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Submissions :: Protocol review process

Protocol Review Process

In a nutshell, after the IRB-SBS receives your submission, your protocol is assigned to a member of our staff whose responsibility is to oversee your review. The staff member will “pre-review” your protocol to make sure that it is ready for a board member’s review. The staff member may require that you make revisions to your protocol so that it is more likely to be approved. When the protocol is ready for a board review, the staff member will either assign the protocol to the next full board meeting or will send the protocol to a board member for an expedited review. In an expedited review, the Board member will either approve or exempt a protocol (sometimes with requested revisions) or will request that the protocol be reviewed by the full board.  In a full board review, the board will meet and discuss the protocol; the protocol will be approved, exempted, not approved, or they will table the protocol until more information is received. The board may also request revisions to a protocol prior to approval/exemption.

This section describes the details of how this process works as outlined by the federal regulations, the foundation for the IRB review process. These regulations describe how the board is constructed, what is required to approve a protocol, the rules for exempting a protocol, the rules for expediting a protocol, and additional rules regarding the details of the protocol. The Board cannot approve protocols unless they meet specific requirements outlined in the federal regulations. All revisions and requirements made by the Board are meant to first, protect participants and second, help researchers have protocols that are in compliance with federal regulations.

Section Topics

Protocol Review Categories
Pre-Review
Expedited/ Exempt Review
Full Board Review
Full Board Meeting
Special Issues for Protocol Review

Additonal Topics

Protocol Submission Process
Events/ Meetings

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