IACUC Definitions

The IACUC protocol requests the PI to determine and justify how many animals will be used in a study. This is due to federal requirements from the Animal Welfare Act, PHS Policy, and the Guide for the Care and Use of Laboratory Animals. These agencies ask for an approximate number of animals that is the minimum number required to obtain valid results.

In the case of traditional biomedical studies, the justification should be the minimum number of animals required to obtain statistically valid results. It includes breeding colonies, control and treatment groups, and the potential for loss of animals (study design, humane endpoints, and not genetically appropriate). The justification should indicate calculations and include group size through a power analysis. Note that all individuals from a production colony are counted against the total number of animals utilized.

For non-biomedical and wildlife studies, other literature and pilot studies may be part of the justification.

Overall, the justification can be based on:

• Power analysis
• Citations from previous research with similar sample size, species, and methodology
• Student to animal ratio in a teaching protocol
• Statistics showing probability of success of experimental procedure or desired effect
• Number needed to provide appropriate amount of specimens for in vitro studies
• Estimation of variance, effect size, and statistical power for pilot studies
• N=1 for feasibility studies
• Pilot studies

Sources:

• Rationale for Species and Animal Numbers in Animal Care and Use Protocols (UC Davis IACUC procedure)

Power analysis links:

• http://www.biostathandbook.com/power.html
• http://www.gpower.hhu.de/

Procedures are classified according to the level of potential pain or distress that the animal may experience. If more than slight or momentary pain and distress could be caused by the procedure, then relief must be provided (pain class D). If relief cannot be provided (pain class E), there must be scientific justification for withholding it, which must be included in the animal use protocol and reviewed by the UCSC IACUC.

Additional information:

• USDA Animal Care Resource Guide, Policy #11, Painful Procedures
• (UCSC IACUC) Pain and Distress Classifications

Animal related activities involve handling of animals or any manipulation of the environment that would influence animals in any measurable way. They would affect the behavior or physiological state of an animal, including animal handling, tagging, tissue sample collection, providing food, playback of sounds, habitat manipulation, or closer approach to the animals by humans than they would typically encounter as background levels from the public.

Protocols are approved by the IACUC with an expiration date up to three years out. If the research will not be completed before the protocol expiration date, a de novo (new) application must be submitted. If this renewal protocol application has not been processed and approved by the expiration date, the IACUC approval for the work will expire and all activities involving the care and use of animals must cease immediately. Any activities conducted under the protocol after expiration will be in direct violation of federal regulations and institutional and IACUC policies.

Certain experimental paradigms require the use of food or water restriction in order to accomplish studies such as operant conditioning work. The UCSC IACUC is required to approve these restrictions to ensure they are scientifically justified, minimize the level of restriction, and have criteria in place to monitor the health of animals in these studies.

Animal use protocols employing food or water restriction must provide the duration of restriction, level of restriction, and justification for the restriction as part of the protocol description. Furthermore, the early removal criteria must provide methods to assess the animal’s health while on restriction. Typically this will require a frequent monitoring method such as daily weighing of the animal. Note that pre-surgical food restriction is detailed in the surgery procedure as part of the animal use protocol, and does not need specific justification.

PHS Policy and the NIH Grants Policy Statement require research institutions like UCSC to compare the care and use of animals section of PHS and NSF grant proposals to the IACUC protocol. Before submitting an initial IACUC protocol or amendment, PIs must ensure that the scope of work, species, numbers, agents and methods for them, procedures, and euthanasia methods are congruent (match) with the grant proposals. Note that in general, the grant proposal descriptions will be broad and the IACUC protocol more specific.

An animal housing area managed by an investigator, also known as satellite housing. It includes a building, room(s),  enclosure(s), or other containment sites in which animals are kept and husbanded for periods longer than 12 hours (USDA regulated species) or 24 hours (all others; non-covered species). These areas are subject to IACUC oversight.

Any investigator­-managed building, room, area, enclosure, or other containment site in which animals are taken for immediate use (i.e., surgery, euthanasia, behavioral testing) on an UCSC IACUC-approved protocol. They are not meant for housing. They are subject to IACUC oversight.

The UCSC IACUC protocol forms require a summary of the study objectives, procedures, and animal use justification that are written in simplified language with minimal scientific jargon to be understandable by members of the general public. Tools like the Flesch–Kincaid readability test are designed to indicate how difficult a passage in English is to understand. Principle II of the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training states that “procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.” The Guide for the Care and Use of Laboratory Animals specifies “The following topics should be considered in the preparation of the protocol by the researcher and its review by the IACUC … a clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee” including non-scientists and unaffiliated members of the IACUC.

Survival surgery is when an animal is anesthetized for a procedure with the expectation it will be recovered and live. A major survival surgery penetrates and exposes the body cavity or produces substantial impairment of physical or physiologic functions (such as laparotomy, thoracotomy, craniotomy, joint replacement and limb amputation). Scientific justification is required in the animal use protocol if more than one major survival surgery is to be performed on an animal while used in  the study. See the IACUC Guidance on Surgical Procedures.

Research permits are broadly defined as a certificate indicating “managing authority” approval to conduct a specific research activity over a specific and finite period. Permits are often issued to legally conduct scientific research, education, move/transfer samples/specimens/individuals, and/or propagation activities involving the take and/or possession of regulated/protected species. The type of permit needed for these purposes varies depending on the special status designation in accordance with the local, state, federal, or international managing authority. Permits are issued to the individual or entity responsible for overseeing the activity (i.e., Principal Investigator or Research Division). Please note that other permits may be required to accompany any existing/current permits based on the intended research activity (e.g., CITES Import/Export, ESA holding permit).

Protocols are typically approved by the IACUC for up to three years. In some cases, the IACUC may approve a protocol for a shorter period, such as with pilot studies. The end date of the approval period is known as the protocol expiration date.

If research activities are anticipated to continue past the protocol expiration date, the PI must submit a de novo (or new) application to the IACUC. De novo applications should be submitted to the IACUC 6 to 8 weeks prior to the expiration date for IACUC review.

If a de novo protocol has not been processed and approved by the protocol expiration date, then no further research activities can occur and the care and husbandry of the animals will be transferred to the campus veterinarian. Federal regulations and UC policy require an active protocol to be in place before any research activities may be conducted or continued.