Need help with your IRB submission forms?  For questions about submitting medical studies, call the IRB at 439-6055.  For  questions about submitting non-medical studies, call the IRB at 439-6002.  We are happy to assist you.

Please ensure that all study staff have current IRB training PRIOR to submitting a proposal for initial or continuing review.  Additionally, when submitting a modification to add study staff, ensure that the newly proposed staff have completed their IRB training PRIOR to submitting the modification.   Click here for instructions for CITI.

IRB Forms

• Initial Submission

  Note: Investigators using Mountain States Health Alliance (MSHA) facilities or patients, click here for guidelines and here for MSHA Research Request Form.

  How to find out if you need IRB approval

  How to submit a new study in IRBManager

• Main Forms
  

  • IRB Form 103  
    
  • Narrative  (for non-VA studies only - VA studies use VA narrative form below) (see instructions and additional information below for help completing this document)
  •    Instructions for Completing Narrative
  •     Additional Information for narrative  NEW help for more difficult narrative questions
  • VA Narrative Form (VA STUDIES ONLY)
  • Informed Consent Document Revision August 2009: Choose appropriate template:
  • Studies not accessing or using protected health information -Informed Consent Document (ICD) Template for Full or Expedited Review
  • Studies accessing or using protected health information- Informed Consent Document (ICD) Template with HIPAA Authorization incorporated
  • Conflict of Interest
  • Potential Conflict of Interest for study staff -see policy revision for details
  • Students Only: Assurance Statement
  • For studies in institutions receiving Dept of Ed funding, Attestation of Compliance or Combo Attestation/Permission
  •  (for information regarding Dept of Ed rules, click here

  HIPAA

  • HIPAA Authorization Template- see informed consent above(now incorporated into consent)
    
  • HIPAA De-Identification Certification Form
    
  • HIPAA Waiver of Authorization

  Supplemental Forms for Studies Involving Vulnerable Populations

  • For studies involving minors, click here
  • For studies involving prisoners, click here
  • For studies involving pregnant women/fetuses, click here
  • For  VA studies involving cognitively impaired or persons with impaired decision-making ability, click here 
  • For non-VA studies involving cognitively impaired or persons with impaired decision-making ability, click here
  • For studies involving neonates, click here
  • For studies involving deception, click here
  • For studies involving community based participatory research, click here
  • For studies involving trans-national research, click here

  Supplemental Forms for Studies Involving Investigational Drugs or Devices

  • For studies involving investigational drugs, click here
  • For studies involving investigational devices, click here

  NOTE: Check question 9 on Form 103 for other applicable documents that must be submitted.

• Continuing Review/Study Closure
  
  • IRB Form 107
  • See September newsletter for relevant information
  • If instructed by IRB to complete Appendix A, click here
  • For additional page for Study Personnel, click here
  • VA Supplemental Narrative Form (VA STUDIES ONLY)  MUST BE ATTACHED TO FORM 107
    
  
  
• Modification
  
  • Request for Modification Approval Form
    
  
  
• Unanticipated Problem Involving Risks to Participants or Others (UPIRTSO)
  
  • IRB Form 109 (note: if reporting a protocol deviation, be sure to include a corrective action plan on this form)
  • Sample Tracking Log For Non-Reportable Events
  • Protocol Deviations: For sample log to report protocol deviations, click here      
     

• Appendix A-  Training Certificates and Personnel Documentation Checklist
  
• Request to Review Research Proposal/Project Instructions and Funding Codes
  
• Request to Review Research Proposal/Project
  Guidelines for Informed Consent
• VA Form 10-1086 Informed Consent Document (Note: to be used for all studies approved after March 31, 2011)
• HIPAA (Note: to be used for all studies approved after March 31, 2011)
  
• VA Form 10-1086 Informed Consent Document (ICD) with embedded HIPAA (Note: to be used for all studies approved on and prior to March 31, 2011)
• VA Narrative
  
• VA Investigational Drug Information Record Form 10-9012
  
• VA Personnel List
• VA Research Protocol Safety Survey Form 10-0398
  
• Investigator Data Page 18
  
• Investigator Data Page 18 Codes
  
• Scope of Practice
• VA Certification Memo
• Rules of Behavior Form
• Abstract Template
• WOC Intellectual Property Agreement
• VA Form 10-3203
• VA Financial Conflict of Interest Overview
• VA Financial Conflict of Interest Form
  
• HIPAA Waiver of Authorization for Recruitment

        VA Medical Record Flagging Instructions

        VA Research Presentation and Publication Request to Review Form  

        VA Research Presentation and  Publication Policy  

        VA Data Use Agreement