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

• Protocol Narrative for Expedited and Full Committee Review — Updated April 2013 [Summary of Changes]
• Protocol Narrative for Exempt Review — [Summary of Changes]
• Protocol Narrative for NCI CIRB Approved Studies — [Summary of Changes]
• Non-Human Subject Research Determination Form


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


• Administrative Registration Form for Multi-Campus Research Approved at Another UC Campus — Updated June 2012


• Certificates of Confidentiality Application and Instructions
• Self-Certification of Surrogate Decision Makers for Research Studies
• Decision-Making Capacity Assessment Tool


• Emergency Use: Notification Form: Emergency Use of a Test Article
• Emergency Use: Memorandum of Understanding Related to the Use of Data Obtained Under Emergency Use


• UCI Non Reportable Events Report
• Internal Unrelated SAE Summary Log
• UCI IRB DoD Supplement Form — Updated February 2011

• 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

• Informed Consent Document Template (Biomedical) — Updated May 2011
• Informed Consent Document Template (Social-Behavioral) — Updated January 2012
• Informed Consent Document Template for Donation of Embryo(s) and Gametes
• Informed Consent Document Template for Donation of Somatic Cells NEW
• Experimental Subject's Bill of Rights — Updated May 2011


• Study Information Sheet — Updated May 2011
• Minor Assent Form Template — Updated May 2011
• Assent Addendum form — New May 2011
• Re-Consent Cover Memo


• UCI Witness Policy Letter — New May 2011
• Sample Certificate of Confidentiality Language
• NCI CIRB Consent Form Check List for UCI Required Additions
• Emergency Use: Consent to Undergo Emergency Treatment with Investigational Drug/Biologic/Device
• Humanitarian Use Device Informed Consent Template

• Experimental Subjects Bill of Rights
  • Chinese - Traditional
  • Farsi
  • Korean
  • Spanish
  • Tagalog
  • Urdu
  • Vietnamese
• Short Forms
  Note: Short Form Consents may be used to consent potential research participants if approved by the UCI IRB.
  Please refer to your UCI IRB approval letter to verify that the IRB has approved the use of Short Forms for consenting subjects.
  • Chinese- Traditional
  • Farsi
  • Korean
  • Spanish
  • Vietnamese
  • English (for reference)
• HIPAA Research Authorization for Release of PHI
  • Chinese- Traditional
  • Farsi
  • Korean
  • Spanish
  • Vietnamese
• Self Certification of Surrogate Decision Makers for Research Studies
  • Chinese- Traditional
  • Farsi
  • Korean
  • Spanish
  • Vietnamese

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

• Current version of UCI's Federalwide Assurance (FWA)
• Letter to Sponsors: UC Compensation for Injury Policy
• Letter to Sponsor: One Letter Addressing All of the Most Commonly Requested Information.