HRP Toolkit
Have Questions About the Transition to ZOT IRB?
Please visit our website that highlights key information about the transition.
User Guides & Manuals
Researchers
IRB Reviewers
IRB Staff
User Guide IRB Staff Guide
User Guide IRB Meeting Management 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 Authority
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
HRP-806 SOP - Review Request to Cede Review
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
Worksheets
Principal Investigator (PI) Worksheets
HRP-322 PI WORKSHEET - Emergency Use
HRP-325 PI WORKSHEET - Expanded Access
HRP-323 PI WORKSHEET - Criteria for Approval HUD
HRP-410 PI WORKSHEET - Waiver or Alteration of Consent Process
HRP-411 PI WORKSHEET - Waiver of Written Documentation of Consent
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-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
HRP-419 PI WORKSHEET - Waiver of Consent Process for Emergency Research
HRP-441 PI WORKSHEET - HIPAA Waiver of Authorization
HRP-450 PI WORKSHEET - International Research
HRP-451 PI WORKSHEET - Right to Try
HRP-832 PI WORKSHEET - Considerations for Relying on an External IRB
HRP-833 PI WORKSHEET - Considerations for Serving as the Reviewing IRB
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
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
Protocol Narratives
Protocol Narratives
Research Team
Consent & HIPAA Forms
Consent Forms
Consent Template: Social/Behavioral/Educational
Consent Template: Donation of Embryo(s) and Gametes
Consent Template: Donation of Somatic Cells
HRP-498 CONSENT - Right to Try
HRP-499 CONSENT - Humanitarian Use Device
HRP-506 CONSENT - Expanded Access
TEMPLATE - Debriefing Statement
TEMPLATE - Decision Making Capacity Assessment Tool
Investigator Certification of Surrogate Decision Maker
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 - English (for reference)
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 - 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
Single IRB Review (sIRB)
UCI is the Relying IRB (UCI cedes review to an external IRB)
UCI is the Reviewing IRB (UCI is the IRB of Record for external site/investigator)
Reliance Agreement Templates:
- 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
Consent Templates:
- Consent Checklist: CHOC Local Context
- Consent/Assent Template: Children's Health of Orange County (CHOC)
- Consent Template: Memorial Health Services (MHS)
- Relying Site HIPAA Research Authorization - Use when UCI is the HIPAA Board for a non-UCI site