US Gov't Principles.....

Question 1

What overall group of animals do the Principles refer to?

a. All mammals except Rattus rats and Mus mice
b. All mammals except rodents
c. All vertebrate animals
d. Livestock animals only

Answer 1

c. All vertebrate animals

Question 2

For what types of research MUST these rules be followed (as opposed to just considered)?

a. Any research involving USDA Category D or E pain
b. Any research sponsored/funded/performed by governmental agencies
c. Any research using BSL 2, 3, or 4 practices
d. Biomedical or toxicology research only

Answer 2

b. Any research sponsored/funded/performed by governmental agencies

Question 3

Which of the following methods are listed as appropriate for selecting number of animals used to obtain valid results?

a. Mathematical models
b. Computer simulation
c. In vitro biological systems
d. All of the above

Answer 3

d. All of the above

Question 4

True or False: Three considerations listed in Principle II for using animals in research include relevance to human or animal health, the advancement of knowledge, and the good of society.

Answer 4

True

Question 5

What other regulatory document is referenced in regards to the transportation, care, and use of animals in Principle I?

a. AVMA Guidelines on Euthanasia
b. PHS Policy
c. OHS in the Care and Use of Research Animals
d. Animal Welfare Act

Answer 5

d. Animal Welfare Act –> and other applicable Federal laws, guidelines, and policies (reader is referred to the Guide for guidance throughout the US Gov’t Principles)

Question 6

True or False: The principles do NOT address pain or distress in research animals.

Answer 6

False –> Principles IV, V, and VI address different aspects of pain recognition, prevention and allevement.

Question 7

According to Principle VII, who should be directing the housing, feeding, and care of research animals? (Choose all that apply)

a. Principle investigator
b. Animal technician manager
c. Veterinarian
d. Scientist trained and experienced in the proper care, handling, and use of the species

Answer 7

c. Veterinarian

and/or

d. Scientist trained and experienced in the proper care, handling, and use of the species

Question 8

What kind of procedures does US Gov’t Principle V address?

a. Procedures that will fall under USDA Category B pain
b. Only procedures that involve penetration of the skin or mucous membranes.
c. Any procedure that may cause more than momentary or slight pain or distress.
d. Any procedure that will fall under USDA Category C pain

Answer 8

c. Any procedure that may cause more than momentary or slight pain or distress.

Question 9

Which of the following would NOT be considered an appropriate anesthesia for surgical procedures?

a. Halogenated gas anesthesia
b. Paralytic agent
c. Combined injectable sedative and analgesic
d. CRI barbiturate

Answer 9

b. Paralytic agent

Question 10

True or False: Principle Investigators are authorized to make decisions regarding exceptions to these rules during the conduct of their protocols as long as the animals fall under USDA Category B.

Answer 10

False –> Should be made by an appropriate review group such as the IACUC

Question 11

What two circumstances can NOT be the only justifications for making exceptions to the Principles according to Principle IX?

1. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
2. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Answer 11

1. Teaching

2. Demonstration

Question 12

Who is responsible for ensuring that investigators are appropriately trained and qualified to conduct procedures on live animals?

a. The attending veterinarian
b. the IACUC
c. Occupations Health and Safety Program
d. Institutional Official

Answer 12

d. Institutional Official –> the IO is responsible for ensuring that ALL of the principles are adhered to.

Question 13

Name the organization that has responsibility for the general administration and coordination of PHS policy.

Answer 13

OLAW

Question 14

Name the public law that provides the statutory mandate for the PHS Policy.

Answer 14

Health Research Extension Act of 1985, Public Law 99-158, “Animals in Research”

Question 15

Name the committee that promulgated the US Gov’t Principles in 1985.

Answer 15

Interagency Research Animal Committee

Question 16

T/F: The Health Research Extension Act of 1985 stipulates that the IACUC must be composed of at least five members.

Answer 16

False: “Each animal care committee shall be composed of not fewer than three members” - includes a DVM & a nonaffiliated member
Contrast to AWA: 3 members, incl. chairman, DVM & nonaffiliated member
Contrast the Guide: 4 members are described, incl. DVM, practicing scientist involved in animal research, non-scientist member, public member. The Guide states “The size of the institution and the nature and extent of the Program will determine the number of members of the committee…”

Question 17

PHS Policy stipulates that the IACUC will review of the care and treatment of animals in all animal study areas and facilities of the research entity at what frequency?

Answer 17

Semiannually - the same as AWA; the Guide requires annual program & facility review

Question 18

How often must program & facility reviews be filed with the Director of NIH?

Answer 18

Annually

Question 19

PHS Policy stipulates how many IACUC members? Describe the qualification requirements of the IACUC according to PHS Policy.

Answer 19

The committee shall consist of not less than 5 members, and shall include at least: one DVM w/ experience/training in LAM & science & has direct or delegated programatic control; one practicing scientist experienced in animal research; one nonscientific member (may be affiliated with institution); one non affiliated member (not necessarily public representative)

Question 20

To what activities does PHS Policy apply?

Answer 20

All PHS-conducted or supported activities involving animals. Activities may be conducted by PHS, an awardee institution, and conducted in the US, Puerto Rico. or any territory or possession of the US. Institutions in foreign countries that receive PHS support shall comply with PHS Policy.

Question 21

What is an Animal Welfare Assurance?

Answer 21

The documentation from an institution assuring institutional compliance with this policy.

Question 22

Who signs an institution’s Assurance?

Answer 22

IO

Question 23

What is a quorum?

Answer 23

A majority of the members of an IACUC

Question 24

To whom shall Assurances be submitted?

Answer 24

OLAW, Office of the Director, NIH

Question 25

How long is an Assurance approved for?

Answer 25

Approval of an Assurance will be for a specified period of time (no longer than 5 years) after which time the institution must submit a new Assurance to OLAW

Question 26

T/F: Without an applicable PHS-approved Assurance, no PHS-conducted or supported activity involving animals at the institution will be permitted to continue

Answer 26

True

Question 27

What does US Government Principle I state?

Answer 27

Transportation, care, and use of animals should be in accordance with the AWA and other applicable Federal laws, guidelines, and policies?

Question 28

What does US Government Principle II state?

Answer 28

Procedures involving animals should have human health, animal health, or the good of society in mind.

Question 29

What does US Government Principle III state?

Answer 29

Animals in research should be of appropriate species and quality, and only the minimum number needed to obtain valid results used.

Question 30

What does US Government Principle IV state?

Answer 30

Pain, discomfort, and distress should be minimized. If a procedure causes a person pain or distress, consider that it causes other animals pain and distress and well.

Question 31

What does US Government Principle V state?

Answer 31

Appropriate sedation, analgesia, or anesthesia should be used with procedures that may cause more than momentary pain or distress.

Question 32

What does US Government Principle VI state?

Answer 32

If animals cannot be relieved of severe or chronic pain or distress, they should be humanely euthanized.

Question 33

What does US Government Principle VII state?

Answer 33

Research animal living conditions should be appropriate for the species and contribute to health and comfort of the animals. Veterinary care shall be provided, and a veterinarian shall direct the housing, feeding, and care of all animals.

Question 34

What does US Government principle VIII state?

Answer 34

People working with research animals should be qualified and trained.

Question 35

What does US Government Principle IX state?

Answer 35

If exceptions need to be made, the IACUC and not the PI should make the decision, and even then not for teaching or demonstration purposes only (implied: for scientific or animal welfare purposes-TC)

Question 36

How many US Government Principles are there?

Answer 36

9