The newly hired quality improvement (QI) director states, "I believe we should seek Institutional Review Board (IRB) approval before starting this new project. The medical center has never involved the IRB committee in QI proceedings
How should the medical center chief operating officer respond to this statement? 1. IRB approval is not necessary in this state.
2. Since we are a federal institution, we do not need IRB approval.
3. We can ask the IRB committee for an opinion on our plan for this project.
4. We should always get IRB approval for our QI initiatives from now on.
3
Explanation: 1. The geographic location does not determine need for IRB approval.
2. IRB committees are required by any entity receiving federal funds.
3. Historically, there was no need for IRB approval for QI work. This has changed in recent times and IRB approval for some initiatives would be prudent.
4. Not all initiative of the QI department would need IRB approval. It is wise to seek that approval for some plans.
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