Post-Initial Submission Instructions
IRBNet Post-Initial Submission Instructions
These instructions apply to ALL committees and PIs and key personnel managing and submitting materials for PIs. This content is also available in a more visual format which can be downloaded as a PDF, from here.
For committee specific information, please select one of the following links: IRB, IACUC, or IBC.
Step 1- Go to www.irbnet.org, and enter your username and password to log in.
Step 2- Click the title of the project
Step 3- Click project history (left side of the screen); click create new PACKAGE (The package number would then be XXXXXX-2). If a prompt to insert the title of the project appears – select “cancel”
Step 4– Click “Work in Progress” or “Designer”
Step 5- Designer page is your project package is built:
a. Download blank forms: Use the dropdown menu for the "Select a Library" to select appropriate institution specific documents to download. Then use the "Select a Document" dropdown menu for documents which will include instruction sheets for IRBNet processes; project specific templates; and other forms which are applicable to the amendment / monitoring, complete, and “save as” to an easily located folder in your computer (these documents default to save in a downloads folder which are very difficult to locate).
b. Add documents in this Package: Click on Add New Document to browse your hard drive for completed documents and attach as required by study and submission type (amendment, renewal, monitoring, etc.). Upload the required completed documents saved to your computer relating to this study (what you completed under Step 5a). As many documents as is necessary for the package submission can be attached. You may view, update, or delete documents any time before the package is submitted.
c. The on-line document is only required to be modified if the content in the online document is updated. If changes are made to the study represented by information on the on-line document, click the “add new document” icon, select the bottom grey box “on-line document”, select the applicable application, click “add”. This will open the wizard, with a prompt to “clone an existing wizard”. In the wizard clone, you can navigate to sections using the Jump tool at the top right. When revisions are complete, select Save and Exit ONLY, which will automatically upload to the package.
Step 6- Click Send Project Mail to communicate with your Chair and/or other signatories (you can quickly send a message by checking the "Send Project Mail" box on the left, asking them to login to IRBNet to review and sign the project).
Step 7- Click Sign this Package (left side of the screen) and select your project role from the drop down Menu, then click Sign.
NOTE: If the PI is a student, a faculty advisor/mentor must be listed on the study and review the finalized documents in the package and sign electronically prior to submitting for review.
Step 8- THE KEY STEP- Be sure that your study is completely ready for review. Click Submit this Package (left side of the screen). The IACUC will be the default choice, please change the committee for IRB or IBC submissions.
Step 9- a submission confirmation should be received via email. Also, when the package has been submitted, the “work in progress” will change to the submission type and “pending review” will be visible. If these actions do not appear, please contact the appropriate committee to confirm submission: IACUC@southalabama.edu, IRB@southalabama.edu, or IBC@southalabama.edu
Once the package has been submitted, it is automatically locked, and can still be accessed. Documents can no longer be edited. If minor changes are required before your study can be reviewed, any full access member on the project may contact the appropriate Research Compliance office via email or phone and request that the study be unlocked. If the package has been unlocked, “Mark Revisions Complete” must be selected to notify the appropriate committee that the project is ready for review. There is no other way for IACUC / IBC / IRB to know that the revisions have been completed.
In the Project Overview tab (left side of the screen), your study will have "Pending Review" status until the appropriate committee reviews it and enters an action for the project (approved, modifications required/information requested, disapproved, etc). An email notice is sent to the Principal Investigator (and all other persons with full access) whenever an action has been taken by the appropriate review committee.
PLEASE REMEMBER –
IF INSTRUCTIONS ARE NOT FOLLOWED,
THERE WILL BE A DELAY IN APPROVAL