All research involving human subjects must be reviewed and approved by the Princeton IRB before initiation. However, the Code of Federal Regulations identifies six categories of minimal-risk Human Subjects research as being exempt from Federal Policy for the Protection of Human Research Subjects. Because investigators are not authorized to make this determination, all requests for “exempt status” must be reviewed and approved before commencement of study procedures. Once IRB staff determines that the proposed research activity meets at least one of the exempt categories below, an “Exemption Notice” will be issued to the Principal Investigator. All future research changes must be reviewed and approved prior to implementation.
No expiration date will appear on the “Exemption Notice” because annual review is not required for exempt research. Additionally, investigators must close projects when completed, when there is no longer access to identifiers, or when the PI leaves the University. Alternatively, applications that do not meet the criteria for “exempt status” may be submitted as one of the following:
- Expedited review ( Questionnaire A required, if one of the expedited categories apply)
- Full Board Review (Questionnaire A required, if the research involves greater than minimal risks).
If you think your proposal may be exempt from IRB review, please review the categories below and submit an Exempt Questionnaire B application. The IRB staff will review the application and follow up with you if more information is needed to make the exempt determination.
Please use the drop down menu to review exempt categories, examples and tips.
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