Institutional Review Board Application

QI and IRB Considerations

One of the main roles of an IRB is to ensure people participating in studies are at low risk of being harmed. Most QI projects are considered exempt from IRB oversight, however submitting an IRB application before beginning a QI project is always recommended. If you are completing an IRB application for a QI project and you are new to QI, consider having someone with experience in QI and the IRB process review your application before you submit. IHQI Staff and Faculty are happy to help.

Should the IRB review my quality improvement project?

IHQI recommends submitting an IRB application before beginning a QI project. Although most QI projects are not research projects and therefore exempt from IRB oversight, an IRB application ensures people involved in the project are considered at low risk for harm.

When in Doubt

• The IRB does not have the option of granting “retroactive” approval after research is done; you should err on the side of submitting or consulting with the IRB if there is any doubt.
• Call the IRB/OHRE office – very helpful, want to guide investigators & improvers – 919-966-3113

Resources

Read

IRB and Office of Human Research Ethics (OHRE): Standard Operating Procedures (on OHRE website, huge document, well-organized, easy-to-navigate) “Quality Improvement Activities Frequently Asked Questions”: General IRB guidance Do I Need IRB Approval to Start My QI Project? Quality Assurance (QA) and Quality Improvement (QI) checklist Quality Assurance and Quality Improvement FAQs