The distinction between QI and research is an important one. There is a spectrum, and it can be blurry sometimes, but there are some key points (with legal implications!).
- Intent is to improve current practice. For internal use only.
- By definition, the data is confidential.
- Action is within existing standards of care.
- Institutional Review Board (IRB) approval is not necessary.
- Intended to create generalized knowledge.
- Desire to publish or present.
- Testing new methods.
- Needs IRB approval!
(Click here to go to the Duke IRB website for more information)
Check your understanding
Is IRB approval needed for these projects?