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

2. 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 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. Chapter 1 Introduction l l LAT certification program allow you to increase your knowledge in:   Diagnostics   Surgical management   Research methodology   Administrative duties l l Laboratory animal technicians are involved in more technical aspects of animal research

4. Chapter 1 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. Chapter 1 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. 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

7. Chapter 1 http://www.nal.usda.gov/awic/legislat/regsqa.htm Legislation & Guidelines

8. 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. Legislation & Guidelines

9. Chapter 1 Guide for the Care and Use of Laboratory Animals The 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.

10. Chapter 1 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. 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

12. Chapter 1 FDA & GLP http://www.fda.gov/cder/about/history/default.htm

13. 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 Importation and Transportation Regulations

14. Chapter 1 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 Guidelines

15. Chapter 1 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. 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 Animal Use Protocol Reviews

17. 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) Inspections & Program Review

18. 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

19. Chapter 1 AAALAC, International http://www.aaalac.org/