IACUC Protocol Review: Overview
IACUC Protocol Review   Institutional Animal Care and Use Committees

Both the USDA animal welfare regulations (AWR) and the Public Health Service Policy on the Humane Care and Use of Laboratory Animals mandate the review of animal research protocols by the animal care and use committee before any research may begin. The AWR also require the IACUC to review all approved protocols on an annual basis. The IACUC must review and approve, require modifications to a proposal in order to secure approval, or withhold approval of any protocol that it receives. The institution is given leeway in determining the most appropriate means of complying with these requirements. The regulations and guidelines do not specify the frequency of meetings for IACUCs, leaving this to the needs of each institution. Animal care committees at large institutions may meet every month while smaller institutions may be able to function with bimonthly meetings.

The AWR mandate very specific criteria that must be met before an IACUC may grant approval to new proposals or changes in existing protocols. Those criteria include:

  • procedures involving animals will avoid or minimize pain or distress to the animals; 
  • an investigator must consider using alternatives to procedures that might cause pain or distress to animals. Further, the investigator must provide a written narrative discussing why alternatives can or cannot be used. The narrative must include the sources consulted (e.g. USDA’s Animal Welfare Information Center);
  • the investigator must provide written assurance that the proposed activities are not unnecessarily duplicative;
  • if painful or distressful procedures are unavoidable, the procedures must be performed with appropriate anesthesia, analgesia, or sedatives, unless withholding them can be scientifically justified; involve a veterinarian in the planning (review by a veterinarian on the IACUC after the protocol has been submitted is not acceptable; the veterinarian should be consulted before the protocol is submitted.); never use paralytics without anesthesia;
  • animals that experience severe or chronic pain that cannot be relieved will be euthanized at the end of the experiment or, if appropriate, during the experiment;
  • the animals’ living conditions must be appropriate for the species and must contribute to their health and comfort;
  • any medical care required by the animals will be provided by a qualified veterinarian, i.e. a veterinarian trained in laboratory animal medicine;
  • people that will be performing any procedures on animals will be qualified and trained to perform the procedures;
  • any procedures that involve surgery will include appropriate pre- and post-operative care. All survival surgeries must use aseptic technique including the use of sterile gloves and masks. Operative procedures that penetrate or expose a body cavity or procedures that result in permanent impairment of physical or physiological functions (major procedures) must be performed in a dedicated surgical facility that is maintained in aseptic condition. Rodents are exempted from this requirement. Minor surgical procedures must be performed aseptically but do not require a dedicated site;
  • use of an animal in more than one major operative procedure, from which it is allowed to recover, is prohibited unless it can be justified scientifically, is necessary for the health of the animal, or unless special permission is obtained from the U.S. Department of Agriculture;
  • use of professionally recognized methods of euthanasia unless a different method can be scientifically justified. The guidelines developed by the American Veterinary Medical Association are generally recognized as the currently accepted standard.
  • identification of the species to be used and the number of animals requested;
  • the scientific rationale for using animals, and the reasons for using the requested species and the number of animals;
  • a complete description of the procedures involving animals; and
  • a complete description of the methods that will be used to minimize pain and discomfort to that which is unavoidable and necessary to the collection of scientifically valuable data.