PHS Policy Flashcards
_____ has the responsibility for the general administration and coordination of the PHS Policy on the Humane Care and Use of Laboratory Animals
A) OLAW
B) NIH
C) DHHS
D) IACUC
D
____ provides the statutory mandate for the PHS Policy.
A) EPA Good Laboratory Practices
B) Health Research Extension Act of 1985, Public Law “Animals in Research”
C) The Guide
D) US Government Principles for Utilization and Care of Vertebrate Animals
B
According to PHS Policy, the IACUC must maintain records of its activities and must report through the IO to OLAW at least
A) Semiannually
B) Annually
C) Every 3 years
D) Every 5 years
B
According to PHS Policy, the Secretary, acting through the Director of NIH, shall establish guidelines for all of the following…
1) Proper care of animals to be used in biomedical and behavioral research
2) Proper treatment of animals while being used in research (use of analgesics, anesthetics and euthanasia and pre-/post-surgical care
3) Organization and operation of animal care committees
To what activities is PHS Policy applicable?
All PHS-conducted or supported activities involving animals no matter where the institution is located
What is the definition of an “animal” in PHS Policy?
Any live, vertebrate animal used or intended for use in research, research training, experimentation or biological testing or for related purposes
According to PHS Policy, a satellite facility is any containment outside of a core facility or centrally designated or managed area in which animals are housed for more than ___ hours.
A) 6
B) 12
C) 24
D) 48
C
For how long is a PHS assurance valid?
For a specified period of time no longer than 5 years
PHS policy stipulates that a program description must be included in the assurance. What must be included in the program description?
1) A list of every branch and major component of the institution
2) Lines of authority and responsibility for administering the program and ensuring compliance
3) Qualifications, authority and responsibility of the veterinarian(s) + % time contribution
4) Membership list of IACUC
5) IACUC procedures
6) Health program for personnel
7) Overview of training in humane animal care and use, methods to minimize animal numbers and animal distress
8) Square footage of animal facilities, species and average census
What are the differences between category 1 and category 2 institutions?
Category 1 - Accredited by AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International)
Category 2 - Not AAALAC accredited; only inspected by IACUC. Must submit most recent semiannual report with assurance
Minimum number of members on an IACUC? Member requirements?
No fewer than 5. Must include…
1) DVM w/ experience in lab animal medicine
2) Practicing scientist w/ animal research experience
3) Non-scientific member
4) Non-affiliated member
5) Someone else
Functions of an IACUC…
1) Review the program at least once every 6 months (Using The Guide to evaluate)
2) Inspect animal facilities at least once every 6 months (Using The Guide to evaluate)
3) Prepare reports of IACUC reviews/inspections
4) Review concerns involving animal care and use
5) Make recommendations to the IO regarding the animal program
6) Review and approve, require modifications in or withhold approval of PHS-supported activities
7) Review and approve, require modifications in or withhold approval of significant changes to activities
8) Be authorized to suspend an activity
If a PHS-supported protocol utilizing mice is suspended, who should be notified?
OLAW
For how long must an institution maintain its records?
At least 3 years (3 years after completion of the activity for records that relate directly to applications, proposals and proposed significant changes in ongoing activities)
How often must the institution report changes to the program category, program description, changes in IACUC membership and dates of IACUC inspection to OLAW?
Annually
