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Public and Private Interests in Animal Research

Public and Private Interests in Animal Research. LAT Chapter 1. LAT Presentations Study Tips. If viewing this in PowerPoint, use the icon to run the show. Mac users go to “Slide Show > View Show” in menu bar

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Public and Private Interests in Animal Research

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  1. Public and Private Interests in Animal Research LAT Chapter 1

  2. LAT Presentations Study Tips • If viewing this in PowerPoint, use the icon to run the show. • Mac users go to “Slide Show > View Show” in menu bar • Click on the Audio icon: when it appears on the left of the slide to hear the narration. • From “File > Print” in the menu bar, choose “notes pages”, “slides 3 per page” or “outline view” for taking notes as you listen and watch the presentation. • Start your own notebook with a 3 ring binder, for later study!

  3. Introduction • 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

  4. Public 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

  5. Competitive 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

  6. Legislation & Guidelines • 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

  7. Legislation & Guidelines http://www.nal.usda.gov/awic/legislat/regsqa.htm

  8. Legislation & Guidelines • 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.

  9. The Guide • Guide for the Care andUse 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.

  10. The 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

  11. FDA & GLP 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

  12. FDA & GLP http://www.fda.gov/cder/about/history/default.htm

  13. Importation and Transportation Regulations • 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

  14. Institutional Guidelines • 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.

  15. IACUCs • 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

  16. Animal Use Protocol Reviews • 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

  17. Inspections & Program Review • 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)

  18. AAALAC, International • 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

  19. AAALAC, International http://www.aaalac.org/

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