When does something qualify as a Non-Exempt Medical Records review?
Frequently Asked Question
The second section of the new IRB application form in ARROW allows study teams to select the most appropriate application type for their study. The Initial Review: Non-Exempt Medical Records application type must be used only for studies involving the collection and use of medical information from medical records and databases, including studies analyzing radiological images collected for medical purposes. However, do NOT select Initial Review: Non-Exempt Medical Records for studies involving use of clinical images to test newly developed imaging software or tools. If study activities include using the images to test new software or imaging tools and are not limited to re-reading of radiological images, the Initial Review Application: Full Review option must be selected.
For more information, see the below documents.