Term
|
Definition
| Center for Alternatives to Animal Testing |
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Term
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Definition
| Center for Information on Research in Animals |
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Term
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Definition
| Convention on International Trade in Endangered Species of Wild Fuana and Flora |
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Term
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Definition
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Term
|
Definition
| Federation of American Societies of Experimental Biology |
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Term
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Definition
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Term
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Definition
| International Air Transport Association |
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Term
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Definition
| International Council for Lab Animal Science |
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Term
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Definition
| Incurably Ill for Animal Research |
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Term
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Definition
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Term
|
Definition
| Interagency Research Animal Committee |
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Term
|
Definition
| Lab Animal Management Association |
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Term
|
Definition
| National Advisory Research Resources Council |
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Term
|
Definition
| National Institute of Occupational Safety and Health |
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Term
|
Definition
| Office of Management and Budget |
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Term
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Definition
| Office of Science and Technology Policy |
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Term
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Definition
| United States Fish and Wildlife Service |
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Term
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Definition
| World Veterinary Association |
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Term
Year the first edition of the Guide was published?
Who developed it?
What was it called? |
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Definition
1963
Animal Care Panel
Guide for lab animal facilities and care |
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Term
Year LAWA/AWA was first passed
Who is responsible? |
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Definition
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Term
|
Definition
|
|
Term
Year of first NIH Policy?
What was it called? |
|
Definition
1971
Humane Care and Use of Lab Animals for PHS Supported Institutions |
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Term
Year of first PHS policy?
What was it called? |
|
Definition
1973
PHS Policy on Humane Care and Use of Laboratory Animals |
|
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Term
| Initial PHS Policy required: |
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Definition
| Each institution to submit assurance and have committee to oversee animal care program |
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Term
| US Govt Principles were promulgated in what year? |
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Definition
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Term
| Year congress passed Health Research Ext Act |
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Definition
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Term
| 1985 AWA Major Amemdments |
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Definition
Covered all USDA registered facilities
Compliance now federal requirement/law
Added alternatives, pain relief, IACUC, responsibility assigned to CEO not vet
Animal well being (dog exercise, NHP enrichment)
USDA required to consult with human and health services
IACUC must have 3 members, 1 vet and one not affiliated
Semiannual inspections, keep records
USDA annual insp
Training requirements on humane handling, asepsis, surgery, alternatives, anesthetics, methods for reporting concerns, prevention of duplication etc etc |
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Term
|
Definition
Applied to research with cats dogs that were federally funded
Dogs cats obtained in interstate commerce
Dealers only registered if buying dogs cats across state lines acquisition records only req dogs cats
Rabbits, GP, hamsters, NHP only covered if in registered facility |
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Term
| 1966 LAWA statement standards |
|
Definition
Must permit continuation of animal research
Definition of 'adequate animal care' requires supervision by vet |
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Term
|
Definition
Ext from animal holding to labs
Required to report number of animals, pain, justification no analgesics
Adequate vet care to include proper anesthetics, analgesics etc
Commerce redefined to intra and inter-state for both dealers and research
Renamed AWA
Includes all warm blooded (except obvious and not marine mammals yet) and covers zoos etc
USDA must consult with fed agencies |
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Term
|
Definition
| Added Transportation for all handlers to include size of containers, ventilation, temp etc |
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Term
|
Definition
Hygienic Lab
Randell Act stating animals can be used for curing diseases resulted in expansion and renaming to NIH |
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Term
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Definition
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Term
1950 Rules Regarding Animals
Who?
What? |
|
Definition
PHS
Source only from dealers
Strays turned over to auth
Comfort and sanitation, under vet supervision
Operations under director supervision
Anesthesia req
Tx of animals at end of study
Rules included in first NIH Manual in 1954 |
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Term
Second edition of Guide published
When?
By?
Changes |
|
Definition
1965
National Academy of Sciences Institute for Lab Animals in Research now called ILAR
Distributed by DRG
? |
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Term
Third Guide
When?
What changes? |
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Definition
|
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Term
OPRR originally called what?
Is now called what? |
|
Definition
Institutional Relations in DRG
OLAW |
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Term
|
Definition
NIH issued policy on Care and Tx of Lab Animals
Would eventually evolve into PHS Policy
covered warm blooded
Required assurance that was AAALAC acred or had IACUC 1 DVM no minimum members to evaluate care
Performed annual inspections with Guide, AWA, and their own 'principles for use of lab animals' as basis |
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Term
|
Definition
| Dept of Health Education and Welfare |
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Term
| 1979 Edition of PHS Policy |
|
Definition
All vertebrates included
Called NIH Manual
Even AAALAC accredited must have IACUC
5 members 1 vet
Ok if not AAALAC but must perform annual program review
All must submit annual report and any deficiencies
Committee compliance inspection
Deficiencies specified plan for correction
Protocol review recommended not required |
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Term
1973 DHEW Policy with NIH
First PHS POLICY
Replaced NIH policy of 1971 |
|
Definition
Non compliance result in pulling assurance
Annual inspections
3 members 1 vet
Rec reviewing protocols not req
Procedures performed under supervision
1973-1979 |
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Term
|
Definition
| Principles apply to all vertebrates only facilities for regular species described |
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|
Term
1986 PHS Policy on the Humane Care and Use of Lab Animals
By
Changes |
|
Definition
OPRR
IO named
IACUC 5 members - 1 vet, 1 scie, 1 non affil
Review protocols
2 cat AAALAC or Non AAAALAC
Training, health programs, # animals, species, facility info, etc in assurance
Includes HREA and US govt principles (IRAC)
Includes extra and intramural research
Members appt by CEO
Semiannual program review |
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Term
|
Definition
Animal welfare education,
Published IACUC guidebook, several NIH policies, enforcing PHS Policy |
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Term
| Responsible for Alternatives and 3 Rs |
|
Definition
OTA
Office of Technology Assessment |
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Term
| Current AWA IACUC Requirements |
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Definition
| 3 members 1 vet 1 non affiliated chair |
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Term
| 1996 Guide, key difference/change |
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Definition
| Emphasizes performance standards not engineering standards |
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Term
| Who published in 1997 the 'Occ health and safety in the care and use of research animals' report |
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Definition
ILAR
Institute of Lab Animal Resources or Research |
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Term
| Institutions with PHS funding require... |
|
Definition
IACUC
Procedures for self reporting
Adequate vet program
Occ health program (not in AWA)
Training program
Environment, housing management program
Appropriate facilities
Animal Welfare Assurance
USDA registration if needed |
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Term
| IACUC Authority is given by |
|
Definition
Law:
HREA and AWA
CEO must appt IACUC
CEO may delegate appt authority if in writing |
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Term
|
Definition
IO
Must keep informed on semiannual review, compliance, program findings and recommendations
IO may not overrule IACUC |
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Term
Vet on IACUC
Who requires? |
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Definition
|
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Term
|
Definition
| AWAR, duties are described in PHS but not specifically stated |
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Term
Nonaffiliated
Who requires? |
|
Definition
PHS Policy and AWR/USDA Policy 15
Also Guide |
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Term
|
Definition
|
|
Term
Non scientist
Who requires? |
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Definition
|
|
Term
| Minimum IACUC members per AWR |
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Definition
|
|
Term
| Minimum IACUC members per PHS Policy |
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Definition
|
|
Term
Max number from each admin unit?
Who requires? |
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Definition
|
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Term
| Examples of protocol conflict of interest |
|
Definition
Involved in activity
Involved in competing research program
Access to funding or info may provide unfair competitive advantage
Personal biases may interfere with impartial judgement |
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Term
|
Definition
FCR - PHS and AWR
Suspension of an activity - PHS and AWR (in convened mtg) |
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Term
| Quorum with Abstentions - number required for decision |
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Definition
| Abstentions do not alter quorum or number of votes required, still need majority (of 11 members, need six votes regardless of number of abstentions) |
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Term
Semiannual program review
Who requires? |
|
Definition
Both
PHS - guide basis
USDA - AWR basis |
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Term
Semiannual facility inspections
Who requires? |
|
Definition
Both
PHS - 24hr areas, Sx, satellite, animal facilities
USDA AWAR - 12hr, animal facilities, animal study areas |
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|
Term
Prepare reports of IACUC evaluations and submit to IO
Who requires? |
|
Definition
Both
PHS - adherence to guide and policy, departures and reasons, significant vs minor with plan and schedule , reports given to OLAW upon request
USDA AWR - signing vs minor, plan and schedule 'dates' for correcting, signif not corrected in time frame must be reported to APHIS and any funding agency within 15 days (by IO) |
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Term
Review concerns regarding animal care
Who requires? |
|
Definition
|
|
Term
Make recommendations to IO
Who requires? |
|
Definition
|
|
Term
Review protocols and amendments
Who requires? |
|
Definition
Both
PHS - only for PHS funded research, complete review required at least every 3 yrs
USDA AWR - continuing review not less than annually |
|
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Term
PHS and AWA
Authorized to suspend activity
Who requires/allows? |
|
Definition
Both
PHS - if not done according to AWA, guide, policy or assurance. Convened quorum, IO consult and report to OLAW
USDA AWR - if not done according to protocol, IO consult and report to APHIS and funding agency |
|
|
Term
Required lines of authority from IO to IACUC, IACUC office, and veterinarian.
Who mandates? |
|
Definition
|
|
Term
T or F
The IACUC is required by PHS to do a side by side comparison of protocol and grants |
|
Definition
False
However, the information must be congruent and the IACUC should have some mechanism in place for checking congruency. If the IACUC requires changes to protocol not in grant then PHS funding agency must be notified.
Institutions must provide approval date. PHS federal funding usually gives 60 day grace period for obtaining approval. |
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|
Term
| For non PHS assured institutions, a grant signature by the official signals what? |
|
Definition
| That the institution will submit an assurance and show IACUC approval upon request by OLAW. |
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Term
| MOUs should originate from which institution |
|
Definition
| primary institution through which funding will be managed or routed |
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|
Term
Custom antibody vendors
Standard antibody vendors
Assurance required? |
|
Definition
|
|
Term
| Who is responsible in the eyes of PHS and AWR? |
|
Definition
PHS - institution with the funding
AWR - institution housing the animals and owns the animals (not necessarily the same) |
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Term
Semiannual Inspections
Who Must Go Where?
USDA vs OLAW
Animal Housing Facilities |
|
Definition
USDA
2 Voting IACUC Members
OLAW
Any trained and qualified person delegated by the IACUC |
|
|
Term
Semiannual Inspections
Who Must Go Where?
USDA vs OLAW
Centralized Surgical Suite |
|
Definition
USDA
2 Voting IACUC Members
OLAW
Any trained and qualified person delegated by the IACUC |
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|
Term
Semiannual Inspections
Who Must Go Where?
USDA vs OLAW
Hamsters in PI Lab for over 12 hrs |
|
Definition
USDA
2 Voting IACUC Members
OLAW
Any trained and qualified person delegated by the IACUC |
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Term
Semiannual Inspections
Who Must Go Where?
USDA vs OLAW
Mice in PI Lab for over 24 hrs |
|
Definition
USDA
Not Required (not USDA covered species)
OLAW
Any trained and qualified person delegated by the IACUC |
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Term
Semiannual Inspections
Who Must Go Where?
USDA vs OLAW
Surgery in PI Laboratory |
|
Definition
USDA
Not Required
OLAW
Any trained and qualified person delegated by the IACUC |
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Term
|
Definition
Minimum: 3
Nonaffiliated member
Chair
Vet with:
Program authority
Training or experience in lab animal science and medicine |
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Term
|
Definition
Minimum: 5
Nonaffiliated member
Practicing scientist
Non scientist
Vet with:
Program authority
Training or experience in lab animal science and medicine |
|
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Term
|
Definition
Minimum: none specified
Nonaffiliated member
Practicing scientist
Vet with:
Program authority
Training or experience in lab animal science and medicine |
|
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Term
|
Definition
Minimum: 5
Chair?
Nonaffiliated member
Practicing scientist
Non scientist
Vet with:
Program authority
Training or experience in lab animal science and medicine |
|
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Term
|
Definition
Minimum: 5
Nonaffiliated member (2)
Non scientist
Vet with:
Program authority
Training or experience in lab animal science and medicine |
|
|
Term
|
Definition
Minimum: 5
Nonaffiliated member
Non scientist
Practicing scientist with:
Expertise in Ag research or teaching involving Ag animals
Expertise in animal, dairy, or poultry and management of Ag animals
Vet with:
Program authority
Qualified in agricultural animal medicine and vet medicine |
|
|
Term
Which guides or regs include Occupational Health and Safety
Which do not? |
|
Definition
Do: The Guides, PHS, VA
Do not: USDA, DoD |
|
|
Term
Required IACUC Records
USDA |
|
Definition
Minutes
Proposed activities or significant changes
Approvals or disapproval of protocols
Semiannual reports with recommendations |
|
|
Term
Protocol Review Process
Who Requires or Mentions?
USDA, PHS, VA
List of proposed activities/protocols be distributed prior to meeting |
|
Definition
|
|
Term
Protocol Review Process
Who Requires or Mentions?
USDA, PHS, VA
Conflict of interest/removal of member during discussion (will not contribute to quorum) |
|
Definition
|
|
Term
Protocol Review Process
Who Requires or Mentions?
USDA, PHS, VA
May invite consultants to review meeting |
|
Definition
|
|
Term
Protocol Review Process
Who Requires or Mentions?
USDA, PHS, VA
Notify PI of approval |
|
Definition
|
|
Term
Protocol Review Process
Who Requires or Mentions?
USDA, PHS, VA
Notification of withholding to PI and allow opportunity for PI to respond |
|
Definition
|
|
Term
Protocol Review Process
Who Requires or Mentions?
USDA, PHS, VA
Continuing reviews of activity annually |
|
Definition
|
|
Term
Protocol Review Process
Who Requires or Mentions?
USDA, PHS, VA
Complete review of activity every 3 years. |
|
Definition
|
|
Term
Protocol Review Process
Who Requires or Mentions?
USDA, PHS, VA
May suspend activity if not done in accordance with:
A. protocol
B. AWAR
C. The Guide
D. Assurance
E. PHS Policy |
|
Definition
A. protocol - USDA, VA, tech PHS
B. AWAR - PHS
C. The Guide - PHS
D. Assurance - PHS
E. PHS Policy - PHS |
|
|
Term
| For VA, report of suspension must include what info? |
|
Definition
When and how IACUC made aware
When investigation performed and results
When IACUC convened to suspend
Corrective actions approved by IACUC |
|
|
Term
| Functions of the IACUC and its activities are based on what two laws? |
|
Definition
HREA of 1985
1985 Amendments to AWA (Improved standards for lab animals Act of 1985) |
|
|
Term
| May an AAALAC report count as a semiannual program review? |
|
Definition
| Yes, if it complies with all regs and is endorsed by the iacuc and sent to IO and only if two iacuc members were in attendance during inspection or review if USDA registered |
|
|
Term
| SA Program Review must be signed by |
|
Definition
|
|
Term
| SA program reports must be kept for how long? |
|
Definition
|
|
Term
| Exemptions to environmental enhancement or exercise plan in AWRs must be: |
|
Definition
scientifically justified in approved protocol and be re-reviewed no less than annually.
If non permanent health or behavior based, AV must review every 30 days |
|
|
Term
| May a part time consulting veterinarian be used instead of having a full time AV? |
|
Definition
| Yes, as long as all vet responsibilities are met. |
|
|
Term
| NHP enrichment and dog exercise plan must be approved by? |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Do not unnecessarily duplicate research |
|
Definition
| AWAR (PHS requires adherence to AWAR) |
|
|
Term
Training
Who is responsible according to:
AWAR
PHS |
|
Definition
AWAR - research facility
PHS - IACUC |
|
|
Term
| Training requirements in AWAR |
|
Definition
Basic needs of each species
Proper handling and care
Proper peri procedural care
Aseptic Sx and procedures
Methods to limit use of or minimize distress
Proper use anes, analgesics, etc
Methods of reporting deficiencies
Alternatives m, duplication, AWA and resources |
|
|
Term
Training documentation
What is required? |
|
Definition
| Technically nothing in regs but agencies may ask to see records as evidence of effective training program |
|
|
Term
| What are the 9 US Govt Principles? |
|
Definition
1. Accordance with AWA and applicable laws regs policies
2. Scientific relevance to society
3. Appropriate number and species, alternatives used
4. Minimize pain distress pain in humans pain in animals
5. Must use anesthetics analgesics etc
6. Severe or chronic pain must be euth during or at end of procedure
7. Appropriate living conditions and vet care
8. Trained and qualified
9. Exceptions must be approved by iacuc or similar review group |
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Justification for species and numbers used |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Avoid pain minimize distress |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Alternatives considered |
|
Definition
US Govt Principles - should
USDA - must
PHS (through the US Govt Princ) |
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Appropriate use of anesthetics etc
No paralytic w/o anesthesia
Analgesic exceptions justified and approved for only the necessary time frame
Require vet consult |
|
Definition
All policies
Us Govt principles and AWAR
AWAR and PHS
AWAR |
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Chronic or severe pain - euth during or immediately following procedure |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
AVMA euth methods |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Appropriate housing vet care |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Personnel trained and qualified |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Proposals must include a complete description of the proposed use of the animals to ensure discomfort is minimized and appropriate drugs are used |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Proposals involving Sx must involve appropriate pre and post op care |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Sx done aseptically |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Specifies Sx locations |
|
Definition
|
|
Term
Protocols, Who requires?
US Govt Principles
PHS
USDA AWAR
Limitations on more than one major survival Sx |
|
Definition
|
|
Term
FCR
Required number of members |
|
Definition
|
|
Term
| Who requires iacuc meeting minutes to include summary of deliberations and member attendance? |
|
Definition
|
|
Term
| Does use of DMR need to be described in PHS assurance? |
|
Definition
|
|
Term
| Can a DMR reviewer Approve/Require Mod/Request FCR/Withhold a protocol? |
|
Definition
|
|
Term
Significant Changes approvable by DMR or FCR
Examples x 8
Change in... |
|
Definition
Study objectives
Non survival to survival Sx
Increase in invasiveness or discomfort
Species or numbers used
Personnel
Anesthetic agents or withholding analgesics
Methods of euth
Duration, frequency or number of procedures |
|
|
Term
| What is the grace period allowed by OLAW for completing the de novo review after the protocol has expired? |
|
Definition
|
|
Term
| What policy or document indicates that studies involving unrelieved pain or distress are inappropriate when employed solely for teaching or instructional purposes? |
|
Definition
|
|
Term
PHS Assurance
How often must it be submitted? |
|
Definition
|
|
Term
USDA Registration
How often is it renewed? |
|
Definition
|
|
Term
| How soon must the USDA be notified of any change to the address or ownership of the institution? |
|
Definition
|
|
Term
| How soon can an institution's USDA registration be placed on inactive status? |
|
Definition
| After 2 years w/o animals |
|
|
Term
| When must SA program and facility reports be submitted to OLAW? |
|
Definition
Every 6 mos if institution is not AAALAC accredited.
Or upon OLAW or PHS request |
|
|
Term
| Failure to correct a serious deficiency within the time frame indicated on the SA review must be reported to who and when? |
|
Definition
|
|
Term
SA review
Who requires report to be viewed and signed by majority of IACUC members? |
|
Definition
|
|
Term
SA Report
Who requires it identify which facilities are AAALAC accredited? |
|
Definition
|
|
Term
| OLAW annual report must include...? |
|
Definition
| Changes in ACP, iacuc members, AAALAC accreditation status, minority reports, dates of SA |
|
|
Term
USDA Annual Report
What is included? |
|
Definition
| Numbers of each covered species used by pain category, assurances for care of animals and search for alternatives, adherence to AWR, iacuc approved deviations including reasons and number/species |
|
|
Term
PHS / OLAW
What to report? |
|
Definition
Serious or continuing noncompliance with PHS policy
Serious deviation from the guide
Suspension of an activity by the iacuc |
|
|
Term
Required Animal Records
AWR |
|
Definition
Records on acquired dogs/cats or offspring including 7 types of info.
Records on dogs/cats transported/euth/sold including 3 types of info.
Random source certificates. |
|
|
Term
| Care and Use of Lab Animals in DOD covers what species? |
|
Definition
| All live or dead vertebrates including birds, cold blooded animals, Rattus, Mus. |
|
|
Term
| Care and Use of Animals in DOD requires what similar concepts? |
|
Definition
Consider alternatives
Require training |
|
|
Term
| Animals in DOD include what distinct concept? |
|
Definition
| Purchase or use of dogs, cats, NHP, or marine mammals for inflicting wounds from any weapon to conduct surgical training is prohibited. |
|
|
Term
DoD
Who is the top person responsible for compliance and is liaison with outside agencies? Under who's direction? |
|
Definition
DDR&E
Director of defense research and engineering
Under direction of secretary of defense acquisition, technologies, and logistics |
|
|
Term
|
Definition
Assistant secretary of defense for health affairs (medical training)
Director DoD veterinary services (animal health) |
|
|
Term
|
Definition
'Joint technical working group'
Central advisory committee on animal use in 'armed services biomedical research evaluation and management'
ASBREM co chairs designate the JTWG chair. The JTWG will consist of reps from DDR&E, each DoD components, and DoD vet services activity |
|
|
Term
|
Definition
| Assistant secretary of defense for health affairs |
|
|
Term
DDR&E
Appoints who to interagency research animal committee |
|
Definition
| Vet with appropriate rank and experience and ACLAM certified |
|
|
Term
DoD
Responsibility for overseeing animal use may only be given to whom by whom? |
|
Definition
Single, senior official at general rank or equivalent or higher
By the DDR&E |
|
|
Term
|
Definition
| Research, development, test and evaluation |
|
|
Term
| What agency coordinates national priorities for using chimpanzees in research? |
|
Definition
| DHHS Interagency Animal Model Committee |
|
|
Term
|
Definition
| 3 years beyond date of the end of the RDT&E or training, or the effective date of the record |
|
|
Term
| Who designates a vet as the director of DoD veterinary services activity, to serve under what agency? |
|
Definition
| Secretary of the Army designates the vet to be director in the Field Operating Agency of the Army to implement FDA requirements among others |
|
|
Term
| Does DoD allow animals to be purchased from suppliers that are exempt from being licensed? |
|
Definition
| Yes, but they must be inspected by a vet unless they are AAALAC accredited |
|
|
Term
DoD
Foreign institutions
Must we inspect? |
|
Definition
| Program and facility review required unless AAALAC accredited |
|
|
Term
DoD
When is AAALAC not required |
|
Definition
| Housing animals less than 8 continuous days (must still be inspected before study starts) |
|
|
Term
|
Definition
5 members
No more than 3 from same admin unit
Vet with training or experience in lab animal
Non affiliated (alternate must be assigned so always present)
Non scientist
For quorum at least vet and non affiliated must be present |
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Term
DoD
What areas need to be inspected and how often? |
|
Definition
| Areas using or housing animals over 12hrs, semiannual and program review |
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Term
Secondary Oversight IACUC
DoD Component headquarters must approve what protocols? |
|
Definition
| Using dogs cats NHP marine mammals and all medical training involving live animals |
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Term
DoD
Protocols re-reviewed how often? |
|
Definition
|
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Term
DoD
Site visit how soon if using animals? |
|
Definition
30 days of animal arrival or signed document
If AAALAC accredited ok to waive requirement |
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Term
DoD
Changes in AAALAC status, adverse events, USDA inspection how soon to notify main office? |
|
Definition
must notify component office within 5 days
Will be inspected by vet within 30 days |
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Term
|
Definition
| Interagency Coordinating Committee on the Validation of Alternative Methods |
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Term
| Field study vs field research |
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Definition
|
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Term
| DoD IACUC members are appointed by whom? |
|
Definition
IO or commander
IO is appointed by commander |
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Term
VA
What document outlines the principles and procedures that govern animal research? And includes basic principles from what other document? |
|
Definition
The Veteran Health Administration (VHA) Handbook
US Govt Principles |
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Term
|
Definition
| Animal Component of Research Protocol |
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Term
|
Definition
| The highest rank admin director of the local VA medical facility |
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Term
|
Definition
Chief Research and Development Officer
VA central office research administrator, directs the office of research and development |
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Term
|
Definition
| Chief Veterinary Medical Officer |
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Term
| VA IACUC is subcommittee of what committee? |
|
Definition
research and development (R&D) committee
Also subs are research safety (SRS), IRB etc |
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Term
|
Definition
| Local medical facility director (unless affiliate is the one AAALAC accredited) |
|
|
Term
| What is the VA ORD review system called that requires proof of IACUC approval if favorable funding score is received? |
|
Definition
|
|
Term
|
Definition
VA Office of Oversight
Advises Under Secretary for Health on matters of compliance etc |
|
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Term
| Does the VA require adherence to PHS policy when PHS funds are not involved? |
|
Definition
|
|
Term
AWA and AWAR
Who is responsible for enforcing?
Who is responsible for monitoring compliance? |
|
Definition
USDA
USDA Animal Care Section of APHIS |
|
|
Term
| What is included in the VMU? |
|
Definition
Animal research facility
Husbandry
Vet technical personnel |
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Term
Who must be involved to suspend VA activity for serious health or welfare concerns?
What about VA field research? |
|
Definition
CRADO and CVMO
Field: same but also VISN Veterans Integrated Service Network and the affected station |
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Term
| VA policy adheres to what other docs? |
|
Definition
| HREA, PHS, the Guide, AVMA, AWA/R, USDA, US Govt Principles |
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Term
| What additional guidelines or docs cover common safety concerns? |
|
Definition
CFR Select agents and toxins
CDC latest guidelines, 'biosafety in microbiological and biomedical labs'
'NIH guidelines for research involving recombinant DNA' |
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Term
VA
Can new or reactivated animal facilities can be used right away? |
|
Definition
| Not until approved by CRADO |
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Term
VA
If concerns are noted in JIT, the CRADO has what options? |
|
Definition
Suspend all or portion of local activities by placing protocol or aspect of protocol on hold
Withhold funding until issues are addressed |
|
|
Term
| Who can suspend a VA protocol or activity? |
|
Definition
CRADO
Under Secretary for Health
ORO |
|
|
Term
VA
Who is responsible for coordinating JIT review process? |
|
Definition
|
|
Term
|
Definition
| Veterinary Medical Consultant |
|
|
Term
| Is ACLAM a requirement for VA vets? |
|
Definition
|
|
Term
| VA VMO or VMC is supervised by whom? |
|
Definition
| ACOS for R&D, COS - Chief of Staff, or medical facility director |
|
|
Term
VA
When must vet consult take place? |
|
Definition
| Prior to submission to IACUC |
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|
Term
VA
Can a local clinical vet without lab animal skills be used? |
|
Definition
| Yes but only to supplement the VMO or VMC. They do not replace. |
|
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Term
|
Definition
| VA Husbandry Supervisor (veterinary medical unit) |
|
|
Term
|
Definition
|
|
Term
| Surprise facility response / overheating tests are required how often? By who? |
|
Definition
At least once a fiscal year
VA |
|
|
Term
| VA SOPs are reviews how frequently? |
|
Definition
|
|
Term
NIH funded project
Academic affiliate is grant recipient
Research done at the university
PI conducts research on non VA time
Is AAALAC needed? |
|
Definition
|
|
Term
| Who assigns IACUC members in VA? |
|
Definition
| Facility medical director aka CEO aka IO |
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|
Term
|
Definition
5 members
Required voting members include:
Chair
AV
Animal research scientist
Non affiliated
Lay member (non scientist)
At least 1 IACUC member should be member of R&D committee and of SRS |
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|
Term
|
Definition
Cannot chair another subcommittee
Senior scientist with animal research experience |
|
|
Term
| Who cannot serve as voting members on VA IACUC? |
|
Definition
Senior admin staff including those in ACOS R&D or AO R&D (considered conflict of interest d/t supervisor or fiscal authority)
RCO - Research Compliance Officer |
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|
Term
VA
How long of a term is Chair of IACUC?
Terms for other members? |
|
Definition
Chair-Renewed annually for unlimited times
Members-up to 3 years, may be reappointed
AV/VMO must always be a member |
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|
Term
If an affiliate's IACUC is used as the VA IACUC who appoints the members in writing?
Who must be on the IACUC? |
|
Definition
VA medical facility director appoints affiliates IACUC
Same member minimum requirements, Also VA VMO/VMC and one other VA scientist must be on its committee |
|
|
Term
| Can commercial IACUCs be used at the VA in place of a VA or affiliate IACUC? |
|
Definition
|
|
Term
| Which policy states no member may review their own proposal? |
|
Definition
| APHIS Animal Care Policy 15 |
|
|
Term
SA Program and Facility Review
VA
What is used as basis? |
|
Definition
| Guide, PHS, AWA/R, VA policy |
|
|
Term
| VA areas inspected during SA |
|
Definition
| All facilities and PI areas where lab animals were acquired with local VA funds and used in procedures, and/or housed more than 12 hrs |
|
|
Term
| VA program review includes what extra requirements? |
|
Definition
Random review of at least 5% (min 5 protocols) of the total active projects
Look for proper doc of review, approval letters, annual and triennial approval, modifications, and PI correspondence |
|
|
Term
| Review checklist must be completed within how long following VA program self review? |
|
Definition
|
|
Term
| SA report must include what other info regarding VA IACUC members? |
|
Definition
Names present during the Self review, degrees held, and IACUC role/position
Signed by voting majority of IACUC include committee roles |
|
|
Term
| Who must conduct VA self review? |
|
Definition
| At least 3 IACUC members including vet (at least 2 voting) |
|
|
Term
VA Self Review SA
Who MUST the signed report be discussed with prior to sending to CVMO? |
|
Definition
The medical facility director aka IO aka CEO, the chair, vet and one research admin (ACOS - assistant chief of staff)
Director must sign and send to CVMO within 60 days |
|
|
Term
| How long must the VA self review SA be kept? |
|
Definition
|
|
Term
| What rev or policy requires vet consult if the activity may cause more than momentary pain or distress? |
|
Definition
USDA AWA/R
Subsequent policies such as VA, PHS etc require you to follow USDA regs |
|
|
Term
VA Policy
DMR
Would summaries of proposed activities be satisfactory to send to IACUC for consideration as DMR? |
|
Definition
| No, full copies must be given. |
|
|
Term
VA
Each protocol must be assigned to a minimum of how many reviewers? |
|
Definition
|
|
Term
| What type of voting process is used at the VA? |
|
Definition
Parliamentary
Results of each members vote should be kept anonymous on paper |
|
|
Term
VA
Annual reviews may performed by whom? |
|
Definition
|
|
Term
VA
When is the term 'ex-officio' used? |
|
Definition
| To describe IACUC member roles that are required based upon position such as the institutional vet |
|
|
Term
VA
What extra annual reports are required? |
|
Definition
Annual VA VMU Report
Includes all animals used during fiscal year
Sent by Jan 15th |
|
|
Term
VA
Copies of new assurances and annual reports must be submitted to CVMO within how many days?
Copies of other correspondence between outside agencies must be forwarded within...? |
|
Definition
|
|
Term
VA
Significant non compliance/deficiencies must be reported to outside agencies within how many days? |
|
Definition
|
|
Term
VA
Suspensions or failure to fix serious deficiencies must be reported to outside agencies within how many days? |
|
Definition
|
|
Term
| What year did the AWA add transportation requirements? |
|
Definition
|
|
Term
| What year did the AWA start requiring annual reports? |
|
Definition
|
|
Term
| What year did the LAWA become AWA? |
|
Definition
|
|
Term
| What year did the AWA require consideration of alternatives? |
|
Definition
|
|
Term
| What year did the AWA include proper anesthetics and analgesics in their definition of adequate vet care? |
|
Definition
|
|
Term
What year did the AWA specify IACUC member composition?
What was the requirement? |
|
Definition
1985
Minimum 3
1 vet
1 non affiliated |
|
|
Term
| What year did the AWA require training? |
|
Definition
|
|
Term
| What year did the AWA include research labs as areas overseen? |
|
Definition
|
|
Term
| What year did the AWA add the exercise plan for dogs and the environmental enhancement plan for NHP? |
|
Definition
|
|
Term
| What year did the AWA include all warm blooded mammals (except the obvious and marine mammals)? |
|
Definition
|
|
Term
| What year did PHS policy include all live vertebrates? |
|
Definition
|
|
Term
What year did PHS policy require all institutions, even AAALAC accredited, to have an IACUC and stipulate the composition?
What was the requirement at that time? |
|
Definition
|
|
Term
| What year did the AWA require semiannual inspections and review by facility and annual inspections by the USDA? |
|
Definition
|
|
Term
|
Definition
| American Registry of Professional Animal Scientists |
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