What is the impact of exemption status on institutional review requirements?

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Exemption status changes how much review the study undergoes. When a project qualifies as exempt, it typically doesn’t go through the full IRB review process. The IRB still makes an exemption determination and ensures the study fits one of the exempt categories, but the level of oversight is reduced. However, this doesn’t mean there is no oversight at all. Researchers must adhere to applicable protections, and in some exempt categories there may still be limited IRB review or specific requirements around privacy, data handling, or consent. Informed consent can be waived or altered in certain exempt scenarios, but that isn’t automatic, and parental consent is not always required.