Animal Subjects in Research

Question 1

Original 1966 version of the Laboratory Animal Welfare Act identified which 6 species as “animals” in its definition of regulated species?

Answer 1

• Dogs
• Cats
• Rabbits
• Hamsters
• Guinea Pigs
• Nonhuman primates

Question 2

Animal Welfare Act Required (x5):

Answer 2

• Dealers who sold regulated animals to be licensed;
• Registration of all research institutions;
• Maintenance of paperwork documenting the source(s) of animals and their final disposition;
• Appropriate identification of dogs and cats and records of individual animals;
• Annual inspection of facilities and records by USDA (only covered an animal while on experiment)

Question 3

Animal Welfare Standards Addressed:

Answer 3

• housing
• feeding
• watering
• shelter
• ventilation
• sanitization
• separation of species
• provision of “Adequate Veterinary Care”

Question 4

1970 Amendment to the Laboratory Animal Welfare Act included what changes?

Answer 4

• Name of law was changed to “Animal Welfare Act (AWA)”
• Other wild mammalian species used in research were now included but it excluded mice, rats, birds and agricultural animals
• Animals were now covered before, during and after use

A subsequent amendment added -
- Agricultural animals used in biomedical research and teaching in 2011

Question 5

passed in response to improper care and use of regulated animals

• one of the changes implemented was the requirement that each research facility establish an Institutional Animal Care and Use Committee (IACUC) to approve and monitor all research conducted at the institution.

Answer 5

The Improved Standards for Laboratory Animals Act (1985)

Question 6

AWA Mandated Duties and Responsibilities

Institution must submit annual report including (x4)…

Answer 6

Must submit an annual report that includes:

• number of animals used and pain category
• deviations from AWA
• justification for category E pain protocols
• facilities where animals are housed

Question 7

IACUC Functions

Answer 7

• Protocol Review
• Amendment Review
• Annual Review of Ongoing Projects

Question 8

AWA Mandated Duties and Responsibilities (IACUC)

Answer 8

• protocol reviews (every 3 years)

every 6 mos…

• review the research facility’s program for humane care and use of animals
• inspect all animal facilities, including animal -study areas
• prepare reports of its evaluations conducted and submit reports to IO of research facility
• make recommendations to IO regarding any aspect of the research facility’s animal program, facilities, or personnel training

Question 9

Protocol requirements

Answer 9

• the species and approx number of animals to be used
• a rationale for using animals
• a complete description of the use of animals
• a description of the euthanasia method
• a description or procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable

Question 10

IACUC responsibilities (every 6 months)

Answer 10

Every 6 mos…
> Review, at least semiannually, the institution’s program for the humane care and use of animals;
> Inspect, at least semiannually, the institution’s animal facilities (including satellite facilities);
> Prepare reports to the Institutional Official (IO) of the IACUC evaluations;
> Review animal welfare concerns;
> Make recommendations to the IO on any aspect of the animal program, facilities, or personnel training;
> Review and approve, those components of PHS conducted or supported activities related to the care and use of animals;
> Review and approve, proposed significant changes to the use of animals in ongoing activities; and
> Be authorized to suspend an activity involving animals.

Question 11

AWA Mandated Training Requires Instruction on:

Answer 11

• the human practice of animal maintenance and experimentation
• research and testing methods that minimize the use of animals or limit pain/distress
• methods to conduct literature searches to determine the availability of alternatives to assure that duplication does not occur
• methods for reporting deficiencies in animal care and treatment

Question 12

How long is IACUC protocol approved for

Answer 12

3 years from date of approval WITH a annual review

Question 13

How often must USDA inspect facilities at NFEs conducting animal research?

Answer 13

• annually

- confirmed in AWA

Question 14

How frequently must IACUC protocols be reviewed?

Answer 14

Annually

Question 15

When is an IACUC protocol required?

Answer 15

• when a live vertebrate animal is used for teaching, breeding, or research
• AWA - all live not dead warm blooded animals except mice, birds, rats
• HREA - all live vertebrate animals

Question 16

• directly related to NIH/PHS funding
• includes ALL vertebrate species
• also requires IACUC
• requires NFE to submit animal welfare assurance to OLAW/NIH

Answer 16

Federal Health Research Extension Act of 1985 (HREA)

Question 17

OLAW iacuc composition

Answer 17

I’m members appointed by IO

1) a chair
2) DVM w lab animal med background
3) scientist experienced w animal research
4) non-scientist (e.g. lawyer, clergy)
5) non-affiliated member