IRB Forms
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Checklists
- Protocol Preparation Checklist
- Checklist - Transition 2018 Common Rule
- Checklist - Continuing Review (Long CPA)
- Checklist - Continuing Review (Short CPA)
- Checklist - Emergency Use of a Test Article
- Checklist - Exempt Research
- Checklist - Informed Consent
- Checklist - IRB Committee Quorum and Expertise
- Checklist - Modification
- Checklist - New Expedited or Full Committee Research
- Checklist - NIH Genomic Data Sharing (GDS) Policy Consent Checklist
- UPDATED! July 2025 Checklist - UCI is Relying IRB
Consent Forms
- Assent Addendum for Minors Able to Get Pregnant
- Assent Template: Children
- Consent Language: China’s Personal Information Protection Law (PIPL)
- Consent Language: General Data Protection Regulation (GDPR)
- Consent Language: NIH Data Management and Sharing (DSM)
- Consent Language: NIH Genomic Data Sharing (GDS)
- UPDATED! April 2025 Consent Template: Biomedical
- Consent Template: Donation of Embryo(s) and Gametes
- Consent Template: Donation of Somatic Cells
- Consent Template: Expanded Access
- Consent Template: Humanitarian Use Device
- Consent Template: Right to Try Attestation
- UPDATED! April 2025 Consent Template: Social/Behavioral/Educational
- Debriefing Template: Debriefing Statement for Research Involving Deception
- Experimental Subject's Bill of Rights
- Investigator-Certification-Surrogate.doc
- Re-Consent Cover Memo
- Study Info Sheet: Exempt Focus Group
- Study Info Sheet: Exempt Interview
- Consent Guidance: Exempt Script and Talking Points
- Study Info Sheet: Exempt Online Survey
- Study Info Sheet: Expedited
- Surrogate Consent Guidance: Decision-Making Capacity Assessment Tool
Documentation for Sponsors
- Current version of UCI's Federal wide Assurance (FWA)
- Letter to Sponsor: One Letter Addressing All of the Most Commonly Requested Information
- Letter to Sponsors: UC Compensation for Injury Policy
- The Exempt Self Determination Process
- Protocol Event Table: When to Report Events to the UCI IRBÂ
- IRB Fee Memo to Sponsors
Foreign Language Translations
- 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 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 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]
- 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
Guidance Documents
Recruitment Templates
Single IRB (sIRB) Review
UCI is the Relying IRB (UCI cedes review to an external IRB)
Consent Templates:
All UPDATED! July 2025
- Consent Addendum: Language for UCI-Advarra Reliance
- Consent Addendum: Language for UCI-NCI CIRB Reliance
- Consent Addendum: Language for UCI-WCG IRB Reliance
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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:
Other Forms
- Department of Defense (DoD) Supplement Form Huron
- Administrative Review Form for non-UCI Investigators
- Counseling Resource Sheet
- Deviation Tracking Log
- Emergency Use Independent Physician Attestation
- Letter of Permission Template
- Release Form Template: A form researchers can use to receive permission to use information.
- Study Team Tracking Log
- IRB Reviewer Desk Reference