Animal Care and Use
Modification Request Forms
Other Forms
Signs, Flyers and Other Printable Media
Conflict of Interest
Addenda
Appendices
Applications
Disclosure Forms
Dual Use Research of Concern (DURC)
Guidelines
Training Materials
Electronic Research Administration
Training Materials
Export Controls
Checklists
Forms
Guidance Documents
Signs, Flyers and Other Printable Media
Human Research Protections
Appendices
- Appendix A - Non-UCI Private 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 - Biorepositories
- Appendix N - Collection of Genetic Specimens and Genetic Testing Studies
- Appendix O - Request for a Waiver or Alteration of the Consent Process
- Appendix P - Request for a Waiver of Signed Consent
- Appendix Q - Request for Use of a Short Form Consent Process
- Appendix R - Single IRB (sIRB) - UCI is not the IRB of record --UPDATED!
- Appendix S - Description of Data Safety Monitoring Plan (DSMP) for Clinical/Biomedical Research
- Appendix T - Waiver of HIPAA Authorization for the Use or Disclosure of Personal Health Information
- Appendix U – Single IRB (sIRB) UCI is the IRB of record --NEW!
Applications
- Access the Non-Human Subjects Research (NHSR) Determination Module in Kuali Research
- Administrative Review Form for non-UCI Investigators
- Application for IRB Review
- Continuing Protocol Application / Closing Report
- Document Depot
- Exempt Self-Determination Tool
- Modification Application
- UCI IRB DoD Supplement Form
- Unanticipated Problems Report
Checklists
- Checklist - Continuing Review (Long CPA)
- Checklist - Continuing Review (Short CPA)
- Checklist - Emergency Use of a Test Article
- Checklist - Exempt Research
- Checklist - Informed Consent
- Checklist - Modification
- Checklist - New Expedited or Full Committee Research
- Checklist - NIH Genomic Data Sharing (GDS) Policy Consent Checklist
- Checklist - NIH sIRB: Lead PI Guidance & Responsibilities
- Checklist - Quorum IRB Reliance: Site Submission Checklist
- Checklist - Transition to 2018 Common Rule
- Checklist - UCI Required Additions to the NCI Consent Form
Consent Forms
- Assent Addendum: Pregnancy Testing for Children
- Assent Template: Children
- Consent Addendum: Language for European Union General Data Protection Regulation (EU GDPR)
- Consent Addendum: Language for Genomic Data Sharing (GDS)
- Consent Addendum: Language for UCI-Advarra Reliance
- Consent Addendum: Language for UCI-WCG IRB Reliance
- Consent Guidance: Exempt Script and Talking Points
- 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
- Consent Template: Social/Behavioral/Educational
- Debriefing Template: Debriefing Statement for Research Involving Deception
- Experimental Subject's Bill of Rights
- Re-Consent Cover Memo
- Study Info Sheet: Exempt Focus Group
- Study Info Sheet: Exempt Interview
- Study Info Sheet: Exempt Online Survey
- Study Info Sheet: Expedited
- Surrogate Consent Guidance: Decision-Making Capacity Assessment Tool
- Surrogate Consent Guidance: Self-Certification of Surrogate Decision Makers for Research Studies
Disclosure Forms
Documentation for Sponsors
Foreign Language Translations
- 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 - 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 - 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
- HIPPA Research Authorization Form - Arabic
- HIPPA Research Authorization Form - Cambodian
- HIPPA Research Authorization Form - Certification of Translation
- HIPPA Research Authorization Form - Chinese
- HIPPA Research Authorization Form - Farsi
- HIPPA Research Authorization Form - Korean
- HIPPA Research Authorization Form - Portuguese
- HIPPA Research Authorization Form - Spanish
- HIPPA Research Authorization Form - Tagalog
- HIPPA Research Authorization Form - Vietnamese
- 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
HIPAA Documents
Other Forms
- Counseling Resource Sheet
- Deviation Tracking Log
- Individual Investigator Agreement (IIA)
- Institutional Authorization Agreement (IAA) - (UCI is IRB of Record)
- Institutional Authorization Agreement (IAA) - (UCI is IRB of Record & HIPAA Board)
- Investigator's Assurance Statement
- New Information Report
- Non-UCI & Dual Researchers Guidance Flowchart
- 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 IRB Ceding Review)
- SMART IRB – Letter of Acknowledgement (UCI is IRB of Record)
- SMART IRB - Letter of Acknowledgement (UCI is IRB of Record & HIPAA Board)
- Study Team Tracking Log
Protocol Narratives
Recruitment Templates
Human Stem Cell Research
Checklists
Guidance Documents
Modification Request Forms
Other Forms
Protocol Narratives
Sponsored Projects
Agreements and MOUs
Other Forms
Questionnaires
Standard Operating Procedures (SOPs)
Subaward Forms
- MCA Commitment Form – for Subawards to other UC campuses
- Mini Audit Questionnaire
- Sole Source Justification
- Subaward Processing Checklist for Dept/PI
- Subaward Request Form (For Modification to Existing Subaward)
- Subaward Request Form (for New Subaward)
- Subrecipient Statement of Collaborative Intent
- Subrecipient vs. Contractor Determination
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