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:
o 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 |
8:45 a.m. |
Animal Research in the Neurosciences |
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 |
9:25 a.m. |
Europe |
9:50 a.m. |
United States |
10:15 a.m. |
Asia |
10:40 a.m. |
South America |
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 |
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 |
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 |
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 |
3:20 p.m. |
Panelists: Use of Rodent Models in Neuroscience When Should Non-Human Primates Be Used as Animal Models? The Ethical and Practical Dilemmas of Research on Non-Human Primates Administrative and Economic Costs |
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 Refinement and Reduction Strategies: Improving Models The Role of Systematic Reviews Future Considerations and Impact of 3Rs |
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 neuroscience, or leading to neuroscience advancements? • Is collaboration between sectors (industry/academia) effec tive 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 Science Writer |
Patient Group Administrator |
|
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 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.
2:00 p.m. | Overview and Session Objectives RICHARD NAKAMURA, Session Chair |
11:25 a.m. |
Panelists:
European Government Regulator U.S. Government Regulator |
Industry Representative ILAR Council Member |
|
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: |
5:00 p.m. | FINAL REMARKS COLIN BLAKEMORE, Co-Chair ARTHUR SUSSMAN, Co-Chair |
5:30 p.m. | ADJOURN |
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