Is an IACUC Application Needed?

Generally, vertebrate animals and cephalopods match the requirements for a protocol application. However, there are many definitions of “animal”:

• The Public Health Service (PHS) Policy, which applies to all PHS-funded activities involving animals, defines “animals” as “any live, vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes.” (https://ori.hhs.gov/content/Chapter-4-The-Welfare-of-Laboratory-Animals-Definitions)
• The Federal Code that implements the Animal Welfare Act (Title 9) defines animals as “any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warmblooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to, livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. This term also excludes falconry. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes.” (https://www.animallaw.info/administrative/us-awa-animal-welfare-definition-animal) 
• Because UCSC is an AAALAC-accredited institution, we are obligated to include animals by following “animal ownership in terms of defining who is responsible for animals at an offsite program.” We need to include the IACUC or comparable oversight body review. Further, “All animals used or to be used in research, teaching or testing at accreditable units are to be included and evaluated in accordance with the standards… [which] includes traditional laboratory animals, farm animals, wildlife, and aquatic animals. Nontraditional animals, inclusive of invertebrate species, are also included where they are relevant to the unit’s mission.” (https://www.aaalac.org/accreditation-program/rules-of-accreditation/)
• NSF holds its awardees responsible for the humane care and treatment of any vertebrate animal used or intended for use in such activities as field or laboratory research, development, training, experiments, biological testing or for related purposes supported by NSF grants, contracts or cooperative agreements. (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-139.html)
• Studies with invertebrates such as insects do not require a protocol for IACUC review and approval. However, some aspects might need review by EH&S. UCSC encourages writing a protocol for cephalopods.

The UCSC IACUC recognizes there are exceptions and complexities to the requirement for an animal study protocol. Because it is not always clear cut, with many “it depends” decisions to be made, based upon funding, species types, regulations, animal protection agencies, covered vs. non-covered designated animals, etc., research staff are encouraged to contact the IACUC office for assistance. 

Examples of activities that fall under the purview of the UCSC IACUC and do require a protocol are:

• Research, teaching, and/or testing with vertebrate animals owned by UCSC, regardless of the funding source.
• Research, teaching and/or testing using vertebrate animals in collaboration with another institution or organization, including commercial entities. Contact the UCSC IACUC prior to initiating animal research at another institution. More on collaborative research
• Field/wildlife research activities using free-living vertebrate animals when the studies involve more than unobtrusive observation.
• Research, teaching and/or testing using cadavers or tissues from dead animals unless the cadavers or tissues are to be acquired from animals specifically purchased or euthanized for the activity. Such activities may also require permits.
• [encouraged] Any activity involving higher level invertebrates in the class Cephalopoda.

Examples of activities that do not require an IACUC protocol are:

• Activities ordered and/or performed by the campus attending veterinarian or designee that involve only standard veterinary or emergency procedures necessary to ensure animal welfare.
• Activities involving retrieval or use of animal-related data from records. The PI should assure that, as applicable, there was an animal welfare oversight body involved when the data were originally obtained.
• Research, teaching and/or testing involving embryonated eggs, prior to hatching as below.
  • For zebrafish, that is considered to be ≤3 days post-fertilization.
  • For avian eggs, that is considered to be prior to hatching. PIs should be prepared to address the potential for hatching unexpectedly.
• Any activity involving lower-level invertebrate species (e.g., brine shrimp, fruit flies, nematodes, mosquitos).
• Activities associated with managing wildlife or field studies, which are not the same as wildlife research. Contact the IACUC office for clarification. 
• Non-research, non-teaching, or non-testing activities involving privately owned animals, in which the activity is not an official UCSC activity.
• Removal of vertebrate vermin.