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Protocol Renewal & Expiration

Pursuant to the federal rules and regulations that govern the responsible use of animals in research, all animal use protocols undergo a de novo review every three years. To help ensure that Study Teams remain in compliance, the Animal Care & Use Program provides various reminders and notifications leading up to the protocol’s expiration date.

The University signs an Assurance with the Office of Laboratory Animal Welfare (OLAW) that states that all research, regardless of funding source, will be conducted following the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals.

This policy prohibits conducting ANY animal activities (procurement, breeding, housing, and/or use) or expenditure of federal funds for animal activities (including the purchase of animals and costs for breeding, housing, or other use) after a protocol has expired.

Accordingly, all protocols undergo de novo review every three years. Any activities conducted after a protocol has expired are considered to be in serious violation of the PHS Policy. These violations are reported to the U-M’s Institutional Official and may also require a report to OLAW.

To ensure compliance PRIOR TO a protocol’s expiration, the Principal Investigator (PI) and Laboratory Contact(s):

  • Will be notified that the protocol is expiring and due for renewal. This notification will include a deadline for renewal and steps to remain compliant with all applicable U-M policies and federal regulations;
  • Are responsible for ensuring that any housed animals are associated with an existing IACUC approved (i.e., in-date) protocol; and
  • Will be required to transfer animals to the U-M Holding Protocol if the renewal protocol will not be approved PRIOR TO the existing protocol’s expiration date.

Failure to renew a protocol with housed animals will result in an investigation of non-compliance pursuant to the standard practices outlined by the Policy on Investigating Noncompliance and Animal Welfare Concerns.

To ensure compliance AT a protocol’s expiration, the PI and Laboratory Contact(s) will be notified:

  • When the protocol has expired, and
  • That no further housing or experimental manipulations shall be permitted under the expired protocol.

Per National Institutes of Health (NIH) policy, any charges to NIH awards for animal activities conducted during a lapse in IACUC protocol approval(s) must be transferred to a non-federal funding source.

If a protocol expires PRIOR TO a renewal protocol being approved, no remaining animals can be used in ANY research or instructional activities. All remaining animals will be moved to the U-M Holding Protocol and a non-compliance investigation will be initiated.

U-M Holding Protocols

The U-M Holding Protocol provides a mechanism for temporarily holding animals when the PI/Study Team does not have an IACUC approved protocol (e.g., protocol suspension due to non-compliance, incoming investigators in the process of receiving IACUC approval).

While on the U-M Holding Protocol, animals:

  • Are not accessible to research staff,
  • May not be used in any research or instructional activities, and
  • Will continue to receive appropriate husbandry and veterinary care at the discretion of U-Mโ€™s Attending Veterinarian or their assigned designee, in accordance with all applicable institutional policies, guidelines, and SOPs.

PIs and laboratory personnel who are placed on the U-M Holding Protocol are responsible for: 

  • All charges incurred for animal husbandry and veterinary care;
  • Assigning all charges associated with animal activities (i.e., per diems, technical services, veterinary care) to appropriate, non-sponsored funds; and
  • Transferring animals to an IACUC approved protocol via the completion of a Transfer Request in eRAM.

Failure to comply with any of the Holding Protocol expectations outlined above and/or received in correspondence from the U-M Animal Care & Use Program will result in an investigation of non-compliance by the IACUC.

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