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Levels of Review
Human subjects research, and when it needs review
Research activities at Indiana University and its affiliated institutions that use humans as research subjects must go through a review and approval process before any interaction with human subjects or data collection can begin.
The Institutional Review Board (IRB) reviews each study submission to ensure that research being conducted adheres to the highest ethical standards involving the use of humans as subjects in research, while complying with all university, state, federal, and agency requirements.
Does my study need IRB review?
- If you gather data about an individual that is identifiable (i.e., the identity of the individual is or may be readily ascertained or associated with the information provided) and is considered private information, then IRB review and approval is required.
- If you have an interaction (communication and/or interpersonal contact) with a human subject for the purposes of gathering data or information about that person for research purposes, then IRB review and approval is required.
- If you perform an intervention that includes physical procedures by which data are gathered (e.g., taking blood or tissue samples, etc.) on an individual and/or that manipulate the individual’s environment for research purposes, then IRB review and approval is required.
- Any activity that is subject to FDA regulations as a clinical investigation must be reviewed and approved by the IRB. FDA regulations apply if:
- Your project involves the use of a drug, biologic, dietary supplement, or medical device that is not approved for use for any purpose in the United States;
- Your project involves the study of a drug, biologic, dietary supplement, or medical device for which some aspect of the administration is dictated by your research protocol (e.g., randomization, protocol dictates route or dose, etc.); OR
- Your study data will be reported to the FDA (e.g., comparison studies of marketed drugs, clinical trials of new or investigational drugs or devices, or studies of in vitro diagnostic devices).
What level of IRB review does my study need?
The Protocol Decision Tree can help you identify what level of IRB review you will most likely need for your study.
Human subjects research review falls into one of the following categories:
Non-human subjects research
If your project is not human subjects research and does not require IRB review and approval, documentation of this decision can be provided by the Human Subjects Office if requested.