New protocol submissions, protocol renewals and protocol amendments must be submitted via eSirius 3G. The review process is as follows.
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.
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.
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.
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).
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.
eSirius 3G automatically emails the PI and protocol contacts confirming that the amendment is approved.
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.
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.
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.