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Everything about the IRB

Current IRB Protocol # 2018-4715

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The IRB approval process at UCI is pretty slow, so make sure to get out any documents ASAP.

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IRB Documents on Server

  • All IRB Documents are located in: smb://odin.ss.uci.edu/dosclab$/IRB Documents

  • Current approved IRB Docs (to print) are located in: smb://odin.ss.uci.edu/dosclab$/IRB Documents/IRB Documents (.pdfs)

  • IRB Docs that are currently pending approval after submitting an amendment are located in: smb://odin.ss.uci.edu/dosclab$/IRB Documents/IRB Pending Approval

    • Documents in this folder will be moved to the "IRB Documents (.pdfs)" and "IRB Editable Docs" folders once they are approved.​

  • Editable IRB Docs (for future amendments) are located in: smb://odin.ss.uci.edu/dosclab$/IRB Documents/IRB Editable Documents

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IRB Amendments:

Our IRB protocol and any amendments are located on ZotIRB. For most amendments to IRB, follow these directions:

  • Locate our current IRB protocol: Click the "IRB" tab --> click the "Active" tab, and select our current IRB. 

  • Hit "Create Modification/CR" (on the left side of the screen) and fill in all necessary amendment information.

    • For most minor amendments (e.g. uploading documents, adding new testing locations, updating language, etc.) you would follow these steps:​​

      • What is the purpose of this submission? --> select "Modification/Update"​

      • Modification scope --> select "Other parts of the study"

      • Prospective Deviation --> select "No"

      • Study enrollment status --> select "No subjects are enrolled to date"

      • Notification of subjects --> select "Not Applicable"

      • Summarize each of the modifications and include rationale for the changes 

  • Submit a copy of all amended documents 

  • Submit a copy of the amended protocol narrative

  • Once you have finished creating your amendment and all information is saved, slack Nadia to let her know that the amendment is ready for submission. As of right now, only Nadia can submit the IRB amendments for approval.

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Once IRB Amendments have been approved, make sure to download documents onto the server and replace amended documents.​ 

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IRB Links:

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ZOT IRB Researchers Guide - A very extensive manual with instructions on how to navigate Zot IRB 

HRB Toolkit - central location for all critical-IRB related documentation.

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