IACUC Review Process


Submission to the IACUC Office
 
New protocol submissions, protocol renewals and protocol amendments must be submitted via eSirius 3G. The review process is as follows.
 
Administrative review
The IACUC Office performs a check for completeness. The PI is notified of any additional data/information needed and makes the corrections using eSirius 3G.
 
IACUC Office notification to the Committee
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). Due to this, federal regulations require that two business days must elapse before the protocol can be assigned for review.

Reviewer assignment
 
Protocols
The IACUC Chair assigns each protocol to a (designated) primary reviewer. The primary reviewer is an IACUC member 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.
 
Amendments
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.

Review process
 
Protocols and amendments may undergo two types of review.
 
Designated Member Review (DMR)
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.
 
Once the review is performed, any issues are routed through the IACUC Office to the PI. PI responses to review comments are returned to the reviewers by the IACUC Office.
 
The desginated member reviewer has the following options:
  • Approve the protocol or amendment, if satisfied that approval criteria are met
  • Request revisions to the protocol or amendment to secure approval, if outstanding issues are present
  • Request FCR, if further review of the protocol or amendment is warranted
Full Committee Review (FCR)
Following a request for FCR, the Chair assigns the protocol or amendment to a primary reviewer. Once the review is performed, any issues are routed through the IACUC Office to the PI. PI responses to review comments are returned to the reviewers by the IACUC Office. The protocol or amendment is then reviewed by the full Committee at the monthly IACUC meeting.
 
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.
 
Note that if hazards are identified, there will be additional review by Research Laboratory Safety Services (RLSS).
 

PI notification
 
Protocol approval
eSirius 3G automatically emails the PI and protocol contacts confirming that the protocol is approved. The IACUC Approval Letter is attached to eSirius and includes the approval and expiration dates and federal grant numbers. This is the document that is provided to funding agencies for proof of IACUC approval and protocol to grant congruency review for PHS or NSF awards.
 
Note that approval dates for protocols may not coincide with funding periods.
 
Amendment approval
eSirius 3G automatically emails the PI and protocol contacts confirming that the amendment is approved.

Annual protocol review / continuing review
 
The USDA requires annual review of animal protocols by the IACUC. The USDA stipulates that these renewals must be done no less than annually. The Continuing Review serves as the mechanism by which the IACUC performs annual review of protocols with USDA regulated species that have a three year approval.
 
For all species, the Continuing Review also serves as a mechanism for post-approval monitoring of IACUC protocols.
 
eSirius 3G sends reminders emails approximately 45, 30 and 15 days before the Continuing Review is due.

Expiration notices
 
Protocol expiration notices are sent to the PI approximately three 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.

When do I need to submit a renewal
 
The protocol renewal [de novo review] should be started well in advance of the actual expiry date of your current protocol. On average, a new protocol takes 30-45 days from the date of submission to approval. Please note that an amendmen cannot be started once a protocol is in the renewal stage.
 
Please note that a new protocol must be in place before the old one expires, otherwise the animals will be unavailable for use. Please see IACUC SOP 107 on protocol renewals.
 
If you do not intend to continue the protocol, any animals still on the protocols must either be euthanized or transferred to another active protocol, if appropriate. The transfer request form is available here.

What is the third year renewal process?
 
A third year renewal of a protocol is performed by the exact same process as for a new protocol submission, with the exception that the Progress Report section must be completed.

Can the IACUC extend my protocol?
 
As per the Animal Welfare Act and the NIH Office of Laboratory Animal Welfare (OLAW), protocols are approved for a maximum of three years. It is not possible for the IACUC to extend the protocol beyond the original three years.
Contact the
IACUC Office 
 
 
626-5304
Protocol amendments
Memoranda of understanding
Continuing reviews
Expiring protocols
Semi-annual lab inspections
Post-approval monitoring
Welfare and non-compliance
 
626-1247
New protocol submissions
eSirius
Issues with web forms

626-9071
Personnel Amendments
CITI training

     
     Report Misconduct
Ethics Hotline


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