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Submissions :: Protocol review process :: Expedited/Exempt Review

Expedited and Exempt Review

If the staff member assigned to "pre-review" the protocol (or the "pre-reviewer") recommends a protocol for expedited/exempt review, the pre-reviewer will send the pre-reviewed protocol to a Board member for review after all recommended changes from the pre-review have been made by the researcher. The Board member makes the final decision as to whether the protocol can be expedited or is exempt. When a Board member receives a protocol for expedited review, he or she first will assess if the level of risk is appropriate for an expedited review (remember that an expedited protocol must meet the level of “minimal risk”). If the Board member feels that the level of risk in the study warrants further review, the protocol will be sent to the next full board meeting. If a protocol is sent to a full board meeting, it may still receive an exemption or be expedited in future reviews (i.e. continuing review if the protocol continues beyond the first year of approval) if the Board determines that the study meets the definition for minimal risk. 

If the Board member agrees with the pre-reviewer’s recommendation, he or she will then review the protocol and determine if it can be approved or exempted.  The Board member may request that additional changes be made to the protocol before it can be approved or exempted (the pre-reviewer will send the changes to you via email). Unless the changes to the protocol are significant, the pre-reviewer can review and process an approval for the revised protocol without sending it back to the Board member for further review.  When the protocol is issued an approval or exemption, you will receive an approval or exemption letter and stamped consent forms (if applicable).  Once you receive your official approval letter, you can begin data collection for your study. An approved protocol that has expedited status is only approved for one year (similar to a full board approval) whereas an exempt protocol is approved for four years.

The expedited/ exempt review is run on a rolling basis and it is not subject to deadlines.  The entire review usually takes at least one to two weeks, though the review often depends on the changes that need to be made and how busy our office is.  However, please be aware that if your protocol is sent to the full board, this can delay the review time by at least a month. If you are trying to meet a specific deadline, please communicate this to your pre-reviewer and don’t submit your protocol at the last minute. Please note that we cannot guarantee that a protocol will be reviewed by a specific date. For time saving tips on writing your protocol, see Tips.

Section Topics

Minimal Risk
Identifiers
Expedited Protocols
Exemption

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