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Appendix B
Workshop Agenda
U.S. AND EUROPEAN ANIMAL RESEARCH REGULATIONS:
IMPACT ON NEUROSCIENCE RESEARCH
July 26-27, 2011
Kavli Royal Society International Centre, Chicheley Hall
Buckinghamshire, United Kingdom
Background: Numerous regulations, laws, directives, and policies are in
place to ensure the ethical use of animals in medical and life sciences re-
search. These regulations are intended to ensure that humane care and use
is provided to animals in research and that practical steps are taken to use
the smallest number of animals to give significant results while ensuring that
each individual animal experiences minimum pain or distress. The goal of
the workshop is to bring together researchers, legal scholars, administra-
tors, and other key stakeholders to discuss current trends and differences in
animal regulations. Particular attention will be paid to identifying potential
implications of new regulations on neuroscience research. The workshop
will also provide an opportunity for international dialog about engaging
public opinion regarding animal use in research and the development of
core principles and outcomes for animal care and use.
79
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80 INTERNATIONAL ANIMAL RESEARCH REGULATIONS
Meeting Objectives:
With particular reference to neuroscience research, to:
• Identify and discuss international differences in animal research
regulations:
Discuss current and emerging issues.
o
• Discuss legal trends and activity in the courts that may impact
research.
• Examine the implications of regulations on the neuroscience esearch
r
enterprise.
• Discuss current communication strategies regarding animal research.
• Explore the feasibility of developing a set of global core principles
and outcomes for animal care and use.
DAY ONE
8:00 a.m. Breakfast
8:30 a.m. Welcome, Introductions, and Objectives
COLIN BLAKEMORE, Co-Chair
ARTHUR SUSSMAN, Co-Chair
8:45 a.m. Animal Research in the Neurosciences
COLIN BLAKEMORE
SESSION I: CURRENT REGULATIONS AND EMERGING ISSUES
Session Objective: Highlight current animal research regulations, poli-
cies, and guidance. Review differences in approaches to regulations and
practices exemplified by the United States and European Union and new
regulations currently being proposed in emerging regions (e.g., Asia and
South America). Include a review of current and emerging issues in animal
research regulations.
9:15 a.m. Overview and Session Objectives
JUDY MacARTHUR CLARK, Session Chair
9:25 a.m. Europe
KARIN BLUMER
Scientific Affairs
Novartis, Switzerland
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81
APPENDIX B
9:50 a.m. United States
TAYLOR BENNETT
Senior Scientific Advisor
National Association for Biomedical Research
10:15 a.m. Asia
JIANFEI WANG
Director, Laboratory Animal Science
GlaxoSmithKline, R&D China
10:40 a.m. South America
EKATERINA RIVERA
Professor, Biological Sciences Institute
University of Goias
11:05 a.m. Panel Discussion with Speakers and Participants:
• hat is the basis for regulatory differences among
W
countries?
• hat are emerging key issues surrounding animal re-
W
search regulations?
12:00 p.m. LUNCH
SESSION II: IMPACT OF LEGAL TRENDS ON ANIMAL RESEARCH
Session Objective: Discuss changes to laws regarding animal rights on regu-
lations and research. Explore emerging laws and legal strategies that have
the potential to directly influence the use of animals in medical research.
1:15 p.m. Overview and Session Objectives
ARTHUR SUSSMAN, Session Chair
1:25 p.m. Animal Rights Laws
• xamine the interplay between the legal system and animal
E
use regulatory system.
• hat are the potential implications of changes in regula-
W
tions to the legal rights of animals? Research?
• hat are current trends, United States versus European
W
differences?
MARGARET FOSTER RILEY
Professor
University of Virginia, School of Law
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82 INTERNATIONAL ANIMAL RESEARCH REGULATIONS
1:45 p.m. Freedom of Information and Openness
• ow are these laws being used by the animal rights
H
movement?
• re there limitations to the type of information that can
A
be obtained?
• an greater transparency lead to less effort needed in re-
C
sponse to Freedom of Information Act demands?
MARGARET SNYDER
Freedom of Information Act Coordinator
Office of Extramural Research
National Institutes of Health
2:05 p.m. State Sunshine Laws
• ow are these laws being used by the animal rights
H
movement?
• re there limitations to the type of information that can
A
be obtained?
• an greater transparency reduce requests for information?
C
RICHARD CUPP
John W. Wade Professor of Law
Pepperdine Law School
2:15 p.m. Discussion with Speakers and Participants
2:40 p.m. BREAK
SESSION III: THE IMPACT OF REGULATIONS ON
ANIMAL-BASED NEUROSCIENCE RESEARCH
Session Objective: Discuss the impact of current regulations, policies, guid-
ance, and economic considerations on the conduct of animal-based neuro-
science research. Consider the role that animals have played in neuroscience
research: the benefits achieved, but also the costs. Include examination of
the administrative load and economic cost associated with animal research
regulations and response of researchers and funders to cost implications.
3:10 p.m. Overview and Session Objectives
ROBERTO CAMINITI, Session Chair
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83
APPENDIX B
3:20 p.m. Panelists:
Use of Rodent Models in Neuroscience
BILL YATES
Professor
University of Pittsburgh
When Should Non-Human Primates Be Used as Animal
Models?
ROGER LEMON
Sobell Chair of Neurophysiology
University College London Institute of Neurology
The Ethical and Practical Dilemmas of Research on Non-
Human Primates
STUART ZOLA
Director
Yerkes National Primate Research Center
Administrative and Economic Costs
CHARLES J. HECKMAN
Professor
Northwestern University Feinberg School of Medicine
4:40 p.m. Discussion with Speakers and Participants:
• ow has the implementation of current and new regula-
H
tions impacted the speed and quality of research, positively
and negatively?
• as the pressure for reduction of numbers, use of “lower”
H
species, reduction of cost, and replacement of animals dis-
torted the balance of neuroscience research in ways that
impede the rate of discovery?
• ow can we assess costs to animals, especially cumulative
H
severity in long-term animal studies, including NHPs?
• ow can administrators and scientists work together to
H
balance the economic costs of animal research regulations
while maintaining public confidence?
5:30 p.m. ADJOURN AND DINNER IN THE HALL’S DINING ROOM
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84 INTERNATIONAL ANIMAL RESEARCH REGULATIONS
DAY TWO
8:00 a.m. Breakfast
SESSION IV: IMPACT OF 3Rs ON THE
NEUROSCIENCE RESEARCH ENTERPRISE
Session Objective: Examine experiences of applying the 3Rs (replacement,
refinement, and reduction) in neuroscience research, including consideration
of opportunities for enhanced scientific outcomes as well as welfare benefits
and potential limitations. Examine the influence that non-researchers and
others have on neuroscience researchers working with animals. Consider
the role of systematic reviews, or the review and synthesis of all relevant
studies by the application of scientific strategies.
8:30 a.m. Overview and Session Objectives
COLIN BLAKEMORE, Session Chair
8:40 a.m. Panelists:
Replacement Strategies in Neuroscience Research: Focus
on Spinal Cord Injury
SUE BARNETT
Professor of Cellular Neuroscience
University of Glasgow
Refinement and Reduction Strategies: Improving Models
of Disease and Using Translational Approaches in Epilepsy
and Parkinson’s Disease
GAVIN WOODHALL
Reader in Neuropharmacology
Aston University
The Role of Systematic Reviews
ANNE MURPHY
Associate Professor
University of California, San Diego
Future Considerations and Impact of 3Rs
JACKIE HUNTER
OI Pharma Partners
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85
APPENDIX B
10:20 a.m. Discussion with Speakers and Participants:
• ow can the 3Rs best be used effectively to deliver advance
H
ments in neuroscience?
• or what areas of neuroscience research is replacement a
F
realistic long-term goal? How can this objective be most
effectively pursued?
• re current regulations causing neuroscientists to move
A
away from animal work or to use less strictly regulated
models?
• re new regulations impeding the progress of neuro cience,
A s
or leading to neuroscience advancements?
• s collaboration between sectors (industry/academia) effec ive
I t
and what is the impact of greater globalization of research?
• ritical analysis of systematic reviews—do they play a
C
role? If so, should there be a new approach to experi-
mental design to facilitate such reviews?
11:00 a.m. BREAK
SESSION V: ENGAGING AND INFORMING THE PUBLIC
Session Objective: Provide an opportunity for international dialog around
communication strategies regarding animal use in research. Examine suc-
cesses and failures in the engagement of the public, politicians, and the
media in productive discussions of the use of animals in research. Iden-
tify opportunities to educate non-researchers in the animal use regulatory
system.
11:15 a.m. Overview and Session Objectives
FRANKIE TRULL, Session Chair
11:25 a.m. Panelists:
Neuroscientist
RANDALL NELSON
Professor
The University of Tennessee Health Science Center
Science Writer
MARK HENDERSON
Science Correspondent
The Times
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86 INTERNATIONAL ANIMAL RESEARCH REGULATIONS
Patient Group Administrator
TIM COETZEE
Chief Research Officer
National Multiple Sclerosis Society
12:25 p.m. Discussion with Speakers and Participants:
• hat is the responsibility of individual scientists, patient
W
groups, and organizations to engage the public in dialogue
about animal research?
• re there teachable examples of successful engagement and
A
dialogue by animal researchers with the public?
1:00 p.m. LUNCH
SESSION VI: CORE PRINCIPLES FOR
ANIMAL RESEARCH REGULATION
Session Objective: Provide an opportunity for international dialog around
the development of core principles and outcomes for regulating animal re-
search. Identify areas of research where such adoption would be beneficial.
Discuss next steps in development of core principles and outcomes, includ-
ing analysis of the role of the 3Rs (replacement, reduction, and refinement).
Identify key stakeholders important for the success of this endeavor.
2:00 p.m. Overview and Session Objectives
RICHARD NAKAMURA, Session Chair
2:10 p.m. Panelists:
European Government Regulator
JUDY MacARTHUR CLARK
Chief Inspector
UK Home Office
U.S. Government Regulator
PATRICIA BROWN
Director
Office of Laboratory Animal Welfare
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87
APPENDIX B
Industry Representative
MARGARET LANDI
Vice President, Global Laboratory Animal Science;
Chief of Animal Welfare and Veterinary Medicine
GSK Pharmaceuticals
ILAR Council Member
TIMO NEVALAINEN
Professor
University of Eastern Finland
3:30 p.m. Discussion with Speakers and Participants:
• re there core principles and outcomes specific to regula-
A
tions for animal use in neuroscience research?
4:15 p.m. MEETING WRAP-UP WITH SESSION CHAIRS
Panelists:
Session I: JUDY MacARTHUR CLARK
Session II: ARTHUR SUSSMAN
Session III: ROBERTO CAMINITI
Session IV: COLIN BLAKEMORE
Session V: FRANKIE TRULL
Session VI: RICHARD NAKAMURA
5:00 p.m. FINAL REMARKS
COLIN BLAKEMORE, Co-Chair
ARTHUR SUSSMAN, Co-Chair
5:30 p.m. ADJOURN
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