Forms, Templates, other Guidance Documents

• English Bill of Rights (with Signature)
• English Bill of Rights (without Signature)
• Translated Bill of Rights/Short Form Document
• Page(s): Experimental Participants Bill of Rights, Short Form Consent

• UCSF HSP completion list
• SFVA HSP completion list
• UCSF GCP completion list
• Page: CITI Training

• Plain Language Template (Biomedical and cancer research, Social, behavioral, and educational research, One-time survey research, Simple blood draw research, Collection and/or storage or biological specimens for research (GWAS compliant))
• ICF Companion Document
• Assent #1 (children 7-12 simple)
• Assent #2 (for more complex study, more mature children)
• Assent #3 (for adolescents 12-17)
• Consent Form Addendum (general)
• Humanitarian Use Device
• General Data Protection Regulation (GDRP) Addendum template
• Individual Patient Expanded Access - Emergency Use and Non-emergency Use
• Intermediate-Size Patient Expanded Access
• Protocol Enrollment Exception Addendum – Additional Risk Information
• Telephone Script (Main Study Procedures)
• Telephone Script (Eligibility Screening only)

Exempt

• Exempt Anonymous Survey Email
• Exempt Anonymous Survey Online
• Exempt Confidential Survey Email
• Education Survey Information Sheet
• Focus Group Information Sheet
• Interview Information Sheet

Checklists:

• Consent Form Checklist for Using a Non-UCSF Consent Form
• Federal Requirements for Approving Consent Forms Checklist

Quick Guides: 

• Non-English Consent Guide
• How to Consent

Page(s): Consent and Assent Form Templates, Exempt Consent Templates and Guidance

• Request Form: Continue Study Activities on an Expired Study
• Form: Relying Site Continuing Review
• Page(s): Continuing Review, 

• Worksheet: Devices
• Worksheet: FDA IND Exemption Worksheet
• Page(s): Investigational Devices, Investigational New Drugs and Biologics

• Emergency Use Form
• Emergency Use Post-Use Report Form
• Page: Emergency Use and Compassionate Use of Experimental Drugs and Devices

• Exempt Category Decision Tool
• Exempt Consent Templates and Guidance
• Page: Levels of Review

• IRB Fee Schedule
• Page: IRB Review Fees

• NIH Genomic Data Sharing (GDS) Consent Checklist
• Page: NIH Genomic Data Sharing (GDS) Policy and the Genome-Wide Association Studies (GWAS)

• UCSF HIPAA Form
• Translated UCSF HIPAA Forms
• UCSF HIPAA Revocation of Authorization
• SFVAMC HIPAA Form
• SFVAMC HIPAA Revocation Form
• Page: HIPAA Requirements and Forms for Research

• FWA (UCSF Federalwide Assurance)
• IORG (Institutional Review Board Organization)
• Page: Federalwide Assurance (FWA)

• Letter for Sponsors
• Page: HRPP Memos

• Post Approval Summary Sheet
• Page: Reporting/Monitoring/Quality Improvement Unit

• Letter to Colleagues (recruitment)
• Sample Recruitment Letter
• Sample Recruitment Phone Script
• Page: Recruitment Methods

• Relying Site Continuing Review
• Relying Site Close Out Form
• Relying on an external AMC (ppt)
• UCSF language Advarra
• UCSF language WCG
• UCSF Local Context
• Using iREX
• Reliance Request Form
• Single IRB Consultation Form
• Page(s): Current External IRBs, Relying on Other IRBs, When UCSF Can Serve as IRB of Record

• HRP-503, Help Guide
• HRP-503a, Help Guide
• HRP-503b, Help Guide
• HRP-503c
• HRP-503d
• HRP-503e, Help Guideexternal site (opens in a new window)
• Page: Research Gateway IRB Application Templates & Help Guides

• User Guide: How to Submit a New Study
• User Guide: How to Submit a Continuing Review
• User Guide: How to Submit 1st Modification for a Migrated Study
• Information Sheet: PI Proxy Guidance
• Page: Research Gateway Training, User Guides, and Information Sheets

• UCSF IRB Roster
• UCSF IRB Meeting Dates
• Page: IRB Rosters & Meeting Dates

• Initial Submission Checklist
• Page: New Study

Children and Minors

• Children involved in research: Summary Table
• Levels of Pediatric Procedures
• Page: Children and Minors in Research

Not Human Subjects Research

• Decision Tree Human Subjects
• Self-Certification Form
• Page: Not Human Subjects Research

Levels of Review

• Exempt Category Decision Tool
• Minimal Risk Tip Sheet
• Page: Levels of Review

Personnel

• PI Status Waiver Form
• Page: Study Personnel

Other Committees/Groups

• Inpatient Care Manager(s) – Letter(s) of Support