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Division of Research & Innovation

IACUC

IACUC Holding Protocol

BACKGROUND

The Guide for the Care and Use of Laboratory Animals (the Guide, NRC 2011) requires that all animals used in research, testing, or education must be covered under a protocol approved by an Institutional Animal Care and Use Committee (IACUC). The IACUC cannot permit any activities on live vertebrate animals without an approved IACUC protocol. This is required by the Public Health Service Policy on the Humane Care and Use of Laboratory Animals (PHS Policy) and the USDA Animal Welfare Regulations. In the event that animals are not on an active protocol (e.g. expiration, suspension, pending-approval) the IACUC has developed the following Standard Operating Procedure to handle animal care and disposition. The IACUC is mandated to report all serious or continuing issues of non-compliance to OLAW and/or the USDA, if applicable.

IACUC Policy

  1. Situations when the IACUC Holding Protocol is utilized:
    • Animals from an expired protocol.
    • Animals on a protocol that has been suspended.
    • Animals from PIs new to Wayne State University that do not have an IACUC-approved protocol, but need housing at Wayne State University.
  2. Process for transfer of animals to the IACUC Holding Protocol
    • Internal Transfers:
      1. The IACUC will notify the Principal Investigator (PI) and his/her Department Chairperson that all animals will need to be immediately transferred to the Holding Protocol via a Holding Protocol Transfer Form. IACUC staff will perform the transfer by noon on day of expiration (or prior business day).
      2. Division of Laboratory Animal Resources (DLAR) will identify cage cards/racks/room under the protocol that the animals have been transferred to the Holding Protocol.
    • External Transfers:
      1. New PI will notify the DLAR to start the process of animal arriving at Wayne State University.
      2. DLAR will identify cage cards/racks/room under the protocol that the animals have been transferred onto the Holding Protocol.
  3. Funding of Animals:
    • DLAR per diem rates for animals maintained on the Holding Protocol will be charged to the PI or his/her department chairperson, as will costs associated with breeding procedures if applicable.
    • External funding sources may not be used for per diem rates or costs associated with breeding procedures while animals are maintained on the Holding Protocol.
  4. Location of Animals:
    • The animals will be maintained in the Division of Laboratory Animal Resources (DLAR) facilities and routine husbandry provided by DLAR staff. Exceptions for species that require specialized facilities and/or husbandry (e.g. zebrafish) may be granted with written consent from the IACUC.
  5. Limitations of Work with Animals on the IACUC Holding Protocol
    • Maintenance/Husbandry: Once animals are transferred to the Holding Protocol, the principal investigator will no longer be able to perform experimental procedures on any animals housed on the Holding Protocol.
    • Breeding: The Chairperson (or designee) of the IACUC has the authority to amend the Holding Protocol to include procedures necessary to allow limited breeding, which could include special husbandry care, genotyping, and/or culling in order to maintain valuable animals or foundation stock (e.g., transgenic, knock-out, or mutant mice). In these instances, the PI must provide scientific justification and no expansion breeding is allowed. 
    • Necessary Special Diets or Oral Medications: Special diets or medications necessary to maintain the health and well-being of the animals may continue to be provided to the animals while on the Holding Protocol under DLAR care. However, no data collection in conjunction with the research described in the protocol may be done.
    • Veterinarian Care: Attending Veterinarian and veterinary staff have full discretion and authority for all veterinary treatment and euthanasia of animals on the Holding protocol.
    • Euthanasia: No tissues may be utilized for research purposes from animals euthanized while on the Holding Protocol. 
    • Time on Holding Protocol: Animals remaining on the holding protocol for over 60 days will be reviewed by the IACUC to determine if ongoing maintenance on the holding protocol is appropriate.
      1. If a resolution as to the disposition of the animals on the Holding Protocol cannot be reached, the animals will either be euthanized by an AVMA-approved method or, if the animals are suitable, offered by the IACUC for transfer to appropriate, approved animal protocols maintained by other investigators. The Institutional Official will be notified.
  6. Animals placed back to PIs
    • Once the protocol is approved or reinstated, the animals will be placed back under the Principal Investigator's care.

Approved: July 2006

Revisions Approved: August 2008, December 2012, October 2018, May 2022