Guide :: Submission :: New Protocol :: Review Process :: Categories
Protocol review categories
In order to understand how your protocol will be reviewed, it is important to know what expedited, exempt, and full board protocols are. A full board protocol is a protocol where the level of risk is greater than what would normally be expected by the participant in the participant’s normal activities. This protocol requires full board review, which is a meeting attended by the Board members to discuss and vote on protocols. A full board protocol can be approved for up to one year. An expedited protocol is a protocol where the level of risk is minimal. The protocol does not require full board review; instead it is reviewed by a member of the Board outside of a scheduled meeting. An expedited protocol can also be approved for up to one year. For a more detailed definition, please see Expedited. An exempt protocol is a protocol that is exempt from IRB review. However, this does not mean that a protocol doesn’t need to be submitted to our office. Although the protocol may be exempt, the Board needs to review the protocol to determine if it is exempt. Despite its contradictory nature, it is important that a neutral party (i.e. the IRB) makes the determination for exemption because the categories for exemption are not always clearly applicable to a protocol. For more a more detailed definition, see Exemption. The review process for full board, expedited, and exempt protocols is described in the next sections.
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