Chapter 1-4 Review Flashcards
What is a research study?
a systematic investigation to establish facts
which of the following is a primary duty of the IACUC?
Review animal welfare concerns
True or False: researchers working for private companies do not need to compete for funding
false
Who makes the decision of how to handle any serious deficiencies found during post approval monitoring?
IACUC
Which entity in AALAC International approves an institution’s application for accreditation?
Council on Accreditation
Who must approve an animal use protocol before a study that involves animals can begin?
IACUC
a document that outlines the steps required to clean an animal room is called a:
standard operating procedure
Who are the main public granting agencies for scientific research?
NIH and NSF
Who monitors PHS Policy compliance?
OLAW
Per the AWR, how long can IACUC approve protocols for (for non-USDA covered animals)
1 to 3 years
How long can protocols containing USDA covered animals be approved for?
1 year
Who has the authority to withhold approval for an investigator to begin a research project?
IACUC
The USDA inspects research facilities for compliance with which mandates?
the Ag Guide, USDA policies, and AVMA guidelines
Why does the OLAW inspect research facilities
routinely and for cause (routine inspections of selected institutions, and potential noncompliance with the PHS policy)
who does the IACUC report to?
the IO, which in turn reports to the USDA, OLAW, AAALAC
What does PAM stand for?
post-approval monitoring
What does suspension of animal activities by the IACUC warrant?
notification to USDA, OLAW, and AAALAC
How often does AAALAC perform site visits?
every 3 years
which entity evaluates an institution’s animal research program based on semiannual reviews, annual reports, and three-year site visits?
AAALAC
When applying for AAALAC accreditation, the institution submits a detailed document outlining the animal care program called a ___
program description
Who is responsible for appointing members to the IACUC?
Chief executive officer
Who implements and enforces the Animal welfare act?
USDA
Who is responsible for conducting unannounced inspections of registered institutions within their respective regions?
USDA Veterinary Medical Officers (VMOs)
What did the USDA create to help institutions meet requirements for VMO visits?
Animal Care Inspection Guide
What is the IO referred to as in AWA and AWR?
chief executive officer
Who is responsible for monitoring compliance with the NIH Policy, Care, and Treatment of Laboratory Animals, now known as the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy)?
OLAW
What must a federal grant or contract involving animals in the PHS policy submit before their grant or contract is approved?
Animal Welfare Assurance signed by the IO
What does the Animal Welfare Assurance commit compliance to?
PHS policy, AVMA Guidelines, the Guide, and the AWA
How many IACUC members does the PHS policy require?
5
how many IACUC members does the AWA/R require?
3
What agencies are responsible for AWR/A?
USDA, APHIS
How long does an Assurance stay in effect?
4-5 years
Which mandate includes the full text of the US Government principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training?
AWR/A, the Guide, and PHS Policy
Although not a regulation, the Guide must be followed for research with animals covered by which mandate?
PHS
What does the Guide take into consideration?
AWA, AWR, PHS Policy, and US Government Principles
The Guide is a required mandate for which entities?
USDA for enforcement of the AWA, and AAALAC international for accreditation
Who requires animal facilities to adhere to the AVMA’s guidelines for euthanasia?
USDA, OLAW, AAALAC
What are the import requirements for laboratory rodents?
animals are shipped from the country of origin, appear health, have necessary export documents and proper identification, and enter the US through designated ports of entry
What regulations apply to research or marketing permits for products regulated by the FDA and the EPA?
GLP
Guidance for controlling laboratory animal allergy can be found in which document?
Occupational Health and Safety in the Care and Use of Research Animals
Who can restrict or withdraw approval of the Animal Welfare Assurance if an institution fails at its responsibilites?
OLAW
In the Guide, which word is defined as indicating a suggestion to be considered for the proper humane care and use of lab animals?
May
The Guide holds which individual responsible for the veterinary oversight of the research program?
attending veterinarian
What does the Guide acknowledge as determing the necessity for various functional areas in the physical plant of a research program?
scope and type of research conducted
In the laboratory animal field, biosecurity refers to the protection of an animal colony from:
microbial contamination
Which of the following is NOT an example of raw data for a GLP study?
health certificate
___ means those actions taken to assure that laboratory animals are treated according to high ethical and scientific standards.
humane care
___ is applied to research funded by federal grants and address some of the ethical concerns involved with research studies using animals.
US Government Principles
when non-animal alternatives or less sentient species can take the place of animals without interfering with the objectives of the study
replacement
using fewer animals in a study without altering the validity of the study
reduction
can the procedures used in the study be changed to lessen pain and distress or minimize the number of potentially painful procedures
refinement
Whistleblower protections are required by which regulation or guidelines?
AWR and the Guide
What is not a method for the technician to support the ethical treatment of animals?
determining if the animal has reached the humane endpoint
how long does PHS policy require that all assurance records related directly to grant applications, research proposals, and changes in research activities be maintained for at least, after completion of an activity?
3 years
How long does the USDA require dog and cat tags to be kept after a study ends?
1 year
Type of animal care program that is usually a separate department that serves all the institutions animal care needs and requests
centralized
What type of management is where each department within the institute houses and uses lab animas for research or teaching and maintains its own animal facility and operating budget?
decentralized
costs that can be attributed to a specific service or project (feed, bedding, labor)
direct
costs that are required regardless of the service, project, or quantity and type of animals cared for (housekeeping, electricity, security, admin)
indirect costs
A cost recovery analysis for technical services offered by the vivarium is based on what?
revenue for the services compared to expenses for related supplies and labor
The NIH is a branch of which of the following?
PHS
In addition to the federal, state, and local laws and regulations, what two documents are used by AAALAC in the US to evaluate institutions for accreditation?
The Guide and the Ag Guide
Who is exempt from participating in the animal care training program?
no one
Which federal mandate provides descriptions of shipping crate sizes and configurations for hamsters?
AWR
