Overview
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An amendment package must be created for your previously approved project in IRBNet and submitted for approval PRIOR to the modification of a previously approved project. Such modifications could include changes in personnel, recruitment, consent, questionnaires, or procedures. Amendments are required for any proposed change to the: |
Step 1: Select your Active Project
Log into IRBNet and select the project title of the project that you would like an amendment for.
Step 2: Select "Create a New Package"
Step 3: Download the Amendment Form
Every amendment package will require an amendment form. This form can be found by going to the Designer Section of IRBNet and going to the drop down "Form Libraries" and selecting "Amendment Form" and then "Download".
Step 4: Attach your Completed Amendment form with any other new or revised files (with the changes highlighted).
From there you will fill out the amendment form. and select, "Attach New Document" and select the "Document Type" as "Amendment/Modification" from the drop down menu.
Then you will want to revise any of your previous files that will need to be changed due to your amendment. This can be done by revising your documents as needed and highlighting the changes in yellow. Next you will select the pencil icon to attach the update updated version of the previous file. If you are adding or deleting staff you will need to update your additional personnel listing in the UWF IRB Application wizard and having affected parties sign the package with the PI.
Step 5: Sign the Package
Once you have attached all the items in the “Designer” section of IRBNet, you will need to select, “Sign this package”. It will ask you to provide your username and password to verify your digital signature. Any newly added or deleted will need to sign as well. If you are unable to have the removed personnel sign the package, please attach documentation that they were informed of the removal.
Step 6: Submit the Package
Once you have signed, you will select “Submit this Package” on the blue menu on the left. It will automatically select the UWF IRB and you will then click, “Continue”. It will then ask you to verify that all who are required to sign have signed the package. For the submission type, you will select, “Amendment/Modification” from the drop-down menu, add any comments, and select, “Submit”.
After submission, someone from the IRB office will be in contact with you. They will either send you a message that your package has been sent to the board for review, or let you know that your package is unlocked for edits if your package is missing any elements. The unlock notification will provide instructions and remind you to select, "Revisions Complete" when you are ready for it to be processed again by the IRB Office. Once submitted to the board, please allow 3-4 business days for review. For questions regarding the submission of amendments, please call the IRB office at 850.474.3484 or email irb@uwf.edu. For more information about amendments in general, please see our IRB Practice and Procedures Manual.
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