Amend
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Submitting an Amendment
Preparing Submission
1. Go to this website and download the amendment form from the link on the right.
2. Fill out the form with all the information.
- 99% of the amendments the lab submits are minor, an exception to this would be if there is a change in risk to subjects.
- You don't actually need signatures on the form, all of this is done electronically.
3. Go into the IRB folder on the z-server and find the IRB folder for the experiment you are submitting an amendment to. See how many amendments there have been in the past and create a new folder for this amendment, numbered sequentially.
- for example, if there were four past amendments, name the new folder "Amendment 5"
Save the amendment form in this folder.
4. For any documents that will be affected by the amendment, put a copy of the changed versions in the new amendment folder.
VERY IMPORTANT NOTE:Get all of the amendments to the IRB approved before implementing them because implementing unapproved changes to an existing IRB is MAKING A PACT WITH SATAN
Upon Approval
1. Digital Form Storage
- Go to the Z-drive on the desktop and open the IRB folder, then the existing IRB folder, then the folder for the particular experiment and, finally, the appropriate Amendment folder.
- Open up the zip file that was attached to the approval e-mail you received, and put everything into the Amendment folder.
- There will also be a folder titled "Current Versions". Copy into this folder the changed versions of any forms which were affected by the amendment. Replace the forms that are in there, so that there is only one currently active and approved version of each form.
2. Paper Form Storage
- Print every attachment to the approval e-mail
- Go to the IRB drawer in the file cabinet in room 330
- Find the folder that matches the IRB
- make a new manila folder labeled with "Amendment" and the number of the amendment you just got approved.
- In the new manila folder, put:
- amendment form
- approval
- any other documents that were affected by the amendment
- Replace any changed documents in the IRB forms folder (or the current consent form folder if that was changed by the amendment)
- note: Old forms that have no replacement are KEPT
3. Replacing Consent Forms
- If the amendment changed in any way the consent form for the experiment, all existing blank consent forms for this project are to be recycled and replaced with new IRB stamped forms.