Admin SOP 1.14 - AUP Submission, Review and Approval Workflow

1. Introduction and Definitions:

All protocol submissions must be submitted in the electronic protocol management system (Topaz Elements). Investigators are encouraged to consult the UACC Coordinator, the UACC Chair or the University Veterinarian with any questions they may have before submitting a protocol for review.

2. Procedures:

Submission Process

Investigators must submit all Animal Use Protocols (AUPs) to the UACC Coordinator using the electronic protocol management system Topaz Elements. Once submitted, all protocol submissions including renewals and amendments undergo preliminary review. New submission and full resubmission protocols may also undergo a veterinary preliminary review. Comments and/or questions, resulting from preliminary review are corresponded to the PI. This feedback should be incorporated into a resubmission of the protocol within the desired meeting submission deadline. If there are no suggested revisions, the submission will be added to the next meeting agenda and assigned to UACC review accordingly. Incomplete applications or those received past the deadline may be deferred to the next monthly meeting.

Review Process

The UACC Coordinator assigns a primary and secondary reviewer to each new submission protocol (level B-E) and full resubmission protocol (level B-E). These reviewers will be responsible for reviewing and leading the discussion of the protocol at the next regularly scheduled UACC meeting. All remaining members of the UACC (apart from those where a conflict of interest is present) will be assigned the protocol as committee reviewers, granting them access to view and comment on the protocol without a requirement to do so.

After UACC members have completed their reviews, they shall discuss the proposal at a full UACC meeting and, taking account of the members’ evaluations, either:

1. approve (with or without comments)
2. return for modification (for subsequent review by the UACC Coordinator (administrative approval), UACC subcommittee, or full UACC at a future meeting)

If the primary or secondary reviewer indicate, they will be given an opportunity to see any clarifications/revisions provided by the PI. Reviewers will also have access to the PI’s grant application(s) and/or other appropriate documents in order to satisfy themselves concerning the nature of the experimental procedures to be utilized. The UACC Coordinator may contact the PI to collect further information on behalf of any reviewer.

Major Amendments/Major Renewals/Level E Renewals

The UACC Subcommittee initially reviews all major amendments; major renewals (renewals with proposed changes defined as “major”) and level E protocol renewals. They provide feedback/request clarification as needed and once a motion for approval is reached, the protocol is presented at the following scheduled UACC meeting for acceptance and final approval.  The UACC reserves the right to reject the Subcommittee motion for approval and to request further clarification from the PI.

Approval Process

Once a protocol has been approved, the PI will receive a notification stating so. If the protocol has not been approved the PI will receive notification explaining the conditions upon which the protocol will/may gain approval status. The office of the UACC maintains the Topaz Elements database of current and historical protocols. Current UACC members, facility managers (and delegated staff), animal care staff, and grant administrators within the Vice Principal Research portfolio may have ‘view only’ access to all current and historical protocols as needed.

A one-year approval period is granted with the possibility for three consecutive yearly renewals (4 years total). Prior to the expiry of the one-year approval period, the PI is sent at least three monthly reminder emails stating that the project will require renewal should the PI wish to continue the research. A full resubmission protocol is required after the full 4-year approval period. Allowing active protocols to expire when animals work is continuing is considered a breach of compliance.

When renewals are approved past the renewal date, the one-year approval period will be pre-dated to fall in line with the initial period and when renewals are approved prior to the renewal date, the one-year approval period begins the date of approval. Approval periods can be no greater than 1 year and the life of any one protocol cannot exceed 4 years total. Short term extensions may be requested only under justified circumstances provided the subsequent renewal or full resubmission has been initiated and preferably submitted.