IACUC Review Process

 

New protocol submissions, protocol renewals and protocol amendments must be submitted electronically to the IACUC Office. The review process is as follows.

 

 

The IACUC Office logs the application and performs a check for completeness. The PI is notified of any additional data needed, makes the corrections and returns the revised form(s) to the IACUC Office.

 

 

The IACUC is notified of all incoming protocols and amendments by the IACUC Office. Species, pain category and a brief description of the animal activities are included in the notice. The Committee is given the opportunity to request a copy of the protocol or amendment and/or to call for full committee review (FCR). Because of this, federal regulations require that two business days must elapse before the protocol can be assigned for review.

 

The IACUC Chair assigns each protocol to a (designated) primary reviewer. The primary reviewer may be either a veterinary or scientific representative with appropriate expertise. The reviewer is also charged with conducting a side-by-side comparison of the protocol to the PI's grant (for PHS funded grants) and reporting any discrepancies. In addition, the protocol is sent to a veterinary reviewer, if the primary reviewer is not a veterinarian.

 

 

The IACUC Chair assigns each protocol to a (designated) primary reviewer. The protocol may also be sent to a veterinary reviewer, depending on the nature of the amendment.

 

 

 

Protocols and amendments may undergo two types of review.

 

 

Following expiration of the committee notification, and in the absence of a request for FCR, the Chair determines whether the protocol or amendment is eligible for DMR.

 

 

The desginated primary reviewer has the following options:

 

 

Following a request for FCR, the Chair assigns the protocol or amendment to a primary reviewer.

 

 

The IACUC can approve or request revisions to the protocol or amendment. In addition, a quorum of the full IACUC Committee can vote to withhold approval of a protocol or an amendment. In cases where the IACUC has voted to withhold approval the PI is notified of reasons for this action and is provided a recommended course of action.

 

 

 

 

The IACUC Office emails the PI confirming that the protocol has been approved. A Verification of Review and approval memo is attached to the email for the PI's records and includes the approval and expiration dates. Protocols are granted three year approvals.

 

Note that approval dates for protocols may not coincide with funding periods.

 

 

 

The Annual Status Report is sent to PIs approximately one month before the anniversary of the protocol approval date. The PI updates the form to include information concerning current personnel and the use location for the protocol. The PI also reports on activities performed on the protocol in the past year, as well as activities planned for the coming year.

 

The Annual Status Report should be completed and returned to the IACUC Office by the due date. Protocols lacking a completed Annual Status Report are placed in an "on-hold" status, halting all animal purchasing.

 

The Annual Status Report also gives the PI the opportunity to identify any administrative changes to the protocol such as change in OSD, removal of inactive personnel, etc... as well as collect information on current project progress and research to be conducted in the next year. It also acts as a reminder to complete the Animal Hazards Checklist.

 

 

Protocol expiration notices are sent to the PI approximately four months prior to the expiration date. Work described in the protocol may not be continued past the approval date unless a Protocol renewal is already in place.