Good care is important to the research process as a whole Animals that are treated well provide the normal biological and behavioral responses

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2 Good care is important to the research process as a whole Animals that are treated well provide the normal biological and behavioral responses researchers need to measure Animals that are undernourished, poorly housed or stressed make poor research models Knowledge gained through the years has improved the care research animals receive Animals are treated with respect and dignity

3 WHO TAKES CARE OF ANIMALS USED IN RESEARCH? Animals used in biomedical research are taken care of by technicians, who act somewhat like nurses in a hospital setting Each animal s health is checked daily Each animal s environment is controlled heat, humidity, noise, light and use of chemicals and detergents Technicians make sure research animals are comfortable Technicians take blood samples and X-rays, give medications or therapy, assist in surgery and provide care after surgery

4 Most animal care technicians are trained in two-year or four-year college programs Many research institutions have in-service training The American Association for Laboratory Animal Science (AALAS) ensures high quality standards in animal care by certifying technicians at three levels Technicians supervised by a Veterinarian who specializes in laboratory animal medicine Veterinarians go through extensive training to qualify for certification as a specialist Veterinarians are responsible for monitoring the animals care and examining the animals that appear to be ill

5 WHAT ARE ANIMAL FACILITIES LIKE? Like a hospital for humans Animal facilities are kept clean Animal technicians wear lab coats, surgical masks and gloves when necessary Technicians and Veterinarians make sure the animals are eating properly, are healthy and comfortable

6 HOW ARE ANIMALS TREATED? Animal caretakers do everything possible to make animals feel comfortable and happy in the laboratory environment Animals are treated with gentle compassion Animals are lifted and held carefully when taken out of their cages The laboratory is the animal s home so researchers do everything they can to make them feel settled

7 WHAT ABOUT PAIN? Except for rare cases in which pain-killing drugs or anesthesia will interfere with a study s results, researchers make every effort to make sure animals don t feel pain Study by USDA in 1991 showed that in 94% of animal studies, animals suffered no pain 61% of the animals were not exposed to pain at all 33% of the cases pain was involved, but animals were given anesthesia or pain relievers 6% of the cases were animals exposed to pain without drugs studies were research on chronic pain Exposure to pain is kept to the minimum level possible

8 FEDERAL REQUIREMENTS FOR ANIMAL TESTING Federal Regulations require that the public be protected from hazardous products and have regulations that require animal testing Four principal federal agencies involved in administering the guidelines: a. Food and Drug Administration (FDA) b. Environmental Protection Agency (EPA c. Consumer Product Safety Commission (CPSC) d. Occupational Safety and Health Administration (OSHA)

9 FEDERAL LAWS, REGS AND GUIDELINES GOVERNING RESEARCH USING ANIMALS US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Developed in 1984, and includes requirements that: a. Procedures involving animals be relevant to humans or animal health b. The minimum number of animals be used to obtain valid results c. Alternatives to animals be considered d. Animal pain or distress be avoided or minimized e. Living conditions for animals be appropriate for their species f. Research scientists and those caring for the animals be properly trained and qualified

10 Animal Welfare Act (AWA): Enacted 1966, amended in 1991 Applies to all public and private research facilities in this country Includes: a. Species covered determined by the Secretary of the USDA and currently includes guinea pigs, hamsters, gerbils, rabbits, dogs, cats, nonhuman primates, marine mammals, farm animal species and warm-blooded wild animals. Rats, mice and birds not covered. b. USDA licensing, reporting and inspection requirements c. Animal Care and Use Committees

11 USDA Animal Welfare Regulations Detailed regulations defining the responsibilities of research facilities, the duties of IACUCs and specific standards for animal care including: a. Before scientists can use any animals, they must assure that any animal pain and distress is minimized, have considered alternatives to using animals, and that activities do not unnecessarily duplicate previous experiments b. Animal welfare standards for specific species include requirements for handling, housing, cage size, feeding, watering, sanitation, ventilation, temperature, humidity and veterinary care c. Must have plans for exercise of dogs d. Must have plans addressing the psychological well-being of nonhuman primates

12 Health Research Extension Act 1985 federal law that applies to all facilities that receive funding to conduct research from the federal government Different from Animal Welfare Act Based on Public Health Service policies that includes the NIH, FDA, CDC PHS grants or contracts can be suspended or revoked for noncompliance with this law

13 Voluntary Professional Standards Since 1965, scientific community has sponsored an independent, peer review accreditation program American Association for Accreditation of Laboratory Animal Care (AAALAC) Promotes highest standards of animal care Periodic inspection of research facilities that exceeds existing laws and regulations 670 research facilities have been approved

14 RESPONSIBILITIES OF AN ANIMAL CARE AND USE COMMITTEE 1985 amendment to AWA requires establishment of an Institutional Animal Care and Use Committee (IACUC) Committee oversees an organization s animal care and use program and reviews each proposed use of animals to assure compliance with federal law and regulations Must include a veterinarian and one person not associated with the organization

15 Responsibilities include: Inspect, at least once every 6 months, all animal facilities and review the condition of the animals to ensure compliance Prepare reports of IACUC evaluations and submit them to the appropriate individual in its organization Review and investigate legitimate concerns received from the public or employees involving the care and use of animals Review and approve proposed activities involving animals can withhold approval if projects do not meet federal criteria Suspend a research activity involving animals if necessary, take steps to correct the problem and report to the USDA

16 CRITERIA FOR IACUC APPROVAL OF RESEARCH In order for the IACUC to approve a research project involving animals, Committee members must be satisfied that the following federally established criteria have been or will be met: a. The research must be planned and performed in accordance with federal regulations and policies b. Pain or distress to research animals must be minimized. If pain or distress is involved, appropriate analgesics or anesthetics must be used c. Alternatives to procedures that will cause more than momentary or sight pain or distress must be considered d. Assurance that the research does not unnecessarily duplicate previous efforts must be provided

17 e. Individuals involved in activities using animals must be properly qualified and trained f. Living conditions must be appropriate for the species of animals used and contribute to the health and comfort of the animals g. If surgery is to be performed, it must meet requirements for sterile surgery and for pre- and post-operative care h. If the animal must be killed, the method of euthanasia must be consistent with USDA regulations