Responsible Conduct in Research Animal Welfare

U.S. Government Principle IV, 1985 Animal Welfare “Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative.” U.S. Government Principle IV, 1985 Animal Welfare Act The Animal Welfare Act was signed into law in 1966. It is the only Federal law in the United States that regulates the treatment of animals in research, exhibition, transport, and by dealers. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimum acceptable standard. The Act was amended six times (1970, 1976, 1985, 1990, 2002, 2007) and is enforced by the Animal and Plant Health Inspection Service (APHIS), USDA. Public Health Services (PHS) Principal Investigators are responsible for the scientific and technical aspects of a grant award and must ensure compliance with public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals when using live, vertebrate animals. PHS Policy incorporates U.S. Government Principles, the Guide for the Care and Use of Laboratory Animals and the Report of the American Veterinary Medical Association (AVMA) Panel on Euthanasia. The PHS vertebrate animal welfare is overseen by the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH).

Definition of “Animal” According to U.S. Code Title 7, Chapter 54: The term "animal" means any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warm-blooded animal, as the Secretary may determine is being used, or is intended for use, for research, testing, experimentation, or exhibition purposes, or as a pet; but such term excludes (1) birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research… However, OLAW requires institutional oversight of all research involving any live vertebrate animal, e.g. mice, dogs, horses, fish, reptiles, amphibians, and birds.

Animal Welfare in Research A simple principle to get one thinking about the issue of animal welfare in research is revolves around the 3 “R”s: Reduction--in the # of animals needed (must maintain an appropriate n for powering and significance). Refinement--of the research protocol to lessen the #’s and/or the pain and stress that the animals must experience. Replacement--of animal models with non-animal models.

INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE All institutions that “use” vertebrate animals for research and teaching are required to create an Institutional Animal Care and Use Committee (IACUC) to oversee and evaluate all aspects of the institution's animal care and use program.  The IACUC is a self-regulating body which derives its existence from : the Animal Welfare Act and its amendments, which are administered by the USDA through APHIS, and the Health Research Extension Act and its amendments, which are administered by the NIH through OLAW. The purpose of the IACUC is to oversee the provisions for the care and well-being of animals used for research and educational purposes.  Additionally, the IACUC is committed to serving the public by ensuring conformance to all legal and ethical standards regarding the use of animals in research.  IACUC Membership The IACUC must be comprised of at least five individuals, including: a veterinarian with program responsibilities, a scientist experienced in laboratory animal procedures, a non-scientist, and a non-affiliate (a person who has no other affiliation with the organization).

Field Research At the Cary Institute, most of the research and educational activities involving animals occur out in the field, i.e. away from the lab. As such, the IACUC must know where field studies will be located and what procedures will be involved. If the activity alters or influences the activities of the animal(s) that are being studied, the activity must be reviewed and approved by the IACUC (e.g. capture and release, banding). If the activity does not alter or influence the activity of the animal(s), review and approval is not often required (observational, photographs, collection of feces). Note: It is always good to contact the IACUC Institutional Official or Chairperson whenever you begin animal work to ensure that you are adhering to all the proper Federal and State regulations. Investigators are encouraged to consult relevant professional societies, available guidelines, wildlife biologists, and veterinarians, as applicable, in the design of the field studies. When capture, handling, confinement, transportation, anesthesia, euthanasia, or invasive procedures are involved, the IACUC must ensure compliance with the regulations and permit requirements of pertinent local, state, national, and international wildlife regulations.

Working with Animals Before anyone may take part in an IACUC-approved protocol at the Cary Institute, they must: Take the Safety Orientation offered by the Cary Institute Safety Officer Lau-rene Manuel, Have read and fully understood the IACUC-approved protocol, Have been properly trained by experienced Cary researcher/educators, and Recognize that respect for every animal’s welfare is an absolute in all related activities, and all reasonable effort should be made to ensure that this remains the case.

Summary IACUC approval is federally mandated for work with vertebrate animals. An IACUC is an Institute’s insurance that the scientists and educators are protecting the welfare of the animals in their research according to published standards of best practice. You must be prepared and properly trained to work with animals in a research or educational setting. As a scientist, ethical treatment of animals is vital to what you do!

Resources The Cary Institute’s link to Animal Welfare: http://www.caryintranet.org/content/compliance The Office of Laboratory Animal Welfare (OLAW) offers a tutorial on animal care, a topic index, and information on what you need to know about the use of animals in research: http://grants.nih.gov/grants/olaw/tutorial/index.htm http://grants.nih.gov/grants/olaw/olaw_topic_index.htm http://grants.nih.gov/grants/olaw/InvestigatorsNeed2Know.pdf The USDA APHIS site offers a wealth of information on animal welfare: http://www.aphis.usda.gov/animal_welfare/index.shtml

Certificate of Completion I certify that I have completed the RCR Training Module on: Animal Welfare Print Name Date Signature Please print out sign and return to Grants and Compliance Office Click to Print