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Office of Research & Development

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VA Central IRB Submissions

What forms do I need to submit and where can I find them?

All VA Central IRB forms are available in IRBNet under Forms and Templates. When filling out any of the forms, you may contact the VA Central IRB general e-mail address at vacentralirb@va.gov with questions that you may have. If able, include the name of your study, funding source, Investigator’s name, and number of VA sites that will be participating in the study. One of our VA Central IRB staff will get back to you to answer your questions.

The forms listed below are required, when applicable, as part of the Principal Investigator (PI) New Project submission for non-exempt projects:

  • Project Cover Sheet – IRBNet Wizard
  • IRB Information Sheet – IRBNet Wizard
  • Study Team Tracking – IRBNet Wizard
  • Form 100 or 101 – Protocol Template
  • Form 102 – Local ACOS Review
  • Form 103 – Waiver of HIPAA Authorization
  • Form 112a – Waiver of Informed Consent
  • Form 112b – Waiver of Documentation of Informed Consent
  • MODEL Informed Consent Form or Combined Informed Consent/HIPAA Form
  • MODEL HIPAA Authorization Form 10-0493
  • Enterprise Research Data Security Plan (ERDSP)
  • CV/ Biosketches – Those in an Investigator Role
  • COI Management Plan(s)
    		•
  • Other Documents:
  • Investigator's Drug Brochure/Device Information
  • MODEL Recruitment Materials/Phone Scripts
  • Survey/Questionnaires
    		•

    The forms listed below are required, when applicable, as part of the Local Site Investigator (LSI) New Project submission for non-exempt projects:

  • Project Cover Sheet – IRBNet Wizard
  • IRB Information Sheet – IRBNet Wizard
  • Study Team Tracking – IRBNet Wizard
  • Form 102 – Local ACOS Review
  • Form 104 – LSI New Project Supplement
  • Local Informed Consent Form or Combined Informed Consent/HIPAA Form
  • Local HIPAA Authorization Form 10-4093
  • Enterprise Research Data Security Plan (ERDSP)
  • CV/ Biosketches – Those in an Investigator Role
  • COI Management Plan(s)
    		•
  • Other Documents:
  • Local Recruitment Materials/Phone Scripts
  • Local Waiver (Form 112a, Form 112b, or Form 103 - ONLY when PI Waiver does not apply. For example, accessing data in a local database).
    		•

    The VA Central IRB requires different forms to be completed and submitted for Exempt projects. If submitting an Exempt project, please follow the form requirements in the instructions provided in the following section under Exempt Research Projects.

    How do I submit a New Project to the VA Central IRB?

    The VA Central IRB application process involves two parts. The first part pertains to the submission of the protocol and supporting documents by the Principal Investigator (PI). In addition, the PI submits all waiver requests as they apply to the study, as well as model informed consent documents, HIPAA authorizations, and recruitment materials as applicable. The second part involves the submission of Local Site Investigator (LSI) Applications after the PI application has been approved.

    A simplified flowchart and detailed instructions guiding the entire VA Central IRB application and review process for PI and LSI New Project submissions can be found by clicking on the files below:

    Non-Exempt Research Projects:

    Exempt Research Projects:



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    Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.