DFF: Animal Use

No animals are sacrificed by ____________. No animals are sacrificed in the ______________.

students; classroom

4. Report of the AVMA Panel on Euthanasia

The PHS Policy requires that euthanasia be conducted in a manner that is consistent with the professional guidance for relieving pain and suffering of animals found in the Report of the American Veterinary Medical Association (AVMA) Panel on Euthanasia (2000 Report).

II. REDUCTION Improved Statistical Design

The availability of low cost statistical packages for almost every computer on the market permits more and more investigators access to sophisticated data management and analysis. With this ability at their finger tips, investigators should be able to maximize the analysis of the data generated from each animal used, thus reducing the total numbers of animals necessary for a particular set of data.

III. REFINEMENT Decreased Invasiveness

A hallmark of most of the new diagnostic and therapeutic techniques used in human medicine is the minimal degree of invasiveness that is required to successfully perform a procedure to obtain a given set of data. In many instances these techniques are applicable in the research environment and can be adopted for use in animals. An example is the vascular access device which permits repeated samples or injections in a single animal instead of using several animals

The University of Iowa Program of Animal Care and Use Occupational Health and Safety

An effective occupational health and safety program must encompass all personnel that have contact with animals. The University Occupational Health program is adminstered by the University of Iowa Employee Health Clinic (General Hospital, Clinic A; 356-3631).

II. REDUCTION The four broad categories for reducing the number of animals used are:

Animal Sharing Improved Statistical Design Phylogenetic Reduction Better Quality Animals

II. REDUCTION Better Quality Animals

By choosing the best quality animal in terms of health status, the possibility that animals will be lost or data compromised by the intrusion of a concurrent disease condition is minimized, if not eliminated.

III. REFINEMENT Improved Instrumentation Analyzing Samples

Examples of decreasing sample size can be found in the commercially available diagnostic laboratory equipment which require only microliter blood samples to perform a variety of diagnostic tests. The use of smaller sample sizes permits the use of smaller animal species and prevents the need to euthanatize many of these species to obtain the necessary volume of blood.

ALTERNATIVE METHODOLOGIES

In the regulations promulgated to implement the Animal Welfare Act, the University of Iowa must provide assurances that the principal investigators considered alternatives techniques to painful procedures and to provide guidance concerning research, testing and teaching methods that limit the use of animals or minimize the animals' distress. Alternatives to refer to those techniques or methods that: replace the use of animals altogether, reduce the numbers of animals required, or refine an existing procedure or technique so as to minimize the level of stress/distress endured by the animal.

PROGRAM OF ANIMAL CARE AND USE The PHS Policy not only addresses the humane use of animals, but the entire institutional program of animal care and use. All programs are expected to include:

Institutional Official The Institutional Animal Care and Use Committee Animal Welfare Assurance Enforced Self-Regulation

ALTERNATIVE METHODOLOGIES 1. REPLACEMENT Use of other Living Systems Invertebrate Animals

Invertebrates are another type of living system which can be used to replace the more commonly used laboratory animals. An invertebrate which has long been used in biomedical research is the fruit fly, Drosophila melanogaster -- a classic model for the study of genetics.

The student may participate in a "hands-off" manner during an exercise involving animals by ___________ their lab partners actually perform the exercise, but by staying __________ in the normal give-and-take class discussion that occurs before, during and after the performance of the laboratory exercises.

Observing; active

ALTERNATIVE METHODOLOGIES 1. REPLACEMENT Use of other Living Systems Plants

Plants offer another alternative living system which can be used to replace animals in studies of basic molecular mechanisms.

3. Animal Welfare Regulations

The Animal Welfare Act (AWA) is the principal Federal statute governing the sale, handling, transport and use of animals. Compliance with the Animal Welfare Regulations, as applicable, is an absolute requirement of the PHS Policy. The AWA applies to all species of "warm blooded" vertebrate animals used for research, testing, or teaching, except farm animals used for agricultural research. The Animal Welfare Regulations that implement the AWA currently also exempt birds, rats of the genus Rattus, and mice of the genus Mus.

III. REFINEMENT Improved Control of Pain

The Animal Welfare Act requires "that the principal investigator consider alternatives to any procedure likely to produce pain or distress in an experimental animal" and in any practice which could cause pain to animals that a doctor of veterinary medicine is consulted in the planning of such procedures for the use of tranquilizers, analgesics and anesthetics.

III. REFINEMENT The Animal Welfare Information Center of The National Agricultural Library

The Animal Welfare Information Center (AWIC) was established to provide information to prevent unintended duplication of animal experimentation, minimize pain and distress to animals and promote the alternatives in animal research. http://www.nal.usda.gov/awic

1. Guide for the Care and Use of Laboratory Animals:

The Guide for the Care and Use of Laboratory Animals is a widely accepted primary reference on animal care and use. The seventh and latest edition of the Guide, published in 1996, was written under the auspices of the Institute for Laboratory Animal Research of the National Academy of Sciences. The Guide is intended to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. Included in the Guide are descriptions of institutional responsibilities and professional standards. Recommendations in the Guide are based on published data, scientific principles, expert opinion, and experience with methods and practices that are consistent with high-quality, humane animal care and use.

The University of Iowa Program of Animal Care and Use Suspension of Animal Activities

The IACUC is empowered to suspend a project if it finds violations of the PHS Policy, Guide, Assurance, or Animal Welfare Regulations.

PROGRAM OF ANIMAL CARE AND USE Enforced Self-Regulation

The PHS Policy is based on a concept of enforced self-regulation. This concept is described as enforced self-regulation because if the institution fails to self-regulate, the approval of the Assurance may be restricted or withdrawn by the NIH.

The University of Iowa Program of Animal Care and Use Reporting Animal Concerns at the University of Iowa

The humane care and use of animals is of paramount importance to the University of Iowa. Individuals who have specific concerns about the treatment of animals should report their observations to the chair, University Animal Care and Use Committee (c/o Program Assistant "Confidential", 400 Med Labs, 5-7985) for investigation. Individuals reporting concerns, should try to be as specific as possible and include the date, time, species involved. specific animal identification numbers, and the names of University personnel.

III. REFINEMENT Handling and Restraint of mice

The laboratory mouse is a docile animal and can be easily handled. When handling mice it is advisable to wear gloves to prevent the development of allergies due to direct contact with animal allergens. Mice are usually caught and lifted by the tail. The tail should be grasped between its midpoint and the mouse's body. The tail may be grasped with the thumb and forefinger or by the used of smooth-tipped forceps. With this simple method of holding, they may be transferred to another cage, a balance, identified, examined casually or sex may be determined.

ALTERNATIVE METHODOLOGIES 1. REPLACEMENT Use of other Living Systems Micro-Organisms

The micro-organisms represent a third system which has been used to replace traditional animal models. The Ames mutagenicity/carcinogenicity test uses Salmonella typhimurium cultures to screen compounds that formerly required the use of animals.

ALTERNATIVE METHODOLOGIES 1. REPLACEMENT Use of Computer Simulation

The standout in the alternative techniques controversy is the claim made for computer simulation as a means of virtually replacing the use of living animals. In order for a biological phenomena to be adapted to a computer model, the basic processes must be expressed in a mathematical formula. The key element for success is the generation of a program from the mathematical formula. The more complete the formula, the more useful the program. The problem is that many of the questions being asked of an animal model are not defined well enough to develop the necessary mathematical model.

ALTERNATIVE METHODOLOGIES 1. REPLACEMENT Alternatives which replace animal models can be classified into the following general categories:

Use of Computer Simulation Use of other Living Systems Use of Nonliving Systems

The student's grade will __________ depend on how well they can demonstrate that they understand and can apply the principles and concepts we are studying.

always

Students are _____________required to kill an animal.

never

Animals which are to be sacrificed are euthanized only by ___________ ___________ following regulations of the University of Iowa Institutional Animal Care and Use Committee, the American Veterinary Medical Association Panel on Euthanasia, and the Federal Public Health Service Policy on Humane Care of Laboratory Animals.

trained personnel

The student need not ________ or ___________ in any way (e.g., they don't have to remove the animal from a cage and hand it to the TA, or carry a cage into or from the prep room, etc.)

watch; participate

The University of Iowa Program of Animal Care and Use Animal Facilities and Husbandry

*animal housing: location, components, construction, management, and operation; *the physical and social environment of the animals; *animal husbandry: food, water, bedding, sanitation, waste disposal, and pest control; *animal identification, genetic monitoring, and animal health records; and *daily observation of and care for animals, including weekends and holidays.

The University of Iowa Program of Animal Care and Use Veterinary Care The veterinary care program provides the following:

*veterinary access to all animals and periodic assessment of animal well-being; *appropriate facilities, personnel, equipment, and services; *treatment of disease and injury, and availability of emergency, weekend and holiday care; *guidelines for animal procurement and transportation; *preventive medicine; *presurgical planning, training, monitoring, and postsurgical care; *relief of pain including choice of analgesics, anesthetics, and tranquilizers; *euthanasia; and drug storage and control.

PROGRAM OF ANIMAL CARE AND USE Animal Welfare Assurance

Before the PHS may award a grant or contract that involves the use of animals, the recipient institution and all performance sites involving or using animals must have on file with the National Institutes of Health (NIH) an approved Animal Welfare Assurance Document. The Assurance Document contains a commitment that the institution will comply with the PHS Policy, with the Guide for the Care and Use of Laboratory Animals, and with the AWA and the Animal Welfare Regulations, and includes a description of the institution's Program for Animal Care and Use.

III. REFINEMENT Refinement refers to techniques which reduce the pain and distress to which an animal is subjected. Such techniques can be classified into the following broad categories:

Decreased Invasiveness Improved Instrumentation Improved Control of Pain Improved Control of Techniques Handling and Restraint of mice

2. United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training The PHS Policy implements nine United States Government Principles that are the foundation for humane care and use of laboratory animals in this country. The principles are:

I. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act and other applicable Federal laws, guidelines, and policies. II. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society. III. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. IV. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals. V. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. VI. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure. VII. The living conditions of animals should be appropriate for their species and contribute to their health and comfort and must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. VIII. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals. IX. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

III. REFINEMENT Improved Instrumentation Monitoring Animals

Improved instrumentation can minimize animal distress by reducing the level of restraint and/or manipulation necessary to obtain biological samples.

The University of Iowa Program of Animal Care and Use Personnel Qualifications and Training

It is the responsibility of the institution to ensure that all personnel involved in animal care and use are appropriately qualified to perform their duties and conduct proposed activities. The PHS Policy explicitly requires that training includes research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress. The University has developed training resources under the guidance of the IACUC, the veterinary staff, and investigators using animals. Program content is governed by legal requirements and by specific scientific activities conducted at the institution. The resource consists of a website that has several modules that address specific species and issues concerning the use of laboratory animals. In addition, a number of self-instructive audiovisual materials and manuals are available. The Animal Care Unit library (400 ML) has numerous books and videos that cover all aspects of animal use.

III. REFINEMENT Improved Control of Techniques

Proficiency in the handling and restraint of animals makes it easier to perform a variety of routine procedures with minimal or no pain or distress to the animals involved. Animals are creatures of habit and when proper handling is part of their regular routine, the degree of distress caused by the procedures is minimized. Animals can be trained or conditioned to accept a variety of procedures which if suddenly forced upon them can be distressful. Almost every animal commonly used in the laboratory responds positively to a little tender loving care. It's inexpensive, readily portable, safe even at the highest doses and spreads rapidly through the staff.

II. REDUCTION Phylogenetic Reduction

Projects which can be designed to use one of the myriad of invertebrate species instead of a non-human primate species represent a type of phylogenetic reduction

II. REDUCTION Animal Sharing

Sharing of animals can significantly reduce the number of animals used within a given institution. Sharing is strongly encouraged by the IACUC committee

PROGRAM OF ANIMAL CARE AND USE Institutional Official

The Institutional Official is a formally designated senior official with the authority to administer the program of animal care and use. The Institutional Official at the University of Iowa is the Vice President for Research.

The University of Iowa Program of Animal Care and Use Addressing Animal Welfare Concerns

The IACUC has developed guidelines/procedures for handling allegations of mistreatment or noncompliance. The IACUC is cognizant of the rights of whistle blowers under the AWA, which prohibits discrimination against or reprisal for reporting violations of regulations or standards under the AWA.

The University of Iowa Program of Animal Care and Use Protocol Review

The IACUC oversees the specific use of animals by formally reviewing all proposed and on-going activities in both research and teaching protocols. The criteria that the IACUC considers in its review of protocols are delineated by the PHS Policy. These criteria must be applied before an animal activity begins, and at appropriate intervals, but at least once every three years.

PROGRAM OF ANIMAL CARE AND USE The Institutional Animal Care and Use Committee

The Institutional Animal Care and Use Committee, or IACUC, is a committee appointed by the Chief Executive Officer of the institution. The Institutional Official relies on the IACUC to oversee the program, to develop plans to correct program deficiencies, to address concerns that may arise regarding the institution's use of animals, and to make recommendations with regard to the program. The IACUC has certain federally mandated responsibilities, such as review of protocols and periodic evaluations of the program of animal care and use, including inspections of facilities

ALTERNATIVE METHODOLOGIES 1. REPLACEMENT Use of other Living Systems In Vitro Techniques:

The most commonly recognized nonanimal living systems are those which fall into the broad category of in vitro methods such as organ, tissue and cell culture. Commonly used in vitro methods are cell culture techniques for monoclonal antibody production, virus vaccine production, vaccine potency testing, screening for the cytopathic effects of various compounds.

ALTERNATIVE METHODOLOGIES 1. REPLACEMENT Use of Nonliving Systems Chemical Techniques

The most widely used nonliving model system involves the use of modern chemical techniques. This is particularly true of the analytical techniques which can be used to identify substances and to determine their concentration or potency. For instance, by adding a color marker to the Enzyme Linked Immunosorbent Assay system (ELISA), the whole process becomes a commercially available test kit such as those used in home pregnancy detection. A test that previously required the use of a rabbit now can be performed using an over-the-counter test kit.

ALTERNATIVE METHODOLOGIES 1. REPLACEMENT Use of Nonliving Systems Physical and/or Mechanical Systems

The use of physical and/or mechanical systems to replace living animals of even the highest order has application in teaching specific skills and/or reactions to a well defined set of predetermined circumstances. The use of computer-linked mannequins in teaching basic principles of medicine and applied techniques can be best illustrated by the mannequins used to train people in cardiopulmonary resuscitation.

The University of Iowa Program of Animal Care and Use Veterinary Care

The veterinary care program is provided by the Animal Care Unit (5-7985) and is staffed by three full time veterinarians and support staff.

If, for any reason, the student cannot participate in the lab exercise at all, they can __________ the classroom. Or, if they ______ their teaching assistant in advance, they can be _________ from attendance that day.

leave; notify; excused

The student's grade will ___________ depend in any way on whether or not they will kill an animal.

never

In all cases, the student remains ____________ for the material covered. The student ______ use any other resources to gain an understanding of the material. All students are required to demonstrate that they ______________ and can _________ the principles and concepts of physiology and metabolism that we are studying by taking quizzes and/or preparing written reports.

responsible; may; understand; apply;