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Animal Use Protocol Review

The Institutional Animal Care and Use Committee (IACUC) is responsible for the review and approval of all animal care and use associated with Saginaw Valley State University or conducted by its faculty, staff, or students. The IACUC has the authority to suspend activities involving animals if the activities are not in compliance with federal regulations, deviate from the approved protocol, or occur in the absence of an approved protocol. Suspensions of activity will be promptly reported to the funding agency and appropriate regulatory agencies. 

Requirements for Invertebrate Studies

The Saginaw Valley State University Institutional Animal Care and Use Committee (IACUC) does not require Principal Investigators to submit an animal use protocol for studies conducted on invertebrates.

Policy Procedure

A.  Basic Principles 

The principal investigator (PI) is the responsible party for all activities included in and related to the animal use protocol (AUP).

Approved AUPs are subject to IACUC full committee review at any time at the request of an IACUC member, the Veterinarian, or the Institutional Official (IO).

The PI will be notified of any request for full committee review and allowed and encouraged to attend the meeting or to send a representative.

B.  Animal Use Protocol (AUP) Application

The AUP application is the official document sanctioned by the IACUC. Modifications of the form must be reviewed by the IACUC to ensure compliance with regulatory requirements.

AUP forms are available on the IACUC website [link] for Educational Animal Use Protocol or Research Animal Use Protocol.

C.  Review of New Protocols and Triennial Resubmissions

Review process using online IRBNet system:  IACUC Coordinator reviews AUP for completeness and assigns it for review.  In order to be considered at the monthly meeting, all materials must be submitted at least two weeks before the meeting.  Shorter submission timelines may be approved by the Chair.

‘A’ protocols are reviewed by a single designated reviewer and the attending Veterinarian.

The protocol is place on the weekly list for review by the IACUC membership.  Additional information or full committee review may be requested.  If after 5 working days there is no call for full committee review, the protocol is approved.

‘B’ protocols are reviewed by two designated reviewers, the attending Veterinarian, and one other reviewer.  The protocol is place on the weekly list for review by the IACUC membership.  Additional information or full committee review may be requested.  If after 5 working days there is no call for full committee review, the protocol is approved.

‘C’ protocols are reviewed by the attending Veterinarian.  Full committee reviews protocol at the convened monthly meeting.  All multiple major surgery protocols are reviewed by the full committee.

Veterinary review:  Drug dosages reviewed; AUP comments are made in IRBNet pertaining to any potential animal welfare issues.

Designated member review:  IACUC Coordinator assigns a member of the IACUC as the reviewer.  Reviewers may approve, recommend revisions, or request a full committee review of the protocol.

Full committee review:  All B, C category protocols, and protocols involving major survival surgery will receive full committee review. Major survival surgery is defined in the Guide as a surgery which "penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions." 

When a full committee review is requested, the AUP is added to the agenda for the next meeting.

PIs may be requested to attend the meeting or to be available by phone to address questions from the IACUC related to the protocol. The IACUC may offer suggestions to revise the AUP prior to approval.

A quorum of the committee must be present, and a majority vote is required for protocol approval. Minority opinions are recorded in the minutes and acknowledged in regulatory reports where required.

Approved protocols receive the approval number from IACUC Coordinator.  "Read only" approval letter from IACUC Coordinator sent to PI and posted in IRBNet, the password-protected website.

D.  Review of Annual Renewals and Amendments

Notification:  The IACUC Coordinator sends electronic reminders of protocol expirations to PIs at 60 and 30 days.  PIs are informed in reminders that submission of renewal requests must be submitted four weeks before the AUP expiration date to allow sufficient time for AUP review if amendments are included.

Review process:  For Significant changes - Proceed through protocol review process as for new protocols and triennial resubmissions.  Minor changes are administratively approved by the IACUC Coordinator.  A password-protected approval letter is sent to the PI by the IACUC Coordinator.  IACUC Coordinator provides a brief report of the number of renewed protocols at each IACUC meeting.

Definitions for Significant changes:

  • Change in PI or key personnel who perform technical procedures on animals or train others in the lab to perform those procedures
  • New invasive or surgical procedure
  • New drug treatment
  • New therapies
  • Increase in animal numbers greater than 10%
  • Addition/substitution of a new species
  • Significant increase in pain or distress
  • Addition of anesthesia, abnormal pathology, water or food restriction, immunization, or hazardous substances
  • Transfer of animals for one AUP to another AUP

Definitions for Minor changes:

  • Change in strain of mice or rats used in the same experiment(s)
  • Change in support personnel (not PI) who do not train others
  • Addition/substitution of new non-invasive procedure for same experiment(s)
  • Increase in animal numbers of less than 10% of zebrafish, rats, and mice

E.  Suspension of AUP Activity

The IACUC may suspend the activity of an approved AUP when necessary to ensure animal welfare.  Suspension of AUP activity should be discussed and voted on at a full committee meeting and requires a majority vote of a quorum of the committee.  Recommended corrective action should be outlined by the IACUC.  Immediately after IACUC suspension of AUP activity, the IACUC Chair or his/her designee will inform the IO of the suspension and recommended corrective actions.  The IO must then notify appropriate regulatory, accrediting, and funding agencies of the suspension and corrective actions taken.  The IO does not have the authority to overturn an IACUC suspension of AUP activity.

F.  Recordkeeping

Responsibility:  The IACUC Coordinator maintains records and official communications concerning protocol renewals with PIs electronically and/or in hard copy form, as appropriate.

Electronic AUP records:  All current and expired AUPs will be maintained in PI folders on the password-protected IACUC website for a minimum of 3 years after expiration of the AUPs.  Permits for AUP approvals from other institutions will be embedded into current AUPs or maintained in the PI folder.