How to Submit in ZOT IRB

ZOT IRB is the submission and management system for UCI's IRB

Effective September 15, 2025, the use of ZOT IRB is required for all IRB submissions or registrations. The IRB will not accept any transactions on the prior IRB system (KRP). For more information about the transition to the new IRB system, please review ZOT IRB Transition and ERA FAQs - ZOT IRB.

Ready to Submit?
Go to ZOT IRB

Review the Human Research Protections (HRP) Toolkit

The HRP Toolkit is a webpage (previously the IRB Forms page) that houses all critical-IRB related documentation in one place. Please take a moment to review the contents of the toolkit prior to submitting in ZOT IRB.

  • HRP-101 Human Research Protection Plan  - The plan references the scope, purpose, mission and all programmatic components of human subject research at UCI. This document, along with the Worksheets and Investigator Manual replace our prior HRP Policies and Procedures.
  • HRP-103 Investigator Manual - The manual provides an overview of expectations and practices to conduct human subject research at UCI. This document serves as a quick reference guide for both new and experienced researchers by providing succinct, basic guidance with web links to our HRP webpages and new Standard Operating Procedures for further details.
  • Standard Operating Procedures (SOPs) - This section of the toolkit includes the SOPs for relevant human research protections topics.
  • Worksheets - Resources for our human researcher community (the IRB, HRP staff, UCI researchers and partners) for relevant IRB considerations.
  • Principal Investigator (PI) Worksheets - The PI Worksheets must be completed and attached, as applicable, to the ZOT IRB application. The PI Worksheets will provide opportunity for PI (expert) input in assessing special topics of research that may require the IRB to make additional regulatory determinations.
  • UCI Templates & Guidance - Templates for the Protocol Narrative, Consent Document, Recruitment, Single IRB (sIRB), etc. are available in the toolkit. As well as guidance on special topics in research.

Verify the Type of Submission

IRB Check #1: Review Not Human Subjects Research Self-Determination to determine whether the activity is human subject research. 

IRB approval is not required and will not be granted for an activity that is not human subject research. Instead, the Principal Investigator (PI) must register a "Non-Human Subject Research Self-Determination" in ZOT IRB. IMPORTANT! The registration process is different than the submission process for IRB review. Review the IRB Researchers Guide (below) to learn how to "Create and Register a Self-Determination".  A complete PROTOCOL NARRATIVE - Not Human Research Self-Determination must be uploaded the registration. No other supplemental documentation is required. 

IRB Check #2: Review Exempt Self-Determination to determine whether the human subject research is eligible for this process.

IRB approval is not required for exempt research that is eligible for self-determination. The PI must complete an "Exempt Self-Determination" in ZOT IRB to register the self-determination with the UCI IRB. IMPORTANT! The registration process is different than the submission process for IRB review. Review the IRB Researchers Guide (below) to learn how to "Create and Register a Self-Determination". A complete PROTOCOL NARRATIVE - Exempt Research Self-Determination must be uploaded with the registration. No other supplemental documentation is required. 

IRB Review Required: Review the PI WORKSHEET - New Study Submission - No Reliance to prepare an IRB Application.

IRB approval is required for human subject research that is not eligible for exempt self-determination. There are instances when a Single IRB (sIRB) process may be used. The PI must submit an IRB application in ZOT IRB and upload supporting documentation.

Review Levels of Review to determine the type of IRB submission and complete the applicable submission documents from the HRP Toolkit. This includes completion of the following documents, as applicable: Protocol Narrative, PI Worksheets, Consent Document, Recruitment Material.

IMPORTANT! Any IRB transaction that was not approved in the prior IRB system (KRP) by September 4, will need to be re-entered in ZOT IRB to continue the IRB review process. For more information, please review ZOT IRB Transition.

Avoid Common Submission Errors

The following errors result in a delay in IRB review or approval:

  1. The Lead Researcher/Principal Investigator Eligibility is not met.
  2. The IRB submission is missing supporting documentation or documentation is incomplete (e.g., Protocol Narrative, PI Worksheet(s), Consent Document(s), Recruitment, etc.).
  3. The Single IRB (sIRB) Process submission is missing supporting documentation (e.g., IRB of record approved documents, letter of agreement, local consent documents, etc.).
  4. The inconstant information presented across supporting documentation (e.g., Protocol Narrative vs Consent vs Recruitment).
  5. Research team members have not completed Training & Education (e.g., CITI Human Research Tutorial or the CITI HIPAA Research Tutorial).
  6. Clearance/approval from Department or Lead Unit is not obtained.
  7. Clearance/approval from Ancillary Processes & Partners is not obtained.
  8. Privacy and Confidentiality safeguards to protect personal health information and research data from an erroneous breach of confidentiality are inadequate (e.g., investigator stores personal information and research data on portable device).

Submit in ZOT IRB

Review the Researcher's Guide below for instructions and screenshots on ZOT IRB basics like drafting and submitting a new study, responding to the IRB and submitting follow on submissions (continuing reviews, modifications and reportable new information).