ILAR 40 (1)

Introduction: Toward a coherent ethic of reserach involving laboratory animals. ILAR 40 (1): 001.
[Reviewer's Note - Any parts of this introductory article which recapped specific articles published in this ILAR issue were not reviewed as other LABSG members will be summarizing these articles for the LABSG list.] Biomedical ethics as a discipline has burgeoned during the second half of the 20th century. Biomedical ethics has become a part of philosophy departments, medical schools, and science departments throughout the US and western Europe. Dramatic advances in the biological sciences and growth of science-based technology have turned hypothetical problems into critical ones and have provided urgency in resolving old problems. Combined public and private funds support more than $40 billion worth of biomedical research each year. Problems facing bioethicists include: the abortion issue, moral propriety of fetal research, human in vitro fertilization, use of "fertility drugs," research involving cognitively impaired patients, manipulations of the human genome, "DO NOT RESUSCITATE" orders, management of intractable pain with life-threatening doses of palliative drugs, and HMO directives on health care. No issue except possibly the abortion question has generated more heated controversy than the appropriate use of laboratory animals. At one extreme, those opposed to animal use in research have used civil disobedience and violence to support their views. Nearly 80% of the public endorse the humane use of animals in research. Consequently, care and use of laboratory animals is among the most strictly regulated industries in the US. There is at present no widely accepted, comprehensive moral theory pertaining to research involving laboratory animals ethical theories pertaining to laboratory animals has lagged behind the development of human medical ethics.
What do the following acronyms stand for? AAR; AAVS; ABR; ALDF; ALF;
AAR = Attorneys for Animal Rights or Action for Animal Rights
AAVS = American Anti-Vivisection Society
ABR = Association for Biomedical Research
ALDF = Animal Legal Defense Fund
ALF = Animal Liberation Front; ALL = Animal Liberation League
APL = Animal Protection League
ARENA = Applied Research Ethics National Association
HSUS = Humane Society of the United States
PRIM&R = Public Responsibility in Medicine and Research.

 Roots of Concern with nonhuman animals in biomedical ethics. ILAR 40 (1): 003.
This paper attempts to explore the history of the movement to improve the treatment of animals. The American animal rights movement has its origins in the British antivivisection societies. Up until the mid-1800's, it was generally accepted that animals did not feel pain. Philosophers began to question that ("The question is not, can they reason? nor, can they talk? but can they suffer? - Bentham). Britian also had a long-standing tradition of keeping pets, and this may have utlimately led to the organized opposition to cruelty to animals.
Martin's Act (the Act to Prevent Cruel and Improper Treatment of Cattle) passed in 1822 and was the first British law to portect animals. Ultimately it covered dogs, bears, roosters, sheep, and bulls. The Royal Society for the Prevention of Cruelty to Animals was founded in 1824. The Cruelty to Animals Act of 1876 established requirements for investigators using animals in research. The Humanitarian League was formed in 1891 to encourage the participation of men in the animal cruelty debate. The Victorian era seems to have been particularly sensitive to the pain of others.
World War I brought medical advances that were due, in large part, to the use of animals. This slowed the force of the antivivisectionists.
America lagged behind some, similar laws were passed about 2 years after those in Britian. The ASPCA was formed in 1866. The years between WWI and the 1960's showed no progress for antivivisectionists. In the 1960's, the increased concern for the environment and writings such as "Animal Machines" and "Silent Springs" brought the concern for animals to the forefront. PETA and ALDF were founded in the 1980's.
Despite the changing philosophical environment, regulatory changes were catalyzed by a few, well-publicized cases of animal abuse. NIH and ILAR developed the Guide in 1963. 1966 saw the passage of the AWA. OPRR and PHS had little bite in the early 60's and 70's. This was due to the lack of central vivaria and veterinarians with authority over the programs. Where these factors were present, strong programs existed. Otherwise, things tended to be more disjointed and done however the researcher desired. The Silver Spring monkeys and University of Pennsylvannia Head Injury Clinic baboons were catalysts for change in OPRR's handling of animal research regulations.
1. What do the following stand for?
b. ALF
2. Which two high profile animal projects were catalysts for changes in animal research regulations?
1. a. People for the Ethical Treatment of Animals
b. Animal Liberation Front
c. Society for the Prevention of Cruelty to Animals
d. Office of Laboratory Animal Welfare (formerly OPRR)
2. Silver Springs Monkeys and U Penn's head injury studies.

 Bioethics, animal research and ethical theory. ILAR 40 (1): 015.
Overview of animal ethis - similar to "Roots of Concern"
Utilitarianism - an action is right if and only if it produces a better balance of benefits and harms than available alternative actions (looks at the consequences of our actions).
Speciesism - coined by Singer; humans cannot discriminate against animals, or privilege humans, merely because they belong to a particular species.
Deontology - insists that some actions may be right even if the consequences are not good, or as good as they could be, while other actions are ethically wrong even though they would produce good consequences (ie. lying to you even if it would make both of us happy). Also called Kantian theory or rights based theory.
No questions

 How and Why animals matter. ILAR 40 (1): 022.
This article is very difficult to relate to and understand as a scientist and veterinarian. Furthermore, I doubt that any of it could be applicable to board certification. It is a review of our encounters with animals and looks at 3 philosophers views of the human and animal relationship. The following is a digest version of the article and paraphrases the author (Donnelley). The views expressed are the authors and not my own. Abridged Summary: The Moral concerns for animals in laboratory research settings are not new. Fundamental moral issues of pain, suffering, distress, death, and respect have long been recognized by animal care and use committees and researchers who have acknowledged the importance of guidelines for laboratory animal care. Yet our basic attitudes and moral stances toward animals remain a crucial and ongoing issue, for these motivate our behavior and concern toward animals--how we follow guidelines and what standards are used. Animals matter to us within particular contexts of human interests, purposes, and concerns; frameworks of thought and action; and situations requiring moral judgment and response. These contexts are as numerous as the various opportunities for thought and action that involve both ourselves and animals. Holistic reflection about our interrelatedness with each other, with animals, and with nature is, understandably, absent from many of our somewhat provincial laboratory settings. Nevertheless, if we are to live morally coherent lives, we need a robust philosophy that persuasively interprets the dynamic whole in which humans, animals, and nature exist and interact. Animal Encounters In the Laboratory: Who or what is the animal (such as a mouse or frog) in laboratory research? First and foremost, it is an object of physiological or behavioral inquiry. It primarily "matters" because it is the practicing scientist's object of scientific curiosity. In the heat of scientific activity, the animal is essentially a physiological or behavioral system unconnected with the environing world. It is an isolated representative or model of physiological, behavioral, or animal (biological) existence. Animal Encounters in the Home: The situation described above changes significantly when the scientist or technician leaves the laboratory and goes home, where many of us encounter animals as pets. Encounters with domestic pets are very different from a scientist's involvements with laboratory animals. In the 2 contexts, the animals exist and matter for human beings in decidedly different ways, and the human actors are animated by dissimilar interests, feelings, and thoughts. Both the humans and the animals exist within different webs of human meanings and values. Central to the world of homes and families are the values of care, concern, and responsibility for one another; and pets fit integrally into this world. Thus, our feelings of concrete responsibility for the care of domestic pets are characteristically different than they are for laboratory animals. Animal Encounters in the Wild: In addition to human and animal experiences of a domestic nature, encounters with animals in the wild, outside the "human city," constitute other philosophically and ethically significant experiences. These encounters are particularly important because the animals again matter differently and play, or can play, a decidedly different role in determining the terms of the human experience and the particular context or web of meanings and values. Human interests and activities become more and more attuned to animals and animate being within the natural world. Philosophic Reflections: The philosophical reflections on animals in the wild that follow are intended to explore the question, Why do animals matter to us? Our reflections may enable us to take a moral stance that we, both as members of the human family and as researchers, can embrace. The reflections are derived, at least in part, from the thought of Charles Darwin, Aldo Leopold, Alfred North Whitehead, and Han Jonas. In a nutshell, Darwin's doctrine of evolution involves the evolution of all life and organic species from a common origin via genetic and behavioral variation and natural selection. Each individual organism is genetically and phenotypically unique, different from all the others. These fundamental themes of individuality, particularity, and diversity are the backbone of the evolutionary story. The patron saint of modem conservation ethics (protection of the natural environment), Aldo Leopold, is famous for his land ethic and for defining the human good and bad in terms of our impact on the "integrity, stability, and beauty" of the biotic community or the land. Earlier in the 20th century, Alfred North Whitehead made a similar philosophic and particularly telling move. Whitehead was particularly interested in what the reigning modern science and philosophy Whitehead rediscovered a significant, valuable, and meaningful nature--instances of life (including human and animal individuals) interconnected and aiming individually and collectively at particular worldly achievements and intensities of experience. From quite a different mood and philosophic perspective, Hans Jonas also revolted against the hegemony of modem materialist science. He found his way to a philosophy of organic life that philosophically, morally, and spiritually rehabilitated humans and nature and that served as a basis for envisioning important ethical responsibilities to the human and natural future. In a philosophic countermove similar to Whitehead's, Jonas denies that materialist science needs to turn philosophical and metaphysical and interpret reality according to its own partial and abstract conceptual scheme. Final Reflections of the Author: These Darwinian, naturalist, perspectives place laboratory animal research and its supporters in an interesting moral situation. Neither Leopold, Whitehead, nor Jonas opposes the use of animals for morally legitimate human purposes, including scientific research. Indeed, a Darwinian evolutionary and ecological nature lends powerful support for legitimate scientific uses of animals. These three philosophers of organic nature provide us with clues to understanding why either humans and animals are, taken together, morally significant, or neither humans nor animals have any significance. If we want to argue that laboratory animal research, which produces advances in human knowledge and benefits to both humans and animals, is a moral enterprise, then--assuming we wish to live morally coherent lives--we must treat laboratory animals with genuine concern, care, and respect. In short, by philosophically coming to appreciate that humans, animals, and nature are intricately interwoven in a single morally significant reality, we can begin to see the outlines of an overall moral outlook or perspective that comprehends or includes humans, animals, and nature. The task then becomes to judge and coordinate our relative obligations to humans, animals, nature, and their worldly future within this overall framework of moral thought.
1) Name 3 philosophers that have contributed theories on human-animal relationships?
2) Who was the scientist who revolutionized the origin of species?
3) What was the authors conclusion in this article?
1) Aldo Leopold, Alfred North Whitehead, Hans Jonas
2) Charles Darwin
3) Who knows?

 Community representatives and nonscientists on the IACUC: What difference should it make? ILAR 40 (1): 029.
Regulatory provisions for community members and non-scientists on the IACUC:
AWA (should represent general community values), Health Research Extension Act, PHS Policy. Other countries with similar requirements include Sweden, Germany, Denmark, Switzerland, and Australia.

Surveys have revealed that most laymembers are comfortable with their position, but that they are not effective (themselves or the IACUCs on which they serve) at improving the welfare of laboratory animals.

There is no meaningful guidance to lay members if the regulations are examined. The lay member often serves as a "constant reminder of the outside world" to whom the institution is responsible. The institution should do its part to ensure that its lay members are adequately educated.
1. List two other countries that require the use of a community member.
2. What is the purpose of the lay member(s)?
3. T/F Lay member(s) should be adequately trained.
1. Sweden, Germany, Denmark, Switzerland, Australia
2. Be representative (constant reminder) of outside world.
3. True

 US laws and norms related to laboratory animals. ILAR 40 (1): 034.
The laws, policies, guidelines, and practices pertaining to laboratory animal research in the United States are complex. The Animal Welfare Act (AWA) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) provide the basis for the laws related to the care and use of laboratory animals in the United States. Both of these regulatory documents are based on the Guide for the Care and Use of Laboratory Animals (Guide). The burden of responsibility is placed upon the institution to implement the performance standards in the Guide to comply with the standards that come with AAALAC accreditation. In addition, ILAR publishes periodicals to help define some of the laws and guidelines to help the institution provide a high-quality of animal care and humane use of animals in research.
Animal Welfare Act (AWA 9 CFR Subchapter A) The Laboratory Animal Welfare Act was passed in 1966 and initially covered only the care and transportation of animals and made provisions to prevent the sale of stolen animals. Since 1966, there have been several amendments that provide detailed protection for laboratory animals. The most recent amendment was passed in 1985. The provisions are now complex and cover not only the care and transportation of animals but also broad aspects of use and justification of the use of animals in research. The species subject to the AWA regulations are "any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes...." Laboratory-bred rats and mice and birds are currently exempted from the AWA regulations. One provision of the AWA is that each institution must have an institutional animal care and use committee (IACUC) and must have at least three members, including one laboratory animal veterinarian and one member who has no affiliation with the institution. The IACUC must approve all proposed experiments before they are initiated, review the institution's animal care and use program at least once every 6 months, inspect the animal facilities at least once every 6 months, and submit a report on each inspection to the responsible official. The US Department of Agriculture (USDA) Animal Plant Health Inspection Service/Animal Care (APHIS/AC) administers the AWA. Inspectors conduct unannounced inspections at least once a year. When minor violations of the AWA are found and cited, the institution has the opportunity to correct the problem within a reasonable time frame. However, major violations can lead to substantial fines and suspension of registration. USDA published a request for public comment in January 1999 regarding the regulation of rats, mice, and birds (Federal Register 1999).
PHS Policy (PL 99-158 Health Research Extension Act, 1785) Compliance with the PHS Policy and adherence to the standards in the Guide are conditions for eligibility of institutions to receive federal funding for animal research. The PHS Policy was issued in 1971, revised in 1986, and reprinted in 1996. The Policy is administered by the Office for Protection from Research Risks (OPRR) within the US Department of Health and Human Services (DHHS). The PHS Policy applies to all vertebrate animals and to all institutions that use vertebrates in research sponsored by the PHS. The National Institutes of Health (NIH) comprises one unit of the PHS and provides most of the federal funding for individual investigator-initiated biomedical research in the United States. Thus, PHS policy applies to most academic and research institutions that conduct biomedical research. One major mandate of PHS Policy is that institutions adhere to the provisions of the AWA, the Guide, and the US Government Principles. Other mandates include record-keeping requirements to ensure clear accountability for the quality of the animal care program and reporting requirements to enable oversight by federal funding agencies. PHS Policy establishes a "trust relationship" between OPRR and each institution receiving PHS funds. It requires these institutions to provide written assurance of compliance with PHS Policy and a detailed explanation of the programs and procedures in place to ensure that PHS Policy is enforced. This document is called an "institutional assurance." PHS inspections are conducted if an institution is suspected of improprieties. A severe and uncorrected violation of PHS Policy can result in revocation of the institutional assurance and loss of all PHS funding to the entire institution.
The Guide (National Research Council, 1996) The "Guide for the Care and Use of Laboratory Animals" is a consensus document reflecting the state of the art of scientifically based laboratory animal care and use. Produced by ILAR, the Guide was first published by the Animal Care Panel (predecessor of the American Association for Laboratory Animal Science) at the request of the NIH in 1963, prior to the AWA (1966) and the PHS Policy (1971). The Guide provides guidelines for scientifically; technically, and humanely appropriate animal care and use. The emphasis on guidelines rather than absolute standards is an important characteristic of the Guide. The 7th edition (1996) applies to all animals, including farm animals used in biomedical. One of the most controversial aspects of both the Guide and the AWA regulations is the emphasis on performance standards rather than engineering standards. Performance standards do not prescribe rigid methods for achieving an objective, but rather allow the use of professional judgment to develop optimal approaches for attaining specific goals or outcomes. A performance approach allows assessments of behavioral characteristics or physiological measures reflective of stress to be used in developing optimal physical environments for individual animals under specified research conditions. Implementation of the guidelines in the Guide is provided by the IACUC.
AAALAC International The Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) is a private nonprofit organization whose mission is to promote the highest standards of laboratory animal care. The qualifications for AAALAC International accreditation are stringent and depend on meeting the provisions of the AWA, PHS Policy, and the Guide. Each institution is evaluated every 3 years. Institutions are provided a reasonable period of time to correct any deficiencies that are detected. If deficiencies are not corrected in the requisite time period, an institution is placed on probation; and withdrawal of accreditation is the ultimate penalty. The AAALAC International program promotes high-quality care of laboratory animals in research and helps to standardize the norms of care among institutions.
ILAR The Institute for Laboratory Animal Research (ILAR) is a unit of the National Research Council of the National Academy of Sciences, a private nonprofit organization that exists to provide expert scientific advice to the government and to the public. ILAR's mission is to develop guidelines and to disseminate information on the "scientific, technological, and ethical use of animals and related biological resources in research, testing, and education". ILAR is responsible for preparing and distributing many documents in addition to the Guide. These include detailed guidelines for the care and use of specific species of laboratory animals. For example, Chimpanzees in Research: Strategies for Their Ethical Care, Management, and Use (1997), Occupational Health and Safety in the Care and Use of Research Animals (1997) and Psychological Well-Being of Nonhuman Primates (1998). Scientists, veterinarians, IACUC members, and AAALAC use such documents as adjuncts to the Guide.
1) Which species are covered by the Animal Welfare Act (9 CFR Subchapter A)?
a. Dog
b. Cat
c. Nonhuman primate
d. Guinea pig
e. Hamster
f. Rabbit
g. Rat
h. Mouse
i. Bird
2) According to the AWA, how many members comprise the IACUC?
3) T or F: Compliance with the AWA, PHS policy, and the Guide are conditions for institutions to receive federal funding for animal research?
4) Who enforces the PHS policy?
5) A written "institutional assurance" statement establishes a trust relationship between what 2 organizations?
a. OPRR and DHHS
b. OPRR and each institution
c. The principle investigator and NIH
6) AAALAC International reevaluates accredited institutions how often?
7) The Institute for Laboratory Animal Research is a unit of what organization?
8) What year was the Guide last published by ILAR?
1)a-f ,
2) At least 3 members,
3) T,
4) b,
5) b,
6) every 3 years,
7) NRC (of the NAS),
8) 1996