How do I obtain approval for any modifications made to the study after the initial IRB-SBS approval?
Submit a Modifications Submission Form (DOC) to the IRB-SBS office via irbsbs@virginia.edu for review and approval prior to making any modifications to an approved/exempt protocol. Modifications include any changes made to the protocol as originally described to and approved by the IRB-SBS. The changes can include new researchers, changes to instruments and/or consent forms, and modifications to the methods described in the original protocol. Modifications are subject to the pre-review process. Modifications that do not change the level of risk in comparison to the previously approved procedures and do not significantly change the original protocol can be reviewed administratively; all other modifications must be reviewed by the full board.
