How To: make an amendment on a Campus IRB
Get the FORMS
Actually, THIS should link you directly to the doc download. (If it doesn't, click on "Amendment Forms" then "Request to Amend an Approved Protocol")
Download it to the psych/BergelsonLab/Lab_Documentation/Protocols/[ProtocolNumber]/in_progress folder, and rename it to include the protocol number, the word "amendment", and the geral date you're making the amendment. E.g. "2022-0296_Bergelson___Amendment_Aug2022.docx"
Open the most recently approved protocol
You can find it in psych/BergelsonLab/Lab_Documentation/Protocols/[ProtocolNumber]/current_protocol.
Fill out the top of amendment form
Make sure to update the protocol number, title, researchers, and today's date as the submission date.
Check off the x's to indicate which segments of the form you're updating.
In the "description of changes" box, be SUPER SUPER SPECIFIC on what changes you made to the form (or any form you're amending). More or less rewrite exactly what you've put in the other sections, and include section numbers to point the IRB rep to the sections they should review (they absolutely will not read any part of the protocol that's not specifically indicated by track changes).
Tip: It often helps to complete this section AFTER you are done making changes to the rest of the protocol.
Copy the entire protocol to the last page of the amendment form
The amendment form tells you to do it too, so this is just me being redundant.
Turn on Track Changes
To add a flyer, screenshot of stimuli, or surveys, delete the old piece, and replace it with the new image(screengrab works well for flyers - Command+shift+4 opens a screen snip tool on Mac).
Manually edit the text of the form. Make sure to be consistent and that all sections that are affected by the new research activites appropriately reflect the updates to the protocol.
Your changes should be appearing like comments in the sidebar.
If you can, highlight or change the font color of what you've changed as well (Track changes now does this automatically).
Add document-internal hyperlinks
Add them from the first page where you are describing what changes you made directly to the new sections. Also add an appendix index with links to each new appendix or attachment.
First, on the new sement, change, or appendix, highlight the first line text and in the Word toolbar, go to "insert->bookmark", and name the bookmark something short but informative. Make sure there's no spaces or punctuation in the bookmark name; if there is, then the "add" button will fade out and it will frustrate you.
Then, In the index or the description of changes, highlight the text you want to link to the new section, click "insert --> link" then go to the "in this document" tab, and find the new bookmark you've just created.
CHECKLIST:
Run it past Elika for approval and to make sure you didn't miss any changes.
Email to Campus IRB with a nice helpful explanation
campusirb@duke.edu. Make sure to attach your amendment form! If you're adding new researchers to the protocol, you can attach the additional personnel form to the same email.
Be prepared to wait a little while for the approval. The IRB rarely has comments but may get back to you with questions or requested edits.
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