
IACUC Learning Module - Laws & Regulations | Previous |
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.IACUC FUNCTIONS REQUIRED BY FEDERAL 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).
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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:
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: The
basic needs of each species of animals;
On appropriate methods of animal care and use;
NIH
Library - Alternatives to Animal Research
a
seminar that guides researchers to resources that help address issues of
reduction, refinement, and replacement (the 3 Rs).
REQUIRED BY LAW IN TRAINING PROGRAM
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;
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.
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Last updated:
01/02/08
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