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    IRB Forms – InfoEd Submission

    The following study protocol forms are to be used together with the IRB-1, IRB-5, IRB-7, IRB-9 protocol application forms when submitting study material to the IRB using the new InfoEd submission process implemented on June 16, 2014.

    Note:  These forms may not be used with paper submissions.

    Contact the IRB office at 6-8802 with questions regarding which form should be submitted.
     

    Study Protocol Forms

    IRB-1 —  Study Protocol
    Click here for instructions.

    IRB-5  Request for Exemption Study Protocol
    Click here for instructions.

    IRB-7  Research Methods Course Protocol
    Click here for instructions.

    IRB-9 Ethnographic/Naturalistic Research Study Protocol
    Click here for instructions.

    Cumulative Inclusion Enrollment Report
    Required at time of re-approval for studies funded by NIH or NSF.

    Please note that the following application forms are now electronic and must be completed online through InfoEd:

    • Appendix A
    • IRB-1A
    • IRB-1B
    • IRB-1C
    • IRB-2
    • IRB-3
    • IRB-4
    • IRB-6
    • IRB-8

    The Face Page is no longer required for InfoEd submission.

     

    IRB Forms – Paper Submission

    The following forms are to be used only when submitting study material to the IRB via paper submission (hand carry or sent through the mail).

    Note:  these forms may not be used with the new InfoEd process.

    Contact the IRB office at 6-8802 with questions regarding which form should be submitted.

     

    Applications

    IRB Face Page
    (Checklist to file w/ each submission)

    IRB-1 —  Protocol Application for the Involvement of Human Participants in Research: for Expedited or Full Board Review. Click here for instructions.

    IRB-2 — Re-Approval/Completion. Click here for instructions. You must also file the Cumulative Inclusion Enrollment Report below if your study is funded by NIH or NSF.

    IRB-5 — Request for Exemption from Continuing IRB Review. Click here for instructions.

    IRB-9 — Protocol Application for Ethnographic/Naturalistic Research. Click here for instructions.

    Appendix A — Personnel and Study Investigators Log/Personnel Amendment Form

     

    Supplemental Forms

    IRB-1A — Drug/Device
    Complete this form if the proposed study involves the use of FDA approved drugs/devices, non-medical devices, investigational drugs/devices, biological agents, or proprietary products.

    IRB-1B — Genetic Testing
    Complete this form if the proposed study involves genetic testing.

    IRB-1C — Treatment
    Complete this form if the proposed study is a treatment study; that is, if the study holds forth the possibility of cure or therapy for the subject’s condition.

    Culumlative Inclusion Enrollment Report
    Required at time of re-approval for studies funded by NIH or NSF.

     

    Additional Forms

    IRB-3 — Amendments. Click here for instructions.

    IRB-4 — Adverse Event/Unanticipated Event. Click here for instructions.

    IRB-6 — Protocol Deviation Report. Click here for instructions.

     

    Research Method Course Forms

    IRB-7 — Protocol Application. Click here for instructions.

    IRB-8 — Re-Approval / Completion

     

    IRB Reviewer Checklists

    IRB-1 — New Submission Protocol Application Checklist

    Re-Approval/Continuing Review Checklist

    Amendment Review Checklist