centre for Biomedical Ethics and Culture, SIUT, Karachi, Pakistan in 2014. He has also done Centre for Collaborative Initiative (CITI) research ethics training. He is a Masters student at the University of Nairobi pursuing a Masters degree in Project Planning and Management.

He has a passion in the field of Bioethics. His interests include community work, good governance in public office, travelling and photography.

Ms. Lilian Achacha

Assistant Research Officer


Lilian Achacha is an Assistant Research Officer at the Scientific and Ethics Unit as a Compliance Officer in charge of Centre for Microbiology Research (CMR). She is well vast in the areas of Research regulation and administration as well as Scientific research.

She holds a Bachelor of Science in Microbiology and Biotechnology from the University of Nairobi

Ms. Mariam Macharia

Assistant Research Officer


Ms. Mariam Macharia is a social scientist professional with a Bachelor of Arts degree in Sociology, Political Science and Public Administration from the University of Nairobi. She also holds a Good Participatory Practice Certificate from AVAC and a public relations certificate from a local college.

She joined KEMRI in July 2013 and has been working as an assistant research officer (research regulation and ethics) at KEMR Scientific and ethics Review Unit. She is the assistant secretary of SERU/ Committee A where she ensures proposals are implemented in accordance with the set guidelines and SOP’S. She also has experience in proposal development, data collection, policy research, governance and social challenges.

Daisy Chebet Cheruiyot

Assistant Research Officer


Ms. Cheruiyot holds a Bachelor of Science in Nursing from University of San Carlos-Philippines and is currently pursing Masters in International Health Research Ethics at Moi University.She is an assistant research officer at the Kenya medical research Institute since 2013.Registered by the Nursing Council of Kenya and a member of Bioethics Society of Kenya.

She has undergone training in; Research and Scientific Writing skill,Research Misconduct, Geographic Information Systems, Health ethics, Research Ethics in Genomics and Biobanking. Her interest is in research regulation and qualitative research.

Ms. Maryanne Metto

Assistant Research Officer


Miss Metto Works at the SERU as a compliance officer for CVR, CRDR and CPHR. She has worked at the Unit since 2013, she has a vast experience in review of resubmitted protocols, request for shipments and annual renewal protocols.

She holds a degree in Business information technology and Has a passion in systems and data security.

Timothy Kipkosgei

Assistant Research Officer


Timothy Kipkosgei is an Assistant Research Officer at the Kenya Medical Research Institute (KEMRI). He is currently the SERU Compliance officer handling research regulatory affairs of CBRD, CTMDR and ESACIPAC. Timothy is pursuing an MSc in International Health at Jomo Kenyatta University of Agriculture and Technology.

He holds a Bachelor’s his Bachelors Science Biochemistry from Egerton University. His research interest focus on Bioethics and Health Systems research. Timothy has served as the production editor for the quarterly KEMRI Bioethics newsletter from 2012 to date. He is also a member of Bioethics Society of Kenya.

Victoria Chepkorir Soi

Assistant Research Officer


Victoria is an Assistant Research Officer at Scientific and Ethics Review Unit (SERU) and she is the Compliance Officer for Centre of Clinical Research (CCR). She joined Kenya Medical Research Institute in 2013. She holds a Bachelor’s degree in Information Technology from Jomo Kenyatta University of Agriculture and Technology and is currently pursuing a Master’s degree in Computer Systems at Jomo Kenyatta University of Agriculture and Technology.

She also holds a Certificate in Clinical Ethics from the Centre of Biomedical Ethics and Culture (CBEC), Karachi, Pakistan. Victoria’s passion is on research regulations and technology in the healthcare research sector. Her hobbies include hiking, travelling and music.

Our Review Process

KEMRI has grown to become one of the leading health research institutes in Africa with demonstrated success in conducting collaborative biomedical research and producing exceptional scientists.

To accomplish this, an effective scientific and ethics review mechanism is necessary to support the diverse range of health research conducted at the Institute. KEMRI has a 2-tier research review system which entails initial scientific peer review by the Centre Scientific Committees (for KEMRI protocols) or scientific review by the host institution (for Non-KEMRI protocols) followed by a simultaneous scientific and ethics review by one of the four committees at the Scientific and Ethics Review Unit

Through SERU, KEMRI is well-placed to provide a robust research review mechanism responsive to the changing and expanding public health landscape in the region. View Our Review Process

Submission Forms

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.

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

Shipping

  1. 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

Electronic Submission

Coming Soon!

Training

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 CITITRREE,NIHFHI 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.

Newsletter

The KEMRI bioethics review is a quarterly electronic Newsletter started by the 2011. The newsletter aims to inform, educate and entertain its readers.

The newsletter also aims to stimulate discussion on prevailing issues related to research ethics and laws. KEMRI Bioethics Review provides information and updates on Ethical issues in research involving human subjects by focusing on specific themes for each quarter. Since inception in 2011, 18 issues have produced and published.

Articles published are contributed by KEMRI affiliated authors and from other contributors from all over institutions within and outside Kenya. The scope of articles ranges from ethical issues in biomedical science, healthcare, technology, law, religion and policy.

The chief editor encourages submission of articles as a way of creating awareness and discussions on bioethics. Please get in touch by writing to seru@kemri.org.

KEMRI Bioethics Review NewslettersYearDownload
KEMRI Bioethics Review Volume 12011Download
KEMRI Bioethics Review Volume 2 Issue 12012Download
KEMRI Bioethics Review Volume 2 Issue 22012Download
KEMRI Bioethics Review Volume 2 Issue 32012Download
KEMRI Bioethics Review Volume 3 Issue 12013Download
KEMRI Bioethics Review Volume 3 Issue 22013Download
KEMRI Bioethics Review Volume 3 Issue 32013Download
KEMRI Bioethics Review Volume 3 Issue 42013Download
KEMRI Bioethics Review Volume 4 Issue 12014Download
KEMRI Bioethics Review Volume 4 Issue 22014Download
KEMRI Bioethics Review Volume 4 Issue 32014Download
KEMRI Bioethics Review Volume 5 Issue 22015Download
KEMRI Bioethics Review Volume 5 Issue 32015Download
KEMRI Bioethics Review Volume 5 Issue 42015Download
KEMRI Bioethics Review Volume 6 Issue 12016Download
KEMRI Bioethics Review Volume 6 Issue 22016Download
KEMRI Bioethics Review Volume 6 Issue 32016Download
KEMRI Bioethics Review Volume 6 Issue 42016Download
KEMRI Bioethics Review Volume 7 Issue 12017Download
KEMRI Bioethics Review Volume 8 Issue 12018Download

FAQs

  1. What is the KEMRI format for writing a proposal?
    Answer: Please click on the following link SERU Guidelines for Writing Project Proposals
  2. How long does it take to review and approve a proposal at KEMRI SERU?
    Answer: It takes approximately six weeks to get the first response which can either be an approval or a request to the study investigators to make further revisions.
  3. What is a minimal risk study?
    Answer: A minimal risk study is a study in which the likelihood of harm posed to the research participants in a study is no more than they would encounter in their daily lives or during routine medical or psychological care/examination.
  4. What is the difference between quick turnaround and expedited review?
    Answer: A proposal qualifies for a Quick Turn Around review if it requires a faster than usual review due to a major public health concern e.g. an epidemic. A proposal qualifies for expedited review if it is not more than minimal risk and involves only procedures listed in one or more of the set-out categories.
    NB- 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.
  5. What is the average turnaround time for an expedited review?
    Answer: The expedited review process and quick turnaround shall take no longer than (10) working days.
  6. What are the review charges/fees at SERU?
    Answer: NON-KEMRI investigators are required to pay KSH 100,000/= for an initial protocol review. However, expedited review requests attract a fee of KSH 200, 000. Please note that this is a one-off fee for each study.
  7. When do we need to close out a study?
    Answer: The PI should submit the request for study closure when there is no more contact with the participant, data set has been closed and the main findings of the study have been published.
    NB- Investigators conducting multi-site studies reviewed by multiple IRBs should comply with all IRBs providing oversight.

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