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-IERC 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-IERC 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-IERC meeting.
- Minor modifications (not impacting safety or methodology) or administrative changes can be submitted as a notification and do not require formal approval.