Applications & Forms
Institutional Animal Care and Use Committee
[+] IACUC Applications
[+] IACUC Appendices
- 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.
[+] IACUC Forms
Institutional Review Board
[+] IRB Applications
[+] IRB Forms
- 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
[+] IRB Appendices
- 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
[+] IRB Consent Forms
- 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
[+] IRB Forms Foreign Language Translations
- Experimental Subjects Bill of Rights
- 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. - HIPAA Research Authorization for Release of PHI
- Self Certification of Surrogate Decision Makers for Research Studies
[+] IRB Committee Checklists
[+] Documentation / Information Commonly Requested by Sponsors or Researchers
Conflict of Interest
Non-Governmental Sponsor
- Statement of Economic Interests for Use with Non-Governmental Sponsors (Form 700U)
- Addendum to Investigator's Disclosure of Economic Interests (Form COI-1) (Updated on 10/31/12)
- Addendum to Investigator's Disclosure of Economic Interests for Gift Funding(Form COI-2) (Updated on 10/31/12)
PHS, NSF, or Other Agencies Adopting Federal Requirements (for proposals submitted/awards issued prior to August 24, 2012)
- Disclosure for PHS, NSF, or Other Agencies Adopting Federal Requirements (Form FFD)
- Addendum to Investigator's Disclosure of Economic Interests (Form COI-1) (Updated on 10/31/12)
- Addendum for Non-UCI Personnel (Form COI-3) (Updated on 10/31/12)
Public Health Service Sponsor (and other agencies following PHS regulations)
For UCI Investigators
- Financial Disclosure for PHS-Funded Research (Form 800) (Effective 8/24/2012)
- Financial Disclosure Appendix for PHS-Funded Research (Form 810) (Effective 8/24/2012) (Updated on 10/31/12)
- Financial Disclosure Addendum for PHS-Funded Research (Form 820) (Effective 8/24/2012) (Updated on 10/31/12)
- PHS Travel Update (Form 815) (Effective 8/24/2012)
For Non-UCI Investigators
- Subrecipient/Non-UCI Investigator Disclosure for PHS-Funded Research (Form 800SR) (Effective 8/24/2012)
- Addendum for Non-UCI Personnel (Form COI-3) (Effective 8/24/2012) (Updated on 10/31/12)
National Science Foundation Sponsor (and other agencies following NSF Conflict of Interest Policy)
- Disclosure Form for NSF Conflict of Interest Policy (Form 900) REVISED (Effective 8/24/2012)
- Addendum to Investigator's Disclosure of Economic Interests (Form COI-1) (Updated on 10/31/12)
- Addendum for Non-UCI Personnel (Form COI-3) (Updated on 10/31/12)
Study Involving Human Subjects (IRB)
- Addendum to Investigator's Disclosure of Economic Interests (Form COI-1)
- Addendum for Non-UCI Personnel (Form COI-3) (Updated on 10/31/12)
Sponsored Projects
- Administrative Approval (AA) Form
- Instructions
- Administrative Approval (AA) FormREVISED (Effective 8/24/2012)
- Research Unit Signatures
- Clinical Study PI Questionnaire
- Mini Audit Questionnaire
- Request for Approval to Spend Funds
- Request for Approval to Transfer an Active Sponsored Project
- Subrecipient Commitment Form REVISED (Effective 8/24/2012)
- Subrecipient FCOI AddendumNEW (Effective 8/24/2012)
- VA/SCIRE Research Proposal Review Checklist
- VA/SCIRE Research MOU for NIH
Human Stem Cell Review Oversight Committee
- Application for hSCRO ReviewNEW
- hSCRO Protocol Narrative REVISED
- Informed Consent Document Template for Donation of Embryo(s) and Gametes REVISED
- Informed Consent Document Template for Donation of Somatic Cells NEW
- Modi?ication Request FormREVISED
- Continuing Protocol Application REVISED
Radioactive Drug Research Committee
- RDRC Application
- RDRC De Novo Review Application
- RDRC Quarterly Report Application (Submit to Research Assurances by April 1, July 1 & October 1)
- RDRC Annual Report Application (Submit to Research Assurances by January 3, 2011)
