Chapter 5 Managing Compliance Flashcards

1
Q

Which of the following is NOT a requirement that is found in the Animal Welfare Act and ts amendments?

A

Young animals may not be used in research before they are weaned.

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2
Q

Birds bred for research are NOT presently covered under the Animal Welfare Act.

A

True

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3
Q

The IACUC has an obligation to identify whistle blowers who report possible animal abuse or neglect so they can receive recognition from the institution.

A

False

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4
Q

USDA does not require that IACUC meeting minutes be recorded.

A

False

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5
Q

Which of the following are mandated by the Animal Welfare Act?

A
  • Establishment of an IACUC
  • Information on how to report deficiencies in animal care
  • Training of all animal care personnel
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6
Q

Amphibians, reptiles, and fish are exempt from coverage under th Animal Welfare Act.

A

True

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7
Q

What needs to be specifically addressed in the required plan for environmental enhancement for nonhuman primate?

A
  • Social grouping

- Restraint devices

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8
Q

Research facilities using regulated species must register with USDA and the registration must be updated every year.

A

False

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9
Q

Which agency is authorized to develop regulations based on the Animal Welfare Act?

A

Animal Plant and Health Inspection Service

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10
Q

Which of the following applies to semiannual inspections conducted by the IACUC?

A

The IACUC can use the Guide as the basis for the inspeciton

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11
Q

Rats and mice bred for research are covered under the PHS policy.

A

True

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12
Q

OLAW requires that institutions submit an assurance document affirming that they will comply with all the PHS Policy requirements.

A

True

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13
Q

The AWA Regulations and PHS Policy both require that the IACUC conduct semiannual inspection of all areas where live animals are housed or used.

A

True

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14
Q

Freedom of Information Act information requests are sent to the institutions.

A

False

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15
Q

Which of the following is an authority granted to USDA APHIS inspectors?

A
  • To make copies of documents in the facility that are required by the regulations
  • To require euthanizing an animal if it is determined that the animal is suffering as a result of noncompliance
  • To take photographs of areas of noncompliance
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16
Q

Which group(s) has/have a right to conduct unannounced inspections of the animal facility?

A

USDA APHIS personnel

-DEA personnel

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17
Q

USDA APHIS inspectors are NOT allowed to take photographs while inspecting a facility.

A

False

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18
Q

USDA APHIS inspectors have the authority to make copies of required records kept in the facility.

A

True

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19
Q

Which statement is FALSE regarding staff responsibilities during a USDA inspection?

A

Inspectors should be provided as much information as possible

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20
Q

USDA inspections may be conducted in response to public complaints

A

True

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21
Q

All regulations regarding obtaining, storing, and disposing of controlled substances are federal statues.

A

False

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22
Q

Many drugs used for analgesia and tranquilization are controlled substances.

A

True

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23
Q

In addition to federal regulations, there are local and state regulations that need to be followed.

A

True

24
Q

GLPs describe the training requirements for personnel involved in covered studies

A

True

25
Q

Which group of compounds falls within the scope of GLPs.

A

Biological products
Veterinary drugs
Food and color additives

26
Q

Nonclinical studies of the effect of pesticides on the embryonic development of fish would fall under the GLPs regulations

A

True

27
Q

An intent of the GLPs is to ensure that studies can be reconstructed accurately if they need to be repeated.

A

True

28
Q

Which regulatory agency codifies GLPs for laboratory studies?

A
  • Food and Drug Administration
  • Organization for Economic Co-operation and Development
  • Environmental Protection Agency
29
Q

The Centers for Disease Control is one of the agencies that regulates the care and welfare of research animals

A

False

30
Q

The importation of animals such as dogs, cats, and turtles is regulated by the Centers for Disease Control

A

True

31
Q

Which agency has regulations or guideline that regulate the transportation of animals?

A
  • US Department of Transportation
  • Food and Drug Administration
  • US Fish and Wildlife Service
32
Q

There are federal regulations that set limits on noise exposure in the animal facility

A

True

33
Q

Under no circumstances can a manufacturer withhold information about a potentially hazardous material

A

False

34
Q

The Nuclear Regulatory Commission regulates use of nuclear materials for medical and academic uses through regulations, licensing, and safety oversight.

A

True

35
Q

Where is low-level waste generally stored?

A

On site

36
Q

The Radiation Safety Officer must monitor the exposure level of all employees who work with low-level radiation sources

A

True

37
Q

Which office has regulations which relate to medical waste?

A
  • Department of Transportation Office of Hazardous Materials Safey
  • US Postal Service
  • Food and Drug Administration
38
Q

All medical waste should be considered infectious.

A

False

39
Q

The Centers for Disease Control may perform biosafety and biosecurity inspections of registered facilities

A

True

40
Q

Which publication describes microbiological practices?

A

Biosafety in Microbiological and Biomedical Laboratories

41
Q

A post-approval monitoring (PAM) program provides review before a study has been started

A

False

42
Q

When responding to a reported noncompliance, the IACUC:

A
  • can work with the researcher to establish a plan
  • may elect to suspend a protocol to protect animal welfare
  • should begin a process of information gathering
43
Q

The IACUC may be made aware of noncompliance through the post-approval monitoring program

A

True

44
Q

Noncompliance can lead to citations and major financial penalties against the institution through enforcement action by regulatory agencies.

A

True

45
Q

Which of the following is often referred to as the Worker Right-to-know legislation?

A

OSHA’s Hazard Communication Standard

46
Q

According to Federal law, which controlled substances must DEA registrants store in a securely locked cabinet?

A

Schedules 2 through 5

47
Q

Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals?

A

The regulatory documents

48
Q

To be compliant with OLAW, what document should be the basis of the IACUC review of the institution’s program for the use and care of animals?

A

Guide for the Care and Use of Laboratory Animals

49
Q

Which of the following statements best apply to Good Laboratory Practices regulations?

A

They apply to nonclinical studies for the assessment of the safety of chemicals to humans, animals, and the environment.

50
Q

Which statement is FALSE regarding post-approval monitoring programs?

A

There are many state regulations with specific requirements for post-approval monitoring programs.

51
Q

Which of the following is often referred to as the Worker Right-to-know legislation?

A

OSHA’s Hazard Communication Standard

52
Q

According to Federal law, which controlled substances must DEA registrants store in a securely locked cabinet?

A

Schedules 2 through 5

53
Q

Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals?

A

The regulatory documents

54
Q

To be compliant with OLAW, what document should be the basis of the IACUC review of the institution’s program for the use and care of animals?

A

Guide for the Care and Use of Laboratory Animals

55
Q

Which of the following statements best apply to Good Laboratory Practices regulations?

A

They apply to nonclinical studies for the assessment of the safety of chemicals to humans, animals, and the environment.

56
Q

Which statement is FALSE regarding post-approval monitoring programs?

A

There are many state regulations with specific requirements for post-approval monitoring programs.