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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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