Public and Private Interests in Public and Private Interests in Animal ResearchAnimal Research

LAT Chapter 1

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IntroductionIntroduction

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

Chapter 1Public and Private InterestsPublic and Private Interests

• 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

Chapter 1Competitive Federal GrantCompetitive Federal Grant

• 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

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• 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 & GuidelinesLegislation & Guidelines

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http://www.nal.usda.gov/awic/legislat/regsqa.htm

Legislation & GuidelinesLegislation & Guidelines

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• 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.

Legislation & GuidelinesLegislation & Guidelines

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• Guide for the Care andUse of Laboratory Animals

The GuideThe Guide

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.

Chapter 1The GuideThe Guide

• 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

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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 & GLPFDA & GLP

Chapter 1FDA & GLPFDA & GLPhttp://www.fda.gov/cder/about/history/default.htm

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• 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

Importation and Transportation RegulationsImportation and Transportation Regulations

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• Policies established for: facility operations care and use procedures veterinary support physical plant

• Standard operating procedures relate to: 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.

Institutional GuidelinesInstitutional Guidelines

Chapter 1IACUCsIACUCs

•IACUCs are mandated by AWA, PHS

policy, and the Guide.

•IACUC functions include:Review and approve protocols for animal useReview animal use program and perform animal

facilities inspections at least every 6 monthsIACUC members include:

Veterinarian with experience in LAScientist who using research animalNon-scientistPerson not affiliated with the institution

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• 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

Animal Use Protocol ReviewsAnimal Use Protocol Reviews

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• 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)

Inspections & Program ReviewInspections & Program Review

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• 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, InternationalAAALAC, International

Chapter 1AAALAC, InternationalAAALAC, International

http://www.aaalac.org/