Misc

Question 1

NASA Principles

Answer 1

Respect for Life
Societal Benefit
Non-maleficence

Question 2

IACUC Minutes must have…

Answer 2

1. Attendees (can be anonymized via initials as long as correlatable with appointments)
2. Deliberations
3. Decisions

(No mention of approving minutes/voting)

Question 3

What type of cages must be scientifically justified and approved by the IACUC?

Answer 3

Wire bottom cages

Question 4

What are the required elements of the Psychological Well-being Plan for NHPs?

Answer 4

Plan must address:
1. Social needs
2. Environmental Enrichment (via cage complexities, interactions, manipulanda, food, foraging)
3. Special needs (young, psychologically distressed, and great apes)

Question 5

Who must approve the plan for canine exercise before it can be implemented?

Answer 5

The Attending Veterinarian

If a dog is exempted from the program, it must be reviewed by the AV every 30 days

Question 6

Personnel Training and Education - whose responsibility is it? USDA vs. PHS

Answer 6

USDA, per the AWRs (Sec 2.32 a&b) - responsibility of the research facility

PHS, per PHS Policy section IV.C.1.f - responsibility of the IACUC

Question 7

Areas to consider in the preparation & review of animal care and use protocols:

Answer 7

• rationale and purpose of the proposed use of animals.
• justification of the species and number of animals
• alternatives: availability and/or appropriateness of the use of less-invasive procedures, other species, isolated organ preparation, cell/tissue culture, computer simulation.
• adequacy of training/experience of personnel.
• unusual housing or husbandry requirements
• appropriate sedation, analgesia, and anesthesia.
• unnecessary duplication of experiments.
• conduct of multiple major operative procedures
• humane endpoints and criteria
• post-procedural care
• methods of euthanasia or disposition of animal
• safety of working environment for personnel

Question 8

Natural food storage temp and humidity, stability?

Answer 8

70’F or 21’C and 50% humidity
Irradiated over autoclaved diets

Usually 6 month shelf life
3 months for diets with unstabilized vitamin C

Question 9

Effective disinfection can be achieved with wash and rinse water at _____

Answer 9

180’F

Question 10

What are the minimum techniques for non-survival surgery?

Answer 10

• Surgical site should be clipped
• Surgeon should wear gloves
• Instruments and surrounding area should be clean

Question 11

What must also be in place when neuromuscular blocking agents (eg. Pancuronium) are used?

Answer 11

Anesthetic agent must be used at a level appropriate without a blocking agent

Question 12

How large must drainpipes be in an animal area?

Answer 12

Drainpipes must be at least 4in (10.2cm) in diameter

Question 13

Storage of dead animals and animal tissue waste should be at what temperature?

Answer 13

Below 7’C (44.6’F)

Question 14

Examples of Significant Changes (for protocol review)

Answer 14

• Change in PI
• Change in study objectives
• Change from non-survival to survival surgery
• Increase in pain/distress or invasiveness
• Change in species
• Increase in animal numbers
• Change in anesthetics or pain-relieving agents
• Change in euthanasia method
• Change in the duration, frequency, or number of procedures

Question 15

Liability
-or-
What can happen if you break the rules?

PHS vs USDA

Answer 15

PHS: OLAW can withdraw Assurance (ineligible to receive federal funding for animal research) - PHS Policy

USDA: USDA can issue cease and desist and impose fines of $2,500 per count and 1 year in prison - 7 U.S.C. Section 2149

Question 16

Are IACUC members’ signatures legally binding?

Answer 16

Yes

Example: Signature on semi-annual report is binding that the report is true. Same for protocol review.

Question 17

Significant Deficiencies on Semi-annual inspections

USDA vs. PHS

Answer 17

Both: SD is or may be a threat to the health or safety of the animals

USDA: If left uncorrected beyond scheduled correction date it shall be reported to APHIS USDA and any agency that funds the activity

PHS: Reports made available to OLAW upon request

Question 18

What is the acceptable volume for CFA injections?

Answer 18

ID:
0.5-0.1mL @ 5 sites

SubQ:
0.10-0.25-0.40 mL @ 4 to 10 sites

Question 19

Definition of major vs. minor surgery?

Answer 19

Major surgery: Penetrates and exposes a body cavity, produces substantial impairment of physical or physiological functions, or involves extensive tissue dissection or transection.
- eg. Laparotomy, thoracotomy joint replacement, limb amputation

Minor surgery: Does not expose a body cavity and causes little or no physical impairment
- eg. Wound suturing, peripheral vessel cannulation, percutaneous biopsy, routine agricultural animal procedures such as castration, and most procedures routinely done on an outpatient basis in veterinary clinical practice.

Question 20

How long must a protocol be kept?

Answer 20

3 years after the end of the activity.

The PHS policy and the AWRs require that animal applications and proposed significant changes be retained for the duration of the animal activity and for an additional 3 years after the end of the activity. Proposal submitted to the IACUC must be kept for 3 years even if approval was not granted or animals were not used. The records must show whether or not IACUC approval was given.

Question 21

Which policy trumps the others?

Answer 21

With few exceptions, most PHS and USDA requirements are identical, practically word for word. On pages 2, 8, 10 and elsewhere in the Guide there is a requirement about being in compliance with “the AWRs (CFR 1985).”

The following statement appears throughout the 1996 edition of the PHS Policy: “Compliance with the USDA Regulations is an absolute requirement of this Policy.”

The first of the U.S. Government Principles states that “the transportation, care, and use of animals should be in accordance with the Animal Welfare Act…”

Where there are inconsistencies between guidelines in the USDA, PHS, or the Guide, adhere to the most stringent.

Question 22

What are the IACUC Recordkeeping Requirements?

Answer 22

Institutions must maintain for three years:

1. Copy of the approved assurance, if applicable.
2. Minutes of IACUC meetings, including attendance records
3. Records regarding protocol review (for duration of project plus 3 years)
4. Records of semi-annual reports and inspections (note signature requirements)
5. Records of accrediting body determinations

Based on regulations found in the PHS “Policy” IV.E.1-2, the “Guide” Chap. 1, p. 8, and the USDA’s 9 CFR 2.35(a-f).

Question 23

Purified and chemically defined diets storage temp and stability?

Answer 23

4’C or 39’F or lower
Shelf life less than 6 months