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IRB review and approval is required for projects that: Meet the definition of research. Involve human subjects and. Include any interaction or intervention with human subjects or involve access to identifiable private information.
IRB review and approval is required for projects that: Meet the definition of research. Involve human subjects and. Include any interaction or intervention with human subjects or involve access to identifiable private information.
An institutional review board (IRB) applies research ethics in the review of proposed research.
If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review.
Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as publicly available.
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Exempt human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations. Studies that qualify for exemption must be submitted to the IRB for review before starting the research.
If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review.
The type of IRB review and the associated review process (e.g., full board, expedited, limited IRB review, system-generated) are determined by the: Level of risk to research participants. Type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
This group review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

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