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Review Categories

The regulations at 45 CFR 46 categorize human subjects research into three levels of review. How a study is categorized depends on the level of risk associated with the study procedures and the planned participants.

Per Liberty University policy, only the IRB can determine which review category is applicable to each research study. To facilitate a determination, please create and submit a research application through the Cayuse IRB (Human Ethics) link.


Exempt and Limited Exemption

Specific types of research that will involve minimal risk to participants are exempt from the regulations at 45 CFR 46. Again, only the IRB can determine whether a study qualifies for an exemption, and a research application must be reviewed by the IRB for a determination to be made. Research involving prisoners cannot receive an exemption unless their participation is incidental and they are not the focus of the research. Some research involving children is exempt. Related information is provided on the PDF. Whether a study involving a vulnerable population qualifies for an exemption depends on the nature of the vulnerability.

List of Exemptions (PDF)


Expedited

Research involving procedures on the list of expedited categories must be reviewed by the chairperson of the IRB committee or by one or more reviewers selected by the chairperson. Expedited does not mean that a study will receive a faster-than-normal review, so researchers should not contact the IRB to request an expedited review.

Expedited Research Categories (PDF)


Full Committee

Research that will involve greater than minimal risk to participants must be reviewed by the full IRB committee during a convened meeting.

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