HRP Toolkit

A ZOT IRB submission requires the completion of the Protocol Narrative and/or any applicable PI Worksheets. Any IRB protocols that were not approved in KRP by September 4, will need to be re-entered in ZOT IRB to continue the IRB review process.

Review the following resources to know what Word documents are required for both current, IRB approved studies and new submissions: 

Review the Investigator Manual to ensure the research follows UCI requirements and expectations.

User Guides & Manuals

Researchers

Do You Need IRB Review? [IRB Review Guide]

IRB Researchers Guide  [ZOT IRB User Guide]

HRP-103 Investigator Manual [UCI SOP Guide]

Ancillary Reviewers

Department or Lead Unit Clearance Guide [How to Provide Clearance in ZOT IRB]

IRB Reviewers

IRB Reviewers Guide [ZOT IRB User Guide]

UCI IRB Reviewers Guide [ZOT IRB User Guide - How to Review Items in ZOT IRB]

HRP-109 IRB Member Manual [Responsibilities and Review Guidance]

IRB Designated Reviewer Desktop Reference

IRB Staff

IRB Staff Guide [ZOT IRB User Guide]

IRB Meeting Management Guide [ZOT IRB User Guide]

Standard Operating Procedures (SOPs)

IRB Worksheets

IRB Worksheets

Investigators do not need to complete the following worksheets, but should be aware of the respective review considerations as it relates to their study. These worksheets are intended to support IRB review of research and guide administrative processes.

Protocol Narratives

Protocol Narratives

Investigators must complete a Protocol Narrative (below) for the following submission types:

  • Not Human Research Self-Determination
  • Exempt Research Self-Determination
  • Exempt Research IRB Review Required
  • Expedited Research
  • Full Committee Research

PI Worksheets

Investigators must complete a PI Worksheet instead of a Protocol Narrative for the following submission types:

  • External IRB Reliance
  • Expanded Access
  • Right To Try
  • Humanitarian Use Device (HUD)

Principal Investigator (PI) Worksheets

PI Worksheets

Investigators complete the following worksheets (as applicable per Protocol Narrative's instructions) to document considerations required by the respective regulations. Review the worksheet instructions to determine if it applies to the submission and how to submit.

Consent & HIPAA Forms

Foreign Language Translations

Other Templates

Human Research Protections (HRP) strives to ensure that people with disabilities have access to all services and content. If you experience any accessibility-related issues with this form or any aspect of the ZOT IRB application process, email OR-Web-Support@uci.edu for assistance.