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.

   

• 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      
     

• VA Guideline for Submitting Applications to Conduct Human Subject Research
• Appendix A-  Training Certificates and Personnel Documentation Checklist
  
• Request to Review Research Proposal/Project Instructions
  
• 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