Radiology IRB Study Plan Template

Through a collaborative effort between radiology and the IRB (including team members Dr. Steven Baccei, Cole DiRoberto, Dr. Karen Johnson, and Sarah Saliba of the IRB) a streamlined template for retrospective radiology chart review studies was developed. Previously, these types of studies (that in most instances ultimately were determined exempt from IRB review) required a full, lengthy study plan. By using the new streamlined template, radiology researchers will be able to expedite the study plan portion of their IRB submission. This exciting initiative is expected to promote a significantly higher rate of research publications in our department.”

For retrospective chart reviews that are exempt under Category 4, the IRB generally expects the following to be included in the eIRB submission:

•  Completed (Streamlined Radiology Specific Template) Investigator Study Plan (ISP)   

•  Completed HIPAA Waiver of Authorization Form

•  The data collection sheets intended to be used to collect the data

The “Checklists” (e.g. HRP-320 CHECKLIST: HIPAA Waiver of Authorization) and “Worksheets” (e.g. HRP-423 WORKSHEET: Exemptions) are to serve as helpful tools for investigators and may provide additional guidance while they prepare their submission. (http://www.umassmed.edu/ccts/irb/policiessops--checklistsworksheets/sop/