Step 1
Complete the amendment form. For protocols reviewed and approved on paper forms, the paper amendment form can be found on the Forms & Templates page. Any changes to the protocol should be incorporated into the actual paper application form. For protocols reviewed and approved in the eProtocol online system, the amendment form is completed online and the application (protocol) is updated at the same time.
Step 2
For older protocols still on paper, submit the electronically signed amendment form via email along with any new or revised supporting materials directly to the IRB for review. If the amendment changes any of the information within the currently approved protocol application, the application must be revised to accurately reflect the research going forward. For protocols in the eProtocol system, submit the amendment following the online procedures.
Step 3
If the IRB asks for revisions or additional information, prepare revised/additional materials and submit them to the IRB, along with a cover memo itemizing the changes/additions (for paper amendments), or the notes requested in the online system (for protocols within the eProtocol system).
Step 4
Once you have appropriately addressed all of the IRBs concerns, the IRB will issue an approval memo, and you are authorized to implement your proposed amendment.
Please Note: Proposed amendment changes can not be initiated until they are approved by the IRB.