MODIFICATIONS TO AN APPROVED PROTOCOL
Investigators are responsible for ongoing requirements in the conduct of approved research. This includes obtaining prior approval from the IBC before implementing any modifications to previously approved research.
Modifications or changes to the protocol are sometimes referred to as “amendments” or “addenda.”
Amendment Classification & Review
The LSUHSC-NO IBC classifies proposed changes to an approved protocol as either minor or major amendments. Both minor and major amendments undergo an initial, administrative review by the IBC Office. Minor amendments typically are reviewed and, if appropriate, approved by the IBC Coordinator, foregoing review by the full committee. Major amendments are placed on the agenda for the next convened meeting for full committee review.
Examples of Minor Amendments |
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Examples of Major Amendments |
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Please Note: |
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How to Submit?
All research applications for IBC review, including modifications/amendments, are submitted through the Kuali Research electronic submission platform which may be accessed by clicking one of the icons below. Detailed instructions for submitting initial and post-approval applications to the IBC are available in the Kuali Quickguide, Creating and Submitting IBC Protocols in Kuali, that can be downloaded from the Resources page.