A deferral indicates that significant changes are required to the IRB application, and/or uploaded materials, and/or study procedures. The IRB deferral letter sent when a study is deferred outlines the revisions and/or additional information that is required. You are expected to carefully review this letter, revise your materials as outlined, and resubmit in IRBManager once all revisions are addressed. Your mentor/faculty instructor should also review the letter and revisions prior to the application being resubmitted.

To make the required changes:

·         login to IRBManager and click ‘1 xForm awaiting your attention’.

·         On the IRB application form, update the answers on your IRB application that are required based on the IRB review.

.         If the deferral letter refers to revisions needed on your attached documents (such as your recruitment materials or informed consent form), then you should make revisions directly on those documents. Attach a copy of the updated version of those documents in the corresponding place on the IRB application. Be sure to also remove any older versions of those documents from the IRB application.

·         If you need to provide information that does not have a corresponding IRB application question, provide the information in the ‘Additional Information’ section located at the end of the IRB application.

·         If you need to provide additional documentation to the IRB that does not have a corresponding IRB application question, provide the documents in the ‘Additional Documentation’ question located at the end of the IRB application.

Be sure to carefully review all items listed in the IRB deferral letter and address them in your materials as needed. Failure to address all deferral items will lengthen the amount of time spent in IRB review.

Review the attached guide outlining the deferral process.