How to Submit IRB Applications for Review

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

IRB Check #1: Review Do You Need IRB Review? to determine whether the activity is human subject research.

IRB approval is not required for an activity that is not human subject research. The Principal Investigator (PI) must complete a "Non-Human Subject Research Self-Determination" in ZOT IRB to register the self-determination with the UCI IRB. This includes completing a PROTOCOL NARRATIVE - Not Human Research Self-Determination and uploading it to the registration.

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. This includes completing a PROTOCOL NARRATIVE - Exempt Research Self-Determination and uploading it to the registration.

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.

Common IRB Submission Errors

The UCI IRB application and consent documentation are designed to obtain information necessary for compliance with federal regulations, state statutes, and UC and UCI Policy regarding the protection of human subjects in research. The following is a list of errors that may contribute to a delay in IRB review or approval:

The Lead Researcher/Principal Investigator Eligibility is not met.
The IRB submission is missing supporting documentation or documentation is incomplete (e.g., Protocol Narrative, PI Worksheet(s), Consent Document(s), Recruitment, etc.).
The Single IRB (sIRB) Process submission is missing supporting documentation (e.g., IRB of record approved documents, letter of agreement, local consent documents, etc.).
The inconstant information presented across supporting documentation (e.g., Protocol Narrative vs Consent vs Recruitment).
Research team members have not completed Training & Education (e.g., CITI Human Research Tutorial or the CITI HIPAA Research Tutorial).
Clearance/approval from Department or Lead Unit is not obtained.
Clearance/approval from Ancillary Processes & Partners is not obtained.
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).

As illustrated by the below Research Personnel Heat Map, only Research Personnel involved in the below activities (illustrated in orange) should be listed in the IRB Application and Protocol Narrative. All other Research Personnel should be tracked in the Study Team Tracking Log. (Note: For more information on IRB COI disclosure requirements, click here).

Role of Research Personnel	Minimal Risk Protocol	Greater Than Minimal Risk Protocol
Access to subject identifiable data including Protected Health Information (PHI) for screening/ determining eligibility	List only the LR and Co-Researcher(s) in the Study Team section in KRP. The LR is required to maintain a Study Team log or something similar to track Research Personnel independently.
Recruiting subjects directly via phone, email or in person
Access to subject identifiable data which may include PHI for data collection purposes
Involvement in the informed consent process (i.e., explaining the study to prospective subject)
Performing research procedures that involve greater than minimal risk		List the LR, Co-Researcher(s) and Research Personnel in the Study Team section in KRP.
Involvement in the interpretation of study data
Finalization of the informed consent process (i.e., able to sign off as the individual obtaining consent)
Has a disclosable financial conflict of interest