Maseno University Irb

By | April 25, 2019

Maseno University Irb, Maseno University now has an Institutional Review Board (IRB) known as the Maseno University Ethics Review Committee (MUERC).  The Committee, currently composed of 15 members, received a certificate of accreditation (registration number 01412) from the National Commission for Science, Technology and Innovation (NACOSTI), formally known as the National Council of Science and Technology (NCST), on the 5th of December 2012 for a period of 3 years.  MUERC was granted renewal of accreditation on the 18th day of August 2015 through to 19th August 2018, for a further period of three years.  

ABOUT Maseno University Ethics Review Committee (MUERC)

•    Mission statement

Research studies/projects carried out at Maseno University, in accordance with the Maseno University Vision and Mission statements, are guided by the Maseno University Research Policy, which in turn informs the oversight of the policies and procedures underscored below.  

In addition, Maseno University is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Ethical Principles and Guidelines for the Protection of Human Subjects of Research [the ‘Belmont Report’]), especially on studies/projects involving human participants.  

•    Establishment of the MUERC

The Maseno University Ethics Review Committee (MUERC) was established by the Office of the Vice Chancellor, Maseno University and mandated to operate through the Office of the Deputy Vice Chancellor in charge of Partnership, Research and Innovations (DVC-PRI). 

MUERC office and secretariat work under the Director of Research, Publications and Innovations (DRPI), a directorate constituted under the office of the DVC-PRI.  

•    Administration of Research Ethics

The composition of the MUERC and the secretariat were constituted in compliance with the requirements outlined in the National Commission for Science, Technology and Innovation (NACOSTI) guidelines. 

MUERC is made up of seventeen (17) members from diverse professional backgrounds, comprising Clinicians, Non-clinician Scientists, a Legal expert, Theologians, Behavioral Scientist / Ethicist, Statisticians, Epidemiologists, and a Community Representative.

The Committee is headed by a Chairman and assisted by a Secretary. In addition, the Committee′s activities are supported by the MUERC secretariat which comprises of a Secretary, a Senior Administrator, a Research Officer and an Office Assistant.


• Functions and Responsibilities

Purpose:

MUERC has developed and set forth the Maseno University Ethics Review Committee Standard Operating Protocols (MUERC SOPs) that describe policies, procedures, and regulations governing research studies/ projects and the requirements for submitting research applications/ proposals for ethical review by Maseno University students, staff, faculty and their collaborators as well independent Scientists carrying out research in Kenya.

The role of MUERC is to review and make informed decisions on all research protocols and/or applications that involve human participation.  As such, it is the primary responsibility of MUERC to protect human participants from undue risk and deprivation of personal rights and dignity. This protection is best assured by consideration of three principles, which are the touchstones of ethical research, involving human participants, namely:

  1. That participation in any study involving human participants shall be voluntary, often indicated by free and informed consent, is assured;
  2. That an appropriate balance exists between potential benefits of the research to participants or to society and the risks assumed by the participants.
  3. That there are fair procedures and outcomes in the selection of Research Participants and the potential distribution of likely benefits.

Objective:  

MUERC is responsible for protecting the rights and welfare of human participants involved in any research studies/projects.  Therefore, MUERC shall review all research studies/projects involving human participation, conducted by the Maseno University academic community, students, staff, faculty and their collaborators and independent Scientists.

The Principal Investigators of the above stated studies/projects must submit, for ethical review, any research study/project involving human participants, regardless of the source of funding (or lack thereof) and/or location at which the research study/project shall be conducted in Kenya.

MUERC shall determine that: (a) the rights and welfare of the research study/project participants are protected adequately, (b) the risks to participants are outweighed by the potential benefits of the research study/project, (c) the selection of participants is equitable, and (d) informed consent is obtained and documented appropriately.

Ethical Review Forms

•   Proposal review application form (MUERC/F1) 

•   Progress report form (MUERC/F2)

•   Protocol deviation/violation form (MUERC/F3)

•   Event reporting form (MUERC/F4)

•   Close out form (MUERC/F5)

•    Application/ proposal development guidelines form – (MUERC/GF1)

•    Guidance on project/study participants rights – (MUERC/GF2)

•   Guidelines for submission of proposals by non-Maseno University applicants – (MUERC/GF3)

•   Format and content of an informed consent form (MUERC/GF4)

•    Requirements for informed assent form (MUERC/GF5)