Here is a decision tree for IRBs to use, that is primarily for AI/ML Human Subjects Research that involves medical devices. This decision tree is primarily for that and won’t do you any good if you aren’t dealing with medical devices. This tree will help you determine if an IDE is required, if the IRB can make an Non-Significant Risk Determination, and which projects can be expedited, or possibly even “exempt” from IRB review. The “Exempt” Decision Tree can be found embedded in the AI HSR Checklist.

Let me know what you think!

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