Changes and Amendments
Regulations stipulate that investigators promptly report any changes in research activity to the IRB. Changes in approved research may not be initiated without IRB review and approval except where necessary to eliminate immediate hazards to participants.
To submit a change request, the investigator will need to log into iMedRIS, click on “Research Assistant” and then on “My Projects” and select the appropriate study. Once opened, a submission form tab will appear and the investigator will select the “Change Request & Amendments” link. The following page will show any previous change/amendment submissions. The investigator will click on “Add New Form”, complete the submission form, sign electronically and submit for IRB review.