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Review Type: What is it and why do I need to know?
Before starting an eProtocol application, investigators must identify the appropriate Review Type. This determines which questions are prompted for on the application. There are three types of review: Exempt, Expedited, and Full Board.
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Exempt review
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Studies meeting specific criteria. These studies are exempted from IRB continuing review - not from initial review. The IRB determines whether the claim for exemption is appropriate and whether it will be granted. Exemption from IRB continuing review continues unless the protocol is to be modified such that it no longer will meet the criteria for exemption.
NOTE: You can also check out our HRPP policy “Exempt Review of Human Subject Research".
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Expedited review
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Minimal risk studies meeting specific criteria. Protocols are generally reviewed by one primary IRB reviewer. Protocols approved under Expedited review are subject to IRB continuing review.
NOTE: You can also check out our HRPP policy “Expedited Review of Human Subject Research".
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Full Board review
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Studies that involve more than minimal risk or do not meet the criteria for Exempt or Expedited. They are reviewed at a convened IRB meeting. Examples of protocols requiring initial regular review are studies using FDA investigational test articles, randomized double-blind placebo-controlled studies, Phase I, II, III and IV clinical trials, and studies using x-rays.
NOTE: You can also check out our HRPP policy “Full Board Review of Human Subject Research".
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