Applications & Forms

• Application to Use Animals [Instructions]
• Annual Continuation Application
• Modification Application [Instructions]

• Appendix A: Three-Year Progress Report
• Appendix B: Create and Maintain a Breeding Colony
• Appendix C: Hazardous Materials
• Appendix D: Use of Prolonged Restraint
• Appendix E: Use of Paralytic Agents
• Appendix F: Multiple Major Survival Surgery
• Appendix G: Production of Antibodies
• Appendix H: Non-UCI Locations
• Appendix I: Investigator-Maintained Animals
• Appendix J: Request for Housing Exception
• Appendix K: Variations in Standard Housing or Husbandry

Not sure which appendices you need? See the protocol preparation checklist for details.

• Investigator's Assurance Statement
• Custom Antibody Production Contract Agreement
• Add Title or Funding Source
• University Laboratory Animal Resources Forms (UCInetiD required)

• Application for IRB Review [Instructions] — April 2008
• Continuing Protocol Application
• Modification Application
• Adverse Events and Unanticipated Problems
• Closing Report
• Document Depot

• Protocol Narrative for Expedited and Full Committee Review
• Protocol Narrative for Exempt Review
• Protocol Narrative for NCI CIRB Approved Studies — Updated February 2009 [Instructions]
• Administrative Registration Form for Multi-Campus Research Approved at Another UC Campus — Updated April 2009
• Request for Determination of Non-Human Subjects Research Form — Updated February 2009


• Disclosure of Investigator's Financial Interests
• Investigator's Assurance Statement
• HIPAA Research Authorization for Release of PHI - 2009
• Standard UCIMC Research Recruitment Advertisement


• Self-Certification of Surrogate Decision Makers for Research Studies
• Decision-Making Capacity Assessment Tool


• Emergency Use: Permission for Emergency Use of Investigational Drug/Biologic/Device for Patient Care
• Emergency Use: Memorandum of Understanding Related to the Use of Data Obtained under Emergency Use Approval


• UCI Non Reportable Events Report
• Internal Unrelated SAE Summary Log

• Appendix A - UCI Research Performed at Non-UCI Sites and Locations
• Appendix B - Vulnerable Populations: Pregnant Women, Human Fetuses, or Neonates
• Appendix C - Vulnerable Populations: Prisoners
• Appendix D - Vulnerable Populations: Children
• Appendix E - Cognitively Impaired/Medically Incapacitated Subjects and Use of Surrogate Consent
• Appendix G - Use of Deception/Incomplete Disclosure
• Appendix H - International Research
• Appendix I - Ethnographic Research/Field Work
• Appendix J - Use of FDA-Approved Drugs and Investigational Drugs or Biological Products in Clinical Investigations
• Appendix K - Use of FDA_Approved or Cleared Devices and Investigational Devices in Clinical Research Studies
• Appendix L - Justification for Use of a Placebo or Sham Procedure, or Placebo Washout Period
• Appendix M - Storage of Data and/or Specimens for Future Research
• Appendix N - Collection of Genetic Specimens and Genetic Testing Studies
• Appendix O - Request for a Waiver of Informed Consent
• Appendix P - Request for a Waiver of Written(Signed) Consent
• Appendix Q - Request for Use of a Short Form Consent Process
• Appendix S - Description of Data Safety Monitoring Plan (DSMP)
• Appendix T - Request for a Waiver or Partial Waiver of HIPAA Authorization

• Re-Consent Cover Memo - New
• Informed Consent Document Template (Biomedical) - New
• Informed Consent Document Template (Social-Behavioral) - New
• Informed Consent Document Template for Donation of Embryos
• Minor Assent Form Template
• Study Information Sheet - New
• Experimental Subject's Bill of Rights
• NCI CIRB Consent Form Check List for UCI Required Additions
• PET Addendum Consent Template
• Emergency Use: Consent to Undergo Emergency Treatment with Investigational Drug/Biologic/Device
• Humanitarian Use Device – Informed Consent Template

• Self-Certification of Surrogate Decision Makers for Research Studies (Spanish)
• Authorization for Release of PHI for Research Purposes--2004 (Spanish)
• Authorization for Release of PHI for Research Purposes--2004 (Vietnamese)
• Subject's Experimental Bill of Rights (Chinese)
• Subject's Experimental Bill of Rights (Farsi)
• Subject's Experimental Bill of Rights (Korean)
• Subject's Experimental Bill of Rights (Spanish)
• Subject's Experimental Bill of Rights (Tagalog)
• Subject's Experimental Bill of Rights (Urdu)
• Subject's Experimental Bill of Rights (Vietnamese)

Note: Only UCI IRB-apporved (stamped) short form consents may be used to consent potential research participants

• English Short Form Consent (for viewing and translation purposes)
• Spanish Short Form Consent
• Vietnamese Short Form Consent
• Chinese Short Form Consent
• Korean Short Form Consent
• Farsi Short Form Consent

• Checklist for Exempt Research
• Checklist for Expedited Research
• Checklist for Full Committee Research
• Checklist for Continuing Review
• Checklist for Modification/Amendment Requests