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8
Summary of Workshop Topics
The topics highlighted in this chapter are based on closing remarks
made by each of the session chairs during the final session. Additional com-
ments by session participants that related to those closing remarks were
included as noted. Comments should not be construed as reflecting on any
group consensus or endorsement by the Institute of Medicine.
SESSION I: INTERNATIONAL ANIMAL RESEARCH REGULATIONS
Global Harmonization
Well-established regulatory systems in the United States and European
Union may seem disparate at first, but various speakers noted, this is due
more to different terminology than to real differences in principles and
outcomes, session chair Judy MacArthur Clark observed. For example,
it was discussed that the United States has no standardized animal study
proposal form comparable to the UK project license form. However, what
must be included in protocols submitted for Institutional Animal Care and
Use Committee (IACUC) approval is standardized. Institutions have the
flexibility to adapt forms and systems to the intricacies of their own animal
research program as long as they meet the standards required by regulation.
Emerging systems, such as those in Brazil and across Asia, are learning
from both the successes and challenges of established systems. MacArthur
Clark suggested that international collaborations and multinational com-
panies are helping to drive regulations and raise standards in emerging
regions, and contribute to global harmonization.
71
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72 INTERNATIONAL ANIMAL RESEARCH REGULATIONS
Costs
Bureaucracy in regulatory systems is a challenge shared by those
involved in animal research; however, it may be more of a hindrance in
some countries than others, MacArthur Clark noted. Regulatory systems
have costs that include finances and time for regulators and scientists (i.e.,
administrative burden). Some participants noted the need to reduce bureau-
cracy that could impact the progress of science.
Several participants noted that opening a dialogue with the public and
politicians about the scientific process, the role of animals in research,
and the animal research regulations in place would be beneficial. Other par-
ticipants noted the need to develop appropriate goals/metrics of success of
animal welfare measures to ascertain whether increased costs and burdens
result in improved animal welfare.
SESSION II: FREEDOM OF INFORMATION LAWS
Session chair Arthur Sussman observed that there seems to be strong
support among workshop panelists and participants for a regulatory envi-
ronment that is both ethical and intelligent. In addition to regulations
specifically governing the use of animals in research, various participants
noted that other laws impact research (e.g., animal rights laws, the Freedom
of Information Act [FOIA], state sunshine laws, and the False Claims Act).
Several presentations discussed how individuals and groups are using FOIA
and sunshine laws to obtain information on principal investigators, grants,
and matters of noncompliance. In some cases, session speaker Richard
Cupp noted that the courts have found connections between release of
information under FOIA and subsequent criminal activity against animal
researchers. However, it was noted that exemptions to the release of such
information are becoming infrequent. Workshop participants noted that
increased transparency might not result in decreased information requests,
and that transparency needs to be balanced with potential risk. Several
panelists and participants emphasized that the suggestion of exercising care
when corresponding about animal use in research might be worth particular
consideration by scientists.
SESSION III: THE ROLE FOR ANIMALS IN
NEUROSCIENCE RESEARCH
Much of the discussion on the impact of animal research regulation on
neuroscience research focused on the use of non-human primates, noted
session chair Roberto Caminiti. Panelists outlined the current role for non-
human primates in biomedical research, including neuroscience research.
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SUMMARY OF WORKSHOP TOPICS
It was noted that primate studies can complement in vitro studies, in silico
modeling, human brain imaging, and parallel investigations in rodents.
A few participants described how public pressure and politics have
phased out certain fields of research in some countries by making it difficult,
if not impossible, to study non-human primates. The high cost of using non-
human primates was also indicated as creating difficulties in developing this
field. Many participants acknowledged, however, that new regulations and
laws have produced a significant improvement in animal care, which has
led to improved science.
Refinements to animal models used in neuroscience have resulted in
reductions in the number of animals required for a study, making the use
of non-human primates more feasible. Although long-term data collection
from an individual animal allows for the use of fewer animals, it includes
numerous independent assessments, which have raised the issue of reuse
and severity classification.
New regulations present a host of challenges for institutions, investiga-
tors, and IACUCs. Several participants raised concerns about regulations
that result in increased costs of conducting biomedical research, without
evidence that additional regulations result in improved animal welfare.
SESSION IV: REPLACEMENT, REFINEMENT, AND
REDUCTION IN NEUROSCIENCE RESEARCH
Session chair Colin Blakemore briefly reviewed the session’s focus on
the 3Rs (replacement, refinement, and reduction), the ethical framework
for the human use of animals in research. Panelists described an in vitro
model of spinal cord injury that replaces the use of animal models and a
new model of epileptogenesis that relies on refining previously described
techniques. Some participants noted that both of these models have led
to the reduction of animal use in experiments. Implementation of the 3Rs
principle has a positive impact on improving neuroscience research, noted
several participants, as demonstrated by the studies presented.
Publication in the peer-reviewed literature is the primary way informa-
tion is disseminated in the scientific community. Blakemore observed that
a few panelists, however, faced challenges in getting refinements to animal
models or replacement methods published, especially when the submitted
manuscript proposed to refine or replace an animal model that has been
used broadly for decades.
Systematic Reviews
Some participants discussed how systematic reviews of preclinical data
could potentially support the 3Rs, thereby improving the quality of animal
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74 INTERNATIONAL ANIMAL RESEARCH REGULATIONS
studies. Participants also noted that systematic reviews provide informa-
tion about the validity of preclinical data for advancing therapeutics for
humans. The value of a systematic review depends on the quality of studies
included. Many participants stressed the need for preclinical animal data to
be more accessible, including primary data, precompetitive data, and nega-
tive data. Establishing repositories of preclinical data is one approach, and
issues of funding, location, oversight, and access were raised. In addition,
several panelists and participants called on publishers and journal editors
to examine current publication requirements for animal studies in hopes of
improving the quality of published studies involving animal models.
SESSION V: BUILDING PUBLIC CONFIDENCE
Many participants stressed the importance of transparency, or being
honest and open with the public about the regulations, laws, and policies
that govern the use of animals in biomedical research. Some participants
noted that educating the public about the societal benefits of research
using animals is important, but potential harms to the animals is often not
discussed. Many participants acknowledge that the public may already
understand the value of animal studies and their concerns may be focused
more on the quality of life of the animals. Explaining how the care and the
husbandry of the animals is managed might be of more interest to the public
than scientific details of research studies.
Scientists Talking Science
Session chair Frankie Trull emphasized that scientists have a respon-
sibility to inform and educate the public. Several participants noted that
neuroscientists may have an additional responsibility to talk more practi-
cally and pragmatically about public outreach programs, as neuroscience
research involves animal models that may invoke greater public concern.
A few participants suggested that government policy makers should hear
directly from scientists about the ongoing need for animals in research. It
was noted that the patient advocacy community does not generally pub-
licize their support of research involving animals for fear of losing donor
support. As patients are the ultimate recipients of the benefits of basic and
clinical science, a few participants suggested that the scientific community
could engage the patient advocacy community to encourage more open
discussion.
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SUMMARY OF WORKSHOP TOPICS
SESSION VI: CORE PRINCIPLES TO ACHIEVE CONSISTENT
ANIMAL CARE AND USE OUTCOMES
Throughout the workshop many panelists and participants empha-
sized the need for animal research regulations that balance quality science,
animal welfare, and public confidence. Science must be subject to strong
evaluation of experiments and experimental design, observed session chair
Richard Nakamura. Key animal welfare considerations are to minimize
pain and distress and improve overall well-being. Many participants em-
phasized that public confidence stems from the assurance that animals
will be appropriately protected and that science will not be inhibited from
discovering much-needed solutions to global problems.
Nakamura suggested that animal welfare should not be considered in
isolation from scientific goals or the larger needs of society. Several par-
ticipants stressed the importance of scientific validation of animal welfare
practices and standards to ensure that they actually do make a difference
in terms of animal welfare. Some panelists and participants said it is also
important to consider the overall costs in terms of resources on animal
welfare measures.
Animal welfare issues are global, and participants urged more discussion
among governments, regulators, and scientists to further the understanding
of differences in regulation and impacts on animal welfare outcomes.
Participants discussed core principles for the regulation of the use
of animals in research, asserting that alignment/harmonization of animal
research principles may be achieved independent of differing policies or
practices. Many participants believe that while there may be a need for
recommendations or guidance on specific neuroscience procedures, the core
principles by which animal studies should be conducted are the same for
any discipline, including neuroscience.
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