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
• 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: Site Continuing Review
• Page(s): Continuing Review, 

• Worksheet: Devices
• Worksheet: FDA Investigational New Drug (IND) Exemption Worksheet
• Worksheet: Drugs, Biologics, Botanicals & Supplements Supplemental Formexternal site (opens in a new window) 
• 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)

• IRB Membership and Function: Letter for Sponsors
• Page: HRPP Memos

• Post Approval Summary Sheet
• Reportable New Information (RNI) Supplemental Formexternal site (opens in a new window) 
• 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 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

• Research Intake Form
  • Sample: Research Intake Form, Research Intake Form Checklist
• Application Templates and Help Guides
  • HRP-503, Help Guide
  • HRP-503a, Help Guide
  • HRP-503b, Help Guide
  • HRP-503c
  • HRP-503d
  • HRP-503e, Help Guide
• Supplemental Forms
  • Affiliated Study Personnel Supplemental Form
  • Department of Defense (DoD) Supplemental Form
  • Electronic Health Record (EHR) Data Request Supplemental Form
  • Reportable New Information (RNI) Supplemental Formexternal site (opens in a new window) 
• Investigator Manuals
  • HRP-103 Investigator Manual
  • HRP-103p
• Review Outcome Determination Criteria
  • HRP-310 Human Research Determination
  • HRP-312 Exempt Determination
  • HRP-314 Criteria for Approval

external site (opens in a new windowPage: Research Gateway IRB Application Templates, Help Guides, and Supplemental Forms

• System User Guide: New Study
• System User Guide: Continuing Review
• System User Guide: 1st Modification for a Migrated Study
• System User Guide: Assign Primary Contact
• System User Guide: Assign PI Proxies
• System User Guide: Migrated Studies
• System User Guide: Study Team Member Changes (Do not use for PI changes)
• System User Guide: Re-Submit an Unapproved iRIS Submission in ReGI
• System User Guide: Principal Investigator (PI) Change
• System User Guide: Respond to IRB Request 
• System User Guide: Report New Information (RNI)
• System User Guide: Adding a pSite - IREX
• System User Guide: UCSF Relying - Blue - Advarra, WGC, Jaeb, CHS Fresno, or NCI
• System User Guide: UCSF Relying - Gold - Academic Medical Center (AMC), other
  academic institution, or other external IRB
• System User Guide: UCSF Relying- Updates and Modifications to External IRB Reviewed Studies

• System User Guide: UCSF Reviewing - Updating single site to multisite in ReGI

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• Read-Only Access in Research Gateway IRB: Guest List Access

• Read-Only Access in Research Gateway IRB: Global IRB Viewer Access

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• Guidance Sheet: PI Proxy Guidance

Page: Research Gateway Training, System 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