The Guide Flashcards

1
Q

The Guide IACUC Composition Rules

A

No minimum

Must have:
Veterinarian with program authority
Non-affiliated member
Practicing scientist

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2
Q

Inspection Requirements from The Guide

A

2 voting members

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3
Q

The Guide on Delivering Annual Report to IO

A

No mention on how this must be done

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4
Q

Per The Guide, how often must an IACUC meet?

A

As often as needed, minimum of every 6 months

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5
Q

Which document describes the training requirements for an IACUC?

A

The Guide
(NOT mentioned in AWA)

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6
Q

What is The Guide’s definition of an ANIMAL

A

Any warm-blooded animal

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7
Q

Which document describes training requirements for IACUC Members?

A

The Guide (p9)

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8
Q

According to the Guide, Identification/Cage Cards should include…?

A

Source of the animal, strain or stock, names and locations of the responsible investigators, pertinent dates, and protocol number

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9
Q

What the Guide says about Multiple Major Survival Surgery?

A

The guide discourages multiple major survival surgery

The Guide suggests that reasons for multiple major survival surgery may include procedures that are related components of a research project, procedures that will conserve scarce animal resources, or procedures conducted for clinical reasons. The Guide precludes cost savings as the soul justification for multiple major survival surgery. Subsequent to approval of multiple major survival surgery the IACUC should ensure that there is sufficient ongoing oversight of the project.

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10
Q

How does The Guide define laboratory animals?

A

Any vertebrate animal (literally any, including wildlife) produced for or used in research, testing, or teaching.

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11
Q

How does The Guide define animal use?

A

The proper care, use, and humane treatment of laboratory animals produced for or used in research, testing, or teaching

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12
Q

How does The Guide define humane care?

A

Actions taken to ensure that laboratory animals are treated according to high ethical and scientific standards.

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13
Q

How does The Guide define animal care and use program?

A

The policies, procedures, standards, organizational structure, staffing, facilities, and practices put into place by an institution to achieve the humane care and use of animals in the laboratory and throughout the institution.

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14
Q

How does The Guide define an engineering standard?

A

A standard or guideline that specifies in detail a method, technology, or technique for achieving a desired outcome.

It does not provide for modification in the event that acceptable alternative methods are available or unusual circumstances arise.

They are prescriptive and provide limited flexibility for implementation, but can be useful to establish a baseline and relatively easy to use when evaluating compliance.

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15
Q

How does The Guide define performance standard?

A

A standard or guideline that, while describing a desert outcome, provides flexibility in achieving this outcome by granting discretion to those responsible for managing the animal care and use program, the researcher, and the IACUC.

The desired outcomes and/or goals must be clearly defined and appropriate performance measures regularly monitored in order to verify the success of the process.

They accommodate the consideration of many variables so that the implementation can be best tailored to meeting the recommendations in the guide.

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16
Q

How does The Guide define practice standard?

A

The application of professional judgment by qualified, experienced individuals to a task or process over time, and approach that has been demonstrated to benefit or enhance animal care and use.

This can come from information in the peer-reviewed scientific literature, textbooks, and from time proven experiences in the field.

In the absence of public scientific literature or other definitive sources, where experiences demonstrated that the particular practice improves animal care and use, practice standards have been used in determining appropriate recommendations in the Guide

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17
Q

How does The Guide define policies?

A

Policies are commonly derived from a public agency or private entity. They are generally practical statements of collective wisdom, convention, or management direction that are internal to the entity.

Policies may assume broader force when they become the means by which and implementing agency interprets existing statutes, such as the PHS policy.

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18
Q

How does The Guide define principles?

A

Principles are broader in scope and intended application, and are accepted generalizations but a topic that are frequently endorsed by many and diverse organizations, such as the US government principles.

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19
Q

How does the guide define procedures?

A

Procedures (often called operating procedures or standard operating procedures) are typically detailed step by step processes meant to ensure the consistent application of institutional practices.

Establishing SOPs can assist an institution in complying with regulations, policies, and principles as well as with day-to-day operations.

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20
Q

Must v Should v May

A

Must indicates actions that are considered an imperative and mandatory duty or a requirement for providing humane animal care and use.

Should indicates a strong recommendation for achieving a goal, however circumstances might justify an alternative strategy.

May indicates a suggestion to be considered.

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21
Q

Responsibilities and Involvement of the IO

A

Bears ultimate responsibility for the program, though overall program direction should be a shared responsibility among IO, AV, and IACUC.

The IO has the authority to allocate necessary resources to ensure overall program effectiveness.

The IO represents senior administration at the institution and his responsible for resource planning and ensuring alignment of program goals with the Institution’s mission.

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22
Q

Responsibilities and Involvement of the AV

A

The AV is responsible for the health and wellbeing of all lab animals used at the institution.

The institution must grant the AV sufficient authority, including access to all animals and resources to manage their program of veterinary care.

AVs you should also oversee other aspects of animal care and use to ensure that the program complies with the guide.

AVs may be full-time, part-time, or consultative, as the needs and size of the program suggest.

If AVs are not full-time, there must be an individual with a signed responsibility for daily animal care and use and facility management.

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23
Q

Responsibilities and Involvement of the IACUC

A

The IACUC is responsible for assessment and oversight of the Institution’s program components and facilities.

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24
Q

What does the Guide say about interinstitutional collaboration?

A

It has the potential to create ambiguities about responsibility for animal care and use.

In cases of collabs beyond animal transport, the participating institutions should have a formal written understanding that addresses the responsibility for off-site animal care and use, animal ownership, and IACUC review and oversight.

25
Q

What does the guide say about responsibilities around personnel training?

A

The institution is responsible for providing appropriate resources to support personnel training.

The IACUC is responsible for providing oversight and for evaluating the effectiveness of the training program.

All personnel training should be documented.

26
Q

What does the Guide say about veterinary and other professional training?

A

Vets providing clinical and/or program oversight and support must have the experience, training, and expertise necessary to appropriately evaluate the health and well-being of the species used.

Veterinarians providing broad program direction should be trained or have relevant experience in laboratory animal facility administration and management.

Depending on program scope additional expertise may be needed from other professionals (eg. genomics, diagnostic lab operations, etc.)

The institution should provide opportunities and support for regular professional development and continuing education to ensure knowledge about latest practices and procedures as well as ensuring the highest standards of animal care.

27
Q

What does the Guide say about animal care personnel training?

A

These individuals should be provided formal and/or on the job training to facilitate effective implementation of the program and humane care and use of animals.

Degree and non-degree training, such as certification through AALAS, are available to laboratory animal care personnel.

Personnel caring for lab animals should also regularly engage and continuing education activities and should be encouraged to participate in local national lab animal science meetings and other relevant professional organizations.

28
Q

What does the Guide say about training the research team?

A

The institution should provide appropriate education and training to members of research teams.

Training should be tailored to the needs of the research groups, however all research groups should receive training and animal care and use legislation, IACUC function, ethics of animal use, 3 Rs, reporting welfare concerns, occ health, animal handling.

Continuing education should be offered, reflecting updates in technology, legislation, etc.

29
Q

What does the guide say about training the IACUC?

A

The institution is responsible to ensure I cook members or provided training opportunities.

Training should include formal orientation, relevant legislation, regulations, guidelines, and policies, processes of animal protocol and program review.

Provide ongoing opportunities for continuing education and understanding of scientific endeavors related to animals, such as meeting with research personnel and animal care teams.

30
Q

What does the guide say about Occupational Health and Safety of Personnel?

A

Each institution must establish and maintain an occupational health and safety program as an essential part of the overall program of animal care and use.

The National Research Council’s “Occupational Health and Safety in the Care and Use of Research Animals” provides more guidance on what this should look like.

An effective OHSP requires coordination between research program, environmental health and safety program, occupational health services, and administration.

31
Q

According to the Guide what are some important components of an effective OHSP?

A

Control and prevention strategies - implementation of control and prevention strategies using engineering controls (appropriate equipment), process controls (SOPs, admin), and personnel protection (PPE, etc).

Hazard identification and risk assessment - involves evaluation by trained personnel, with knowledge of the relevant type of hazards (physical, biological, chemical, radiation, allergens, zoonoses, etc.)

Facilities, equipment, and monitoring - use of necessary safety equipment such as BSCs or chemical fume hoods, ergonomic design of equipment, etc. May also include isolation of parts of the facility to restricted personnel to avoid pathogen exposure etc.

Personnel training

Personal hygiene

Special consideration for animal experimentation involving hazards - BMBL

Personal protective equipment - use of appropriate gear

Medical evaluation and preventive medicine - evaluation for personnel specific risks, immunization against potential agents such as tetanus, rabies, hepatitis, routine screening for zoonoses as appropriate.

Accident reporting

32
Q

Thermoneutral zone for Mice, Rats, Gerbils, Rabbits, Cats and Dogs

A

Mice - 26-34’C or 78.8-94.2’F

Rats - 26-30’C or 78.8-86’F

Gerbils - 28-32’C or 82.4-89.6’F

Rabbits - 16-20’C or 59-68’F

Cats and Dogs - 20-25’C or 68-75’F

33
Q

Recommended Dry-Bulb Macroenvironment Temps for Common Lab Species

A

Mouse, Rat, Hamster, Gerbil, Guinea Pig - 20-26’C or 68-79’F

Rabbit - 16-22’C or 61-72’F

Cat, Dog, NHP - 18-29’C or 64-84’F

Farm Animals, Poultry - 16-27’C or 61-81’C

Room temps are typically set below animal’s lower critical temperature (LCT) to avoid heat stress but animals should be provided with adequate resources for thermoregulation (nesting materials, shelter, etc)

34
Q

Recommended Humidity range for mammalian species?

A

30-70%

35
Q

How many air changes per hour is acceptable?

A

10-15 fresh air changes per hour in housing rooms, more or less may be needed depending on heat load in the room, frequency of cage changes, efficiency of air distribution within room and between room and cages

36
Q

Guidance for use of recycled air

A

Minimum 85-95% ASHRAE efficient filters should be used to remove airborne particulates before air is recycled to animal rooms. Consideration should also be made for filtering volatiles such as ammonia.

In the case of biohazards / NHP it may be too risky to recycle air.

37
Q

What does the Guide say about light levels in housing rooms?

A

Light should be on a timer to select a uniform day-night cycle.

325 lux (30ft-candles) at 1 meter above the floor seems sufficient for animal care while also preventing phototoxic retinopathy in albino rats.

Up to 400 lux (37ft-candles) at 1 m above floor level is satisfactory for rodents if management practices are in place to prevent eye damage.

Some guidelines recommend light intensity of 40 lux or lower at the position of an animal in midcage.

Light intensity decreases with the square of the distance from its source.

From top to bottom of a rack of clear cages, light may be 80fold different between top an bottom cages.

Within the cage, light differences of 20fold may be present

38
Q

According to the Guide, what is the dB threshold for noise disruption (auditory and nonauditory)

A

85 dB

39
Q

Considerations for Sheltered or Outdoor Housing?

A

Animals should be protected from weather extremes

Housing or other shelter should be constructed so that replacement and/or cleaning can be in accord with general husbandry practice.

Ground cover should be able to be removed or replaced when needed to ensure appropriate sanitation.

Need adequate security (fences, etc.)

Training and acclimation of animals for weather conditions and handling for investigative and veterinary procedures.

40
Q

Considerations when evaluating floor space in animal housing?

A

Space allocations should be assessed, reviewed, and modified by the IACUC considering performance indices (health, reproduction, growth, behavior, activity, use of space, special needs)

At minimum, animals must be able to express natural postures and postural adjustments without touching the enclosure walls or ceiling, be able to turn around, and have ready access to food and water. Animals must be able to rest comfortably away from areas soiled by urine or feces.

Floor space taken up by food bowls, water containers, litter boxes, and enrichment devices, should not be counted as part of the floor space.

41
Q

Cleaning / Disinfection Guidelines

A

Enclosures and accessories should be sanitized at least every 2 weeks.

Solid bottom cages, bottles, sipper tubes should be sanitized at least once a week

Performance standards will affect this

42
Q

Common Zebrafish Housing Density?

A

Five adult animals per liter of water

43
Q

Common Xenopus housing density?

A

One frog per 2 liters of water

44
Q

According to the Guide, what are important components of adequate veterinary care?

A
  • Animal procurement and transportation
  • Preventive medicine (incl. quarantine, animal biosecurity, and surveillance)
  • Clinical disease, disability, or related health issues
  • Protocol-associated disease, disability, and other sequelae
  • Surgery and perioperative care
  • Pain and distress
  • Anesthesia and analgesia
  • Euthanasia
45
Q

Considerations for animal procurement?

A

If dogs/cats are obtained from random sources (eg. shelters/pounds), animals should be inspected for tattoos or other ID to verify lack of ownership/status

Purpose Bred animals (eg. USDA class A dealers) have a known health status and are likely to produce more reliable results

46
Q

Which organizations have transportation regulations?

A

AWRs - standards for interstate and export/import of regulated species

IATA - international air transport association - Live Animals Regulations (updated yearly)

CDC/USDA - regulations to prevent introduction, transmission, or spread of communicable diseases and zoonosis capable animals

USFWS - regulations for import/export of wild verts/inverts and their tissues (also enforces CITES regs in the US, including captive breds)

47
Q

Emergency Care and Veterinary Authority

A

If the responsible person, such as principal investigator, is not available or if the investigator and veterinary staff cannot reach consensus on treatment, the veterinarian must have the authority, delegated by senior administration and the IACUC, to treat the animal, remove it from the experiment, institute appropriate measures to relieve severe pain or distress, or perform euthanasia if necessary.

48
Q

Health Related Recordkeeping

A

A veterinarian should be involved in establishing, reviewing, and overseeing medical and animal use records.

All those involved in animal care and use must comply with federal laws and regulations regarding human and veterinary drugs and treatments.

Drug records and storage procedures should be reviewed during facility inspections.

49
Q

What to do about recurring or significant problems involving animal health?

A

Recurrent or significant problems involving experimental animal health should be communicated to the IACUC, and all treatments and outcomes should be documented.

50
Q

Who is responsible for determining that personnel performing surgical procedures are appropriately qualified?

A

The IACUC and the AV

51
Q

Where should aseptic surgery take place?

A

In dedicated facilities or spaces, unless an exception is specifically justified as an essential component of the research protocol and is approved by the IACUC.

52
Q

Guidelines for corridor width?

A

6-8 feet, allowing personnel and equipment movement, consider double doors to dampen sound from equipment or loud animals, shields/guards around protruding items on walls

53
Q

Suggested door size?

A

Large enough to allow easy passage of racks and equipment (approx. 42 × 84 in).

Self closing and equipped with recessed or shielded handles, sweeps and kick plates are helpful to protect the door.

Should open into animal rooms rather than into corridors

Locks to prevent entrance from the outside of the room, but allow free egress

Doors with viewing windows may be helpful, but should be able to be covered if necessary

54
Q

Guidance on ceilings from the Guide?

A

Suspended ceilings should not be used in animal rooms unless they are sealed from the space above with gaskets and clips. When used they should be fabricated of impervious materials, have a washable surface, and be free of imperfect junctions. Expose plumbing, ductwork, and light fixtures are undesirable unless the services can be readily cleaned.

55
Q

What are the Guide’s suggested topics for protocol review?

A

Rationale and purpose of the proposed use of animals

Clear and concise sequential description of procedures

Refinement and replacement

Justification of species and animal numbers proposed

Unnecessary duplication of experiments

Description of non-standard housing and husbandry requirements

Impact of procedures on animals well-being

Appropriateness of sedation, analgesia, and anesthesia

Conduct of surgical procedures, including multiple major survival surgery

Post procedural care and observation

Description and rationale for selected endpoints

Criteria and process for intervention or endpoints on a humane basis

Appropriateness of euthanasia

Adequacy of training and experience

Use of hazardous materials and safety provisions therefore

56
Q

The Guide on special considerations for IACUC review

A

Rationale and purpose of the proposed use of animals

Clear and concise sequential description of procedures

Refinement and replacement

Justification of species and animal numbers proposed

Unnecessary duplication of experiments

Description of non-standard housing and husbandry requirements

Impact of procedures on animals well-being

Appropriateness of sedation, analgesia, and anesthesia

Conduct of surgical procedures, including multiple major survival surgery

Post procedural care and observation

Description and rationale for selected endpoints

Criteria and process for intervention or endpoints on a humane basis

Appropriateness of euthanasia

Adequacy of training and experience

Use of hazardous materials and safety provisions therefore

57
Q

What is PAM according to the Guide

A

May consist of continuing protocol review, laboratory inspections, vet or IACUC observation of selected procedures, observation of animals, external regulatory inspections.

The IACUC, vet, animal care, and compliance staff may conduct PAM

58
Q

Effective PAM strategies according to the guide

A
  • examine surgical areas, and associated equipment/supplies
  • review of protocol related health and safety issues
  • review of anesthetic and surgical records
  • review of adverse or unexpected experimental outcomes affecting the animals
  • observation of lab practices and procedures and compliance with approved protocols