Any proposed change to research previously approved using an Expedited Review procedure requires review and approval by the IRB prior to implementation. The amendment will be reviewed by at least one member of the IRB. The proposed changes to the protocol will be assessed to determine if the study continues to satisfy IRB approval criteria and if the study continues to qualify for Expedited review.
Submission Requirements for Changes
Prepare an Amendment Application and include all applicable materials. At least one member of the IRB will conduct the review.
- IF STILL EXPEDITED, at least one member of the IRB will conduct the review and RCS will communicate any additional requirements to secure approval.
- IF NO LONGER EXPEDITED, the amendment will be reviewed by the fully convened IRB. RCS will communicate next steps to the investigator.