Transcript Interests - AZ Branch AALAS Homepage

Public and Private Interests in
Animal Research
LAT Chapter 1
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Chapter 1
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Introduction
Chapter 1

LAT certification program allow you to
increase your knowledge in:
 Diagnostics
 Surgical management
 Research methodology
 Administrative duties

Laboratory animal technicians are involved in
more technical aspects of animal research
Public and Private Interests
Chapter 1
• U.S. Government provides approximately
two-thirds of research/development funds
spent by college and universities
• Grant applications used to request funds:
 Detailed description of research goals
 Scientific basis of study
 Review of relevant literature and all procedures to be
performed
Competitive Federal Grant
Chapter 1
• Federal grant programs
 NIH & NSF: Main public granting agencies for
biomedical research
 NIH: primary granting agency: academia, federal agencies,
biomedical research
 NSF: funds basic research in math, medicine, biology, etc.
• Others: “mission agencies”
 Departments of Defense, Energy, Agriculture, NASA
• Private funding of research
 Pharmaceutical companies , non-profit organizations
Legislation & Guidelines
Chapter 1
• USDA
 Enforces and amends the AWA
 Auction, sale, exhibit, transport, breeding or conduct of
research with animals
 Animals exempt from AWA: cold-blooded species,
birds, mice, rats, and farm animals used for food, fiber,
and nutrition
 Research institutions must register with USDA
 Supply annual reports
 Inspection records are available to public via Freedom
of Information Act (FOIA)
 Unscheduled inspection once per year
Legislation & Guidelines
Chapter 1
http://www.nal.usda.gov/awic/legislat/regsqa.htm
Legislation & Guidelines
Chapter 1
• Public Health Service (PHS) Policy
 Institutions which receive funding from PHS & NIH
must follow these guidelines.
 Requires filing of an Animal Welfare Assurance
document that demonstrates that your institution is
following the Guide, PHS policy, AWA, and any
other applicable laws.
The Guide
Chapter 1
• Guide for the Care and
Use of Laboratory Animals
 Provides basic information on
animal use for researchers
 “Gold Standard” for institutions
to model their animal care
programs
 AAALAC, International uses the Guide to evaluate
and accredit animal care programs.
 AAALAC accreditation is a voluntary process for
animal care and use programs.
The Guide
Chapter 1
• Specific segments of the Guide include:
 Institutional policies and responsibilities
 Describes necessary compliance requirements
 Laboratory animal management
 Focuses on recommended cage sizes and construction
requirements
 Also covers recommended equipment, food, bedding, etc.
 Veterinary medical care
 Outlines major considerations related to animal selection,
procurement, and health maintenance
 Physical plant
 Emphasizes proper construction of an animal facility
FDA & GLP
Chapter 1
Food and Drug Administration (FDA)
 Assures that new drugs and medical devices are safe
and effective before approved for use in humans
 Monitors drugs after approval
 Includes human and veterinary drugs, food, and
medical devices
 Requires that effectiveness be demonstrated through
well controlled investigations
Good Laboratory Practices (GLP)
 Established in 1978 with implementation of laboratory
audits and inspection program
 Details requirements for QA and SOPs
FDA & GLP
Chapter
1
http://www.fda.gov/cder/about/history/default.htm
Importation and Transportation Regulations
Chapter 1
• For protection of humans and environment from
potential disease carrying organisms
• Several agencies control importation:
 CDC
 USDA
 US Fish & Wildlife Service
• Most states also have anti-cruelty laws
Institutional Guidelines
Chapter 1
• Policies established for:




facility operations
care and use procedures
veterinary support
physical plant
• Standard operating procedures relate to:

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

all aspects of animal care and support
personnel management
health surveillance of animals and personnel
equipment
investigators
• Technicians must have thorough knowledge
of proper animal and facility maintenance.
IACUCs
Chapter 1
•IACUCs are mandated by AWA, PHS
policy, and the Guide.
•IACUC functions include:
Review and approve protocols for animal use
Review animal use program and perform animal
facilities inspections at least every 6 months
IACUC members include:
Veterinarian with experience in LA
Scientist who using research animal
Non-scientist
Person not affiliated with the institution
Animal Use Protocol Reviews
Chapter 1
• Animal care and use protocols
 Principal Investigator provideswritten details of how
animals will be used in the research project.
 IACUC must review all protocols using animals.
 IACUC must approve all protocols before any animal
research can begin.
• IACUC:




Can deny permission to start a project
Can stop a research project
Ensures compliance with regulations
Reviews complete protocols at least every 3 years;
reviews updates to protocols yearly
Inspections & Program Review
Chapter 1
• Use The Guide as basis for inspection
• Inspection performed by the IACUC members
 Inspections performed every 6 months
 Report issued to Institutional Official
• Reports available to outside inspectors (USDA,
AAALAC)
AAALAC, International
Chapter 1
• Association for Assessment and Accreditation
of Laboratory Animal Care, International
 Non-profit organization that provides a mechanism for
peer review of animal care and use programs by
scientific community
 Detailed application with information on facilities,
procedures, programs, and research animal use
 Annual report must be submitted to AAALAC on status
of animal care program
 Site inspection and program evaluation every 3 years
 Institutional goal = full accreditation
AAALAC, International
Chapter 1
http://www.aaalac.org/