were used not only in research in his department but also, of
more immediate need, in the training of first- and secondyear surgical residents. Also note that there is nothing like
being part of the power of the process needed to get us to a
place where we could pass a new visit. The animal care fa­
cility was given two floors of one of the new research build­
ings, as well as the whole top floor of our new, and major,
research building.
We needed a cage washer, so I went to the dean’s office
and he said, “OK, what’s it cost?” I named the figure—I can­
not remember what it was—and the response was, “Is that
all? Buy two of ’em and the vets will decide where they have
to go.”
I had a regular lunch meeting with the vets, a representa­
tive of the contractor doing the renovation, and the head of
the grants and contracts office. Since I had been at the medi­
cal school for over 20 years, I knew how to expedite repairs
and installations of new equipment.
The physical plant was only part of the problem. How
do you get the IACUC up to speed? What does the protocol
form need to ask? Enough to ensure animal welfare but not
too much to be a barrier to research. How much justifica­
tion of a new project is needed? How much of a literature
search do you need to ensure that there’s no unnecessary
duplication?
You can imagine all the meetings that this required, not
only to manage deciding how often we needed renewals. I
spent hours meeting with department heads, speaking at fac­
ulty meetings, and so forth. The job did not—underline
not—increase my popularity. When I walked into someone’s
lab, everyone froze and silence fell. I either skipped lunch
because I would be besieged by angry faculty members or I
brought in lunch.
Finally, it practically took an act by the dean to get com­
mittee members. I had more difficulty recruiting members
than the institutional review board (IRB) did. What do you
look for on a semiannual inspection? It finally came down to,
Do you want to use animals in research? Then you must fol­
low the Guide. There are no musts in the Guide, right? Well,
the Guide may be written to allow professional judgment,
but you are not a veterinarian. The ultimate threat that I had
was another shutdown and that was a very effective threat.
After things were up and running, protocols were being
processed in a timely manner and investigators began to un­
derstand what we needed on the protocol form, [and] things
began to run more smoothly. After several months of being
back in operation, people even began to ask us for help in
designing the animal care aspects of their research projects.
It took 6 months to renovate the facilities, hire and train ani­
mal care staff, and meet with the investigators and staff to
emphasize proper care of the animals—for example, no it is
not OK to put out sticky traps for feral animals. By the end
of the 6 months, I had practically memorized the Guide.
Also we built a very good office staff, which was invalu­
able. When the dean asked me to take on the animal care
committee and the renovation, I said I would agree to do it if
he provided me with two people for the IACUC office staff.
“OK,” he said, but then almost reconsidered when I asked
for his deputy office manager and another one of his top aides.
I also was promised $1.7 million to bring the facilities up
to snuff. There are some advantages to being shut down.
That said, I don’t recommend it. I do recommend training
people to use animals properly in justifiable research. I do
recommend getting AAALAC accredited, a good way to
show that you operate a good animal care and use program.
It’s hard to achieve compliance if you don’t have the backing
of the top institutional official.
One year after all this drama, I was asked by James Tay­
lor to go on an AAALAC site visit. This led to increasing
involvement with AAALAC and ultimately to being a mem­
ber of AAALAC Council for several years. And finally, I
worked for 3 years as Director of ILAR.
There is one thing I can say about retirement: I no longer
have the Guide memorized.
The IACUC’s Impact on Advancing Best Practices and the Three Rs
Kathryn Bayne
Introduction
I
n the decades since the publication of the 1985 edition of
the Guide for the Care and Use of Laboratory Animals,
passage of the Improved Standards for Laboratory Ani­
mals Act, and issuing of the US Government Principles
(page 551)—all of which reference the establishment and
describe responsibilities of the institutional animal care and
436
use committee—the positive impact of the IACUC on re­
search animal welfare and the quality of science has been
significant. Over time, the IACUC’s scope of oversight and
level of responsibility have increased. Protocol review has
intensified, the semiannual program reviews and facility in­
spections conducted by the IACUC are more detailed and
structured, postapproval monitoring systems have been es­
tablished at many institutions, formal mechanisms have been
ILAR Journal
established for the IACUC to receive reports of concerns,
and the IACUC’s role as gatekeeper in promoting high-qual­
ity science at the institution, while being sensitive to societal
concerns about the use of animals and promoting institu­
tional self-correction of program issues, has achieved wide­
spread success.
With the expanding role of the IACUC comes a need for
enhanced infrastructure and support for the committee to
function successfully. This is being met, in part, by the vari­
ety of IACUC-specific conferences hosted each year; highquality books and journal articles that explore the various
aspects of the committee’s responsibilities; and dedicated
support staff, many of whom have achieved professional cer­
tification. Critical to the committee’s ability to fulfill its regu­
latory and moral responsibilities are IACUC member training,
adequate fiscal resources, and sustained and visible support
from upper administrative officials. As the role and function
of IACUCs have matured over the years so, too, has the com­
mittee’s ethics-based decision-making process. In partner­
ship with scientists, IACUCs have encouraged the use of less
painful methods such as in vitro tests, imaging technology,
computer modeling, and the establishment of humane end­
points; they have ensured that staff are competent in perform­
ing procedures; they have closely evaluated the justification
of animal numbers used; and they have encouraged innova­
tive refinements in animal housing and procedures.
The Three Rs and Ensuring Best Practices
According to www.businessdictionary.com, best practices
are “methods and techniques that have consistently shown
results superior [to] those achieved with other means, and
are used as benchmarks to strive for.” This source notes,
however, that “there is…no practice that is best for every­
one or in every situation, and no best practice remains best
for very long as people keep finding better ways of doing
things.” Thus, for institutions to ensure that best practices
are employed in both the care and use of animals there must
be a cultural acceptance that ongoing review of procedures
and practices is necessary and that animal care and use pro­
grams are not static but continue to evolve and change. Us­
ing the descriptors in the newest edition of the Guide for the
Care and Use of Laboratory Animals (NRC 2011) for the
Three Rs, this change will include replacement techniques,
through which the use of animals will be avoided; reduction
strategies, in which similar amounts and types of informa­
tion can be obtained from the use of fewer animals, or the
amount of information obtained from a set of animals is
maximized; and refinements that involve modifications to
husbandry practices or experimental procedures that will im­
prove animal well-being, including the minimization of pain
and distress.
The IACUC’s role in promoting the Three Rs and best
practices is partially accomplished by methods described in
the PHS Policy on Humane Care and Use of Laboratory Ani­
mals (1985, rev. 2002). Specifically, the Policy requires a
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2011
semiannual IACUC review of the institution’s program and
inspections of the facilities using the Guide as the reference
point. The reports of those reviews must be provided to the
Institutional Official, who is ultimately responsible for ensuring
that animal care and use conform with applicable regulations
and policies.
Over time, both the breadth and level of detail of con­
cerns the IACUC must attend to have increased. For
example, the 1985 publication of the Guide contained ap­
proximately 10 pages focused on the discussion of institu­
tional policies, of which a very small portion addressed the
function of the IACUC. At that time, the Guide stated that
“An institutional animal care and use committee should be
established to monitor the [animal care and use] program.”
The committee was encouraged to meet at intervals appro­
priate to the institution’s program, but not less than annu­
ally. In 1996, the Guide contained approximately 19 pages
describing elements of the program that should be covered
by institutional policies, and in the new 8th edition the con­
tent related to this subject expanded to approximately 27
pages.
For 45 years AAALAC International has reviewed and
accredited institutional animal care and use programs. This
places AAALAC International in the unique position of be­
ing able to look at these program improvements over the
long term and to witness changes in IACUC functioning. For
example, the enhanced oversight of animal care and use pro­
grams by IACUCs is evident in the increasingly intense re­
view of proposed animal work exemplified by the inclusion
of statisticians on many committees, routine inclusion of the
principles of the Three Rs when conducting protocol re­
views, and accessing resources such as the Animal Welfare
Information Center (AWIC) and the Center for Alternatives
to Animal Testing (CAAT) to aid in searches for alternatives
to painful or distressful procedures. IACUCs have intensi­
fied their semiannual program reviews and facility inspec­
tions, and many have additional postapproval monitoring
systems in place. IACUCs take very seriously their responsi­
bility to self-report adverse events or issues of noncompli­
ance, thereby fostering a culture of self-identification and
correction of issues. In response to federal requirements,
IACUCs have established mechanisms to receive reports of
concerns involving the animal care and use program so the
committee is able to launch an investigation into the allega­
tion and respond appropriately.
This enlarged scope of responsibilities of the IACUC has
necessitated that focused training be provided to committee
members. Such training is often accomplished through
IACUC-specific conferences and workshops, such as those
offered by IACUC 101, PRIM&R, and SCAW. In addition,
several texts have been published that serve as useful refer­
ences for IACUC members; these include The IACUC Hand­
book (Silverman et al. 2007) and the Institutional Animal
Care and Use Committee Guidebook (ARENA/OLAW
2002). This training would not be as available to committee
members if there was not a concomitant institutional com­
mitment to support the activities of the IACUC.
437
Box 1 Protocol elements recommended for
IACUC attention in the 1996 Guide
• Rationale and purpose of proposed use of animals
• Justification for species and number of animals
•
•
•
•
•
•
•
•
•
•
requested
Availability of alternatives
Adequacy of training/experience of personnel in
procedures used
Unusual housing and husbandry requirements
Appropriate sedation, analgesia, anesthesia
Unnecessary duplication
Surgical procedures
Humane endpoints
Postprocedure care
Euthanasia
Personnel safety
The importance of institutional commitment to the
proper function of the IACUC cannot be overstated. This
support takes many forms, depending on the size and type of
institution. For example, institutional support is often evi­
denced by the employment of dedicated staff, such as IACUC
administrators/coordinators/directors, many of whom have
demonstrated their expertise through a specialty certification
program, the Certified Professional IACUC Administrator,
initiated by PRIM&R in 2006. Other methods of support [in­
clude] the provision of IACUC software products to aid in
protocol and committee meeting management, as well as
ensuring a direct reporting line from the IACUC to the Insti­
tutional Official, which helps to ensure timely and accurate
communications between the committee and the designated
responsible administrator at the institution.
Changes in Protocol Review
While the 1985 Guide made no specific mention of protocol
elements that the IACUC should review, the 1996 Guide in­
troduced several benchmarks to aid the committee in assess­
ing the impact on the animal and to evaluate ways to foster
the gathering of good scientific data while ensuring the best
possible animal welfare. Items that the 1996 Guide recom­
mended that the IACUC pay particular attention to are listed
in Box 1.
The 8th edition of the Guide (NRC 2011) added items to
this list and expanded on some of the points identified in the
1996 Guide (Box 2).
Thus, over time, discussion of the subject of protocol re­
view in the last three editions of the Guide has become more
detailed and comprehensive. For example, in 1985 the Guide
did not contain any recommendations specific to protocol
review, in 1996 12 items were highlighted for attention by
the IACUC, and in the 2011 version of the Guide 15 items
are listed.
438 Box 2 New and expanded-upon protocol
elements described in the prepublication of
the 2011 Guide
• A clear and concise sequential description of the
•
•
•
•
•
procedures involving animals that is easily under­
stood by all [IACUC] members
Impact of the proposed procedures on animals’
well-being
Postprocedural care and observation of animals
Description and rationale for anticipated or se­
lected endpoints
Planning for the care of long-lived species after
study completion
Evaluation of scientific elements of the protocol as
they relate to the welfare and use of animals
Also of note, the 2011 Guide has included a term not
mentioned in previous editions, namely the obligation for
the IACUC to conduct a harm-benefit analysis during proto­
col review. Specifically, the new Guide states that “the
IACUC is obliged to weigh the objectives of the study
against potential animal welfare concerns.”
The AAALAC International Perspective
Against this backdrop of the evolution of the Guide and the
concomitant increase in IACUC duties, AAALAC Interna­
tional has witnessed many changes in the functioning of the
IACUC. AAALAC International has also offered guidance
of its own in how best to fulfill the numerous responsibilities
of the IACUC through newsletters1 and presentations (e.g.,
www.aaalac.org/resources/presentations.cfm).
AAALAC assesses the operations of the committee ini­
tially through the information provided in the program de­
scription filed by the institution with AAALAC prior to
the initial and triennial on-site assessments. While on site,
AAALAC International representatives review IACUC
procedures and policies; protocol files and related documen­
tation; minutes of committee meetings; the semiannual re­
ports pertaining to the facility inspections and program
reviews; and the PHS Animal Welfare Assurance, as appli­
cable. They also tour the animal facilities and visit laborato­
ries. In combination, this input provides a very thorough
picture of the IACUC’s activities and how well the commit­
tee discharges its responsibilities.
An analysis of letters sent to institutions visited by
AAALAC International during 2003–2008, representing al­
most 1500 visits, shows a general decline in the total number
of IACUC-related “findings” (Figure 1), which are catego­
rized as “Mandatory Items” and “Suggestions for Improve­
ment.” Mandatory Items must be corrected by the institution
1See the AAALAC Connection newsletters of spring 2003, spring 2001, and
summer 2000, available online at www.aaalac.org/publications/.
ILAR Journal
• ensuring a sound system of review of animal use propos­
als and of the animal program;
• ensuring appropriate cage space for animals;
• ensuring adequate sanitation and condition of cages;
• providing environmental enrichment to animals;
• referencing the Three Rs during deliberations of pro­
posed animal work, to include an emphasis on the pre­
vention of pain and distress as well as attention to
preemptive analgesia and intensified review of humane
endpoints; and
• ensuring adequate training of personnel.
in order to be granted full accreditation; the Council on
Accreditation offers Suggestions for Improvement to enhance
an acceptable or even commendable animal care and use pro­
gram and as a means of promoting continuous improvement
in a high-quality program. The strong commitment that
IACUCs at accredited institutions have made to provide ap­
propriate oversight of animal care and use programs is evi­
denced by the fact that approximately 98% of institutions
have Full Accreditation [from AAALAC International].
Since the publication of the 1985 Guide, AAALAC In­
ternational has observed many examples of improvement in
animal welfare and in the resulting quality of science as the
IACUC has engaged in increasingly comprehensive over­
sight of the animal care and use program. Given the overarching scope of IACUC input to the animal program, the
number and types of program enhancements are also broad.
Examples of this improvement include
• improving the level of veterinary care provided to the
animals, and a consequent minimization of pain and
distress;
This remarkable progress in fostering best practices and
the Three Rs over the last 25 years is testament to the com­
mitment of researchers, veterinarians, and their host institu­
tions to a culture of care, conscience, and responsibility
(Klein and Bayne 2007) that will facilitate high-quality sci­
ence and innovation for the next 25 years.
References
ARENA [Applied Research Ethics National Association]/OLAW [Office of
Laboratory Animal Welfare]. 2002. Institutional Animal Care and Use
Committee Guidebook (M. Pitts, Chair, and K. Bayne, Co-Chair,
Editorial Board). Available online (http://grants.nih.gov/grants/olaw/
GuideBook.pdf), accessed on March 15, 2011.
Klein HJ, Bayne KA. 2007. Establishing a culture of care, conscience, and
responsibility: Addressing the improvement of scientific discovery and
animal welfare through science-based performance standards. ILAR J
48:3-11.
NIH [National Institutes of Health]. 1985. Guide for the Care and Use of
Laboratory Animals. NIH Publication No. 86-23. Rockville MD.
NRC [National Research Council]. 1996, 2011. Guide for the Care and Use
of Laboratory Animals. Washington: National Academies Press.
Silverman J, Suckow MA, Murthy S. 2007. The IACUC Handbook, 2nd ed.
New York: CRC Press, Taylor & Francis Group.
The Future: Continuing IACUC Challenges
Jerry Collins
A
s we all know, NIH is focused on improving the
health of citizens of the world. That undertaking in­
volves many activities and this symposium is fo­
cused on a key component of those activities, animal models
of health and disease.
It was decided by leaders in the field, many of whom are
present with us today, that performance- rather than engi­
neering-based standards would underpin the oversight pro­
cess of the use of live vertebrate animals in research,
Volume 52, Supplement
2011
teaching, and testing in the United States. The IACUC pro­
cess is an essential component of that activity and I have
been asked to discuss some possible future challenges to be
faced by members of institutional animal care and use
committees.
Please note my use of the word continuing in the title of
this presentation. In my brief comments today I will focus on
familiar IACUC challenges that are likely to appear in
slightly different forms in the future.
439