Animal Care and Use: What Researchers Need to Know

1. Animal Care and Use: What Researchers Need to Know

2. Animal Research Statistics • 2001 statistics (National Association for Biomedical Research) • 30 Million lab animals used annually • 1.2 million regulated species • Slight trend toward annual reductions • USDA Regulated Animals in Research (FY 2004) SpeciesNumbers • Dogs 64,932 • Cats 23,640 • Non-human primates 54,998 • Guinea pigs 244,104 • Hamsters 175,721 • Rabbits 261,573 • Sheep 19,218 • Pigs 54,504 • Other farm animals 31,956 • Other animals 171,312 • Total 1,101,958

3. Legislation • Animal Welfare Act (1966) and Health Research Extension Act (1985) stipulate animal welfare regulations • Humane care • Minimization of pain and distress • Emphasizes minimal use of animals and appropriate justification • The 3 r’s

4. U.S. Government Principles Used to Guide Animal Research • Justification of research • Relevance to human or animal health, the advancement of knowledge, and good of society • Justification of animal use and numbers • Proper use of animals • Minimization of pain, discomfort, and distress • Humane euthanasia if pain cannot be relieved • Appropriate care of research animals under veterinary supervision by trained personnel • Experimentation only by trained personnel

5. Standards for Animal Care • Primary reference for animal care and use • National Academy of Science publication • Basis for Public Health Service standards on animal care

6. Requirements of Research Institutions • Assurance to follow federal guidelines - OLAW • Describes program for animal care and use including facilities and training program for researchers • Occupational health and safety program • Numbers and types of animals used • Submit to inspections • Institutional Animal Care and Use Committee (IACUC) • Assesses all research activities involving live vertebrate animals • Keep records of all activities • Provide annual report to OLAW

7. IACUC Requirements • Membership – at least five members with four mandatory components • Veterinarian • Scientist • Non-scientist • Community member (not affiliated with institution)

8. IACUC Functions • Review all research proposals and monitor their activity to assess adherence to PHS government principles • Semi annual facilities inspections • Semi annual program reports and recommendations to Institutional Official • Program review • Suspend research activities if violations occur

9. Importance of IACUC oversight for researchers • Meet legal requirements – significant penalties for non-compliance • Training – improves study design • Research quality – healthy animals yield better data • Publication requirement – IACUC approval is a publication prerequisite in most journals

10. Requirements for Researchers: Prerequisites for Research • Training • Online Animal Care Module(s) • Lab-specific Training • Occupational Health Screening • Protocol approval by IACUC

11. Animal Care and Use Training

12. Responsibilities of Researchers • Obtain permission to conduct research on vertebrate animals • Abide by all institutional and PHS policies • Ensure that all personnel involved with approved projects are appropriately trained • Comply with IACUC decisions • Allow inspection of animal care and research areas • Make no changes to approved protocols without IACUC consultation and approval

13. The research protocol: basic components • Species and approximate numbers used • Rationale for animal use, appropriateness of species, and benefits of research • Complete description of animal use and care • Descriptions of how injury and discomfort will be minimized to that which is unavoidable to conduct research and managed by anesthetics or analgesics • Description of any euthanasia methods used

14. MSU Protocol Cover Page • Project Title • Contact Information • Principal investigator • Project Characterization • Status (new, renewal, amendment to existing protocol) • Type • Research category

15. Protocol : Section 1 • Personnel Information • Identify everyone involved with project • Describe all relevant training • List online modules • Lab –specific training • Previous experience

16. Protocol Section 2: Project Description • Non-technical summary – lay audience • Objectives • Benefit of study (society, education, animals) • Experimental design and methods • Duration of project • Justification • Species used and numbers required • Use as many relevant arguments as possible

17. Protocol Section 2.3Required Keyword Search • Evaluate literature for appropriate and/or alternative methods • Important criteria • Duplication of effort • Use of animal model • Must be current (< 2 months old) • Required information: • Date of search • Keywords used • Search resources • Years covered by search results • Written summary of results

18. Section 3: Animal Use • Animal Sources, species, and numbers used • Sources must be approved for lab animals • Wild animals must be collected with permission • Animal facilities: • Where housed • Location of any research activities • Animal husbandry summary • Housing, food, environmental or lab conditions, etc.

19. Animal Use: Procedures • Animal procedures • Check appropriate boxes • Some require additional forms (surgery, field studies, etc.) • Pain and distress • Indicate number of each animal used in each pain category • Category 5 pain must be carefully justified • Pain alleviation • Drug type and administration

20. Investigator Assurances • Signed list of statements that confirms adherence to rules • Declaration that everything is correct and that you will follow the protocol as approved • Signature for PI and Co-PI (graduate student)