Animal Care and Use
Modification Request Forms
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Signs, Flyers and Other Printable Media
Human Research Protections
Appendices
- Appendix A - UCI Research Performed at Non-UCI Sites and Locations
- Appendix A - ›› Guidance on Letter of Permission
- Appendix A - ›› Letter of Permission Template
- 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/Fieldwork
- Appendix J - Use of FDA-Approved Drug/Biologic & Investigational Drugs/Biologic in Clinical Investigations
- Appendix K - Use of Medical Devices
- 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 R - Single IRB (sIRB) Review
- Appendix S - Description of Data Safety Monitoring Plan (DSMP)
- Appendix T - Waiver of HIPAA Authorization for the Use or Disclosure of Personal Health Information
Applications
Checklists
- Checklist for Continuing Review
- Checklist for Emergency Use of a Test Article
- Checklist for Exempt Research
- Check List for Making the UCI Required Additions to the NCI Consent Form
- Checklist for Modification/Amendment Requests
- Checklist for New Studies
- Checklist for NIH sIRB – Lead PI Guidance & Responsibilities
- Informed Consent Checklist
- Quorum IRB Reliance - Site Submission Checklist
Consent Forms
- Assent Addendum Form
- Consent Form – Emergency Use or Expanded Access
- Consent Script and Talking Points
- Debriefing Statement Template
- Decision-Making Capacity Assessment Tool
- Experimental Subject's Bill of Rights
- Humanitarian Use Device Informed Consent Template
- Informed Consent Document Template for Biomedical
- Informed Consent Document Template for Donation of Somatic Cells
- Informed Consent Document Template for Social-Behavioral
- Informed Consent Template for Donation of Embryo(s) and Gametes
- Minor Assent Form Template
- Re-Consent Cover Memo
- Self-Certification of Surrogate Decision Makers for Research Studies
- Study Information Sheet - Expedited Level
- Study Information Sheet – Focus Group (Exempt Level Only)
- Study Information Sheet – Interview (Exempt Level Only)
- Study Information Sheet – Online Survey (Exempt Level Only)
- UCI Informed Consent Template Language for GDS
- UCI-Quorum Consent Form
- UCI-Schulman Consent Form
- UCI-WIRB Consent Form
Disclosure Forms
Documentation for Sponsors
Foreign Language Translations
- Consent Short Form - Cambodian
- Consent Short Form - Chinese
- Consent Short Form - English (for reference)
- Consent Short Form - Farsi
- Consent Short Form - Korean
- Consent Short Form - Spanish
- Consent Short Form - Tagalog
- Consent Short Form - Vietnamese
- Experimental Subjects Bill of Rights - Cambodian
- Experimental Subjects Bill of Rights - Chinese
- Experimental Subjects Bill of Rights - Farsi
- Experimental Subjects Bill of Rights - Korean
- Experimental Subjects Bill of Rights - Spanish
- Experimental Subjects Bill of Rights - Tagalog
- Experimental Subjects Bill of Rights - Urdu
- Experimental Subjects Bill of Rights - Vietnamese
- HIPAA Research Authorization Form – UCOP Translations
- 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
Guidelines
HIPAA Documents
Other Forms
- Counseling Resource Sheet
- Deviation Tracking Log
- Individual Investigator Agreement (IIA)
- Institutional Authorization Agreement (IAA)
- Investigator's Assurance Statement
- New Information Report
- Notification Form - Emergency Use of a Test Article
- Prospective Deviation Request
- Release Form Template: A form researchers can use to receive permission to use information.
- SMART IRB – Letter of Acknowledgement (UCI as IRB of Record)
- SMART IRB – Letter of Acknowledgement (UCI IRB Ceding Review)
Protocol Narratives
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Human Stem Cell Research
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