Quality animal research as well as teaching requires the use of quality animals. Since the quality of the University of Wisconsin-Platteville animals is directly linked to the quality of those entrusted to use and care for them, all personnel who use and care for these animals are required to be certified.

As part of the University of Wisconsin-Platteville animal welfare assurance, the IACUC has provided a formally approved training program for all personnel involved with the use and care of research and teaching animals. The portion of the training which satisfies this requirement is the University of Wisconsin-Platteville Animal Certification Program. This document is your guide to successful completion of this certification process. This guide along with the Guide for the Care and Use of Laboratory Animals, Public Health Service Pol icy on Humane Care and Use of Laboratory Animals and Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching provides all the information necessary to successfully complete the enclosed certification examination. In addition to preparing you for the certification exam these guides provide you with the basic principles necessary to provide quality care to your research animals. Since guides provide only the basic principles, you are encouraged to utilize the Office of Sponsored Programs for support in planning, implementing, and conducting research using animals on this campus.

The Vice Chancellor acts on behalf of the Chancellor as the administrative head for animal care and use issues. The Vice Chancellor serves as spokesperson for the University on all animal care and use issues.

The University of Wisconsin-Platteville Institutional Animal C are and Use Committee membership is listed in Appendix A. IACUC has full responsibility for animal care and use oversight. They are responsible under the Animal Welfare Act and the Public Health Service Policy on Humane Care and Use of Laboratory Animals to assure the institution's compliance. IACUC must have at least five members. The membership must include: a Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated prog ram responsibility for activities involving animals at the institution; one practicing scientist experienced in research involving animals; one nonscientist; and one individual who is not affiliated with the institution except as a committee member, and is not related to any affiliate of the institution. The committee has the following important functions:

All personnel working with research and teaching animals for the University of Wisconsin-Platteville are required to be certified. This program is administered by the IACUC, and is coordinated with the animal care and use protocol review process to assure that everyone listed on any protocol is certified. The first step to certification is to request the certification packet from the Office of Sponsored Programs, 401 Karrmann, (phone 342-1456). T his packet includes the certification examination and all materials necessary for successful completion. The examination is open-book and you can use any resources available. The goal is to encourage you to read and understand the information provided, and to introduce you to the important resources available to you. You are encouraged to ask questions or provide comments to Office of Sponsored Programs, the IACUC, or the Vice Chancellor. Upon successful completion of the examination, your name is entered into the certification data base and you will receive a certificate of completion. Remember that all personnel working with animals must be certified. This includes students and technical staff.

Prior to initiation of any research or teaching which utilizes vertebrate animals, it is necessary to have an approved Animal Ca re and Use Protocol Review Form on file (Appendix B). These forms are available from the Office of Sponsored Programs either as hard copies or computer diskettes in IBM format. These forms are also available within the School of Agriculture and Biology Department.

Animal Care and Use Protocol Review Forms are supplied with two attachments. The first attachment is a cover page which has some helpful guidelines for filling out the form. The second attachment provides some suggested methods of e uthanasia for various species, plus the classification scheme for help in assigning an appropriate level of invasiveness to the proposed project. The review form is composed of four parts. Part one is the general portion, which is required for all projects involving vertebrate animals. Part two is required only on projects which involve surgical procedures. Part three is required only if you are using wild-caught animals, and part four is required only for projects involving non-human primates.

It is vitally important that these forms be completed thoroughly with close attention to detail. However, where you are unsure of specific details or want maximum flexibility, more general statements may suffice. It is also important to write them in lay terms as much as possible so all committee members and the public can understand them, and to show compassion and sensitivity toward any potential pain of discomfort which the animals may suffer. A well written, approved Animal Care and Use Protocol Review Form is your best insurance of being able to continue vital research and instruction without undue outside interferences. This document is most effective when it clearly shows your commitment to humane animal care and use.

Once you have a well written protocol review form prepared, make sure that you have all the appropriate signatures. These will include your department or director chairperson, the director or department chairperson where animals are to be h oused (if different from your own department), and the principal investigator. Make a copy for your file and submit the original to the IACUC Chairperson.

What happens next? Once the IACUC Chairperson receives the form, they will check it for completeness and accuracy, and then submit it to the IACUC for approval. A copy will forwarded to the Office of Sponsored Programs.

The reviewing committee will either a) approve as written, b) approve pending the receipt of additional information or cla rification, c) delay approval until additional information or clarification can be reviewed, d) require part or all of the proposal to be rewritten and resubmitted, or e) deny approval of the project.

After everything is approved, you will receive an approval letter and copies of any changes to your original document which occurred during the review process. Individual approval letters are addressed to all potential funding sources, and the principal investigator is responsible for forwarding t he letter(s) to these agencies. Approval letters are only valid if they have the IACUC chairperson's signature. Your original protocol and copies of approval pages and approval letters will be filed in the Office of Sponsored Programs.

Once you have an approved protocol, it is mandatory that all animals covered by this document be clearly identified and easily associated to the unique protocol number. If all animals in a room are assigned to a single protocol number, it is only necessary to h ave the number posted on the door to the room. Information as to treatment group(s) in the room, if different, should be provided at the cage or rack level. For example, if you have several treatment groups each on separate racks you can label the rack, but, if you have several treatment groups on the same rack, then each cage must be marked. Where there are animals from two or more protocols in the same room, appropriate numbers must be posted at the rack or individual cage level as appropriate.

Animals should not be procured without an approved protocol on file in the Office of Sponsored Programs. Investigators must not exceed the number of animals allowed by protocol in the specified approval period without further committee approval. Conducting research or teaching that utilizes animals without an approved protocol is strictly forbidden, and appropriate action will be taken by the IACUC(s). Remember, these acts could even result in revocation of your animal usage rights.

The Animal Care and Use Protocol is a dynamic document. Since the nature of research is discovery, it must be constantly open to changes in direction and the researcher must be as flexible as possible in the ability to guide these changes. On the surface, the Animal Care and Use Protocol may appear to im pede the researcher's ability to change or react to new discoveries. However, if prepared properly and maintained as an integral part of the research, this document can be a quick reference record of the progression of the research.

There are two types of changes to protocol review forms, administrative/minor and "significant." Administrative changes include any change which does not affect the direct animal work or change the scientific goals. These changes include personnel a) additions or deletions, b) changes in granting agencies, or c) project period, etc. Minor changes are those which add, delete, or modify non-invasive procedures (Category 1) on animals. These changes are best made by submitting an "Addendum to Protocol Use Form" labeled for administrative or minor changes (Appendix C).

"Significant" changes are those which add animal numbers, species, or invasive procedures (Categories 2-5). Under the Animal Welfare Act, any proposal to make a "significant" change in an ongoing activity involving animals must contain the following:

To assist you in keeping your protocol active and current, the Office of Sponsored Programs will send out reminders on an annual basis. These reminders will be either a request for an update of your protocol or a renewal request. To update, file any changes using the above methods. If there are no changes, return the updated form marked "no change". If you receive a renewal request, you must file a new Animal Care and Use Protocol Review Form. The existing protocol will expire and be removed from the files. If removed from the files, all animal-related work on that project must end.

Since pre-historic times humans have used other animals to satisfy their own needs. Evidence is bountiful of ancient and even modern day tribes utilizing animals for food, shelter, warmth, utensils, weapons, and tools. It appears that as long as people remain dependent upon animals to sustain their own lives, little controversy over their use exists. Also, the more dependent people are on animals the less misuse and waste occurs. It was only after agricultural societies developed, and societies of people became less dependent on animals that problems (real and perceived) of abuse and waste arose within those societies. Only after humankind started domesticating animals and developing special bonds with them did their treatment or use come under scrutiny and question.

Initially, protests and concerns raised were associated with prevention of cruelty. The first anti-cruelty law on this continent was enacted in 1641 by the Massachusetts Bay Col ony. The British Royal Society for the Prevention of Cruelty to Animals was established in 1802. However, it was not until 1870 that the Royal Society developed rules for humane experimentation with animals, and the British Cruelty to Animals Act which regulated animal experimentation was finally enacted in 1876.

While legislation was first introduced in the United States in 1880, it was not until 1966 that a law was enacted to regulate the use of laboratory animals (The Laboratory Anim al Welfare Act PL 89-544). Subsequently, this Act of 1966 has been amended three times, and it is now known as The Animal Welfare Act.

In 1975, Peter Singer changed the complexion of the battle against the abuse of animals being used by man by introducing a new agenda. With his book "Animal Liberation: A New 'Ethics' For Our Treatment of Animals," Singer introduced the idea of specieism. This new thinking ascribed equal "rights" to animals, and advocated that if man used animals in any way it was "specieism."

The shift from an animal "welfare" perspective to an animal "rights" perspective has profoundly affected the discussion over the use of animals in research. Animal rights advocates have very rapidly intensified their attack against biomedical research using animals not only on the basis of humane treatment, but through questioning whether animals should be used at all. While much of their argument still centers around how "scientists abuse animals," they have als o attacked research using animals as erroneous, too costly, unnecessary, too duplicative, and without real value. Currently the animal rights groups depend heavily upon animal "welfare" advocates to add the strength of numbers to their less popular held belief that animals have separate but equal rights as man, and therefore should not be used for any purpose. One clear strategy of the animal rights groups has been to infiltrate and take over animal welfare groups. To secure their posi tion and add credibility to their cause, they have masked their original agenda behind the above secondary arguments. However it is important for us to understand and expose their true agenda. Most clearly advocate cessation of all misuses of animals.

Since we have a controversy between two ethics, it seems important to define ethics. Ethics is a discipline within philosoph y concerned with the examination and establishment of criteria for making judgments concerning value (good and bad) and judgments concerning new responsibility and duty (right and wrong). Applied ethics is ethical reflection, as defined above, applied to a specific area of concern, e.g., the use of laboratory animals. Given these definitions we still need a conceptual framework for ethical decisions. The framework provides a method or formal structure for making decisions. The utilitarian ethical a pproach involves risk/benefit analysis where the best action is determined by the effects of the action in a particular circumstance or on the effects on all concerned (the social utility of the action). The deontological approach determines an action by comparison with a highest duty (e.g., respect for dignity, beneficence, justice) or with universal moral obligation derived from cultural or religious principles.

When one examines the arguments used by those advocating the humane use of animals for human purposes, it is apparent that the primary focus is utilitarian. However, some deontological arguments are also used. Researchers utilizing animals point to the benefits to health and welfare of humans and animals. They argue that research with animals has made possible the advancement of knowledge in the medical and veterinary sciences in ways that otherwise would not have been possible. Animal use advocates also argue that society accepts the idea of a hierarchy of species in its attitude to ward other animal species, and that humankind has the moral responsibility to enhance the well-being of other humans and also the moral duty to use wisely and prudently all resources that nature provides, including the use of animals for good purposes.

In contrast, the animal rights advocates argue almost exclusively from a deontological ethical approach. They argue that animals are intelligent and sentient beings, with feelings not unlike our own. That animals have inherent value and have a r ight to fulfill their destiny as independent beings, and as independent beings, they are "subjects-of-a-life," that is, they have desires and intentions that should be respected. They state that because animals have the capacity for suffering, humans have no rights to use them. Therefore, humankind has no right to exploit them for human purposes because this violates their integrity as separate species.

Unfortunately, the general public tends to use the dictionary definition of "alternative" which reads: "a choice between two or more things, only one of which may be chosen," or more simply, "instead of." The deliberations of philosophers with varying definitions of what they mean by "alternatives" also creates false impressions in the minds of the public, some of whom have come to believe that their interests and needs in research can be accomplished without any live animals being used. With the current state of the art, thi s is simply not possible and may never be. No computer model or tissue culture can react with the physiologic interdependence and subtle homeostasis of a living animal that is needed to probe many questions in biomedical research.

Earl Wood, past President of the Federation of American Societies for Experimental Biology and an internationally known cardiologist, has stated: "Alternative methods to the use of animals in biomedical research are only adjuncts, aids, shortcuts, or supplements whi ch help an investigator to decide whether an experiment on an animal is likely to produce a useful result. These adjuncts provide no substitutes. They cannot replace animals or humans in biomedical research and it would be unforgivable to represent that they can. They are useful in early feasibility studies and can help a scientist to determine whether he or she is headed in the right direction, but their uses are restricted by the limits of the technologies involved. Alternative methods of research can and do help reduce the numbers of animals required for research, but there is no way they can eliminate the need for animals in research and testing preliminary to testing in man."

Franklin Loew, D.V.M., Chairman of the National Research Council's Institute of Laboratory Animal Resources and Dean of Veterinary Medicine at Tufts University, has said: "The apparent 40% decrease in animal use, and the concurrent increase in the use of tissue culture and biotechnology seems t o indicate that, where scientifically valid, non-animal techniques are widely used. Economic considerations related to the costs of animals and their care, maintenance of animal space and equipment, and appropriate staff appear to be powerful and effective incentives for the conservative use of laboratory animals and the substitution of less costly approaches when scientifically valid. Nearly always, non-animal techniques are less expensive than those which employ animals. We hasten to add, however, that most fields of medicine and biology must rely in greater or lesser part on the study of a variety of animals in research into heart disease, cancer, genetic disorders, to name a few. Particularly, advances in surgery, anesthesiology, environmental safety, drug safety, and nutrition emanate from studies of animals."

Robert Herndon, M.D., of the University of Rochester Medical Center, adds: "The closer a proposed therapy is to human use, the more likely it will require animal research. Where feasible, some new drugs are designed on the basis of theoretical considerations, and initial testing carried out using techniques that do not involve the use of live animals. However, after the new compound has been produced, its toxicity, as well as its beneficial properties must be determined. No new drug can be used in patients until it has been extensively tested in animals. There is no reasonable alternative to such testing. Tissue culture, even extensive series of tissue cultures, cannot come close to mimicking the complexity of the interactions that occur in the intact animal. Few, I think, would advocate the alternative of testing in humans. Adequate alternative testing methods, if feasible, are at least decades away, not just around the corner."

Replacement of animals with insentient material of substitution of a lower species, which might be less sensitive to pain and distress, for a higher species may be acceptalbe insome cases.

Reduction in the number of animals used to obtain information of a certain amount and precision has been made more feasible with improved statistical methods. It is important that one always gives careful thought to experimental methods. It is important that one always gives careful thought to experimental design, plans carefully, and consults with a qualified biostatistician to assure experiments which provide the maximum information from the minimum number of animals. Statistical evaluation designed to provide the correct number of animals to be used may not always reduce the numbers in a given experiment, but by assigning the correct numbers to the original protocol one prevents the wastage involved in repeating a project due to inadequate numbers the first time around. Good animal management and healthy stock selection can also reduce numbers by preventing losses from illness or injury.

Refinement of existing procedures can sometimes result in a less severe trauma or distress in a laboratory animal. Such procedural changes include better anesthesia regimes, euthanasia of animals after surgery instead of allowing multiple surgeries, and utilizing more refined end points which reduces pain or distress in the animals. Refinements may increase the number of animals used in research as often as it allows reductions.

Models can be used in place of live animals to teach basic anatomy and demonstrate physiological systems. Model systems are limited and do not replace the need for actual dissection in all cases.

Computer simulations, films, and videotapes can be used to reduct the number of animals needed in both teaching and research. Computer models of biological systems are useful for searching through numerous parameters but aer only as good as the information (which is originally obtained from animals) that is put in. Caution should be exercised when using computer models, because they may oversimplify complex biological systems.

Audiovisual aids such as chalkboard, printed diagrams, slides, videotapes, and television are alternatives to repeated demonstrations on live animals. Many important techniques in animal experimentation are difficult to carry out; therefore, having these techniques recorded makes them available to a wider audience. Audiovisual aids, however, cannot replace the practical experience of tissue handling, blood collection, animal restraint, and other skills that are needed by those involved with animal research and teaching. The American Veterinary Medical Association and the American Physiology Society are two organizations which have a wide variety of videitapes available.

Tissue culture and other in vitro methods can be used for testing substances in much smaller quantities than testing in whold animals. While it is possible to vary the chemical composittion of the media, incubation temperature, and other parameters, in vitro testing lacks the interactions of enzymes, hormones, nerve impulses, antibodies, and other factors present only in the living animal. While early in vitro tests may be of great value, final tests must usually be done in animals.

Lower organisms such as microorganisims, plants, invertebrates, and eggs of birds and reptiles are often used as alternatives or adjuncts to warm-blooded animal use. However, their structures are usually much less complex, and complete studies eventually require the use of higher animals. The Ames test for carcinogenicity, for example, is quite valuable but is limited in its validity for a large set of compounds. It also presupposes that all mutagens are carcinogens, chich is not the reality. Hence, many compounds require further testing in animals also.