IACUC Learning Module - Laws & Regulations

IACUC Learning Module - Laws & Regulations

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Institutional Animal Care and Use Committee (IACUC)

Federal law requires each institution which uses animals for research or teaching to form an Institutional Animal Care and Use Committee (IACUC). The primary mission of the IACUC is to ensure that animals are used and cared for in a responsible manner and that all legal guidelines are observed.

IACUC FUNCTIONS REQUIRED BY FEDERAL LAW

  • A. Review and approve all activities involving animals
  • B. Inspect animal housing areas and laboratories (at least twice a year)
  • C. Insure adequate veterinary care and oversight
  • D. Keep records to verify compliance with all regulations
  • E. Supervise the training required by the law

IACUC members report directly to the official at the institution with authority for compliance (the institutional official for the University of Arizona is Dr. Leslie Tolbert, Vice President for Research & Graduate Studies).

Federal law protects the right of IACUC members to vote without threats of institutional retribution.

Under Public Health Service policy there is no maximum size limit though it does require at least 5 members.  Therefore, most IACUCs are composed of 5-15 people with diverse backgrounds. Although each IACUC is unique in composition, it is common to have biomedical scientists from various disciplines, philosophers, medical professionals, teachers, and persons active in local, humane associations.

Animal Welfare Act requires the IACUC to have at least three members: including a doctor of veterinary medicine, one member who is not affiliated with the institution (an "outside" member) and one scientist.

Generally, the IACUC does not pass judgment as to scientific merit (leaving that function to granting agencies); however, there is no way to dissociate responsible animal use from the question of "what constitutes good and necessary science". Certain proposals will entail pain and distress, if the scientific question being asked is to be answered. Although the veterinarian has many roles in research, their primary role on the IACUC is to suggest methods whereby pain and distress can be kept to the absolute minimum. The "outside" members are to represent the concerns of the general community. The "outside" members apply common sense to determine whether or not a specific project warrants the use of animals.

The research investigator should not view the IACUC as "just one more, meaningless, hurdle in the review process"; rather, the IACUC protects the scientist from unfounded criticism by performing an impartial review. Before a research or teaching project involving animals can begin, an investigator must submit to the IACUC a written proposal outlining the entire project. This written description is termed the "protocol."   Protocol forms can be found online at: http://www.iacuc.arizona.edu/iacucforms/. The IACUC is required by law to show that each investigator has adequately addressed specific questions and topics in the written protocol.

Items Investigator Must Complete for Adequate Protocol Review

  • list and describe training for all persons on project
  • explain the relevance of the proposal,
    USE LANGUAGE THAT A LAY PERSON WILL UNDERSTAND
  • explain why non-living systems can not be used for project
  • explain why the particular animal is the best species to use
  • explain how the literature search was conducted
    NAME of DATABASE, WHICH KEY WORDS, WHAT TIME PERIOD was SEARCHED?
  • explain how the requested number of animals was derived
  • provide a detailed description of experimental design, include how the data will be collected and analyzed
  • list the location for survival surgery (location must be appropriate for the species)
  • explain how pain and distress will be minimized
    DISCUSS TRAINING OF STAFF, PAIN RELIEVING DRUGS, ANIMAL CONDITIONING
  • if pain can not be alleviated, give scientific justification for withholding analgesic
  • explain how animals will be killed-method must be humane and approved by the American Veterinary Medical Association

The IACUC has the authority and the responsibility to suspend any activity which is not in compliance with Federal laws, or, which deviates from the approved protocol. Both the Federal Animal Welfare Act and the Public Health Service Policy require the IACUC to report any suspensions. The funding agency will then conduct their own investigation and may choose to withdraw funding from the project.

When an investigator needs to change any aspect of the approved protocol, they should send a brief memorandum to the IACUC in which the reasons for the changes are outlined or use the IACUC forms.  The amendment cannot be implemented until proof of IACUC review and approval is received. Please remember to write the IACUC and request to amend your protocol(s) when any person is added to or removed  from the research project(s).

Investigators MUST strictly observe all procedures as they are described in the approved protocol.  Institutions have received violations and fines when investigators have made relatively minor changes in their projects without IACUC approval for the amendments:

At least twice a year, the IACUC must inspect all housing areas and laboratories where animals are used. University Animal Care staff have been designated as official representatives of the IACUC and will also perform periodic inspections of areas where animals are used for teaching and research.

One additional responsibility of the IACUC is to supervise the training of all persons using or caring for animals. The laws are quite specific as to which topics must be covered. This take-home module on "Laws & Regulations" includes the required topics in the order in which they are written below:

REQUIRED BY LAW IN TRAINING PROGRAM

a)    It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties.  This responsibility shall be fulfilled in part through the provision of training and instruction to those personnel

b)    Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section.

c)     Training and instruction of personnel must include guidance in at least the following areas:

  1. Humane methods of animal maintenance and experimentation, including:

    The basic needs of each species of animals;
    Proper handling and care for the various species of animals used by the facility;
    Proper pre-procedural and post-procedural care of animals; and
    Aseptic surgical methods and procedures;

  2. The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress;
  3. Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility;
  4. Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility.  No facility employee, committee, member or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act;
  5. Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information:

    On appropriate methods of animal care and use;
    On alternatives to the use of live animals in research;
    That could prevent unintended and unnecessary duplication of research involving animals, and;
    Regarding the intent and requirements of the Act.


Suggested Link:  Federal and many private granting agencies require a database search for using alternatives to animals in research.  Up to now, the world of database searching for alternatives has been confusing and frustrating.  The National Library of Medicine, NIH has just made a search engine available that is very easy to use at: http://toxnet.nlm.nih.gov/altbib.htmlYou can search by keyword and/or category (e.g., carcinogenesis).  Bookmark this site and use it for your animal use protocol submissions to the IACUC!

NIH Library - Alternatives to Animal Research  a seminar that guides researchers to resources that help address issues of reduction, refinement, and replacement (the 3 R’s).


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Last updated: 01/02/08
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