For IACUC Members
This bibliography may serve
as a guide to published and online material assisting non-affiliated
and affiliated members of IACUCs in their commitment to ensure
ethically and scientifically acceptable research protocols involving
- Animal Care Matters. 1993. Committee on Animal
Care, Massachusetts Institute of Technology (MIT). Available
from MIT, 37 Vassar Street 45-105, Cambridge, MA 02139.
- This 25 minute-videotape is designed to aid institutions
in providing effective education to animal research personnel.
Included are constructive discussions of the ethical and moral
issues concerning animal research, the role of laboratory personnel
for ensuring humane treatment and species-adequate housing of
research animals, applicable legislative and regulatory guidelines,
the responsibility of IACUCs, and alternatives to animals in
- Animals, Science, and Ethics. Donnelley S and Nolan K, eds. 1990. The
Hastings Center Report, Supplement May/June.
- Invaluable background information
addressing ethical theory and the moral status of animals, animals
in science, animal suffering and IACUCs.
- Animal Welfare Information Center Bulletin. Animal
Welfare Information Center, National Agricultural Library, USDA.
- A quarterly publication providing
"current information on animal welfare to investigators,
technicians, administrators, exhibitors and the public."
- Guide to the Care and Use of Experimental
Animals, Volume 1
(2nd Edition). Olfert ED,
Cross BM and McWilliam AA, eds. 1993. Canadian Council on Animal
Care. Ottawa, Ontario.
- Very thorough manual with a clear
discussion of relevant literature. Pertinent chapters: responsibility
for the care and use of experimental animals; laboratory animal
facilities; laboratory animal care; social and behavioral requirements
of experimental animals; restraint and manipulations; standards
for experimental animal surgery; control of animal pain in research,
teaching and testing; anesthesia; euthanasia; use of animals
in psychology; use of animals in neuroscience research; space
requirements; categories of invasiveness in animal experiments;
ethics of animal investigation.
- In the Name of Science: Issues
in Responsible Animal Experimentation. Orlans
FB. 1993. Oxford University Press. New York, NY.
- Comprehensive analysis of the
social, political, and ethical conflicts surrounding the use
of animals in scientific experiments. The author makes "recommendations
for policy changes that are achievable within the foreseeable
future and that would improve the lot of animals used for experimentation
without hampering the scientific process
A reasonable way
of looking at these issues is to ask the question. 'Can the harms
be reduced?' "
Laboratory Animal Science. 1987. 37 (Special Issue).
- "Case studies of ethical
dilemmas." Orlans FB, 59-64.
- Five cases based on actual situations
are discussed in depth to illustrate opportunities for the IACUC
to modify protocols to introduce more humane experimental design.
- "Reducing pain in laboratory
animals." Spinelli JS, 65-70.
- Terminology of pain is summarized;
simple but effective strategies for the control of pain are proposed.
- "Assessment of animal pain
in experimental animals." Soma LR, 71-77.
- The signs and behavioral changes
associated with acute and chronic pain in animals are clearly
described. Dr. Soma states, "When there is doubt, the bias
should be in favor of the animal."
- "Public concerns for animals
in research." Clark J, 120-121.
- The author highlights the fundamental
dilemma of regulated animal welfare: "If we want to protect
laboratory animals from neglect or abuse, we must insist on strong
laws that can be enforced."
- The Monkey Wars. Blum D. 1994. Oxford University Press. New
- A realistic picture of the scientific
and ethical dilemmas that accrue from biomedical and psychological
experimentation with animals, in particular with nonhuman primates.
Succinct discussions include the standpoints of extremists and
moderates and are based primarily on interviews with leading
primatologists and animal advocates across the US.
Back to Table
ANIMAL CARE AND USE COMMITTEES (IACUCs)
"Such members shall
possess sufficient ability to assess animal care, treatment, and
practices in experimental research as determined by the needs
of the research facility and shall represent society's concerns
regarding the welfare of animal subjects used at such facility."
animal protectionists to Institutional Animal Care and Use Committees."
Levin LA and Stephens ML.1994/95. Animal Welfare Information
Center Newsletter 5(4), 1-2 & 8-9.
- Authors "propose that animal research facilities,
as a show of good-will, voluntarily appoint individuals to their
IACUC who are recognized in the local community as advocates
for animals." The advantages and potential pitfalls are
- "The attending veterinarian
as an ally and leader of the IACUC?" Silverman J. 2000.
Lab Animal 29(10), 26-27.
- The role of the attending veterinarian (AV) is clearly
delineated as a moral and scientific leader of the IACUC who
must take an active part in the committee's work. "The veterinarian
can take an assertive yet non-confrontational role in helping
the IACUC ensure the proper care and use of research animals"
in the spirit of the 3 Rs, "preferring
not to use animals if efficacious alternatives are available." The AV needs job security,
i.e. tenure, since "fear of retribution can negatively affect
the AV's performance on the IACUC."
practices for animal care committees and animal use oversight."
DeHaven WR. 2002 ILAR Journal 43 (Supplement).
- There are many "best practices"
that can help the animal care committees (ACC) promote institutional
compliance and good animal welfare. These practices, although
not universally appropriate for all institutions or activities,
include ACC coordinator or administrator, designated protocol
reviewer, alternate or dual ACC members, generic protocols and
standard operating procedures, centralized controls and animal
care facilities, conducting pilot studies, and ensuring the most
- "A current perspective on the role and needs of IACUC
unaffiliated members." Mondschein SG 2007. Lab Animal 36(6),
- "The unaffiliated member, whose role on the Committee
is to represent the general public, is often a non-scientist
with little or no previous exposure to the concepts described
in the animal-use protocols he or she is charged with reviewing.
The author, himself an unaffiliated IACUC member, provides advice
- "Community members on animal review committees."
Orlans FB. 1993. In In the Name of Science: Issues in Responsible
Animal Experimentation. 99-117. Oxford University Press.
New York, NY.
- To be effective, community members "need to be able
to withstand role ambiguity and to deal with group pressures.
an ability to present a reasoned view with dignity
and without hostility to persons who do not agree with them.
They must be satisfied with having only moderate or minor impact
on the committee and seeing only occasional disapprovals of protocols.
Their overall impact of contributing balance and some measure
of public accountability to the proceedings must suffice. For
this, they must be prepared to devote a considerable amount of
topics for Animal Care Committees." 2007. ILAR [Institute
for Laboratory Animal Research] Journal 48 (1) Whole issue.
- Recent studies, new approaches,
and ethical challenges in animal research are presented.
- "Defining the animal care
and use program." Sandgren EP. 2005. Lab Animal 34(10),
- "An effective Animal Care
and Use program is critical to an institution's ability to ensure
that animal research is conducted humanely and follows all applicable
regulations and guidelines. The author provides a global view
of the key programmatic components, which can be used to improve
existing programs or implement new programs."
- "Do pressure and prejudice
influence the IACUC?" Silverman J. 1997. Lab Animal 26(5),
- "I believe that the disparity
of IACUCs being less rigorous in their deliberations when approving
a given number of mice versus the same number of dogs is the
more significant dilemma" [than the influence of the perceived
power of an investigator]. "IACUCs and laboratory animal
specialists must overcome any of our own prejudices and take
the lead in speaking out on behalf of animals, all animals."
- "Engaging the IACUC through
comprehensive training." Haywood JR, Greene M, James ML
and Bayne, K. 2005. Lab Animal 34(10), 33-37.
- "The IACUC is one of the
most important committees at a research institution and plays
a critical role in the success of an animal care and use program.
It is the responsibility of the institution to provide IACUC
members with adequate and appropriate training. The authors explore
various IACUC training options."
of animal welfare in research: The institution's attempt to achieve
appropriate social balance." Prentice ED, Zucker IH
and Jameton A. 1986. The Physiologist 29(2), 17 &
- Paper describes 14 ethical principles
governing research involving animals adopted by the University
of Nebraska Medical Center. These clearly stated principles serve
as the protocol review criteria employed by the IACUC.
- The IACUC Handbook. Silverman J, Suckow MA and Murthy
S, eds. 2nd ed. 2006. CRC Press. Boca Raton, FL.
- This practical guide for IACUC members uses a question-and-answer
format to address the problems and concerns often confronting
IACUCs. The book's chapters not only discuss the structure and
responsibilities of the IACUC, they also include such issues
as pain and distress, euthanasia, surgery, occupational health
and safety, laboratory animal enrichment, and animal mistreatment
and protocol noncompliance. The second edition features comprehensive
updates for all pertinent federal laws, regulations, and policies
and also contains an expanded survey of IACUC practices from
institutions around the nation.
Resources for Institutional Animal Care and Use Committees 1985-1999.
Allen T, ed. Revised 2000. AWIC Resource Series No. 7.
U.S. Department of Agriculture, National
Agricultural Library, Animal Welfare Information Center. Beltsville,
- Extensive resource. "This publication is divided
into 10 sections: Introduction to Animal Care and Use Committees;
U.S. Government Principles, Regulations, Policies and Guidelines;
Agency Directives for Federal Fund-holders; Professional Guidelines;
World Wide Web Resources; Articles and Bibliographies; Primary
References; Selected Software Providers; Organizations; and an
- Institutional Animal Care and Use Committee
Research Ethics National Association (ARENA); Office of Laboratory
Animal Welfare (OLAW). 2002. 2nd edition. National Institutes
of Health. Bethesda, MD.
- Information about authority,
composition and functions of IACUCs, issues, criteria, oversight
of animal care and use program, evaluation of animal welfare
concerns, record keeping and reporting, and special considerations
such as alternatives to the use of live animals, instructional
use of animals, farm animals, and legal concerns. Subject areas
covered in the second edition, but not the first, include the
following: IACUC operation and administration; training for IACUC
members; oversight of the animal care and use program; behavioral
management; emergency preparedness; breeding colonies and transgenic
Animal Care and Use Committees: A Comprehensive Resource of Online
Web site. Duffee N, Barnett
L, Cody C and Silver C. 2009*. AALAS. Memphis, TN.
- Useful links archive to resources
for IACUCs, organized by area of interest.
- Public Health Service Policy on Humane Care
and Use of Laboratory Animals.
Office of Laboratory Animal Welfare (OLAW). 1985. Rev. 1986;
- Functions of IACUCs as defined
by the Public Health Service policy are clearly outlined. Useful
on the PHS policy is offered.
- Public Health Service Policy
on Humane Care and Use of Laboratory Animals: Frequently
Asked Questions. OLAW.
- The purpose of the new page is to provide up-to-date guidance
for institutions and IACUCs to use in implementing the Public
Health Service Policy on Humane Care
and Use of Laboratory Animals (PHS Policy). Many of the answers
refer to guidance previously published as articles in journals
and magazines. The new FAQs provide guidance on the Freedom of
Information Act, post-approval monitoring, HVAC malfunctions
and failures, rodent cage density, and other issues not previously
addressed by OLAW.
of protocol reviews for animal research." Plous S and Herzog H. 2001. Science
293 (July), 608-609.
- "A random sample of 50 Institutional
Animal Care and Use Committees participated in a study of the
protocol review process. Each committee submitted three animal
behavior protocols it had recently reviewed, and these protocols
were reviewed a second time by another participating committee.
The result showed that approval decisions were statistically
unrelated. On most cases, proposals that were disapproved by
one committee were approved by the second committee. "All
told, 61% of  protocols were judged as either "not
very understandable" or "not understandable at all,"
as having "poor" research designs and procedures, or
as justifying the type and number of animals in a way that was
deemed "not very convincing" or "not convincing
for "Lay Members" of Ethics/Animal Care and Use Committees.
Web Site, RSPCA,
- Scientific research needs to
take place within a framework that allows for ongoing critical
evaluation of the ethical and welfare issues relating to the
use of animals. This includes consideration of the validity and
justification for using animals - the potential harms for animals,
likely benefits of the research and how these balance; experimental
design; implementation of the 3Rs; animal husbandry and care
and other related issues such as staff training.
- "The SCAW IACUC survey part
II: The unaffiliated member." Theran P. 1997. Lab Animal
- An interesting break down of
responses from 427 unaffiliated IACUC members. For example: 98%
felt able to fulfill their role on the committee; 31% felt their
committee was less than thorough to make sure that there is no
duplication; 29% indicated that their committee was less than
thorough to make sure that alternatives to live animals were
- "Should IACUCs review scientific merit of animal
research projects?" Mann MD and Prentice ED. 2004. Lab
Animal 33(1), 26-31.
- Whether IACUCs should review animal research protocols
for scientific merit is not addressed in the federal regulations,
resulting in ongoing confusion on the subject. The authors examine
this issue, discuss the pros and cons, suggest how IACUCs can
go about reviewing protocols for scientific merit, and question
what effect recent changes in regulations will have on this issue.
"Lawmakers and regulatory agencies expect the IACUC to serve
as a "gatekeeper" that ultimately ensures that research
involving animals is justified and humanely conducted."
- "A study of three IACUCs and their views of scientific
merit and alternatives." Graham K. 2002. Journal of Applied
Animal Welfare Science 5(1), 75-81.
- Three IACUCs were evaluated using a 19-question survey.
"Although 76% of members answered that scientific merit
should be more diligently assessed if more than slight pain is
caused, 14% believed that assessing scientific merit is not the
role of the IACUC. Nearly 86% agreed that the search for alternatives
should be more diligent for protocols that incur more than slight
pain to the animals involved. Some members believed that alternatives
were not actively enough sought after, while others believed
no viable alternatives existed."
- "Toward better unaffiliated
members: Goal of two unaffiliated members per IACUC offers advantages."
Liss C. 2000. Science and Animal Care 11(1), 1-4.
- "Outside members on IACUCs
have a very tough job. These lone representatives, unaffiliated
with the research institutions and unpaid for their services,
carry the responsibility of representing the community's concerns
for the welfare of the animals used for experimentation, teaching
Bringing in a second unaffiliated member (UM)
on the IACUC would relieve some of the pressure. If one of the
UMs is unable to attend a meeting, the other will be there thus
ensuring that an outside member is always present for committee
In addition, each of the UMs should bring an
unique perspective to the meetings."
- What Investigators Need to Know About the
Use of Animals.
- This brochure educates investigators
about their responsibilities under PHS Grants Policy and PHS
Policy. It describes the expectations and requirements when using
animals in research supported by the PHS.
- "What's wrong with the IACUC?"
Opinion. 2000. Lab Animal 29(10), 28-29.
- "IACUCs need an IACUC Chair
and members who are not concerned about promotion and tenure
issues being compromised by their IACUC role. IACUC members told
me they would never take serious action against other faculty
members because it would be taken against them during promotion
and tenure." Diane McClure.
Back to Table
REGULATIONS AND GUIDE
Related Documents and Articles
- ANIMAL WELFARE ACT & REGULATIONS:
Welfare Act as Amended. (7 USC, 2131-2156) Federal law.
- Chief federal animal protective
law, adopted in 1966 and amended in 1970, 1976, 1985, 1991 and
2002; sets minimum standards for the care and housing
of animals used in research, exhibition and the wholesale pet
trade; mandates principal investigators to consult with a veterinarian
and to consider alternatives before conducting any procedure
likely to produce pain or distress in an experimental animal;
requires semi-annual inspections by the IACUC and at least one
inspection per year by USDA; places the authority and control
of animal usage with the IACUC. Contains the 2002 Farm Bill amendments
to the Animal Welfare Act.
- 2. Code
of Federal Regulations, Title 9, Chapter 1, Subchapter A
- Animal Welfare. USDA. 2008.
- Regulations developed by the
USDA that specify how to comply with the Animal Welfare Act and
its amendments, divided into 4 sections: definitions, regulations,
standards and rules of practice. The bulk of the subchapter is
the third section that provides standards for specific
species or groups of species such as cats and dogs, guinea pigs
and hamsters, rabbits, nonhuman primates, marine mammals, and
the general category of "other warm-blooded animals."
Standards include those for facilities and operations, health
and husbandry systems, and transportation.
- 3. Animal
and Plant Health Inspection Animal Care Policy Manual. USDA. 1999-2000.
- "The Animal Care Policy
Manual further clarifies the intent of the Animal Welfare Act."
Policy and enforcement guidelines that determine many of the
actions that IACUCs must take as they inspect facilities and
The manual includes:
" USDA's AWA
Policy #11 -- Policy about painful/distressful procedures"
- April 14, 1997.
- "A painful procedure is
defined as any procedure that would reasonably be expected to
cause more than slight or momentary pain and/or distress in a
human being to which that procedure is applied. The Institutional
Animal Care and Use Committee (IACUC) is responsible for ensuring
that investigators have appropriately considered alternatives
to any procedures that may cause more than slight or momentary
pain or distress." Examples of such procedures are given.
- "USDA's AWA Policy #12 -- Consideration of alternatives
to painful/distressful procedures" June 21, 2000."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." Gives guidance on the requirement
to provide a written narrative, and search for alternatives.
- Guide for the Care and Use of Laboratory
Animals. Institute of Laboratory Animal Resources,
National Research Council. 1996. National Academy Press. Washington,
- Updated basic reference on housing,
handling and care of animals in scientific institutions and government
agencies. Includes US
Government Principles for the Utilization and Care of Vertebrate
Animals Used in Testing, Research, and Training.
- "Unless the contrary is
established, investigators should consider that procedures that
cause pain or distress in human beings may cause pain or distress
in other animals."
- Animal Welfare Act 1966-1996: Historical
Perspectives and Future Directions. Kreger M, Jensen D'A, and Allen T, eds.
1998. Proceedings of a symposium sponsored by the USDA, held
on September 12, 1996 in Riverdale, Maryland. WARDS (Working
for Animals in Research, Drugs, and Surgery). Vienna, VA.
- "This symposium takes a
retrospective look at the development and effectiveness of the
Federal animal welfare regulations since 1966. Leaders from government,
including those directly involved in writing the regulations
of the original act, industry, and humane groups offer their
views of the history and impact of the act and their visions
for its future."
"Animal Welfare Act Requirements for the minimization
of pain and distress." DeHaven WR. 1998. Pain Management
and Humane Endpoints. Johns Hopkins Center for Alternatives
to Animal Testing (CAAT) workshop.
- Clear explanation of policy No.
11 and 12 and the role of the IACUCs in implementing them.
Back to Table
"Ethics in our Western
world has hitherto been largely limited to the relations of man
to man. But that is a limited ethics. We need a boundless ethics
which will include the animals also." Albert Schweitzer
- Animals, Nature and Albert Schweitzer. Free
AC , ed. 1982. Animal Welfare Institute. Washington, DC. Available
from Animal Welfare Institute, PO Box 3650, Washington, DC 20007.
- A brief outline of Albert Schweitzer's
ethic of Reverence for Life. "Whenever an animal is somehow
forced into the service of men, every one of us must be concerned
for any suffering it bears on that account. No one of us may
permit any preventable pain to be inflicted, even though the
responsibility for the pain is not ours."
- "Beyond 'adequate veterinary
care'." Anchel M. 1976. Journal of the American Veterinary
Medical Association 168, 513-517.
- A very clear definition of the
laboratory animal veterinarian's professional and ethical obligations.
"The veterinarian must have the courage and it will require
courage to insist on standards that are absolute, and not relative
to the pressures within any institution."
- Cost of Caring: Recognizing Human Emotions
in the Care of Laboratory Animals. AALAS. 2001.
- "The human-animal bond in
the field of animal research exists in many forms. Kindness and
concern for animals are desirable characteristics in animal care
and research workers." Acknowledging feelings of grief or
bereavement at the death of animals used for research or teaching
and providing support in the workplace are important. "The
bond between people and animals in the laboratory can minimize
certain variables related to stress in the animals. The research
community can reap the benefits of these essential relationships."
- A Critical Look at Animal Experimentation. Kaufman,
SR, Cohen, MJ, Cramer M, Contard PC, Hahner K and Todd B. 1995.
Medical Research Modernization Committee, New York, NY.
- "The value of animal experimentation has been grossly
exaggerated by those with a vested economic interest in its preservation.
Because animal experimentation focuses on artificially created
pathology, involves confounding variables, and is undermined
by differences in human and nonhuman anatomy, physiology, and
pathology, it is an inherently unsound way to investigate human
disease processes. Billions of dollars invested annually in animal
research would be put to much more efficient, humane, and effective
use if redirected to clinical and epidemiological research and
public health programs."
- "Editorial: Caring for animals,
caring for ourselves." Spaeth GL. 1994. Ophthalmic Surgery
- "When we act uncaringly
toward experimental animals we become uncaring human beings.
What is the worth of medical miracle achieved at the cost of
inflicting trauma on others that cannot help but scar our own
aspects of relationships between humans and research animals."
Herzog H. 2002. ILAR [Institute for Laboratory Animal Research]
Journal 43(1), 27-32.
- "Ways that research institutions can help individuals
cope with the ethical consequences of relationships with research
animals include the following: supporting the development of
human-animal relationships in laboratories, giving animal care
personnel an ethical voice through involvement in the institutional
animal care and use committee decision process, publicly acknowledging
the emotional and moral costs of human-laboratory animal relationships,
and educating animal care staff about the purpose and possible
benefits of research projects."
- "Ethical consideration in
toxicology." Zbinden G. 1985. Food and Chemical Toxicology
- "Toxicologists must realize
that their important mission ... does not give them an unconditional
license to kill as many laboratory animals as they wish and to
hide behind regulatory requirements, testing guidelines and bureaucratic
prescriptions for good laboratory practice."
- "Ethical decisions concerning animal biotechnology:
what is the role of animal welfare science?" Olsson IAS
and Sandoe P. 2004. Science in the Service of Animal Welfare.
Kirkwood JK, Roberts EA and Vickery S, eds. Proceedings of the
UFAW International Symposium, Edinburgh, 2-4 April 2003. Animal
Welfare 13: S139-144.
- "In this paper we discuss the role of animal welfare
science in aiding ethics decisions about animal biotechnology.
We give a summary of the different ethical concerns expressed
by ethicists and by the general public. Focusing on one of them,
animal welfare, we give an introduction to the animal welfare
implications of recent developments in reproductive and gene
technologies. The importance of animal welfere aspects is discussed
in relation to other ethical concerns about animal biotechnology."
- "Ethical guidelines for
investigations of experimental pain in conscious animals."
Zimmermann M. 1983. Pain 16, 109-110.
- Guidelines of the International
Association for the Study of Pain. "It is essential that
intended experiments on pain in conscious animals be reviewed
beforehand by scientists and lay-persons." Investigators
"should accept a general attitude in which the animal is
regarded not as an object for exploitation, but as a living individual."
- "The ethical socialization
of animal researchers." Arluke A. 1994. Lab Animal 23(6),
30-32 & 34-35.
- "Newcomers face a closed
moral universe where issues of morality are defined institutionally,
and hence are rarely confronted openly by individuals. Anti-ethical
training processes support ideological claims for the importance
of knowledge production, the need for objectivity and professionalism,
and the priority of the concerns of humans over those of animals."
- "Ethics and welfare of animals
used in education: an overview." King LA. 2004. Science
in the Service of Animal Welfare. Kirkwood JK, Roberts EA
and Vickery S, eds. Proceedings of the UFAW International Symposium,
Edinburgh, 2-4 April 2003. Animal Welfare 13: S221-227.
- Ethical, regulatory and scientific
issues arise from the use of animals in education. The implementation
of alternatives to animal use is inconsistent, and barriers to
the adoption of alternatives include specific curriculum and
legislative requirements, traditional educational methodology,
and resource and training limitations, particularly when the
alternative methods involve new technologies.
- Ethics, Humans and Other Animals:
An introduction with readings. Hursthouse,
R. 2000. Routledge: London.
- The author deals with the three
major approaches to our use of animals, namely utilitarianism,
deontology and virtue ethics, and the texts are taken from the
works of Singer, Regan, Midgley and Scruton. She analyses them
in a way that enables the reader to comprehend and criticise
each of the theories. She applies them to real situations.
Ethics of Animal Investigation. 1989. Canadian
Council on Animal Care. Ottawa, Ontario.
- "Animals should be used only if the researcher's
best efforts to find an alternative have failed. A continuing
sharing of knowledge, review of the literature, and adherence
to the Russell-Burch "3R" tenet of "Replacement,
Reduction and Refinement" are also requisites. Those using
animals should employ the most humane methods on the smallest
number of appropriate animals required to obtain valid information."
- The Ethics of Research Involving Animals. Nuffield
Council on Bioethics. 2005. London, UK.
- "This Report seeks to clarify
the debate and aims to help people think through the ethical
issues that are raised. The ways in which animals are used in
different areas of research are reviewed, including: basic or
'blue sky' research, the development of new medicines and vaccines,
and toxicity testing. The Report makes practical recommendations
for future policy and practice, relating, among other things,
to the use of GM animals, ways of improving the quality of debate,
the implementation of the Three Rs (Refinement, Reduction and
Replacement), and the responsibilities of researchers, reviewers
and funding bodies."
- The Human Use of Animals:
Case Studies in Ethical Choice.
Orlans FB, Beauchamp TL, Dresser R, Morton DB and Gluck JP. 1998.
Oxford University Press: New York.
- This easy-to-read book includes
an introductory chapter on morality providing a broad background
information and describing several methods useful to resolve
ethical dilemmas. Subsequent chapters are individual case studies
covering most major areas of animal use, and discussing the ethical
issues and welfare concerns involved. This book helps readers
reflect on their own ethical outlook.
of human-animal interactions and bonds in the laboratory."
2002. ILAR Journal 43(1) [whole issue]
- Number of articles addressing
the ethical implications of the human-animal bond in research
laboratories, and its impact on caregivers and on animal well-being.
- "Sacrificial symbolism in
animal experimentation: Object or pet." Arluke AB. 1988.
Anthrozoos 2, 98-117.
- "Many principal investigators
do not handle animals at all, although a few may do surgery after
the animal has been prepared fully by a technician Laboratories
should adopt a moral attitude that sanctions the expression of
emotions and condones the human side of scientific work."
in a guilt cage." Arluke A. 1993. Animal Welfare
Information Center Newsletter 4(2).
- The author studied laboratories and research centers to
investigate the impact of experiments on the people who carry
them out. "Episodic feelings of discomfort were common and
were expressed as background uneasiness and guilt... Open discussion
of these feelings was taboo. Scientists, veterinarians, and administrators
tended to deny that laboratory workers could be troubled by their
use of animals. Uneasiness was not seen as an issue, and was
not allowed to intrude on the normal course of work.... Yet within
the laboratory culture were unspoken rules and resources for
dealing with unwanted emotions and thoughts, despite the silence
surrounding this topic." The surfacing of conflicts that
prompt defensive behavior among researchers may be due to the
"diffusion into the laboratory of society's heightened awareness
of how animals should be viewed and treated. Coping devices will
be called out when humanity's standards clash with traditional
scientific practice. This is cheering to some who see this as
a willingness to pay more attention to humanitarian ideals in
- "Understanding the emotional
experiences of animal research personnel." Halpern-Lewsi
JG. 1996. Contemporary Topics 35(6), 58-60.
- Research personnel "who
demonstrate caring and compassionate behaviors add to the integrity
of the animals, which ultimately results in higher quality research
protocols. Individuals interacting with animals ... should be
encouraged to engage in caring behaviors without fear of reprisal."
Suggestions are provided to help research participants to do
their work without compromising humane relationships with experimental
- The Use of Animals in Higher
Education : Problems, Alternatives, & Recommendations. Balcombe J. 2000. Humane Society Press. Washington,
- "The aim of this monograph
is to present a comprehensive examination of the issue of animal
use in education from an ethical and humane perspective."
Back to Table
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." USDA AWA's policy
to Animal Testing: Refinement, Reduction, Replacement (ALTWEB Web Site). 2009*.
- Up-to-date, comprehensive site
on alternatives containing a number of full-text documents, abstracts
of journals on alternatives (http://altweb.jhsph.edu/pubs/),
a search engine, Frequently-Asked-Questions on alternatives,
and further links, including to the John Hopkins Center for Alternatives
to Animal Testing (CAAT) , http://caat.jhsph.edu/
- Alternatives to Laboratory Animals (ATLA Journal).
FRAME (Fund for the Replacement of Animal in Medical Experiments.)
- This quarterly journal covers
"all aspects of the development, validation, introduction
and use of alternatives to laboratory animals in biomedical research
and toxicology testing."
- Alternatives to Pain in Experiments on Animals. Pratt
DP. 1980. Argus Archives. New York, NY.
- Well written account of ethically
and scientifically unacceptable practices in animal experimentation.
The author describes specific experiments and matches them with
Page of The Animal Welfare Information Center's Web Site
- This site contains online articles;
a list of databases and organizations; and help with the literature
search in the form of guidelines, a thesaurus of alternatives
terminology, worksheets and an AWIC alternatives workshop on
the web. A number of bibliographies are available from AWIC's
publications page relating to animal care, use and welfare; ethical
and moral issues; and IACUCs.
Interagency Coordinating Committee on the Validation of Alternative
- NICEATM and ICCVAM seek to promote
the validation and regulatory acceptance of toxicological test
methods that will enhance the agencies' ability to assess risks
and make decisions, and methods that will refine, reduce, and/or
replace animal use.
- "The interplay between replacement, reduction and
refinement: considerations where the Three Rs interact."
de Boo MJ, Rennie AE, Buchanan-Smith HM and Hendriksen CFM. 2005.
Animal Welfare 14(4), 327-332
- This paper explores the interplay between the Three Rs
and provides examples where the Three Rs have a positive interaction
and where they are in conflict with each other.
- Fund for the Replacement of Animals in Medical
Experiments: Information Resources (FRAME).
- This excellent site offers a
clear introduction to the three Rs, Replacement, Reduction, Refinement.
Annotated links to databases, resources and organizations are
provided as are very helpful guidelines in searching for alternatives.
- Laboratory Animals
The Three Rs: developments in laboratory animal science. 1994.
Laboratory Animals Ltd. London, England. Contains three reprints
from Laboratory Animals, 28, 1994.
- "Replacement of animal procedures: alternatives in
research, education and testing." Balls M, 193-211.
- "Reduction of animal use: experimental design and
quality of experiments." Festing MFW, 212-221.
- "Refinement of animal useassessment and alleviation
of pain and distress." Flecknell PA, 222-231.
- National Centre for the Replacement, Refinement
and Reduction of Animals in Research (NC3Rs) Information Portal
- The National Centre for the Replacement,
Refinement and Reduction of Animals in Research provides a UK
focus for the promotion, development and implementation of the
3Rs in animal research and testing. The Information Portal contains
annotated links to online databases, websites, journal articles,
legislation and other publications. These resources provide information
to help apply the 3Rs and ensure the best possible standards
in animal welfare.
- The Principles of Humane Experimental Techniques. Russell
WMS and Burch RL. 1959. Methuen and Co. London, UK.
- The authors introduce the concept
of the 3 Rs: Replacement, Reduction, Refinement. "Desirable
as replacement is, it would be a mistake to put all our humanitarian
eggs in this basket alone. The progress of replacement is gradual,
nor is it ever likely to absorb the whole of experimental biology.
Refinement may reach such a pitch that a given procedure employing
animals is absolutely humane, but in any given field there is
bound to be a latent period before such success is attained.
Reduction remains of great importance, and of all modes of progress
it is the one most obviously, immediately, and universally advantageous
in terms of efficiency."
to Animal Testing and Experimentation. Proceedings of the
6th World Congress on Alternatives & Animal Use in the Life
Sciences Tokyo, Japan August 21-25 2007.
- Japanese Society for Alternatives
to Animal Experiments (JSAAE). AATEX 14 special Issue, 2008.
- Excellent and expert contributions
reflect the present state of knowledge in many areas including
adverse effects; animal models; biologicals; barrier systems
in vitro; carcinogenicity testing; ethical committees; ethical
aspects of transgenesis; humane endpoints; outreach on the Three
Rs to scientists and the general public; experimental design,
data analysis and reduction; refinements in animal housing and
husbandry; refinement in experimental design and techniques;
skin and eye irritation testing; toxicogenomics; use of animals
in education and training; and use of reconstituted tissues and
- "Refinement, reduction,
and replacement of animal use for regulatory testing: Current
best scientific practices; future improvements and implementation
within the regulatory environment; recommendations for implementation
of best scientific practices." 2002. In: Regulatory
Testing and Animal Welfare. Proceedings of an International
Symposium. International Council for Laboratory Animal Science
& Canadian Council on Animal Care; Quebec City, Canada, June
21-23, 2001. ILAR Journal 43 Supplement.
- The main objective of the symposium
was to identify best practices to minimize or eliminate pain
and distress for animals used in safety evaluation and testing
procedures. The presentations and discussions described the current
best practices for using animals in regulatory testing procedures.
Widespread implementation of these best practices could improve
the welfare of animals used for safety testing and contribute
to reduced animal use.
- The Three Rs at the Beginning of the 21st
Century: Proceedings of the Fourth World Congress on Alternatives
and Animal Use in the Life Sciences, 11-15 August 2002, New Orleans, LA, USA. Balls M, Firmani D and Rowan A, eds. 2004.
ATLA 32, Supplement 1 & 2.
- This new volume reflects the progress that has been made
in implementing the concept of the Three Rs of reduction, refinement
and replacement in animal research, education and testing. It
includes papers on replacement and reduction alternatives; refinement
and reduction alternatives; policy and ethics; eudcation and
information resources; test development, validation and implementation
and point-counterpoint debates.
- "The '3Rs' model and the concept of alternatives
in animal research: A questionnaire survey." Pollo
S, Vitale A, Gayle V, and Zucco F. 2004. Lab Animal 33(7),
- The authors used a questionnaire survey to determine how
well-known experts judged issues related to the 3Rs. In the authors'
opinion "there is a critical need for an integration between
the practical and ethical aspects of the alternatives. The need
is for 'a tool-kit to help apply the philosophical ideal to the
practical environment of the laboratory'."
- "The Three Rs: past, present
and future." Russell WMS. 2005. Animal Welfare 14(4),
- "We originally envisaged
refinement as minimising pain and distress, and by 1959, discomfort.
It is now clear that we must aim positively at optimal well-being."
- "The three Rs: The way forward."
Balls M, et al. 1995. ATLA (Alternatives to Laboratory Animals)
- A clear and comprehensive explanation
of the ethical, scientific and methodological ramifications of
the three Rs. "The Three Rs should be seen as a challenge
and as an opportunity for reaping benefits of every kind - scientific,
economic and humanitarian - not as a threat.
- University of California Center for Animal
- Information and bibliographies
on animal welfare and alternatives.
Back to Table
REPLACEMENT/IN VITRO TESTING
"We shall use the
term `replacement technique' for any scientific method employing
non-sentient material which may, in the history of animal experimentation,
replace methods which use conscious living vertebrates."
Russell W and Burch
in In Vitro Testing
- Alternative Toxicological
Methods. Salem H and Katz
S. 2003. CRC Press. Boca Raton.
- Explores the development and
validation of replacement, reduction, and refinement alternatives
(the 3 Rs) to animal testing. Contributions present what has
been accomplished thus far in developing acceptable alternatives
to traditional animal toxicological assessment and provide potentially
of some in vitro tests to reduce and replace the sub-acute animal
toxicity studies." Chhabra RS, Ress NB, Harbell JW and
Curren RD. 2004. The Three Rs at the Beginning of the
21st Century: Proceedings of the Fourth World Congress on
Alternatives and Animal Use in the Life Sciences. Balls M, Firmani
D and Rowan A, eds, 43-49. ATLA 32, Supplement 1 &
- "At present, in addition
to refining the current testing protocols, the NTP is evaluating
the potential for in vitro test methods to partially or completely
avoid the need for 14-day toxicity studies, especially for chemicals
where the dermal route of exposure is used. The in vitro assays
used were the EpiDerm bioassay to estimate dermal irritation,
the neutral red uptake (NRU) bioassay to estimate systemic toxicity
and the primary rat hepatocyte cytotoxicity (PRHC) assay to estimate
vitro and other non-animal experiments in the biomedical sciences."
Blaauboer BJ. 1996. Australian and New Zealand Council
for the Care of Animals in Research and Teaching (ANZCCART) News
9(4), insert: 1-4. An ANZCCART News Fact Sheet.
- "Developments in cellular
and molecular biology, as well as computerised modelling, provide
ample opportunities for change and the incorporation of knowledge
of the mechanisms of toxicity. New procedures must be validated
in order to assess their reliability and relevance. Validation
should have a sound scientific basis and should also be practical.
In this validation process an important driving force should
be the improvement of the relevance of toxicological risk assessment."
Vitro Methods for Assessing Acute Systemic Toxicity.
ICCVAM and NICEATM. 2007. National Institute of Environmental
Health Sciences. National Institutes of Health. U.S. Public Health
Service. Department of Health and Human Services.
- The workshop evaluated the status of available in vitro
methods for assessing acute toxicity. It also developed recommendations
for validation efforts.
for In Vitro Sciences.
(IIVS website) 2009*
- The Institute (1) provides non-animal
research and testing services, (2) sponsors workshops and training
courses in in vitro methods, and (3) creates a forum where Industry,
Government and Animal Welfare proponents can meet to determine
constructive programs which effectively reduce animal use.
- Selection and Use of Replacement
Methods in Animal Experimentation.
UFAW, FRAME, 1998. Available from UFAW, The Old School, Brewhouse
Hill, Wheathampstead, Herts AL4 8AN UK.
- The booklet is "a practical
guide to help ensure that those considering animal experimentation
have explored all opportunities to avoid animal use and attempted
to minimize the numbers involved." Detailed overview of
replacement options, including a summary of the current uses,
advantages and limitations for each method.
use of human cells in biomedical research and testing."
Combes R. 2004. The Three Rs at the Beginning of the
21st Century: Proceedings of the Fourth World Congress on
Alternatives and Animal Use in the Life Sciences. Balls M, Firmani
D and Rowan A, eds, 43-49. ATLA 32, Supplement 1 &
- It is only comparatively recently that the safe and controlled
acquisition of surgical waste and non-transplantable human tissues
has become feasible with the establishment of several human tissue
banks. Recently, the formation of a UK and European centralised
network for human tissue supply has been initiated. The problems
of short longevity and loss of specialisation in culture are
"Using In Vitro
prediction models instead of the rabbit eye irritation test to
classify and label new chemicals: a post hoc data analysis of
the international EC/HO validation study." Modlenhauer F. 2004. The Three Rs at the Beginning of the 21st Century: Proceedings of the Fourth World Congress on Alternatives
and Animal Use in the Life Sciences. Balls M, Firmani D and Rowan
A, eds, 29-39. ATLA 32, Supplement 1 & 2.
"A battery of cell
toxicity assays as predictors of eye irritation: a feasibility
HS and Cunningham AR. 2000. ATLA 28(4).
of the enucleated eye test with eyes of slaughterhouse animals
as an alternative to the Draize eye irritation test with rabbits."
Prinsen MK and
Koeter HBWM. 1993. Food and Chemical Toxicology 31, 69-76.
|72.5% of the
chemicals in the undivided sample were correctly classified when
applying the in vitro endpoints lgNRU of the neutral red uptake
test and IgBCoPo5 of the bovine opacity and permeability test.
The accuracy increased to 80.9% when six in vitro features wre
used, and the sample was subdivived. The subset of surfactants
was correctly classified in more than 90% of cases, which is
an excellent performance.
that a battery of cytotoxicity tests could provide a viable alternative
to the animal-based procedure."
The authors examined 21 test materials and concluded that the
enucleated eye test provides a very accurate means of assessing
eye irritant potential without using laboratory animals.
antibody production in vitro: Methods and resources" Jackson
LR, Trudel LJ and Lipman NS. 1999. Lab Animal 28( 3),
the Production of Monoclonal Antibodies Workshop August 29, 1999,
McArdle JE and Lund CJ , eds. Alternatives Research and Development
Foundation and the 3rd World Congress on Alternatives and Animal
Use in the Life Sciences.
"Guidance Document for IACUC Evaluation of Monoclonal
Antibody Production Protocols." Adapted from DeTolla
and Smith. Available from Alternatives Research and Development
Foundation, 14280 Golf View Drive, Eden Prairie, MN 55346
Review of in vitro
production of MAbs. Highlights some of the in vitro technologies
most commonly used and points to consider when selecting an in
vitro method for MAb production.
including animal welfare implications of the ascites method;
description of advantages and disadvantages of in vivo and in
vitro methods; up-to-date review of laboratory-scale in vitro
methods for producing MAbs; IACUC guidance for protocol review
Applicable concepts and guidelines appropriate for protocol review
of Mabs are presented. Each of the questions listed in the IACUC
checklist are discussed.
use of alternative methods in toxicological risk evaluation."
Blaauboer B. 1999.
ATLA 27(2), 229-238.
of in vitro model systems in toxicology. " Davila JC, Rodriguez RJ, Melchert
RB and Acosta D. 1998. Annual Review of Pharmacology and Toxicology.
methods for predicting human toxicity." Silber P, Ruegg
CE and Myslinski N. 1994. Lab Animal 23(2), 33-37.
prediction systems with in vitro methods towards a better
understanding of toxicology." Barratt MD. 1998. Toxicology Letters
"Integrated In Vitro approaches
for assessing systemic toxicity."
Forsby A and Blaauboer B. 2003. In Alternative Toxicological Methods. Salem H and Katz S. 2003. CRC Press.
In this report,
a generic scheme for local/systemic toxicity, and a specific
scheme for target organ toxicity, are proposed. The scope and
limitations of the approaches are discussed.
Overview of the use
of in vitro model systems to investigate target organ toxicity
of drugs and chemicals; also provides selective examples of these
model systems to better understand cutaneous and ocular toxicity
and the role of drug metabolism in the hepatotoxicity of selected
A brief but very clear
introduction to in vitro prediction of target organ-specific
toxicity using human tissues and cells.
Ways in which computer
prediction systems and in vitro toxicology can complement each
other in the development of alternatives to live animal experiments
"It is necessary to find a strategy
by which cellular toxic concentrations determined in vitro can
be 'converted' to doses that are relevant for risk assessment.
One approach is to integrate the in vitro data with computer-based
of the validation of toxicity test procedures. " Balls M. 1995. ATLA 23(1),
"Update on the
validation and regulatory acceptance of alternative tests for
skin corrosion and irritation" Fentem JH and Botham PA. 2004. The Three Rs at the Beginning of the 21st Century: Proceedings of the Fourth World Congress on Alternatives
and Animal Use in the Life Sciences. Balls M, Firmani D and Rowan
A, eds, 683-688. ATLA 32, Supplement 1 & 2.
made concerning the practical and logistical aspects of validating
alternative toxicity testing procedures .
Discussion of validation
issues. Includes tables giving an overview and summary of the
validation and regulatory acceptance of in vitro methods for
skin corrosion and irritation.
potential use of non-invasive methods in the safety assessment
of cosmetic products."
Rogiers, V et al. 1999. ATLA 27(4), 515-537.
of using non-invasive techniques in safety assessment with human
volunteers is reviewed.
Note: *Web sites and databases are updated regularly.
Back to Table
Back to Table