The objective of ZU-ISERC SOPs is to ensure quality and consistency in the review of research proposals. This will be achieved through maintaining effective functioning of the ZU-ISERC through safeguarding the dignity, rights, safety, health, and well‐being of all actual or potential human research participants. The ZU-ISERC will strive to provide independent reviews (devoid of political, institutional, professional, and market influences).
The SOPs set out the requirements for ethics review and approval at the ZU-ISERC in Kenya. The procedures form part of a broader policy framework of a set of policies designed to guide the researchers in ensuring proper conduct and integrity of research undertaken across Zetech University, regardless of the research's geographical source or philosophical approach.
These SOPs should be read in conjunction with Zetech University's policies, which include, but are not limited to:
- Research policy
- Intellectual Property Rights Policy
- Grant management policy
- Anti-plagiarism policy
- Zetech Business and Technology Journal Editorial Policy
Mandate & Objectives
The Zetech University Institutional Scientific Ethics Review Committee (ZU-ISERC) was established following a recommendation by the Zetech University Research and Innovation Committee and approved by the Vice-Chancellor, aligning with national research policies and ethical guidelines.
Purpose, Goal, and Objectives:
- To ensure quality and consistency in the review of research proposals.
- To maintain the effective functioning of the ZU-ISERC through safeguarding the dignity, rights, safety, health, and well-being of all actual or potential human research participants.
- To provide independent reviews (devoid of political, institutional, professional, and market influences).
- To provide an independent, competent, and ethical review of research proposals, amendments, and requests for continuing approval within a reasonable time.
- To safeguard the rights, dignity, well-being, and safety of all study participants and/or communities, paying special attention to research involving vulnerable participants.
- To provide ethical oversight through monitoring of approved projects, and to suspend, withdraw approval, or stop research protocols where the risk-benefit ratio is ethically unacceptable.
- To review all research involving human and animal research subjects.
- To review and approve the ethical aspects of research proposals on behalf of the National Commission for Science, Technology and Innovation (NACOSTI).
Types of Ethics Reviews
There are five types of review:
- Exempt Review – A research study may be exempt from full review if the committee determines that it presents minimal risk to participants. Only ZU-ISERC has the authority to grant exemption.
- Expedited Review – An expedited review shall be carried out by the Committee Secretary together with two reviewers appointed by the Chair.
- Full Review – Any research proposal that does not qualify for expedited or exempt review will be subjected to a full ethical review process.
- Continuing Review & Amendments
- Continuing Review: All research approvals are valid for one year. The PI must apply for annual renewal using the designated Continuing Review Form (Appendix 6) for studies extending beyond one year. This is discussed at the next scheduled committee meeting.
- Protocol Amendments: These are substantial modifications to an approved protocol that affect participant safety, research methodology, the scope of the study, or the scientific integrity of the project.
- The PI must use the "Application for Approval of Amendment" form (Appendix 7) and clearly mark the amended sections in the updated proposal, providing the rationale for the changes.
- Amendments shall only be implemented after ZU-ISERC has reviewed and approved them at the monthly meeting.
- If an amendment is urgent due to participant safety concerns, it can receive provisional approval from the Chair, which must then be ratified at the next formal ZU-ISERC meeting.
- Minor modifications (not impacting safety or methodology) or administrative changes can be submitted as a notification and do not require formal approval.
