Chapter 5 Managing Compliance Flashcards
Which of the following is NOT a requirement that is found in the Animal Welfare Act and ts amendments?
Young animals may not be used in research before they are weaned.
Birds bred for research are NOT presently covered under the Animal Welfare Act.
True
The IACUC has an obligation to identify whistle blowers who report possible animal abuse or neglect so they can receive recognition from the institution.
False
USDA does not require that IACUC meeting minutes be recorded.
False
Which of the following are mandated by the Animal Welfare Act?
- Establishment of an IACUC
- Information on how to report deficiencies in animal care
- Training of all animal care personnel
Amphibians, reptiles, and fish are exempt from coverage under th Animal Welfare Act.
True
What needs to be specifically addressed in the required plan for environmental enhancement for nonhuman primate?
- Social grouping
- Restraint devices
Research facilities using regulated species must register with USDA and the registration must be updated every year.
False
Which agency is authorized to develop regulations based on the Animal Welfare Act?
Animal Plant and Health Inspection Service
Which of the following applies to semiannual inspections conducted by the IACUC?
The IACUC can use the Guide as the basis for the inspeciton
Rats and mice bred for research are covered under the PHS policy.
True
OLAW requires that institutions submit an assurance document affirming that they will comply with all the PHS Policy requirements.
True
The AWA Regulations and PHS Policy both require that the IACUC conduct semiannual inspection of all areas where live animals are housed or used.
True
Freedom of Information Act information requests are sent to the institutions.
False
Which of the following is an authority granted to USDA APHIS inspectors?
- 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
Which group(s) has/have a right to conduct unannounced inspections of the animal facility?
USDA APHIS personnel
-DEA personnel
USDA APHIS inspectors are NOT allowed to take photographs while inspecting a facility.
False
USDA APHIS inspectors have the authority to make copies of required records kept in the facility.
True
Which statement is FALSE regarding staff responsibilities during a USDA inspection?
Inspectors should be provided as much information as possible
USDA inspections may be conducted in response to public complaints
True
All regulations regarding obtaining, storing, and disposing of controlled substances are federal statues.
False
Many drugs used for analgesia and tranquilization are controlled substances.
True
In addition to federal regulations, there are local and state regulations that need to be followed.
True
GLPs describe the training requirements for personnel involved in covered studies
True
Which group of compounds falls within the scope of GLPs.
Biological products
Veterinary drugs
Food and color additives
Nonclinical studies of the effect of pesticides on the embryonic development of fish would fall under the GLPs regulations
True
An intent of the GLPs is to ensure that studies can be reconstructed accurately if they need to be repeated.
True
Which regulatory agency codifies GLPs for laboratory studies?
- Food and Drug Administration
- Organization for Economic Co-operation and Development
- Environmental Protection Agency
The Centers for Disease Control is one of the agencies that regulates the care and welfare of research animals
False
The importation of animals such as dogs, cats, and turtles is regulated by the Centers for Disease Control
True
Which agency has regulations or guideline that regulate the transportation of animals?
- US Department of Transportation
- Food and Drug Administration
- US Fish and Wildlife Service
There are federal regulations that set limits on noise exposure in the animal facility
True
Under no circumstances can a manufacturer withhold information about a potentially hazardous material
False
The Nuclear Regulatory Commission regulates use of nuclear materials for medical and academic uses through regulations, licensing, and safety oversight.
True
Where is low-level waste generally stored?
On site
The Radiation Safety Officer must monitor the exposure level of all employees who work with low-level radiation sources
True
Which office has regulations which relate to medical waste?
- Department of Transportation Office of Hazardous Materials Safey
- US Postal Service
- Food and Drug Administration
All medical waste should be considered infectious.
False
The Centers for Disease Control may perform biosafety and biosecurity inspections of registered facilities
True
Which publication describes microbiological practices?
Biosafety in Microbiological and Biomedical Laboratories
A post-approval monitoring (PAM) program provides review before a study has been started
False
When responding to a reported noncompliance, the IACUC:
- 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
The IACUC may be made aware of noncompliance through the post-approval monitoring program
True
Noncompliance can lead to citations and major financial penalties against the institution through enforcement action by regulatory agencies.
True
Which of the following is often referred to as the Worker Right-to-know legislation?
OSHA’s Hazard Communication Standard
According to Federal law, which controlled substances must DEA registrants store in a securely locked cabinet?
Schedules 2 through 5
Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals?
The regulatory documents
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?
Guide for the Care and Use of Laboratory Animals
Which of the following statements best apply to Good Laboratory Practices regulations?
They apply to nonclinical studies for the assessment of the safety of chemicals to humans, animals, and the environment.
Which statement is FALSE regarding post-approval monitoring programs?
There are many state regulations with specific requirements for post-approval monitoring programs.
Which of the following is often referred to as the Worker Right-to-know legislation?
OSHA’s Hazard Communication Standard
According to Federal law, which controlled substances must DEA registrants store in a securely locked cabinet?
Schedules 2 through 5
Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals?
The regulatory documents
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?
Guide for the Care and Use of Laboratory Animals
Which of the following statements best apply to Good Laboratory Practices regulations?
They apply to nonclinical studies for the assessment of the safety of chemicals to humans, animals, and the environment.
Which statement is FALSE regarding post-approval monitoring programs?
There are many state regulations with specific requirements for post-approval monitoring programs.
