Internal: Animal Care and Use
FAQs and References

FAQs

Federal Regulations and Granting Agency Requirements

  • Animal Welfare Act 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 is enforced by the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.  The Animal Welfare Regulations require institutions to establish an IACUC.
  • Public Health Service Policy on Humane Care and Use of Laboratory Animals establishes guidelines for the proper care and treatment of animals used in research, and for the organization and operation of animal care committees. The law requires that the guidelines address appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia, and appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals. The requirements for reporting minority views of animal care committee members, for Animal Welfare Assurances, and for instruction or training in methods that limit the use of animals or limit animal distress, are all embodied in this Act. The PHS Policy implements the Health Research Extension Act of 1985 (Public Law 99-158).
  • Guide for the Care and Use of Laboratory Animals (8th Edition) is the primary reference on animal care and use. Its use is required in the United States by the Public Health Service Policy. The Guide was developed to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. The Guide is also intended to assist investigators in fulfilling their obligation to plan and conduct animal experiments in accord with the highest scientific, humane, and ethical principles.

Standards and Best Practice Guidebooks

  • AVMA Guidelines for the Euthanasia of Laboratory Animals: 2013 Edition The 2013 Edition of the AVMA Guidelines for the Euthanasia of Animals was recently revised and released.  The AVMA Guidelines are intended for use by members of the veterinary profession who carry out or oversee the euthanasia of animals. The overriding commitment of these Guidelines is to provide veterinarians guidance in relieving pain and suffering of animals that are to be euthanized. PHS-Assured institutions are required to use the 2013 Guidelines
  • Guide for the Care and Use of Agricultural Animals in Research and Teaching (FASS Ag Guide, 3rd edition) was published by the Federation of Animal Science Societies (FASS). The FASS Ag Guide serves as a primary reference document for meeting the needs and requirements of agricultural animals utilized in research and teaching.
  • Guidelines of the American Society of Mammalogists cover current professional techniques and regulations involving mammals used in research and teaching. Included are details on marking, housing, trapping, and collecting mammals. It is recommended that investigators use these guidelines as a resource for protocols involving wild mammals.

Additional References

  • Office of Laboratory Animal Welfare provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.
  • USDA APHIS Home Page is a multi-faceted Agency with a broad mission area that includes protecting and promoting U.S. agricultural health, regulating genetically engineered organisms, administering the Animal Welfare Act and carrying out wildlife damage management activities.
  • Animal Welfare Information Center is mandated by the Animal Welfare Act (AWA) to provide information for improved animal care and use in research, testing, teaching, and exhibition.
  • American Association of Laboratory Animal Science is an association of professionals that advances responsible laboratory animal care and use to benefit people and animals.
  • NIH Brochure – What Investigators Need to Know About the Use of Animals (rev. 04-2016)

Sample Size Calculations

Federal law, policy and U.S. Government Principle III mandate that investigators use the minimum number of animals necessary to obtain valid results. Therefore, the IACUC must review the number of animals requested in each protocol and agree that the number is appropriately justified in terms of the stated goals of the project. Section 3 of the IACUC protocol addresses this requirement.

“Section 3: Appropriateness of Animal Numbers. Provide the rationale for the number of animals requested and how the number of animals was determined to be appropriate. Whenever possible, the number of animals requested should be justified statistically.”

— In general, this means do a power analysis.
— Alternatively, if animal numbers to be used are based on previous work or publications, provide citations