Animal Use Protocol Form Approval in eSirius
According to MAPP 7.12 Policy and Procedures for the Use of Animals in Research, Testing and Teaching, the review and approval of Animal Use Protocol (AUP) forms by the Animal Use Subcommittee (AUS) is required prior to the commencement of all research, teaching and testing involving animals.
Formal protocol review follows one of three processes: Office Review, Designated Review, or Full Review, which adhere to established timelines as detailed within the AUS Protocol Review Process SOP.
The submitted AUP will undergo pre-meeting review involving a protocol facilitation service and review workflow assessment according to established criteria, as detailed within the AUS Protocol Review Process SOP.
Most full AUPs will undergo review and approval following the Full Review & Approval Process unless otherwise noted in the associated Full Review Criteria, listed below.
Once approved by the AUS, the approved Animal Use Protocol will no longer appear within the Alerts - New Protocols section of your eSirius Hom Page. A confirmation email along with the related Approval Letter will be electronically forwarded to the Principal Investigator (PI), PI Designate, if applicable, and related Facility Manager via email. An AUP is in effect for exactly four years to the last day of the month of the initial approval. The protocol number issued at approval remains with the protocol for its entire life within eSirius. However, in order to continue with the approved Animal Use Protocol, annual Protocol Renewal form submissions are required (see below). Additionally, all changes to the AUP must receive AUS approval via a Protocol Modification form.
Every 4th year of the protocol's life, you will be required to submit a Full Renewal application, which involves the verification and resubmission of the entire AUP document. You may also choose to expire your AUP at the time of Full Renewal. If no response is received (a new AUP form submission) prior to the Full Renewal due date, the Animal Use Protocol will be expired within eSirius by the AUS Administrative Officer (a courtesy email notice will be sent in advance of expiry).
Annual Protocol Renewals in eSirius
Yearly renewals are required from the 2nd to the 4th year following the AUP's initial approval and each subsequent full renewal in the life of the protocol. For each of your approved AUPs, you must submit an Annual Renewal form to the AUS Office each year including a 3R’s Progress Report, Project Status (notice of AUP changes – checkbox only as all AUP changes require a Protocol Modification) & Animal Use Update, Animal Use Complications Progress Report and Analgesia Administration Update. eSirius automatically sends protocol holders a notice within the Alerts - Annual Renewals section of their eSirius Home Page 75 days prior to the protocol's yearly expiry date.
As a courtesy, protocol holders will also receive an email renewal reminder approximately 60 and 30 days in advance of the protocol's yearly expiry date. Unrenewed Animal Use Protocols will be archived, which will result in cessation of all animal-based protocol related activity. For associated review and approval processes, see the Protocol Form Workflow Assessment.
Should you have any questions related to Annual Protocols Renewals, please contact us via email@example.com or by phone at x82242.
Protocol Modifications in eSirius
All changes to the original approved Animal Use Protocol - including but not limited to changes involving titles, funding, animal procedures, drugs/agents, staff and their animal procedure involvement, emergency contact numbers, animal holding and use locations, authorized animal numbers, source, species - must be requested via submission of a Protocol Modification within eSirius.
eSirius allows you to request Protocol Modifications to an approved AUP by re-submitting the protocol itself with requested updates to the form content. During the Protocol Modification review workflow process, you will not be able to access the protocol to make any further changes until the modification has been assigned either an ‘Approved (w/out Stipulation)’ or ‘Not Approved (w/ Stipulation)’ status by the AUS Office. Once the modifications to the AUP have been approved, the protocol is updated as per your requested changes in eSirius and you may choose to submit additional protocol modification(s) at this point.
However, major project changes - including the addition of more invasive procedures, species change, or a substantial animal number increase - may require submission of a full Animal Use Protocol, and/or review and approval assessment following the Full Review Workflow. For associated review and approval processes, see the Protocol Form Review Workflow Assessment.
Protocol Form Review Workflow Assessment
A first draft of a completed AUP, Annual Protocol Renewal or Protocol Modification form, authorized by the Principal Investigator (PI) or Designate, must be submitted to the AUS Office via eSirius. Every protocol will be assigned to a specific AUS AO & ACVS Veterinarian. The assigned AUS AO will assess form content and determine one of the following review workflows:
Additionally, the PI has an opportunity during the pre-meeting review stage to request the Protocol Facilitation Service, as described below.
Protocol Facilitation Service
The protocol facilitation meeting service, offered to all PIs for all AUP forms, and MOD forms involving potentially significant changes during the pre-meeting review time period, provides an opportunity for the Researcher, Designate, ACVS Veterinarian and AUS AO to collaborate with the objective of developing a protocol application that facilitates a streamlined review. This meeting is also offered to PIs requesting advance assistance in initial form completion. Protocol facilitation is an optional service for all, except for forms identified by the AUS AO or ACVS Veterinarian as needing significant revisions or clarification. Specific benefits of this service include:
- Immediate response to Researcher questions and concerns by an ACVS Veterinarian and AUS AO;
- The opportunity to receive ACVS Veterinarian expertise relating to refinements for animal-based project elements including species use and number justification and animal-related procedures (e.g. anesthesia and analgesia regimes, endpoints), if applicable;
- The opportunity to receive suggestions from an AUS AO specific to AUS form content requirements that ensure a complete and understandable format (e.g. flow chart design).
Office Review workflow will be used for requested ‘minor’ changes within Protocol Modifications that neither deleteriously impact the animal(s) nor require new skills. Approval will be granted by either the AUS AO, or an ACVS veterinarian. Additionally, all office approvals will be presented to the full AUS on a monthly basis.
Office Review Criteria
AUS AO may grant approval for the following Protocol Modification changes:
- Staff & their training requirements
- Protocol Title
- Granting information
- Animal Source (except involving transfer of previously ‘used’ animals between protocols)
- Animal Strain - addition of non-genetically modified strains
- Animal Number increase up to 10%
ACVS Veterinarian may grant approval for the following Protocol Modification changes:
- Housing or Use location change (Facility Managers will be included in review process);
- Euthanasia method change (CCAC acceptable only) not involving SOPs;
- Acute procedures on a fully anesthetized animal that will not be recovered;
- Analgesia & anesthesia regime change;
- A change to a less invasive, distressful or painful procedure;
- Animal Number increase up to 25%;
- Transfer of animals between protocols (Protocol Transfers involving previous animal use, excluding breeders, moms & surplus animals)
- Animal Strain – addition of genetically modified strains
Designated Review Workflow
The Designated Review process involves a Protocol Review Committee consisting of an alternating subset of five AUS members having the following roles:
- AUS Chair/Vice Chair,
- ACVS Veterinarian,
- AUS Scientific Representative (PI, Grad. Student, or Animal Technician),
- AUS Community Representative,
- AUS Administrative Officer.
Designated Review Criteria
Following opportunity to call for full review, the review and approval by the designated reviewers will be carried out during weekly online Designated Reviews. Protocol forms involving the following elements will undergo Designated Review:
- Protocol Modifications involving:
- Chronic studies containing animal procedural changes;
- Species change, except involving species deemed ethically sensitive by the AUS;
- Animal number increase up to 100%
- New agents, materials, or devices.
- Annual Renewals;
- Animal Use Protocols involving:
- Pilot study Animal Use Protocol submissions, excluding ‘E’ Category of Invasiveness and ethically sensitive species;
- Final review and approval of Animal Use Protocols approved pending clarification during monthly meetings;
- Interim approval of Animal Use Protocols to be used infrequently.
- For the Designated Review Approval Process detail, see AUS Protocol Review SOP.
Full Review Workflow
Full review and approval determination involves the full monthly AUS meeting, and is used for most full Animal Use Protocols, as well as some Protocol Renewals and Protocol Modifications, as per the Full Review Criteria listed below.
Full Review Workflow Criteria
Animal Use Protocol, Annual Renewal and Protocol Modification forms involving the following elements will be automatically considered to require Full Review:
- Any protocol form upon request by any AUS Member, ACVS Veterinarian, or regulatory body (OMAFRA, CCAC);
- All new Animal Use Protocols, except Pilot studies (see AUS Protocol Review SOP)
- Post Pilot Full Animal Use Protocol submission;
- Pilot Animal Use Protocols involving Level ‘E’ Category of Invasiveness;
- Interim-approved Animal Use Protocols (See AUS Protocol Review SOP)
- Annual Renewals as requested by the full AUS and/or AUS Protocol Review Committee;
- Protocol Modifications involving:
- Animal procedural changes involving Category of Invasiveness level ‘ E’
- Use of animal models that employ ascites;
- Multiple major survival surgeries;
- Food and/or water deprivation resulting in pain or distress as determined by the reviewing ACVS Veterinarian;
- Species change involving species deemed ethically sensitive by the AUS
Possible Approval Delays
The following review elements may delay AUS approval:
- Institutional Safety Officer Approval – Contact Institutional Safety Officer(s) directly;
- Institutional Biohazard Sub-committee or Biosafety Committee Approval – BARF form pre-submission & review – Contact Institutional Biosafety Officer;
- Scientific Peer Review Pre-Approval - Contact the AUS AO;
- Delayed PI Response to outstanding reviewer questions or concerns;
- Outstanding Training - Personnel, including PI, on Protocol with previously outstanding training: Contact firstname.lastname@example.org;
- AUS AO Vacation Coverage – During vacation time periods, workloads double for the remaining AUS AO, which may result in protocol processing delays;
- Summer Break - The AUS does not meet during one month in the summer semester. Consequently, the review and approval assessment of all Protocol forms requiring Full Review during that month may require additional processing time.
AUS Committee - AUP Review in eSirius
For the AUS Committee Only: Click on the AUS Committee - AUP Review in eSirius page for detailed instructions regarding the use of eSirius, the web-based protocol management program, for AUP review. You will also be informed of any upcoming events or important notices that are relevant to AUS Committee Members. AUS Committee access is only offered to those having a UWO email user ID and password. If you have access difficulty, please inform the AUS office.