ILAR The Guide

Laboratory Animals

Laboratory Animals

Any vertebrate animal produced for or used in research, testing, or teaching.

Animal Use

The proper care, use, and humane treatment of laboratory animals in research or teaching.

ILAR

Establishes general principles and ethical considerations for the use of laboratory animals, focusing on improvement in well-being.

Replacement

The principle of avoiding the use of animals by using alternatives like computer programs or lower species.

Refinement

Modifications in procedures to enhance animal well-being and minimize pain and distress.

Reduction

The principle of obtaining comparable information from fewer animals to minimize the number needed for scientific research.

Veterinary Consultation

Required when pain or distress exceeds expected levels or when interventional control is not feasible.

Animal Welfare Responsibility

All individuals involved in animal research, testing, or teaching must ensure the well-being of the animals.

Engineering Standard

A prescriptive guideline detailing specific methods or technologies to achieve desired outcomes without modification for alternatives or unusual circumstances.

Performance Standard

A flexible guideline that describes desired outcomes while allowing discretion for program managers, researchers, and IACUC members to achieve those outcomes.

Practice Standard

The application of professional judgment by qualified individuals to tasks or processes in the absence of definitive scientific literature, often based on expert consultation.

Principles

Broader in scope and application, endorsed by many organizations, such as the US Government Principles.

Policy

Derived from a public agency or private entity; practical statements of collective wisdom that can influence how an implementing agency interprets existing statutes.

Procedures

Detailed standard operating procedures (SOPs) that assist an institution in complying with regulations, policies, principles, and day-to-day operations.

ACU Program

Composed of all activities at an institution that impact animal well-being, including policies, care, management, and facility design.

Institutional Official (IO)

Holds ultimate responsibility for the ACU Program and shares direction with the Attending Veterinarian (AV) and IACUC.

Responsible for the health and well-being of laboratory animals and ____ have authority and access to enough resources for veterinary care management.

must

IACUC

Responsible for assessing and overseeing the institution's animal care program and facilities, with authority and resources to fulfill its duties.

Resource Allocation

The IO has the authority to allocate resources and ensure alignment of the ACU Program with the institution's mission.

The AV ____ oversee all aspects of animal care, including husbandry and housing, to ensure compliance with established guidelines.

should

If a full-time veterinarian is unavailable, a consulting or part-time veterinarian ____ visit at appropriate intervals to meet program needs.

must

An individual _____ be assigned to manage daily animal care and facility management in the absence of a full-time veterinarian.

must

Institutions

Resources to support personnel training in animal care and research.

IACUC

A committee responsible for oversight and evaluating the effectiveness of animal care training.

Individuals caring for animals ___ receive appropriate training beyond basic requirements to effectively implement the animal care program.

should

Institutions ____ provide formal and/or on-the-job training for personnel involved in animal care

should

Members of research teams ___ receive appropriate education and training specific to the animal procedures and species used in their research.

Should

●       Personnel _____ be trained regarding:

o    Zoonoses

o    Chemical, biologic and physical hazards (e.g., radiation and allergies)

o    Unusual conditions/agents (e.g., use of human tissue in immunocompromised animals)

o    Handling of waste materials

o    Personal hygiene

o    Appropriate use of PPE

should

o    Personnel _____ wash their hands and change clothing as often as necessary to maintain personal hygiene.

o    Outer garments worn in the animal rooms ____ be worn outside the animal facility.

Personnel ____ be permitted to eat, drink, use tobacco products, or apply cosmetics in animal rooms

1. should

2. should not

3. should not

Institutions _____ have written policies and procedures governing experimentation with hazardous biologic, chemical, and physical agents

should

An oversight process (such as use of a safety committee) ____ involve persons who are knowledgeable in the evaluation and safe use of hazards

should

Formal safety programs _____ be established to assess the hazards, determine the safeguards needed for their control, ensure that the staff has the necessary training and skills, and ensure that the facilities are adequate for the safe conduct of the research.

should

Select agents and toxins”: institution _____ develop program and procedures for procuring, maintaining, and disposing these agents

must

Hazardous agents ____ be contained in the study environment (airflow control)

Waste anesthetic gases ____be scavenged to limit exposure

should

PPE appropriate for the work environment, including institution-issued protective clothing, _____be provided.

Hearing protection _____ be available in high noise areas

should

Development and implementation of a program of medical evaluation and preventive medicine _____ involve input from trained health professionals, such as occupational-health physicians and nurses. Confidentiality and other medical and legal factors _____ be considered in the context of appropriate federal, state, and local regulations

1. should

2. must

An appropriate immunization schedule _____ be adopted

should

Pre-exposure immunization ____ be offered to people at risk of infection or exposure to specific agents such as rabies virus or hepatitis B virus.

should

Pre-employment or pre-exposure serum collection is advisable only in specific circumstances as determined by an occupational health and safety professional. In such cases, identification, traceability, retention, and storage conditions of samples ____ be considered, and the purpose for which the serum samples will be used ____ be consistent with applicable federal and state laws.

1. should

2. must

The medical surveillance program ____:

o    promote the early diagnosis of allergies & include evaluation of an medical history for preexisting allergies.

o    Include zoonosis surveillance

o    Screen NHP users for tuberculosis.

should

Personnel who work with macaques _________ have access to and be instructed in the use of bite and scratch emergency-care stations.

should

Clear procedures _______ be established for reporting all accidents, bites, scratches, and allergic reactions.

should

Contingency plans ______ consider criminal activities, such as personnel harassment and assault, facility trespassing, arson, and vandalism pose to animals, personnel, and the facility.

should

Safeguarding animal welfare is the responsibility of every individual associated with the program. The institution _____develop methods for reporting and investigating animal welfare concerns.

must

The responsibility for review and investigation of animal welfare concerns:

IO / IACUC

Employees ______ be aware of the importance of and mechanisms for reporting their animal welfare concerns

should

It is the ______responsibility to provide suitable orientation, background materials, access to appropriate resources, specific training for IACUC members to understand their responsibilities, and evaluating issues brought before the committee

institutions

IACUC Committee members

o    1 DVM who is certified (ACLAM, ECLAM, JCLAM, KCLAM, PCLAM) or with training and experience in laboratory animal science and medicine or in the use of the species at the institution.

o    1 practicing scientist experienced in research involving animals.

o    1 nonscientific background, drawn from inside or outside the institution.

o    1 public member (“not affiliated”) to represent general community interest.

▪        Should not be laboratory animal users; affiliated with the institution; members of the immediate family of a person who is affiliated with the institution.

▪        May receive “sufficiently modest” compensation

●       No more than three voting members should be associated with a single administrative unit.

The IACUC ____meet as often as necessary to fulfill its responsibilities. Program review and facilities inspections should occur at least _____or more often as required (e.g. AWR & PHS Policy = every ______).

1. must

2. annually

3. 6 months

Records of committee meetings and of results of deliberations ____ be maintained

After review and inspection, a written report (including any minority views) _____ be given to the IO on the ACUP

should

Justification of the species and number of animals proposed; ____ be statistically justified

should

While the responsibility for scientific merit review normally lies outside the IACUC, the IACUC ____evaluate scientific elements of the protocol as they relate to the welfare and use of the animals.

should

IACUC members named in protocols or who have other conflicts _____recuse themselves from decisions regarding these protocols.

must

Contributes to refinement; ____ be relevant and reliable

should

The PI ____ identify, explain and include a study endpoint that is both humane and scientifically sound.

should

The identification of humane endpoints is often challenging because multiple factors _____ be weighed, including the model, species (and sometimes the strain or stock), animal health status, study objectives institutional policy, regulatory requirements, and occasionally conflicting scientific literature.

must

Determination of humane endpoints _____ involve PI, vet, and IACUC. ____be defined prior to the start of the study

should

GMAs (genetically modified animals)

models for which increased monitoring for unexpected outcomes can be implemented

Anything that negatively affects animal well-being ____ be reported to IACUC

should

Restraint devices ____be suitable in size, design, and operation to minimize discomfort, pain and distress, or the potential for injury to the animal and the research staff. _______ use positive reinforcement and habituation training

should

Prolonged restraint, including chairing of nonhuman primates, _____be avoided unless approved by IACUC

should

Restraint devices ______not be considered a normal method of housing and ____ be justified in the animal use protocol

1.should

2.must

o    Guidelines for Restraint:

▪        ______ be used simply as a convenience in handling or managing animals.

▪        Alternatives _____ be considered.

▪        The period of restraint ____ be the minimum required to accomplish the research objectives.

▪        Animals _____ be given training to adapt to the equipment and personnel.

Animals that fail to adapt ____ be removed from the study

▪        Provisions _______ be made for observation of the animal at appropriate intervals, as determined by the IACUC.

▪        The purpose of the restraint and its duration _____ be clearly explained to personnel involved with the study.

1. should not

2. the rest are should

Veterinary care ______be provided if lesions or illnesses associated with restraint are observed. The presence of lesions, illness, or severe behavioral change often necessitates temporary or permanent removal of the animal from restraint.

must

Major survival surgery

penetrates and exposes a body cavity, produces substantial impairment of physical or physiologic functions, or involves extensive tissue dissection or transection.

Multiple major survival surgical procedures on a single animal used within separate protocols are discouraged and _____ be reviewed critically by the IACUC

should

When applicable, the IO ____submit a request to the USDA/APHIS and receive approval to allow a regulated animal to undergo multiple major survival surgical procedures in separate unrelated research protocols.

must

Some procedures characterized as minor may induce substantial post-procedural pain or impairment and _____similarly be scientifically justified if performed more than once in a single animal.

should

Restriction:

total volume of food or fluid consumed is strictly monitored/controlled

Scheduled access

animal consumes as much as desired at regular intervals

o    Close monitoring of the animals _____occur to ensure that intake meets the animal’s needs.

o    Body weights _____ be recorded at least _____ and more often for animals requiring greater restrictions.

Written records ____be maintained for each animal to document daily food and fluid consumption, hydration status, and any behavioral and clinical changes as criteria for removal from a protocol

1. should

2. should

3. weekly

4. should

o    Pharmaceutical grade: _____be used when available for all animal-related studies

should

If species removed from the wild, protocol ____ include a plan to return to their habitat or their final disposition

should

Post-Approval Monitoring (PAM)

●       Continuing IACUC oversight of animal activities is required by federal laws, regulations and policies.

●       Methods include: continuing protocol review; laboratory inspections; veterinary or IACUC observation of select procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections.

●       The veterinary, animal care, IACUC, and compliance staff may all conduct PAM

●       Typically consists of annual update or review as well as triennial review required by PHS/AWA

The level of formality and intensity of PAM _____ be tailored to institutional size and complexity, and in all cases ______ support a culture of care focusing on the well-being of animals.

should

Facilities _____have a disaster plan.

must

The disaster plan

____ define the actions to prevent animal pain, distress, and deaths due to loss of systems such as those controlling ventilation, cooling, heating, or provision of potable water.

_____ describe how the facility will preserve animals that are necessary for critical research

_____ identify essential personnel; ______ be trained in advance

Should for all

Animals that cannot be protected from the consequences of the disaster or relocated _____ be humanely euthanized.

must

Microenvironment

The immediate physical environment surrounding the animal (i.e., primary enclosure: cage, pen, or stall

Macroenvironment

The physical environment of the secondary enclosure (e.g., a room, a barn, or an outdoor habitat).

Temperatures

1.Mouse, rat, hamster, gerbil, guinea pig:                       

2.Rabbit:                                                                            

3.Cat, dog, nonhuman primate:                                        

4.Farm animals and poultry:                                      

1. 68-79° F

2. 61-72° F

3. 64-84° F

4. 61-81° F

Humidity for most animals

30-70%

Ventilation cycles for most animals

10-15 cycles

Recycled air ____ be filtered, at minimum, with 85-95% ASHRAE efficient filters

should

●      Lighting ______ provide for adequate vision; approx. ____ lux @ 1 meter above the floor

●      A time-controlled lighting system ____be used to ensure a regular diurnal cycle

Susceptible to phototoxic retinopathy, _____ be _____lux in the room at cage level.

1. Should, 325

2. should

3. should, 130-325

Sound >____DB can have negative effects (e.g., eosinopenia, increased adrenal weights & decreased fertility in rodents; increased blood pressure in NHPs)

85

Sanitation:

1. Enclosures and accessories= q _____

2.Solid-bottom caging, bottles and sipper tubes= q ____

3. Bedding change=_____

4. Pens/runs=_____

1. 2 weeks

2. 1 week

3. as needed

4. daily

Thermoneutral zone

between the upper and lower critical temperatures (UCT and LCT) where thermoregulation occurs w/o increasing metabolic heat production or activating evaporative heat loss mechanisms

Dry bulb temperatures ____ be set below the LCT to avoid heat stress

should

Newborn animals’ lower critical temps are usually ______than adults

higher

Animals ________be provided with adequate resources for thermoregulation—ex. Nesting material, shelter, to avoid cold stress   

should

Dry-bulb temperatures______ be selected & maintained with minimal fluctuation near the middle of the room ranges.

should

Elevated humidity in rodent isolator cages may lead to:

●       Elevated humidity in rodent isolator cages may lead to high intracage ammonia concentrations

Animals _____ be closely monitored for negative effects when insufficient level of humidity

should

humidity negative impacts on animals

1. ring tail in rodents

2. excessive flacky skin

3. molting difficulties in reptiels

4. dessication stress in semiaquatic animals

Direct exposure to air moving at a high velocity (drafts) ____ be avoided-affect the rate of heat and moisture removal

should

Photo-stressors

▪   Inappropriate photoperiod

▪   Photo-intensity

▪   Spectral quality of the light

Factors that can affect animal’s need for light

▪   Light intensity and wavelength

▪   Duration current and prior exposure to light

▪   Animal’s pigmentation

▪   Circadian rhythm

▪   Body temperature

▪   Hormonal status

▪   Species, age, sex, and stock or strain

Lighting should be:

▪   Diffused throughout an animal holding area

▪   Provide sufficient illumination for the animals’ well-being

▪   Permit good housekeeping practices

▪   Allow adequate animal inspection including the bottom-most cages in racks

▪   Allow for safe working conditions of personnel.

▪   Provide for adequate vision & neuroendocrine regulation of diurnal and circadian cycles

__________ are more susceptible to phototoxic retinopathy

Albino rodents are more susceptible to phototoxic retinopathy