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Submissions :: Protocol review process :: Protocol review 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, or in other words, greater than minimal risk. This protocol requires full board review, which will occur at a full board meeting, 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 as stipulated in the federal regulations. 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. An exempt protocol generally is processed similarly to an expedited protocol, avoiding review at a full board meeting. For more a more detailed definition, see Exemption.

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