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Animal Research Glossary

AA - Animal Amendment - Animal Amendment-PHS Policy (IV, B, 7) requires PIs to seek IACUC approval for significant protocol changes.  The purpose of an AA is to allow a PI to change an approved Animal Use Application.

AAALAC, International - Association for Assessment and Accreditation of Laboratory Animal Care International.  A voluntary accreditation organization that works with institutions and researchers to ensure high standards of animal care and use.

AALAS - American Association for Laboratory Animal Science.  A nonprofit membership association considered the premier forum for the exchange of information and expertise in the care and use of laboratory animals.  Offers certification for technicians in the field of laboratory animal science.

AVMA - American Veterinary Medical Association.  Parent organization for all veterinarians.

Animal - PHS Definition: Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.

Animal Assurance - The animal assurance describes the institution's program for the care and use of animals and is the basis for IACUC oversight.  No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with PHS Policy.

Animal Care Policies - Set of policies which apply the AWA/AWR to specific instances and provide clarification for applicability of specific mandates.

Animal Welfare Assurance Number - Number is A3102-01.  This number is assigned by the Office of Laboratory Animal Welfare (OLAW) once an institution's animal assurance application/renewal is approved.  This number should be referenced in all correspondence to OLAW.

AR - Annual Renewal - Principal Investigators are required to submit an Annual Renewal for active Animal Use Applications within 365 days from original approval date or latest annual renewal.  (Annual Renewals are performed in Year 1 and Year 2.  On the third year of a renewal, a 3 year de novo Renewal is required.  See 3 Year de novo Renewal.)

APHIS - Animal and Plant Health Inspection Service (USDA).  Division of USDA responsible for adminstering the Animal Welfare Act through the Animal Welfare Regulations.

AUA - Animal Use Application (formerly known as a protocol) is completed by an investigator and/or research staff and submitted to the IACUC for approval to use animals in research.  The AUA outlines research activity and justifies the appropriateness of the species, number of animals being used, location of the research activity, types of surgery involved, Laboratory Safety Committee intervention, and the level of pain and medication involved.  The AUA also identifies resources consulted to determine the proposed research is not a duplication or that lower vertebrate or non-animal alternatives are not available as well as the names of individuals associated with the research.  All animal research must be submitted to the IACUC via eBridge for review and approval before beginning any animal research activity.

AV - Attending Veterinarian, as defined in the AWR, is an individual who has received training or experience in the care and management of the species being attended and who has direct or delegated authority for activities involving animals.

AWA - Animal Welfare Act - The law by which the USDA regulates the use of all warm-blooded vertebrates in research except mice, rats and birds bred exclusively for research, cold-blooded animals, and farm animals used or intended for use as food or fiber.

AWRs (AWAR) - Animal Welfare Regulations (USDA) - Detailed regulations and standards for implementing the AWA, found in title 9 of the Code of Federal Regulations (9 CFR), Chapter 1, Subchapter A, Parts 1, 2, and 3.

Controlled Substances - Drugs that have the potential for physical addiction, psychological addiction and/or abuse.  Because of this potential, their possession and use are regulated under the Controlled Substance Act by the Drug Enforcement Administration (DEA) and State of Wisconsin Controlled Substances Board (CSB).

de novo - Anew.  Afresh.  Considering the matter anew, the same as if it had not been heard before as if no decision previously had been rendered.  Also, "again".  (See Three Year de novo Renewal)

DEA - Drug Enforcement Administration - Responsible for regulating the possession and use of controlled substances.  A DEA license is required in order to obtain controlled substances.

Environmental Enrichment - Altering the living environment of captive animals in order to provide opportunities to express more of their natural behavior.

FDA - Food and Drug Administration - Division of US Department of Health and Human Services that is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

FOIA - Freedom of Information Act - The federal law that applies to the AWA and PHS policy and that required federal agencies to release, upon FOIA requests, most of the official documents containing information pertaining to institutional animal care and use programs regulated by these agencies.

GLP - Good Laboratory Practice - A set of regulations that applies to animal and non-animal research and safety studies funded or reviewed by the FDA.  MCW is NOT a GLP-compliant facility.

Guide - The Guide for the Care and Use of Laboratory Animals - a booklet published by ILAR to help institutions address issues that concern the humane care, use and maintenance of laboratory animals. Compliance with this booklet is required by PHS Policy.

HREA - Health Research Extension Act - statutory authority for the PHS Policy on Humane Care and Use of Laboratory Animals.

IACUC -Institutional Animal Care and Use Committee - Committee mandated by the Health Research Extension Act (HREA) of 1985 and the AWA to perform semiannual program evaluations, animal facilities inspections and given authority to review and approve animal products.

ILAR - Institute of Laboratory Animal Welfare - An organization that provides institutional guidelines for the care and use of laboratory animals; a division of the National Research Council.

IBC - Institutional Biosafety Committee - Committee at MCW which has the responsibility to assure the safe use of recombinant DNA as outlined by NIH, to assure the safety of MCW personnel and others, and to limit the adverse environmental impact of biological agents utilized by researchers at MCW.

IO - Institutional Official - Person at an organization who has administrative and operational authority to commit institutional resources to ensure the animal care and use program complies with AWA and PHS Policy.

LAT - Laboratory Animal Technician - Level of certification offered by AALAS.

LATg - Laboratory Animal Technologist - Level of certification offered by AALAS.

Legacy Studies - Studies that were processed and approved by the IACUC before the eBridge system went into operation on October 22, 2007.

NIH - National Institutes of Health.

NHP - Nonhuman primate.

OHSP - Occupational Health and Safety Program.

OLAW - Office of Laboratory Animal Welfare -  The enforcement branch of NIH, which receives and reviews Animal Welfare Assurance Statements from institutions conducting research with animals.

PHS - Public Health Service - The federal agency which, in cooperation with the USDA, sets standards for the operation of laboratory animal facilities.

PHS Policy - Public Health Service Policy on Humane Care and Use of Laboratory Animals - A set of regulations covering the care and use of laboratory animals that is enforced by the PHS; all institutions receiving funds through the PHS are required to follow these guidelines.

Quorum - A simple majority of IACUC members.  A quorum must be present in order for the IACUC to vote on matters.

Three-Year de novo Renewal - PHS requires 3 year de novo review within three years from the original Animal Use Application approval date.  PI is required to update the complete Animal Use Application and submit for approval.  Once approved the Animal Use Application is approved for another three years. (See Annual Renewal)

USDA - United States Department of Agriculture - The federal agency responsible for administration and enforcement of the Animal Welfare Act.

Washout - The period of time that is allowed for an animal to excrete/metabolize an administered drug or a radioactive tracer/other hazardous agent before it is used again in the same study, entered into another study or released back into the colony for future use.

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