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THE HUMAN RESEARCH PROTECTION PROGRAM

THE COMMITTEE ON HUMAN RESEARCH (CHR)

APPLYING AND REPORTING TO THE CHR

Overview of Application Process
  FAQ about Applying to the CHR
  Determining Whether Human Subjects are Involved in Research When Obtaining Private Information (data) or Biological Specimens
  Scientific or Scholarly Review of Human Researach Protocols - Revised May 2008
  CHR Review fees
  Top Tips for Speeding Up Your CHR Approval - Revised June 2008
Applications for Initial Review (See the Overview above to select type)
Full Committee Review Application
    General Instructions: Full Committee Application
    Full Committee Application Form and Supplements
    Submission Checklists
Expedited Review Application
    General Instructions: Expedited Application
      Expedited Review Categories
    Expedited Application Forms and Supplements
    Submission Checklists
Exempt Application and Non-Human Subjects Research
    General Instructions - Exempt Certification Application and Non-Human Subjects Research
    Exempt Application Forms
  Emergency Use and Compassionate use of Experimental Drugs and Devices
    Guidelines
    Emergency Use Written Report Form
    Emergency Use Compliance Checklist
     
Modifications
    General Instructions: Modification Request
    Categories of Modifications
    Modification Forms
    Modification Checklists
  Renewals
    General Instructions: Renewal Application
    Status Report for Renewals and Major Modifications (Continuing Review)
    Checklist for Renewals and Major Modifications (Continuing Review)
    General Instructions: Completing the SFVAMC Supplement (SFVAMC studies only)
  Administrative Review for Human Research Studies Not Being Conducted by a UCSF Principal Investigator But Accessing UCSF Facilities, Patients or Personnel (Faculty, Staff, or Students)
    Who must have CHR Approval Before Enrolling Human Subjects in Research
    Administrative Review Form
  Post-Approval Reporting
    Summary Sheet for Post-Approval Reporting Requirements
  Adverse Event Reporting
  Guidelines
  Adverse Event Reporting Forms
  Reporting Violations and Incidents in Research Protocols
  Guidelines
  Protocol Violation or Incident Reporting Form
  Reporting and Responding to Research-Related Concerns and Complaints
  Study Close-out Reporting
  General Instructions: Study Close-out Reporting
CHR Review Process
    Categories of Approval
    General Conditions of Approval
    Responding to Contingent Approval and Return Letters
    Determining Expiration Dates
    CHR Meeting Dates
    Turnaround Time
    Screener's Checklist
    Reviewer Checklist
    Presentation Checklist
       
    Letter to Sponsors about IRB Membership