Responsible Care and Use of Animals in Research and Teaching

Part 1

Objective

The objective of the Institutional Animal Care Training Program is to provide an understanding of the principles of humane and judicious use of laboratory animals and of the responsibility for their humane care.  Through this program, the HSC hopes to ensure that all administrators, faculty, staff, and students are actively involved in the humane care and use of research animals and that all personnel are aware of the issues involved in the use of animals in education, research, and training.  Institutional policies governing this program can be found in Appendix A.  All aspects of this training program are designed to promote compliance with Federal Law (the Animal Welfare Act), federal agency requirements (PHS, NIH Office of Laboratory Animal Welfare, and USDA) as well as accreditation standards of the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC).

Concept

The large number of UTHSCSA staff working with laboratory animals requires a systematic training program to ensure the humane care and use of such animals.  The program is designed to meet the needs of four separate categories of personnel: administrators, investigators and staff, Departmental Animal Research Officers, and the Department of Laboratory Animal Resources staff.  The program takes into consideration the experience, education, and previous training of personnel.  For convenience, the program defines four levels of training (I-IV), according to depth of information covered.

All personnel, regardless of experience, education, and training, are required to complete Level I, which involves reading the UTHSCSA "Responsible Care and Use of Animals in Research and Teaching" training booklet and completing questionnaires, watching the three videos titled "The New Research Environment” parts I & II and “Hazardous Communications:  Right to Know”, reviewing of the brochure on the “Occupational Health Program for Personnel with Laboratory Animal Contact,” and completing a Risk Assessment evaluation.   Level II of the training program includes issues pertaining to the animals to be used.  Levels III and IV delve more deeply into the care and use of research animals and are designed for personnel whose responsibilities require broad knowledge in this area.  Figure 1 illustrates the training program overview.

The Vice President for Research (IO), the Institutional Animal Care and Use Committee (IACUC), the Institutional Animal Care Program office (IACP), and the Department of Laboratory Animal Resources (LAR) provide technical and administrative oversight for this training program.  The "Responsible Care and Use of Animals in Research and Teaching" training booklet and the videos include self-administered documents to be kept on file in the Institutional Animal Care Program (IACP) office. 

Each Departmental Animal Research Officer is responsible for encouraging completion of the prescribed training.  Principal investigators are responsible for verifying that all persons working on a research project have completed the required training.

Figure 1:  Training Program Overview

Requirements
Personnel		Level I	Level II	Level III	Level IV
Administrators
Investigators & Staff
Departmental Animal Research Officers
Department of Laboratory Animal Resources Staff
Required Offered

Level	Content
I	Review of the ethics of using laboratory animals for research and teaching, and awareness of the occupational health and safety program.  Includes rules and regulations of NIH, AAALAC, the USDA, UTHSCSA policies, IACUC procedures and history of the animal welfare movement. Review of the “Responsible Care and Use of Animals in Research and Teaching” training booklet, completion of accompanying questionnaire. Viewing of the following three videos, completion of video cards:  #88-385 Hazardous Communications: The Right to Know #87-239 The New Research Environment #1: Animal Rights: The Threat to Research #87-240 New Research environment #2: The Animal Care and Use Committee, Common Procedures and Techniques, Survival Surgery, Review of the Occupational Health Program brochure, completion of the Risk Assessment evaluation, and occupational health program card
II	Review of the ethics of using laboratory animals for research and teaching, animal handling, animal welfare, occupational health and safety, and experimental procedures.  Includes rules and regulations of NIH, AAALAC, the USDA, UTHSCSA policies, IACUC procedures and history of the animal welfare movement. Completion of Level I Viewing of required videos that pertain to the actual species/manipulation being worked with, completion of video cards. Completion of lectures and/or demonstrations by LAR personnel.
III	In-depth training in issues dealing with the ethics of using a wide variety of laboratory animals for research and teaching; the animal rights movement; rules and regulations of the NIH, AAALAC and the USDA; UTHSCSA policies; IACUC procedures; occupational health and safety; protocol for monitoring departmental research involving animals; and methods of reporting. Completion of Level I Completion of Level II Orientation by the IACUC and written material provided
IV	This level is designed primarily to meet the training needs of the Department of Laboratory Animal Resources.  To provide general animal handling, animal welfare, occupational health and safety, sanitation, nutrition and all aspects appropriate to the specific job(s) to be performed.  Includes rules and regulations of NIH, AAALAC, AALAS and the USDA, UTHSCSA policies, IACUC procedures and history of the animal welfare movement.  The training program is reviewed and updated on a regular basis in accordance with the policies of AALAS and the USDA. Completion of Levels I, II, and III, or demonstrated proficiency In-depth training using the LAR training S.O.P.s In-depth training using the AALAS “Manual for Laboratory Animal Technicians” as a training guide.  Testing of all personnel by written and practical examinations Fully trained and certified to handle all types of laboratory animals with the goal of AALAS certification at the Assistant Level for all animal handlers.
Documentation of completion of training is on file in the IACP Office.

UTHSCSA Lines of Authority

Compliance of the institution's animal care program with the National Research Council Guide for the Care and Use of Laboratory Animals (Guide) and the Animal Welfare Act is assured through the reporting lines of authority shown in Figure 2.  Both the IACUC and the Director of Laboratory Animal Resources report directly to the Vice President for Research.  A concept unique to the HSC is that of the Departmental Animal Research Officers (DARO).  Each academic department has one or more DARO who is available to meet and consult with investigators and their staff.  Further information about the DARO program is in Appendix B.

The Department of Laboratory Animal Resources, as well as the IACUC, and the IACP office has the responsibility and authority to ensure institutional compliance with and accreditation by federal and other regulatory agencies. The assistance in ensuring compliance with federal, regulatory, and institutional standards is provided to help prevent problems that would not only jeopardize accreditation and future funding but would also likely affect the validity of research data.  The Director of LAR, and the veterinarians reporting to him/her, have the responsibility of reviewing all protocols submitted for review to the IACUC.  They also have the responsibility of recommending to the IACUC the cessation of research in progress.  Other responsibilities include assisting investigators and staff with all aspects of animal care and use as well as providing veterinary care to all animals used and housed at this institution.  LAR maintains a library of pamphlets, books, and reference lists and refers investigators to others on campus with experience in specific fields. 

Occupational Health Program

An integral part of the institution's animal care program is the Health Science Center's Occupational Health Program for Personnel with Laboratory Animal Contact.  This program, operated by the University Physicians Group, is designed to protect both HSC personnel and the laboratory animals.  All HSC personnel who work in laboratory animal facilities or who have contact with laboratory animals or animal tissue, should participate in this program.  Those working with nonhuman primates and random source animals are required to participate to protect the health of the animals and the staff.  The IACP office, 210-567-3718, can provide information on how to enroll in the program.  Or, you may contact the University Physicians Group at 210-592-0400 to enroll in the program.  Information about requirements of the occupational health program can be found in Appendix C.   A brochure on the program is available in the IACP office, Room 406L or via the Internet at http://research.uthscsa.edu/lap/domain/OHP-overview.asp.

Zoonotic Diseases

While there are many diseases that can be considered transmissible from animals to humans, in the laboratory setting one must also consider the risk of transmitting common human diseases to research animals.  At a minimum, there are 200+ diseases of varying levels of importance.  Since the scope of possible zoonotic infections is quite large, only specific examples will be described here.  Additional information is available in the brochure titled "Occupational Health Program for Personnel with Laboratory Animal Contact" available in the IACP office, room 406L.

When dealing with small animals, one should take precautions against such diseases as rabies, toxoplasmosis, lymphocytic choriomeningitis (LCM), and salmonellosis/ shigellosis, as well as ringworm and other dermatomycoses.  Parasites such as visceral larval migrans from dogs, some tapeworms from rats, and sarcoptic mange are also a risk to those handling infected animals.  Thorough sanitation and routine cleanliness are essential to prevent the possible spread of these and any Salmonella, Shigella, or mycotic organisms. The possibility of an infected caretaker spreading these to animals must be considered. 

Pregnant caretakers should not be exposed to possible toxoplasmosis infection by infected species (in particular, cats).  The risk of intrauterine toxoplasma infection exists and precautions should always be taken.  Since asymptomatic toxoplasma infection is common before child-bearing years, serological samples should be taken on all women handling high-risk species prior to beginning work to avoid confusion about the significance of positive antibody tests in case of subsequent pregnancy.  LCM, a murine neurological virus, has also been reported to be transmissible to humans; care must therefore be taken when handling infected species (e.g., hamsters, mice, etc.) as well as infected materials in the laboratory.

Dogs and cats must be vaccinated against rabies.  An exception is made for those animals used in acute experiments.  Students in general, however, are not allowed to use such unvaccinated animals, and faculty or staff doing so should be vaccinated.  All new animal caretakers are required to be vaccinated against rabies if they will be handling dogs and/or cats.  Investigators, students, and other staff that come in contact with these species should also consider vaccination.  Rabies can also be a threat in large animals, such as sheep and goats, as well as cattle and horses; blood-sucking bats can pose another serious risk of rabies.

Primate colonies run special zoonotic risks.  Measles can be transmitted from humans to primates, a particular concern for those with children at home.  Tuberculosis may be transmitted both from animals to humans and from humans to animals.  In all primate colonies, regular TB testing should be done of both the primates and the personnel exposed to them.  Common human viruses may also pose particular risks for a number of primate species.  Herpes B, which is carried by Old World primates, is the primate virus of most concern to people who handle these animals. 

Shigella and Salmonella enteritidis are quite common in primate species and precautions should be taken to prevent either human or primate cross-contamination.  Parasites such as Entamoeba histolytica can also be transferred to humans and provide further reason for careful hygiene after exposure to primate feces.

Unusual research species pose other risks.  Birds have diseases such as psittacosis and avian TB.  Mycotic organisms (histoplasmosis, aspergillosis) can be found in bird droppings and dander.  Only inspected and properly quarantined birds should be used in research studies or teaching demonstrations.  Erysipelas in pigs can be transmitted as a severe focal skin infection to humans, and pigs showing diagnostic lesions should be handled with care.  While erysipelas in swine is caused by an Erysipelothrix organism, erysipelas in humans is due to a streptococcal organism.  Erysipelothrix infection in humans is called "erysipeloid."  Similar appearing though less severe hand lesions are also seen after contacts with sheep and goats infected with contagious ecthyma, "Orf," and proliferative stomatitis.

Q fever, a serious human disease caused by the ricketsia Coxiella burnettii, was formerly quite common in slaughterhouse workers exposed to the tissues of freshly slaughtered cattle, sheep, and goats.  It is now known that the organism is shed abundantly in the placental membranes of sheep.  This route of exposure has been the cause of recent cases of Q fever pneumonia in laboratory workers.  Sheep to be used in reproductive studies or teaching should be titered for possible infection, and personnel working where exposure is possible should take extra precautions. 

Additional information is available through the UTHSCSA Laboratory Animal Programs web site:  http://research.uthscsa.edu/lap/domain/OHP-overview.asp.

In Conclusion

It is of utmost importance that all persons who work with animals fulfill the spirit of the rules and regulations regarding the care and use of animals as well as follow those rules and regulations in detail.  Of vital importance to the Health Science Center is the care and treatment of each laboratory animal, as well as the care and safety of each personnel who work with animals.  The mechanism for reporting animal misuse or abuse is found in Appendix A.

Please read the following pages carefully, respond to the enclosed questionnaire, and return both to the IACP office, 406L.

Acknowledgment

This program is an adaptation of the one developed by Annette P. Gendron-Fitzpatrick, D.V.M. and James A. Will, D.V.M., Ph.D., at the University of Wisconsin-Madison.

Figure 2
UTHSCSA Organizational Structure for the
Institutional Animal Care Program
as of 02/2006

Lines of Authority & Responsibility

Animal Welfare, Ethics and Alternative

Part 2

Development of our Present Animal Welfare Legislation

Animal welfare regulation is not a new concept; many laws enacted during the last century are still in effect.  These and others form the basis of our present legislation.  The most relevant steps in this progression are highlighted here.

1641:	First Anti-cruelty Law was American (Massachusetts Bay Colony).
1800s:	British Royal Society for the Prevention of Cruelty to Animals established. Royal Society started establishment of rules for humane experimentation. First Federal Law to Prevent Cruelty to Animals (known as the Twenty-Eight Hour Law).  This Act was a step forward in developing humane standards for the transportation of cattle, sheep, and swine.  In order to comply with the Act, transportation companies were obligated to provide facilities at convenient places on their lines where feed, water, and rest could be furnished no less frequently than at 28 hour intervals.  This act of 1873 was replaced by the present Twenty-Eight Hour Law in 1906. British Cruelty to Animals Act regulating animal experimentation enacted. The United States Congress was asked to enact legislation specifically requiring humane treatment of research animals. A bill with provisions roughly similar to the British Act of 1876 was proposed for the District of Columbia.  It was opposed by those agencies, which would have been regulated and was soon forgotten.
1900s:	First animal procurement law (also commonly called seizure, forced surrender, or pound laws) passed in Minnesota.  It required release to research institutions of impounded animals from humane society shelters and municipal pounds that received funds from local taxes. First case in which an experimental animal was given protection under a State anti-cruelty law occurred when the Massachusetts Society for Prevention of Cruelty to Animals successfully prosecuted a research scientist and animal caretaker for cruelty in maintaining and transporting experimental dogs while those dogs were outside of the institution's premises.
1960s:	First Federal Humane Slaughter Act; became effective on June 30, 1960. First edition of The Guide for the Care and Use of Laboratory Animals. The Animal Welfare Act (Public Law 89-544) was signed by President Johnson August 24, 1966.  This Act was the culmination of intensive efforts by many groups for federal legislation to regulate the use of laboratory animals.  This legislation: Established responsibilities for dealers of dogs and cats. Required the U.S. Department of Agriculture to establish standards for housing, feeding, watering, sanitation, ventilation, shelter, separation of species, and adequate veterinary care.
1970s:	Amendment to Animal Welfare Act, Public Law 91-579: Extends coverage to other species. Covers carnivals, zoos, and exhibitions. Covers animals during research. Experimental animals used in scientific institutions are specifically excluded from protective coverage of the anti-cruelty laws of Wisconsin. Amendment to Animal Welfare Act, Public Law 94-279, regulates commerce in order to: Insure that animals intended for use in research facilities, for exhibition purposes, or for use as pets are provided humane care and treatment. Assure the humane treatment of animals during transportation in commerce. Protect the owners of animals from the theft of their animals by preventing the sale or use of animals, which have been stolen. Make it unlawful for any person to take a dog or any animal across state lines or to other countries for use in animal fighting ventures. Food and Drug Administration established "Good Laboratory Practices."
1980s:	Update of PHS Administrative Manual, Chapters 1-43, "Animal Welfare", adds "Responsibility for care and use of animals" to the NIH policy and specifies that all species including domesticated (farm) animals are subject to the same high standards of care. Publication of the US Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, Research and Training. Health Research Extension Act of 1985, Public Law 99-158, "Animals in Research". National Institutes of Health publication of Public Health Service "Policy on Humane Care and Use of Laboratory Animals". The USDA published the Standards by which IACUCs are to administer the overall laboratory animal program.  This is known as 9 CFR Parts 1 and 2, and sets down in detail the type of program the USDA deems acceptable and the recordkeeping required.
1990s:	The USDA published guidelines for specific care of laboratory animals excluding dogs, cats and nonhuman primates.  This is known as 9 CFR Part 3, Standards, Subparts B, C, E, and F, and sets down in detail the animal husbandry the USDA deems acceptable and the recordkeeping required. The USDA published guidelines for specific care of dogs, cats and nonhuman primates.  This is known as 9 CFR Part 3, Standards, Subparts A and D, and sets down in detail the animal husbandry the USDA deems acceptable and the recordkeeping required. Throughout the 1990s USDA issued animal care policies to guide institutions in compliance with animal welfare regulations. The Guide for the Care and Use of Laboratory Animals was revised in 1996.
2000:	The component of the NIH Office for Protection of Research Risks governing the use of laboratory animals was elevated and renamed Office of Laboratory Animal Welfare. USDA guidelines for nonhuman primates, update version is currently in progress.

Philosophy of Animal Welfare Ethics

1. In 1909, the American philosopher John Dewey, in an essay entitled "The Ethics of Animal Experimentation", commented on the anti-science problems of his day.  His message is as true today as it was then:
   "It is not so long ago that a scientist in a laboratory was popularly regarded as a magician engaged in unlawful pursuits, about whom all sorts of detrimental stories were circulated and believed.  Those days have gone; generally speaking, the value of free scientific inquiry as an instrumentality of social progress and enlightenment is acknowledged.  At the same time, it is possible, by making irrelevant emotional appeals and obscuring the real issues, to galvanize into life something of the old spirit of misunderstanding, envy, and dread of science.  The point at issue in the subjection of animal experimentation to seek supervision and legislation is thus deeper than at first sight appears.  It behooves every thoughtful individual to be constantly on the alert against every revival of the spirit, in whatever guise it presents itself."
   
   
2. G. L. Van Hoosier's 1974 syllabus "Laboratory Animal Medicine":
   "Animals have been used extensively in medical research since the time of Pasteur because the basic principles of anatomy, physiology, medicine, and surgery are true for all animals including man.  Lower animals can be manipulated and controlled in ways that would be impossible or unethical for human beings.  Animals can be used in large numbers, are relatively inexpensive, and can be controlled with respect to genetic background, nutrition, environment, and previous exposure to pathogenic agents.  Animals have contributed to classical medical research including discoveries on the role of bacteria and viruses in disease production, development of vaccination, the use of anesthetics, and the discovery of circulation of blood.
   
   

   A few of those medical milestones are:  Circulation of blood in 1628 by William Harvey using fish, crabs, frogs, and dogs; Rabies immunization in 1885 by Louis Pasteur using dogs and rabbits; Transmission of malaria by mosquitoes in 1889 by Ronald Ross using birds; Insulin in 1921 by Banting and Best using dogs; Polio vaccine in 1954 by Jonas Salk using non-human primates; and Cardiac transplantation in 1967 by Christian Barnard using dogs. In spite of great advances made through research using animal subjects, some people oppose the use of animals in medical research on the basis that man does not have the right to inflict any kind of pain on any other being.  Others object to animal research because results cannot be reliably applied to the human situation.  The fact remains that information obtained by using animals is basic to understanding and curing human disease."

   
   
3. From "Ethical Constraints and Imperatives in Medical Research," M.B. Visscher, Ph.D., M.D. - American Lecture Series, 1975:
   "Ethics is obviously that aspect of mental activity which deals with what individuals and societies at large think that they ought to do.  What people think they ought to do depends, of course, on value systems.  This is where controversy enters.  A person who starts, as for example Albert Schweitzer did, with a value system that begins by asserting the theoretical equivalence of the value of all life, from the protista to man, and giving to the life of a mosquito or a daisy the same absolute value as to the life of a human, is bound to encounter a hard time in his logic.  Schweitzer did.  He spoke feelingly about never thoughtlessly crushing a flower or an earthworm, but he always ended up justifying the act of crushing countless plants and animals to meet a human need, provided that one always cut a field of grain, for example, with a conscious sense of remorse that it had to be done.  Likewise in his expressions about the sacrifice of lower animal life for medical research, he recognized the ethical propriety of such sacrifice but labored the need for conscious recognition that in each instance a judgment should be made.  His exact words were, 'Those who carry out scientific experiments with animals, in order to apply the knowledge gained to the alleviation of human ills, should never reassure themselves with the generality that their cruel acts serve a useful purpose.  In each individual case they must ask themselves whether there is a real necessity for imposing such a sacrifice upon a living creature.  They must try to reduce the suffering insofar as they are able.'  (Quote from Albert Schweitzer in The Teaching of Reverence for Life, 1965.)"
   
   
4. From Edward Carpenter's 1981 book entitled Animals and Ethics - A Report of the Working Party,:
   "There are basic guidelines respecting the dignity of the animal, which should govern the management of any animals managed by men.  These seek to ensure that no husbandry method will deny the environmental requirements of the basic behavioral needs of the animals."
   
   
5. The IACUC of The UTHSCSA supports the principles embodied in the Canadian Council on Animal Care "Ethics of Animal Experimentation," issued February 1986.  (See Appendix F.)

Alternatives to Animal Experimentation

Individuals and organizations representing a broad spectrum of opposition to the use of animals in research have grasped "alternatives to animals" as a catch phrase meaning anything from absolute to partial replacement of live animals in biomedical research and testing.

One of the principle difficulties with the subject of alternatives is semantics.  Andrew Rowan, Ph.D., formerly Associate Director, The Institute for the Study of Problem Animals, who has actively promoted the concept, defines the term to include "any technique which could preclude or replace the need for laboratory animals."  W.M.S. Russell and R.L. Burch promote their definition of alternatives as "the three Rs - replacement, reduction, and refinement" with special definition of each of those terms.  Carol Newton proposes a "3-S" principle - good science, good sense, and good sensibility.  Harry Roswell added his tenet of “the right animal for the right reason”.

The general public tends to use the Webster's Dictionary definition of alternative:  "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 create false impressions in the minds of the animal-loving public who 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, this is just not possible.

Earl H. Wood, MD, Past-President of the Federation of American Societies for Experimental Biology (FASEB) and an internationally known cardiologist, stated:

"Alternative methods to the use of animals in biomedical research are adjuncts, aids, shortcuts, or supplements which 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 technologies involved.  Alternative methods of research can and do help to 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 M. Loew, DVM, former Dean of The Tufts University School of Veterinary Medicine, states:

"The apparent 40% decrease in animal use, and the concurrent increase in the use of tissue culture and biotechnology seems to 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, immunologic diseases, human reproduction, and metabolic disorders, to name a few.  Particularly, advances in surgery, anesthesiology, environmental safety, drug safety, and nutrition emanate from studies of animals."

Robert Herndon, MD, University of Rochester Medical Center, states:

"For many years now, there has been a carefully planned, well-financed animal rights movement whose goal is the reduction and ultimately the elimination of the use of animals in research.  The closer a proposed therapy is to human use, the more likely it will require animal research.  Where feasible, appropriate alternatives are already used.  For example, 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."

Alternatives to animal experimentation most often suggested include:

1. Dummies.  These can be used as an alternative to dissection for teaching the structure of the animal body at the elementary level or teaching clinical medicine, but cannot replace actual dissection for the serious student.
   
   
2. Models and Computers.  Mechanical models for various physiological systems have been constructed and simple models for the heart and blood pressure have long been used.  Their primary limitation is their over-simplification of a complex biological situation.  Models of this kind tend to be superseded by computer models, films, videotapes, and other audio-visual techniques.  Computers can be used to predict properties of new drugs, in biomedical information retrieval systems, do laborious calculations on data, and analyze experimental data.  However, they cannot test the drugs produced.  This must be done on animals.  Computers manipulate data; they do not create it.
   
   
3. Audio-visual Aids.  Chalkboards, 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.
   
   
4. In-vitro Methods and Tissue Cultures.  In general, testing substances on in-vitro preparations can be done with far smaller quantities than carrying out tests in the entire animal.  While it is possible to vary the chemical composition of the media, temperature of incubation, mechanical agitation or lack thereof, you cannot include the interactions of enzymes, hormones, circulating body fluids, nerve impulses, and other factors present in the intact animal.
   
   
5. Lower Organisms.  Micro-organisms, plants, invertebrates, and eggs of birds and reptiles are often used as alternatives to warm-blooded animal use; however, their structures are usually less complex, with most studies eventually requiring the use of higher animals for the final work.  The Ames Test, for instance, is quite valuable but is limited by its invalidity for a large set of compounds.  It also presupposes that all mutagens are carcinogens, which is not yet a fully accepted fact.  This then requires further testing for many compounds.
   
   
6. Use of Fewer Animals.  This is an effective alternative that can be carried out in various ways.  Giving careful thought to experimental design, careful planning, and consultation with a biostatistician make it possible to plan experiments which derive the maximum amount of 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 waste 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.

Animal Welfare Organizations

Various organizations concern themselves with animal welfare and legislation.  During the course of your work and reading you may want to know more about these organizations and their support.  A partial list is provided in Appendix H.  Additional information is also available from the IACP office.

Responsible Care and Use of Laboratory Animals

Part 3

Introduction

The University of Texas Health Science Center at San Antonio, as an institution conducting research, teaching, and education using laboratory animals, adheres to Federal regulations as published in the Animal Welfare Act (AWA); the Guide for the Care and Use of Laboratory Animals (Guide); the Public Health Service Policy; and the U.S. Government Principles Regarding the Care and Use of Animals.  The University has a letter of assurance on file with the Public Health Service Policy, is registered as a research facility with the United States Department of Agriculture (USDA), and is certified by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).  The Assurance Statement to the NIH Office for Laboratory Animal Welfare (OLAW), certifies that this institution is following all current rules and regulations regarding the use of animals in research, teaching, and other activities. It also states that instruction is provided for all faculty, staff, students, and animal caretakers concerning the responsibilities incumbent on them when using animals.  The Health Science Center’s program for the humane care and use of laboratory animals involves four entities working together to ensure that the University remains in compliance with Federal and institutional guidelines and regulations and remains accredited by the regulatory agencies. The four entities are the Departmental Animal Research Officers (DARO), the Institutional Animal Care and Use Committee (IACUC), the Office of the Institutional Animal Care Program (IACP), and the Department of Laboratory Animal Resources (LAR).

The Institutional Animal Care Program office and Department of Laboratory Animal Resources maintain a library of pamphlets, books, and reference lists and are able to refer you to those people on campus with expertise in the fields that you may require.  LAR responsibilities include assisting campus investigators with all aspects of animal use and care as well as providing pathology services in the case of disease outbreak.  LAR's assistance in ensuring your compliance with federal and university standards is provided to help prevent problems that might affect the validity of research data.

The University offers several courses in which laboratory animals are an integral part of the curriculum.  Although students are encouraged to take advantage of every educational opportunity offered, they are not required to participate in manipulations involving laboratory animals.  Alternatives exercises may be substituted at the discretion of and in consultation with course director.

Definitions and policies

Analgesics - Drugs that produce insensibility to pain without loss of consciousness.

Anesthetics - Drugs or chemicals that produce sleep, relaxation, loss of sensation, or loss of reflex activity, or any combination of the four.

Animal - Any live vertebrate used or intended for use in research, experimentation, testing, training, or related purposes.  Although the Guide does not apply to cold-blooded animals and the Animal Welfare Act does not pertain to rats, mice, and birds (as of 11/2000), the Principles and Policy apply to all live vertebrate animals.  Furthermore, the UTHSCSA Assurance Statement includes all live animals.  Therefore, all animals used or housed at the Health Science Center or by UTHSCSA personnel receive equal consideration in protocol review and animal husbandry.

Animal Facility - Any and all buildings, rooms, areas, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation.  A satellite facility is any containment outside the core LAR facility in which animals are housed for more than 24 hours. Standards for the construction and use of housing, service, and surgical facilities should meet those described in the Guide or as otherwise required by the USDA regulations established under the terms of the Animal Welfare Act.

Animal Housing - Proper management of animal facilities is essential to the welfare of animals, validity of research data, and health and safety of the animal care staff.  The caging or housing system is one of the most important elements in the physical and social environment of research animals.  The veterinary staff can assist you in determining adequate housing.  Animals are not to be housed outside the LAR facility without the written permission of the IACUC.  Specific requirements are in the Guide and USDA regulations and must be adhered to by all research personnel. 

Animal Welfare Act - Public Law 89-544, 1966, amended in 1970, 1976, 1989, 1990, and 1991, contains provisions to prevent the sale or use of animals that have been stolen; prohibit animal fighting ventures; and ensure that animals used in research, for exhibition, or as pets receive humane care and treatment.  The law provides for regulating the transport, purchase, sale, housing, care, handling, and treatment of such animals.  Implementing regulations are published in the Code of Federal Regulations (CFR), Title 9, Subchapter A, Parts 1, 2, 3, and 4, and are administered by the U.S. Department of Agriculture.

Assurance Statement - The formal document submitted to the National Institutes of Health by the HSC fulfilling the requirements of PHS Policy.  See Appendix A for further information

Departmental Animal Research Officer (DARO) - Faculty member or senior research technician designated by the Department Chair and assigned the responsibility of insuring continuing compliance by departmental researchers with the Institutional regulations regarding animal care and use.  See Appendix B for further information.

Guide – National Research Council’s Guide for the Care and Use of Laboratory Animals, 1996 edition, or succeeding revised editions.  The care and use of laboratory animals at the HSC is in accordance with guidelines set forth in this document.

Identification of Animals - Accurate identification of laboratory animals is essential for proper facility management and accurate research data.  Methods of animal identification include collars, bands, plates, and tabs; colored stains; ear notches and tags; tattoos; freeze brands; and room, rack, and cage cards.  Consult with the veterinary staff regarding appropriate identification of your research animals.  Specific requirements, found in the Guide and the recently published USDA regulations, must be adhered to by all research staff.

Institutional Animal Care and Use Committee (IACUC) - A committee appointed by the president of the Health Science Center whose members are qualified by experience and expertise to ensure that the care and use of animals is appropriate and humane in accordance with the Public Health Service Policy and the Animal Welfare Act.

Policy - The Public Health Service Policy on Humane Care and Use of Laboratory Animals.  In a 1985 policy statement, the PHS endorsed the ‘Principles’ (see below).  The PHS Policy implements and supplements these principles.  (See Appendix E.)

Policy 12 – Consideration of Alternatives to Painful/Distressful Procedures. (See Appendix F.)

Principles - U.S. Government "Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training."  (See Appendix E.)

Proposal - Includes grant applications, contract proposals, or any other request for financial support.

Protocol - The HSC's internal "Application for the Use of Laboratory Animals " which must be completed and submitted to the IACUC before any work with animals commences.  Federal regulations require annual review of such activities.  A copy is available at the Institutional Animal Care Program office and through the Internet at http://research.uthscsa.edu/lap/domain/forms/applicationforuse.doc.

Public Health Service - The Public Health Service (PHS) includes the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA); the Centers for Disease Control (CDC); the Food and Drug Administration (FDA); the Health Resources and Services Administration (HRSA); the National Institutes of Health (NIH); and the Office of the Assistant Secretary for Health, Department of Health and Human Services (DHHS).

Rodent Disease Control - LAR is committed to providing an environment in which quality biomedical research can be conducted.  Many common murine pathogens alter, invalidate, or otherwise compromise data obtained from infected rodents.  To minimize any negative impact upon research being conducted, LAR has a rodent disease control program.  It is imperative that all personnel using rodents adhere to the guidelines established to protect the animals and the research being conducted.   Specifics on the program are included in Appendix H.

Tranquilizers - Substances used to reduce anxiety and tension without impairing mental awareness.

Transportation of Animals - Transportation of animals must be in accordance with applicable standards and regulations, especially those intended to reduce discomfort or stress to the animals, or spread of disease.  All animals are to be covered by non-transparent material when transported through the HSC.  See Appendix D for the complete UTHSCSA policy.

Responsibilities for the Institution's Laboratory Animal Care Programs

A. All Personnel (including faculty, staff, students, volunteers, visitors, and technicians) working with animals are responsible for:

1. Being certified for the appropriate research species and maintaining an awareness of the ethical considerations involved and a commitment to responsible animal use and care.
2. Completing the required training.
3. Reporting any infraction of the animal care and use regulations or mistreatment or misuse of research animals to the LAR staff or the IACP office (after hours to University Police).  The IACUC will investigate the matter and, if the complaint is valid, discuss with the investigator and department officials the steps needed to correct the situation.  (See Appendix A.)

B. The Principal Investigator is responsible for:

1. Consulting with the veterinary staff prior to formulating a research or teaching project involving animals.
2. Ensuring that all personnel involved in research or teaching projects are certified for the species used and are aware of the occupational health and safety program.
3. Making certain that all involved personnel are adequately trained to carry out the experimental and caretaking duties required to insure the humane use and care of all research animals.
4. Filing an "Application for the Use of Laboratory Animals" with the IACUC through the Institutional Animal Care Program office for all projects regardless of funding source. 
5. Completing the annual Progress Report on time in compliance with federal requirements for annual review of each project.
6. Receiving IACUC approval prior to beginning work involving laboratory animals.
7. Adhering to all recommendations or conditions placed upon their study by the veterinarians or the Committee.

C. The Academic Departments are responsible for:

1. Ensuring the responsible and humane use and care of all research animals used by personnel of that department.
2. Ensuring that all faculty, staff, students, volunteers, visitors, and technicians involved with animals in research and teaching are informed of the need for IACUC certification in the appropriate species prior to any animal use.
3. Ensuring that all animals used in the department are handled by certified personnel.  This includes recertification for use of a new species of animal.
4. Ensuring that all investigators file an "Application for the Use of Laboratory Animals" for every project undertaken regardless of the source of funding.

D. The Departmental Animal Research Officer is responsible for:

1. Providing assurance that the Department is in compliance with rules and regulations regarding the use of laboratory animals.
2. Providing information or referral for department personnel with regard to the humane care and use of animals, the Institutional Animal Care Training Program, and the Occupational Health Program.
3. Assisting the IACUC during inspections of the department’s research facilities.

E.      The Institutional Animal Care and Use Committee is responsible for*:

1. Assuring that the use of animals in research is in accordance with institutional and federal guidelines.
2. Assisting the faculty whose research endeavors involve animals.
3. Reviewing the care and treatment of animals in all areas of the HSC at least semiannually to assess compliance with institutional and federal standards.
4. Reviewing all "Applications for the Use of Laboratory Animals" and “IACUC Progress Reports”.
5. Reviewing and advising on all aspects of the University programs for animal care as needed, or at least on a semiannual basis.
   (*Note:  As defined by the President's charge to the IACUC.)

F.      The Institutional Animal Care Program Office is responsible for:

1. Providing administrative support to the IACUC.
2. Reviewing and processing all "Applications for the Use of Laboratory Animals” and “IACUC Progress Reports”.
3. Administering the Institutional Animal Care Training Program.
4. Filing the Assurance Statement with NIH.
5. Informing investigators and staff of changes in rules and regulations regarding the care and use of laboratory animals.
6. Administering the educational component of the Health Science Center’s “Occupational Health Program for Personnel with Laboratory Animal Contact”.
7. Managing monthly laboratory inspections.
8. Provide protocol operational instructions at scheduled LAR training classes.
9. IACUC compliance with federal and regulatory agency rules and regulations.

G.     Laboratory Animal Resources is responsible for:

1. Assuring the institution's compliance with the Animal Welfare Regulations and the Guide, and accreditation by Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) and the USDA.
2. Advising investigators and their staff on the humane care and use of animals in research and teaching projects.
3. Monitoring the health and well being of all laboratory animals and the animal care and housing facilities.
4. Providing seminars and courses to supplement other instructional materials.
5. Filing annual Animal Activity Forms with the USDA.
6. Assisting in the evaluation process of the "Application for the Use of Laboratory Animals."

Guidelines for the Humane Care and Use of Laboratory Animals

All research, teaching, and education conducted at the Health Science Center or by Health Science Center personnel involving the use of laboratory animals must adhere to the following:

1. All animals used for training, teaching, research, and any related activities by UTHSCSA faculty, staff, volunteers, visitors, and students in UTHSCSA facilities or elsewhere shall be used and cared for in accordance with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to the humane care and use of laboratory animals.
2. Experiments involving live, vertebrate animals and the procurement of tissues from live animals for research must be performed by, or under the immediate supervision of, a qualified biological, behavioral, or medical scientist.
3. The housing, care, and feeding of all experimental animals must be supervised by a properly qualified veterinarian or other scientist competent in such matters under the direction of the UTHSCSA’s Attending Veterinarian.
4. The research should be such as to yield fruitful results for the good of society and not random or unnecessary in nature.  Research projects should produce new information unavailable through other techniques.  The principal investigator should document in writing that the project is not unnecessarily duplicative of other studies.
5. The experiment should be based on knowledge of the disease or problem under study and so designed that the anticipated results will justify its performance.
6. Statistical analyses, mathematical models, or in-vitro biological systems should be used when appropriate to complement animal experiments and to reduce the numbers of animals used.
7. Animals used in survival surgery procedures (Class B2) must be provided all the care and attention given to a human patient, with written documentation that such care was given.  Surgery on large animals (rabbits and higher) must be conducted in the Experimental surgery facility, Room 128D.  Surgeries on smaller animals may be conducted in departmental labs; however, the aseptic techniques as described in the Guide must be followed.  The UTHSCSA Guidelines for Animal Care in Survival Surgery are in Appendix H.
8. Multiple survival surgeries on a single animal are discouraged by the Guide and not allowed at the UTHSCSA without prior approval from the IACUC.  In cases where research or instruction protocols require multiple survival surgeries, they may be permitted with approval of the IACUC based upon scientific justification and proper post-operative care designed to alleviate any post-operative pain or disability.
9. Post-experimental care of animals must be such as to minimize discomfort and the consequences of any disability resulting from the experiment in accordance with acceptable practices in veterinary medicine.
10. If it is necessary to euthanize an experimental animal, this must be accomplished in a humane manner, i.e., in such a way as to ensure immediate death in accordance with procedures approved by the IACUC.  No animal shall be discarded until death is certain.  The UTHSCSA adheres to the guidelines published in the "1996 Report of the AVMA Panel on Euthanasia", or latest revision.
11. Report incidents of abuse or misuse of laboratory animals to the LAR, IACP offices, or University Police.  See Appendix A.
    
    Regarding pain and distress in laboratory animals: 
    
    
12. Pain and suffering are not always obvious to the observer and signs can vary within species and across species.  In general, the following signs should suggest that an animal is not comfortable and may be suffering: depression, not eating or drinking, reluctance to move, crying or vocalizing, obvious wounds or discharges, or abnormal movements or behavior.  If any of these signs are observed, the animal should be examined and treated so as to eliminate the cause and any accompanying pain.
13. An UTHSCSA veterinary must be consulted during the design and development of any protocol, which has the potential to cause pain and distress to laboratory animals.
14. Experiments should be conducted so as to avoid all unnecessary suffering and injury to the animals.  Alternative procedures must be considered and implemented whenever possible.  Such consideration must be documented in writing by the principal investigator.
15. The scientist in charge of the experiment must be prepared to terminate it whenever he/she believes that its continuation may result in unnecessary injury or suffering to an animal, or when directed to terminate the experiment by the IACUC or attending veterinarian.  The UTHSCSA veterinarians are authorized to euthanize an animal believed to be in unnecessary pain and distress that cannot be alleviated.
16. If the experiment or procedure causes more than momentary or slight pain or distress, the animals must first be rendered incapable of perceiving pain and be maintained in that condition until the experiment or procedure is ended.  The only exception to this guideline should be in those cases where the use of anesthesia would defeat the purpose of the experiment and the necessary data cannot be obtained by any other humane procedure and IACUC approval has been granted.  Such procedures must be carefully supervised by the principal investigator or other qualified senior scientist.

Laboratory Animal Facilities and Health Management

The requirements for a laboratory animal facility are detailed in the Guide For the Care and Use of Laboratory Animals and the Animal Welfare Act.  All researchers should check with the veterinary staff for the requirements specific to the species being used.

Loss of animals to disease or trauma during an experiment and before its conclusion is not only costly, but may also affect the validity of the results of the experiment.  Good management is essential to prevent these losses.  Proper cage construction and selection along with careful attention to avoid overcrowding can minimize the risk of trauma.  Knowledge of proper grouping is also important both for effective breeding and avoiding stress-related influences on a study. 

Subclinical illness can be a major factor in biasing research results.  Careful feeding and nutrition coupled with sanitary care and appropriate vaccination can do much to prevent unnecessary illness.  New shipments of laboratory animals are carefully checked with appropriate serology, hematology, and parasitology examinations.  Those animals that that do not come from a pre-approved source must go through a quarantine and screening period prior to being released to the investigator.  A period of quarantine and conditioning is essential after receipt of a new animal, before it is made part of an experiment.  When dealing with non-experimental variations in an animal's normal environmental conditions, the researcher must ensure a gradual adjustment and be aware of additional stress factors that could precipitate serious illness or even death. 

In the case of a fatality either before or during the experiment, the animal should be submitted for necropsy.  Not only can this determine the cause of death, thus helping to assess the danger to the rest of the group, but often it may also provide information related to the experimental procedures themselves which may affect the results obtained.

Other aspects of management such as pest control and sterilization of cages, premises, and feeding utensils are necessary to ensure the good health of research animals.  All these measures permit the use of fewer animals which is not only economical, but also a demonstration of responsible use.

The Guide and the LAR veterinarians can provide specific information needed for each species.  Please consult these resources so that management problems do not interfere with research efforts.  Good management practices essential for good results include:

• Proper caging or housing specific for each species.
• Essential nutrition, feeding practices, and exercise.
• Vermin control.
• Sanitation and sterilization of cages, utensils, premises, etc.
• Appropriate vaccinations and preventive health care.
• Quarantine and conditioning programs.
• Trained animal caretakers.
• Veterinary supervision and consultation.

LAR personnel provide service to all animal research staff on the UTHSCSA campus.  Trained laboratory personnel perform routine serology, hematology, parasitology, microbiological, and viral examinations.  Pathology service is available with necropsies and histopathology performed by an ACVP certified veterinary pathologist.  Samples are accepted at the laboratory each workday and at other times by special arrangement.

At The UTHSCSA, veterinary care includes:

1. Programs of disease prevention and parasite control, euthanasia, and adequate veterinary care established and maintained under the supervision of the veterinarians.
2. A pest control program reviewed by the veterinarians for the safe use of materials and methods. 
3. Daily observation of all animals by a veterinarian or by someone working under his/her direct supervision.  Sick or diseased, stressed, injured, or lame animals are provided with veterinary care or humanely destroyed, unless such action is inconsistent with the research purposes for which the animal was obtained and is being held.
4. The appropriate use of anesthetic, analgesic, or tranquilizing drugs when such use is proper in the opinion of the attending veterinarian.  The use of these drugs is in accordance with the currently accepted veterinary medical practices as cited in appropriate professional journals or reference guides.  The use of those three classes of drugs must effectively minimize the pain and discomfort of the animals while under experimentation.  These drugs shall produce in the individual subject animal a high level of tranquilization, anesthesia, or analgesia consistent with the protocol or design of the experiment.  LAR provides guidelines and consultation to research personnel with respect to the type and amount of tranquilizers, anesthetics, or analgesics recommended as being appropriate for each species of animal used. 
5. Veterinarians who are graduates of approved colleges of veterinary medicine.

Appendices

 

Part 4

APPENDIX A

The University of Texas Health Science Center at San Antonio
Policy on the Humane Care and Use of Laboratory Animals

In accordance with federal rules and regulations, the University has provided an Assurance Statement to the Office for Laboratory Animal Welfare, National Institutes of Health, United States Public Health Service.  This report states that "The University of Texas Health Science Center at San Antonio ... will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals," and that "This assurance is applicable to all teaching, research, research training, experimentation, and biological testing and related training activities, ... involving live, vertebrate animals." 

The Institutional policy, as given in the Assurance Statement, states:

1. This institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
2. This institution is guided by the U.S. Government “Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" (Principles).
3. This institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance.  As partial fulfillment of this responsibility this institution will make a reasonable effort to ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance as well as all other applicable laws and regulations pertaining to animal care and use.

All animals used for teaching, training, and research, or any other activities by UTHSCSA personnel on this campus or elsewhere shall be used and cared for in accordance with this Assurance Statement.  In addition to guidelines as written in the Animal Welfare Act and the Principles, the HSC adheres to the principles set forth in the NIH Guide for the Care and Use of Laboratory Animals (Guide). 

As further demonstration of the institution's commitment to the humane care and use of animals, the HSC is accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).  Through a voluntary peer evaluation program, AAALAC provides "a mechanism for the accreditation of laboratory animal care and use programs which ensures a high regard for animal welfare and enhances the quality of scientific research that uses experimental animals."

As a major biomedical research and teaching institution, The University of Texas Health Science Center at San Antonio values its laboratory animals.  The UTHSCSA administration endorses the following training requirement included in the Amendments to the Animal Welfare Act (published 8/31/89):

"Training and instruction of personnel must include guidance in.  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."  [USDA 9 CFR Part 2, Subpart C, 2.32(c)(4)]

To comply with this requirement, the University has posted announcements in every laboratory in which animals are used throughout the school, on every official bulletin board, every departmental bulletin board, and throughout the Laboratory Animal Resources facility.  Any deficiencies or perceived deficiencies in animal care and treatment should be reported promptly to the LAR staff, the IACP staff, any DARO or departmental Chair, any IACUC member, or the University Police.  The identity of those filing reports will be kept confidential.  Reports of abuse or misuse of laboratory animals will be investigated immediately by the veterinarians, the IACUC, and, if necessary, the University Police.

APPENDIX B

Departmental Animal Research Officers

In 1986 the position of Departmental Animal Research Officer (DARO) was created to assist researchers in compliance with the requirements of the Guide and the Animal Welfare Act through peer review and guidance.  The DARO is appointed by and reports to the Department Chair.  To be prepared for this task, the DARO receives support and information from the Department of Laboratory Animal Resources, IACUC and IACP office as stated in the Guide, the Principles, and the Act. 

The DARO has two concerns:  the department’s faculty and staff, and the research animals.

• The central responsibility of the DARO is to provide documented assurance to the Chair that practices of department personnel, both faculty and staff, that relate to animal welfare are in accord with UTHSCSA, NIH, USDA, and AAALAC requirements.
• The DARO will provide consultation for faculty and staff in matters related to the care and use of animals in research, education and training.

The DARO is authorized to enter any and all laboratories in the department and give counsel on appropriate practices with regard to the care and use of animals.  The DARO will be present during the IACUC's inspection of departmental animal facilities to act as liaison between the Committee and the investigators.  The DARO will work together with the LAR veterinarians in assisting faculty should deficiencies be found during laboratory inspections.  Similarly, the DARO is expected to consult the Director of LAR or the IACUC to resolve any matters discovered during discussions with the department investigators.

In addition, the DARO will facilitate the administration of the training program and the Occupational Health Program by acting as a source of information about these subjects. 

A list of the DAROs assigned to the various departments is available at the IACP Office or through the Internet at http://research.uthscsa.edu/lap/domain/darolist.asp.

APPENDIX C

University of Texas Health Science Center at San Antonio
Occupational Health Program for Personnel with Laboratory Animal Contact

The University of Texas Health Science Center at San Antonio Occupational Health Program for Personnel with Laboratory Animal Contact is designed to meet the requirements of the NIH Guide for the Care and Use of Laboratory Animals and the University's commitment to providing a safe and healthful environment for its personnel.  While the University recognizes that health maintenance is primarily the responsibility of the individual, it also recognizes that there is a great benefit in contributing to the health of its personnel through an occupationally-oriented health program.  Toward this end, UTHSCSA offers personnel with laboratory animal contact this Occupational Health Program.

The categories of individuals would likely include LAR staff; investigators and laboratory assistants; and, on occasion, maintenance, physical plant, security, and housekeeping staff, as well as some students, consultants, and visitors.

The Occupational Health Program includes

• medical examinations,
• tuberculosis screenings,
• chest x-rays,
• rabies vaccinations,
• tetanus-diphtheria vaccinations, and
• medical evaluation and treatment. 
• Measles and other immunizations if indicated. 

The attached chart outlines the content and frequency of the examinations, immunizations, and tests offered in this program.  Examinations, immunizations, and tests will be performed by an Occupational Health physician from the University Physicians Group Occupational Medicine Program at the UPG Diagnostic Pavilion, 4647 Medical Drive.  Appointments can be arranged through the University Clinic at 592-0400.

While the University Physicians Group is responsible for administering the Occupational Health Program, the following will assist with identification of personnel to be included in the program:

Occupational Health Program
Requirements

PROCEDURE	101 RODENTS	101 RABBITS	101 DOGS	102 CATS	103 PRIMATES	102 LIVESTOCK	POLICE	+DLAR PERSONNEL
Banked Serum	O&O Q5yr	O&O Q5yr	R Q5yr	R q5yr	R Qyr	R q5yr	R Q5yr	R qyr
Tetanus/Diph Booster (TD)	O&O Q10yr	O&O Q10yr	O&O q10yr	O&O Q10yr	O&O q10yr	O&O q10yr	O&O Q10yr	R q10yr
TB Test (PPD)	O&O Q10yr	O&O Q10yr	O&O q10yr	O&O Q10yr	RPD R/6 mos.	O&O q10yr	R Qyr	R 6 mos.
Chest X-Ray	O&O	O&O	O&O	O&O	q1yr if PPD + or conv	O&O	Qyr if PPD +	q1yr if PPD + or conv
Pre-Employment Chest X-Ray	O&OE	O&OE	O&OE	O&OE	R unless PPD-	O&OE	O&O	R uneless PPD-
Pre-Exposure Rabies Prophyl	-	-	O&O	O&O	-	O&O	O&O	R done when hired
Rabies AB Follow-Up (Titer)	-	-	O&O	O&O	-	O&O	O&O	R q2yr
Pre-Placement History/Physical	O&O	O&O	O&O	O&O	O&O	O&O	O&O	R
Periodic History/Physical	O&O	O&O	O&O	O&O	O&O	O&O	Q2yr	R qyr
Blood Chemistry (SMAC)	O&O	O&O	O&O	O&O	O&O	O&O	Q2yr	R qyr
Audiogram	O&O	O&O	O&O	O&O	O&O	O&O	O&O	R Qyr
Pulmonary Function Test	Possible pre-placement and periodic when history of asthma or significant laboratory animal allergy is elicited.						O&O	R Qyr

Occupational Health Program for Personnel with Laboratory Animal Contact
Also includes an educational program on zoonotic diseases and aspects of biologic and radiation safety
+ DLAR personnel are exposed to all species
R - Required
O&O - Optional and offered
O&OE - Optional, offered upon employment.
Audiograms offered only for areas with high volume noise.

 

APPENDIX D

UTHSCSA
IACUC POLICY

TRANSPORTATION OF LABORATORY ANIMALS

Approved July 25,1986
Amended April 18, 1990
Amended March 22, 2000 

At no time should animals be transported between LAR and the various laboratory units by other than the following means.

It is essential that animals be transported in covered plastic, fiberglass, or metal (or any other material that can be sanitized) transport cages in order to avoid transmission of disease, an unsafe situation if the animal escapes, and soiling of hallways. These transport devices are also designed to minimize behavioral stress to the animal and potential physical injury due to excitement. Transport animals directly from their animal holding rooms at LAR to outside laboratories. Wherever possible, the route taken should minimize or eliminate use of areas frequented by the general public. Only those elevators designated for animal transportation will be used. The following elevators are NOT suitable for animal transport:

M4/M5 - the glass elevators by the Courtyard

M2 - the elevator located in the center of the Medical School building, and

D3 - the elevator by the Bookstore

Certain aspects of care in transportation are unique to various species and should be taken into consideration:

1. Rodents - transport in plastic cages either carried or on laboratory cart with the water bottle turned up. The micro barrier hood should remain in place on the cage. The cage should be covered with a dark sheet or similar, non-transparent material.
2. Rabbits - transport in large, enclosed plastic containers. These can either be hand carried or transported on a laboratory cart. The cage should be covered with a dark sheet or similar, non-transparent material.
3. Dogs and ungulates - transport in metal or fiberglass transport cages (either hand portable or rolling), not on leash.  The cage should be covered with a dark sheet or similar, non-transparent material.
4. Nonhuman primates - transport in hand portable or rolling metal cages.  The cage should be covered with a dark sheet or similar, non-transparent material.

The above requirements apply also to anesthetized animals.

Following euthanasia all animals are to be placed into appropriate size plastic bags for transport in cages to the refrigerated holding room.  No other color of bag should be used for this purpose.  Black plastic bags are available in General Stores.

One final request - if any "accidents" occur during transport, please clean up as you go.

 

Appendix E

Public Health Service Policy and
US Government Principles Regarding the Care and Use of Animals

 Public Health Service Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions was updated in 2000.  The PHS endorses the U.S. Government “Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Education”  (reprinted below).  The PHS Policy implements and supplements these Principles.  Information concerning the policy can be obtained from the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health, Building 31, Room 4B09, Bethesda, MD  20205.

US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training

The principles below were prepared by the Interagency Research Animal Committee, which was established in 1983 to serve as a focal point for federal agencies discussions of issues involving all animal species needed for biomedical research and testing.  The committee’s principal concerns are the conservation, use, care, and welfare of research animals.  Its responsibilities include information exchange, program coordination, and contributions to policy development.

“The development of knowledge necessary for the improvement of the health and well being of human as well as other animals requires in vivo experimentation with a wide variety of animal species.  Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered: and whenever these agencies actually perform or sponsor such procedures, the responsible institutional official shall ensure that these principles are adhered to:

1. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et seq.) and other applicable Federal laws, guidelines and policies¹.
   
   
2. 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.
   
   
3. 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.
   
   
4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound
   
   
5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia.  Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.
   
   
6. 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.
   
   
7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort.  Normally, the housing, feeding, and care of all animals used for biomedical purposes 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.  In any case, veterinary care shall be provided as indicated.
   
   
8. 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.
   
   
9. 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, with due regard to Principle II, by an appropriate review group such as an institutional animal research committee.  Such exceptions should not be made solely for the purposes of teaching or demonstration.

¹For guidance throughout these Principles the reader is referred to the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources of the National Research Council.

APPENDIX F

USDA Policy #12
CONSIDERATION OF ALTERNATIVES TO PAINFUL/DISTRESSFUL PROCEDURES
6/21/00

References: AWA Section 13(a)(3)(B), 9 CFR, Part 2, Section 2.31 (d)(1)(ii) and (e), 9 CFR, Part 2, Section 2.32 (c)(2) and (5)(ii), Animal Welfare Information Center

History: Provides guidance on the requirement to provide a written narrative of the consideration of alternatives to painful and distressful procedures. Replaces Policy #12 dated April 14, 1997.

Justification: The Animal Welfare Act (AWA) regulations require principal investigators to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and provide a written narrative of the methods used and sources consulted to determine the availability of alternatives, including refinements, reductions, and replacements.

----------

Policy:

Alternatives or alternative methods are generally regarded as those that incorporate some aspect of replacement, reduction, or refinement of animal use in pursuit of the minimization of animal pain and distress consistent with the goals of the research. These include methods that use non-animal systems or less sentient animal species to partially or fully replace animals (for example, the use of an in vitro or insect model to replace a mammalian model), methods that reduce the number of animals to the minimum required to obtain scientifically valid data, and methods that refine animal use by lessening or eliminating pain or distress and, thereby, enhancing animal well-being. Potential alternatives that do not allow the attainment of the goals of the research are not, by definition, alternatives.

A fundamental goal of the AWA and the accompanying regulations is the minimization of animal pain and distress via the consideration of alternatives and alternative methods. Toward this end, the regulations state that any proposed animal activity, or significant changes to an ongoing animal activity, must include:

1. a rationale for involving animals, the appropriateness of the species, and the number of animals to be used;
2. a description of procedures or methods designed to assure that discomfort and pain to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals;
3. a written narrative description of the methods and sources used to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals; and
4. the written assurance that the activities do not unnecessarily duplicate previous experiments.

We believe that the performance of a database search remains the most effective and efficient method for demonstrating compliance with the requirement to consider alternatives to painful/distressful procedures. However, in some circumstances (as in highly specialized fields of study), conferences, colloquia, subject expert consultants, or other sources may provide relevant and up-to-date information regarding alternatives in lieu of, or in addition to, a database search. When other sources are the primary means of considering alternatives, the Institutional Animal Care and Use Committee (IACUC) and the inspecting Veterinary Medical Officer should closely scrutinize the results. Sufficient documentation, such as the consultant's name and qualifications and the date and content of the consult, should be provided to the IACUC to demonstrate the expert's knowledge of the availability of alternatives in the specific field of study. For example, an immunologist cited as a subject expert may or may not possess expertise concerning alternatives to in vivo antibody production.

When a database search is the primary means of meeting this requirement, the narrative must, at a minimum, include:

1. the names of the databases searched;
2. the date the search was performed;
3. the period covered by the search; and
4. the key words and/or the search strategy used.

The Animal Welfare Information Center (AWIC) is an information service of the National Agricultural Library specifically established to provide information about alternatives. AWIC offers expertise in formulation of the search strategy and selection of key words and databases, access to unique databases, on- and off-site training of institute personnel in conducting effective alternatives searches, and is able to perform no-cost or low-cost electronic database searches. AWIC can be contacted at (301) 504-6212, via E-mail at awic@nal.usda.gov, or via its web site at http://www.nal.usda.gov/awic. Other excellent resources for assistance with alternative searches are available and may be equally acceptable.

Regardless of the alternatives sources(s) used, the written narrative should include adequate information for the IACUC to assess that a reasonable and good faith effort was made to determine the availability of alternatives or alternative methods. If a database search or other source identifies a bona fide alternative method (one that could be used to accomplish the goals of the animal use proposal), the written narrative should justify why this alternative was not used.

The written narrative for federally mandated animal testing (for example, testing product safety/efficacy/potency) needs only to include a citation of the appropriate government agency's regulation and guidance documents. Mandating agency guidelines should be consulted since they may provide alternatives (for example, refinements such as humane endpoints or replacements such as the Murine Local Lymph Node Assay) that are not included in the Code of Federal Regulations. If a mandating agency-accepted alternative is not used, the principal investigator should explain the reason in the written narrative.

Alternatives should be considered in the planning phase of the animal use proposal. When a proposal is modified during its performance, significant changes are subject to prior review by the IACUC, including the review of the implications of those changes concerning the availability of alternatives. Although additional attempts to identify alternatives or alternative methods are not required by Animal Care at the time of each annual review of the animal protocol, Animal Care would normally expect the principal investigator to reconsider alternatives at least once every 3 years, consistent with the triennial review requirements of the Public Health Service Policy (IV,C,5).

APPENDIX G

Ethics of Animal Experimentation

The UTHSCSA IACUC endorses these principles developed by the Canadian Council on Animal Care, the Canadian Federation of Humane Societies, scientists and other Canadians concerned with the humane treatment of animals.

1. The use of any animal for experimental purposes should only be considered after all efforts to seek an alternative have been exhausted¹, and should entail a continuing review of the pertinent literature.  Scientists should recognize the importance of sharing research data, methodology and experience.  Providing access to research information is a scientific responsibility.
2. Those using animals should recognize the need to use the best methods on the smallest number of appropriate animals required to obtain valid information².  Proposed experiments must be justifiable in terms of the declared objectives.  The experimental design must offer every practicable safeguard to the animal.
3. There must be reasonable expectation that studies involving animals will contribute significantly to knowledge, which may eventually lead to the protection and improvement of the health and welfare of either humans or animals.  Expert opinion must attest to this premise in particular before undertaking the following procedures, which are restricted:
   
   i. prey killing and fighting;
   ii. burns, freezing injuries, fractures, and other types of trauma investigation.  These require anesthesia during procedures, and must include acceptable veterinary practices for the relief of pain.
   
   
4. Animals are not to be subjected to unnecessary pain or distress.  Their physical and mental well being is paramount.
5. If pain or distress are necessary concomitants to the experimental study, these should be minimized both in intensity and duration.
   An informed assessment of the probable degree of pain and its duration is required, in order to relate these to acceptable, or unacceptable, limits.  Investigators, animal care committees, grant review committees and referees must be especially cautious in evaluating the proposed use of the following procedures:
   
   i. experiments involving withholding pre and post-operative pain-relieving medication;
   ii. paralyzing and immobilizing experiments where there is no reduction in the sensation of pain;
   iii. electric shock as negative reinforcement;
   iv. extreme environment conditions such as low or high temperatures, high humidity, modified atmospheres, etc., or sudden changes therein;
   v. stress and pain research.
   
   
6. An animal observed to be experiencing severe, unrelievable pain should immediately be humanely killed, using a method providing initial rapid unconsciousness.
7. Studies such as toxicological and biological testing, cancer research and infectious disease investigation may, in the past, have required continuation until the death of the animal.  However, in the face of distinct signs that such processes are causing irreversible pain or distress, alternative end points should be sought to satisfy both the requirements of the study and the needs of the animal.
8. In test procedures, cost and ease of application should not overrule the need to prevent pain and distress.
9. Experiments involving the withholding of food or water should entail only short-term deprivation and have no detrimental effect on the health of the animal.
10. Physical restraint should only be used after alternative procedures have been fully considered and found inadequate.  The method of restraint must provide the animal with the opportunity to assume as many of its normal postural adjustments and reactions as possible, and minimize physical discomfort and disturbed behavior.  Such an animal must receive exceptional care and attention, in compliance with species and general requirements as set forth in the Guide.
11. Painful experiments or multiple invasive procedures on an individual animal, solely for the instruction of students in the classroom or for the demonstration of established scientific knowledge in e.g. exhibits, conferences or seminars, cannot be justified.  As a replacement, audiovisual techniques should be employed to convey such information.
12. Acute (non-recovery) procedures involving animals anesthetized and insensitive to pain during an entire study are considered acceptable, as are studies, which involve no pain or distress.
13. The following experimental procedures are known to inflict excessive pain and are thus unacceptable:
    
    i. utilization of muscle relaxants or paralytics (curare and curare-like) alone, without anesthetics, during surgical procedures;
    ii. traumatizing procedures involving crushing, burning, striking or beating in unanesthetized animals.
14. The above principles should be applied in conjunction with those outlined in the "Guide to the Care and Use of Experimental Animals", as prepared and distributed by the Canadian Council on Animal Care.

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2. Rowsell HC, McWilliam AA.  The right animal for the right reason.  In:  Proc.  1978/79 CALAS Convention.  Canadian Association for Laboratory Animal Science, c/o Biosc