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:Â
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]
Single IRB Review (sIRB)
Researchers Guide - UCI IRB is the Relying IRB (External IRB Reliance) [ZOT IRB User Guide]
Researchers Guide - UCI IRB is the Reviewing IRB [ZOT IRB User 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 Staff
IRB Staff Guide [ZOT IRB User Guide]
IRB Meeting Management Guide [ZOT IRB User Guide]
Standard Operating Procedures (SOPs)
IRB Review SOPs
HRP-001 SOP - Definitions
HRP-012 SOP - Observation of Consent Process
HRP-013 SOP - LARs, Children, and Guardians
HRP-020 SOP - Incoming Items
HRP-021 SOP - Pre-Review
HRP-023 SOP - Emerg and Device Comp Use Review
HRP-024 SOP - New Information
HRP-025 SOP - Investigations
HRP-026 SOP- Susp or Term Issued Outside of Conv IRB
HRP-027 SOP - Emerg Use Comp Use Indiv Pt Access Post Rev
HRP-030 SOP - Designated Reviewers
HRP-030a IRB Delegation of AuthorityÂ
HRP-031 SOP - Non-Committee Review Preparation
HRP-032 SOP - Non-Committee Review Conduct
HRP-044 SOP - Not Otherwise Approvable Research
HRP-050 SOP - Conflicting Interests of IRB Members
HRP-051 SOP - Consultation
HRP-052 SOP - Post-Review
HRP-055 SOP - Financial Conflicts of Interests
HRP-063 SOP - Expiration of IRB Approval
HRP-064 SOP - NIH GDS Institutional Certification
HRP-090 SOP - Informed Consent Process for Research
HRP-091 SOP - Written Documentation of Consent Activities Subject to IRB Jurisdiction
HRP-099 SOP - Veterans Affairs Research
HRP-801 SOP - Establishing Authorization Agreements
HRP-802 SOP - Institutional Profile Management
HRP-804 SOP - External IRB Post-Review
HRP-805 SOP - External IRB Updates
Administrative SOPs
HRP-040 SOP - IRB Meeting Preparation
HRP-041 SOP - IRB Meeting Conduct
HRP-042 SOP - IRB Meeting Attendance Monitoring
HRP-043 SOP - IRB Meeting Minutes
HRP-054 SOP - Institutional Conflicts of Interests
HRP-060 SOP - Annual Evaluations of the HRPP
HRP-061 SOP - Quarterly Evaluations of the HRPP
HRP-065 SOP - Response Plan for Emergencies-Disasters Impacting the HRPP
HRP-070 SOP - IRB Records
HRP-071 SOP - Toolkit Management
HRP-072 SOP - IRB Records Retention
HRP-080 SOP - IRB Formation and Registration
HRP-081 SOP - IRB Removal
HRP-082 SOP - IRB Membership Appointment
HRP-083 SOP - IRB Membership Removal
IRB Worksheets
IRB Review Worksheets
HRP-301 WORKSHEET - Review Materials
HRP-302 WORKSHEET - Approval Intervals
HRP-303 WORKSHEET - Communication of Review Results
HRP-306 WORKSHEET - Drugs and Biologics
HRP-307 WORKSHEET - Devices
HRP-308 WORKSHEET - Pre-Review
HRP-309 WORKSHEET - Ancillary Review Matrix
HRP-310 WORKSHEET - Human Research Determination
HRP-311 WORKSHEET - Engagement Determination
HRP-312 WORKSHEET - Exemption Determination
HRP-313 WORKSHEET - Expedited Review
HRP-314 WORKSHEET - Criteria for Approval
HRP-314a WORKSHEET - Criteria for Consent
HRP-315 WORKSHEET - Advertisements
HRP-316 WORKSHEET - Payments
HRP-317 WORKSHEET - Short Form of Consent Documentation
HRP-318 WORKSHEET - Additional Federal Agency Criteria
HRP-319 WORKSHEET - Limited IRB Review
HRP-320 WORKSHEET - Scientific or Scholarly Review
HRP-321 WORKSHEET - Review of Information Items
HRP-330 WORKSHEET - HIPAA Authorization
HRP-331 WORKSHEET - FERPA Compliance
HRP-332 WORKSHEET - NIH GDS Institutional Certification
HRP-333 WORKSHEET - Certificate of Confidentiality
HRP-401 WORKSHEET - Pre-Review
HRP-402 WORKSHEET - Non-Committee Review
Administrative Worksheets
HRP-304 WORKSHEET - IRB Composition
HRP-305 WORKSHEET - Quorum and Expertise
HRP-326 WORKSHEET - Performance Evaluation for IRB Chairs
HRP-327 WORKSHEET - Performance Evaluation for IRB Members
HRP-328 WORKSHEET - Performance Evaluation for IRB Staff
HRP-351 WORKSHEET - Protocol-Specific Emergency-Disaster Risk Mitigation Planning
HRP-352 WORKSHEET - Additional Emergency-Disaster Review Consideration
Protocol Narratives
Protocol Narratives
Research Team Table
Principal Investigator (PI) Worksheets
Waivers of Consent & HIPAA
Single IRB Review (sIRB)
HRP-832 PI WORKSHEET - Considerations for Relying on an External IRB
HRP-832a PI WORKSHEET - Continuing Review or Closing for Relying on an External IRB
HRP-833 PI WORKSHEET - Considerations for Serving as the Reviewing IRB
- Individual Investigator Agreement (IIA)
- Institutional Authorization Agreement (IAA) - UCI is IRB of Record
- Institutional Authorization Agreement (IAA) - UCI is IRB of Record & HIPAA Board
- SMART IRB Letter of Acknowledgement - Research Does Not Involve Access to Medical Records
- SMART IRB Letter of Acknowledgement - Research Involves Access to Medical Records
Vulnerable Populations
HRP-412 PI WORKSHEET - Pregnant Women
HRP-413 PI WORKSHEET - Non-Viable Neonates
HRP-414 PI WORKSHEET - Neonates of Uncertain Viability
HRP-415 PI WORKSHEET - Prisoners
HRP-415a GUIDANCE - Prisoner Research
HRP-416 PI WORKSHEET - Children
HRP-417 PI WORKSHEET - Adults with Impaired Decision-Making Capacity
HRP-417a Decision Making Capacity Assessment Tool
HRP-417b Investigator Certification of Surrogate Decision Maker
Expanded Access, Right to Try, Humanitarian Use Device
HRP-322 PI WORKSHEET - Emergency Use
HRP-325 PI WORKSHEET - Expanded Access
HRP-323 PI WORKSHEET - Humanitarian Use Device
HRP-451 PI WORKSHEET - Right to Try
Consent & HIPAA Forms
Consent Forms
HRP-502 CONSENT - Biomedical
HRP-502a CONSENT - Social/Behavioral/Educational
HRP-502b CONSENT - Donation of Embryo(s) and Gametes
HRP-502c CONSENT - Donation of Somatic Cells
HRP-502d CONSENT - Right to Try
HRP-502e CONSENT - Humanitarian Use DeviceÂ
HRP-506 CONSENT - Expanded Access
HRP-507 CONSENT - Short Form
TEMPLATE - Debriefing StatementÂ
TEMPLATE - Decision Making Capacity Assessment Tool
Investigator Certification of Surrogate Decision Maker
Single IRB Review (sIRB) Consent Forms
UCI Is the Relying IRB
Consent Addendum: Language for UCI-Advarra Reliance
Consent Addendum: Language for UCI-NCI CIRB Reliance
Consent Addendum: Language for UCI-WCG IRB Reliance
UCI Is the Reviewing IRB
Consent/Assent Template: Children's Health of Orange County (CHOC) [Preferred Method of Consent at CHOC]
Consent Checklist: CHOC Local Context [Use When UCI Consent is Used at CHOC]
HIPAA Forms
UC HIPAA Research Authorization Cancellation Form
UCI HIPAA Research Authorization
Relying Site HIPAA Research Authorization [Use When UCI is the HIPAA Board for a Non-UCI Site]Â
Foreign Language Translations
Consent Short Forms
Consent Short Form - Amharic [Certification of Translation]
Consent Short Form - Bengali [Certification of Translation]
Consent Short Form - Cambodian [Certification of Translation]
Consent Short Form - Farsi [Certification of Translation]
Consent Short Form - Korean [Certification of Translation]
Consent Short Form - Russian [Certification of Translation]
Consent Short Form - Simplified Chinese [Certification of Translation]
Consent Short Form - Spanish [Certification of Translation]
Consent Short Form - Tagalog [Certification of Translation]
Consent Short Form - Traditional Chinese [Certification of Translation]
Consent Short Form - Urdu [Certification of Translation]
Consent Short Form - Vietnamese [Certification of Translation]
Experimental Bill of Rights
Experimental Subjects Bill of Rights - Amharic [Certification of Translation]
Experimental Subjects Bill of Rights - Cambodian [Certification of Translation]
Experimental Subjects Bill of Rights - Farsi [Certification of Translation]
Experimental Subjects Bill of Rights - Korean [Certification of Translation]
Experimental Subjects Bill of Rights - Simplified Chinese [Certification of Translation]
Experimental Subjects Bill of Rights - Spanish [Certification of Translation]
Experimental Subjects Bill of Rights - Tagalog [Certification of Translation]
Experimental Subjects Bill of Rights - Traditional Chinese [Certification of Translation]
Experimental Subjects Bill of Rights - Urdu [Certification of Translation]
Experimental Subjects Bill of Rights - Vietnamese [Certification of Translation]
HIPAA Forms
HIPAA Research Authorization Form - Amharic [Certification of Translation]
HIPAA Research Authorization Form - Arabic [Certification of Translation]
HIPAA Research Authorization Form - Cambodian [Certification of Translation]
HIPAA Research Authorization Form - Traditional Chinese [Certification of Translation]
HIPAA Research Authorization Form - Simplified Chinese [Certification of Translation]
HIPAA Research Authorization Form - Farsi [Certification of Translation]
HIPAA Research Authorization Form - Gujarati
HIPAA Research Authorization Form - Haitian Creole [Certification of Translation]
HIPAA Research Authorization Form - Korean [Certification of Translation]
HIPAA Research Authorization Form - Portuguese [Certification of Translation]
HIPAA Research Authorization Form - Spanish [Certification of Translation]
HIPAA Research Authorization Form - Tagalog [Certification of Translation]
HIPPA Research Authorization Form - Vietnamese [Certification of Translation]
Surrogate Certification Forms
Self Certification of Surrogate Decision Makers for Research Studies - Chinese
Self Certification of Surrogate Decision Makers for Research Studies - Farsi
Self Certification of Surrogate Decision Makers for Research Studies - Korean
Self Certification of Surrogate Decision Makers for Research Studies - Spanish
Self Certification of Surrogate Decision Makers for Research Studies - Vietnamese