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Institute of Medicine (US); National Research Council (US). International Animal Research Regulations: Impact on Neuroscience Research: Workshop Summary. Washington (DC): National Academies Press (US); 2012.

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International Animal Research Regulations: Impact on Neuroscience Research: Workshop Summary.

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Appendix BWorkshop 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 research. 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, administrators, 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.

Meeting Objectives:

With particular reference to neuroscience research, to:

  • Identify and discuss international differences in animal research regulations:
    • Discuss current and emerging issues.
  • Discuss legal trends and activity in the courts that may impact research.
  • Examine the implications of regulations on the neuroscience research 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, policies, 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
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:
  • What is the basis for regulatory differences among countries?
  • What are emerging key issues surrounding animal research 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 regulations 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
  • Examine the interplay between the legal system and animal use regulatory system.
  • What are the potential implications of changes in regulations to the legal rights of animals? Research?
  • What are current trends, United States versus European differences?

 MARGARET FOSTER RILEY
 Professor
 University of Virginia, School of Law
1:45 p.m.Freedom of Information and Openness
  • How are these laws being used by the animal rights movement?
  • Are there limitations to the type of information that can be obtained?
  • Can greater transparency lead to less effort needed in response 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
  • How are these laws being used by the animal rights movement?
  • Are there limitations to the type of information that can be obtained?
  • Can greater transparency reduce requests for information?

 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, guidance, and economic considerations on the conduct of animal-based neuroscience 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
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:
  • How has the implementation of current and new regulations impacted the speed and quality of research, positively and negatively?
  • Has the pressure for reduction of numbers, use of “lower” species, reduction of cost, and replacement of animals distorted the balance of neuroscience research in ways that impede the rate of discovery?
  • How can we assess costs to animals, especially cumulative severity in long-term animal studies, including NHPs?
  • How can administrators and scientists work together to 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

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
10:20 a.m.Discussion with Speakers and Participants:
  • How can the 3Rs best be used effectively to deliver advancements in neuroscience?
  • For what areas of neuroscience research is replacement a realistic long-term goal? How can this objective be most effectively pursued?
  • Are current regulations causing neuroscientists to move away from animal work or to use less strictly regulated models?
  • Are new regulations impeding the progress of neuro science, or leading to neuroscience advancements?
  • Is collaboration between sectors (industry/academia) effective and what is the impact of greater globalization of research?
  • Critical analysis of systematic reviews—do they play a role? If so, should there be a new approach to experimental 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 successes and failures in the engagement of the public, politicians, and the media in productive discussions of the use of animals in research. Identify 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

 Patient Group Administrator
  TIM COETZEE
  Chief Research Officer
  National Multiple Sclerosis Society
12:25 p.m.Discussion with Speakers and Participants:
  • What is the responsibility of individual scientists, patient groups, and organizations to engage the public in dialogue about animal research?
  • Are there teachable examples of successful engagement and 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 research. Identify areas of research where such adoption would be beneficial. Discuss next steps in development of core principles and outcomes, including 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

 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:
  • Are there core principles and outcomes specific to regulations 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
Copyright © 2012, National Academy of Sciences.
Bookshelf ID: NBK100124

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