Future Directions for Laboratory Animal Law in the United States: Workshop Lawrence Schook, Ph.D. Gutgsell Professor University of Illinois at Urbana-Champaign
Presentation Outline Perspective: Personal path & Setting the Stage Changing Animal Research Landscape Myths and Facts Path Forward: Defining roles and responsibilities
Perspective: Personal path 1. Researcher using rodents, wild and farm animals 2. Medical, veterinary and agricultural faculties 3. Urban, rural and wild environments 4. Endpoint to variable phenotypic models (LD 50 to quantitative traits) 5. Private, foundational and governmental sources (NSF, DOD, USDA and NIH) 6. Single to multi-pi, multi-institutional grants 7. International research programs (Asia, South America, and Europe). 8. Student, investigator, department head, associate dean for research, vice president for research.
Setting the Stage AWA exempts animals used in agricultural research. Not a species issue but a research outcomes issue. Personal activities utilize the pig- must address its current exemption in food and fiber research. As a biomedical model as an initially healthy animals subjected to potentially or truly painful or distressful procedures. Focus on addressing costs (effort and financial) through efficiencies rather than standards.
NIH Model Organisms for NIH Biomedical Model Organisms Research for ISAG Amsterdam, 2008 Biomedical Research
NIH justifications for large animal genome sequencing The Long and Winding Road: From Genotype to Phenotype Improve health Inform biology Inform sequences (comparative) Expand knowledge of biological processes Provide surrogate experimental systems Facilitate positional cloning Expand understand of evolutionary processes
Creating and Effectively Evaluating Clinically Relevant Animal Models Exp. Biol. Med. 229:866-875, 2004 1995 2005 Current Enabling Technologies Available Genome sequence information Conditional transgenesis Recombineering Comparative/Functional genomics Multiple allelic substitutions Proteomics/metabolomics Bioinformatics/predictive profiling
The TJ Tabasco Genome Story Google Other Species images and Research Purposes
The TJ Tabasco Genome Story: A Porcine Blueprint for Agriculture, Life and Biomedical Sciences AGRICULTURAL SCIENCES: Genotypes and Phenotypes
The TJ Tabasco Genome Story: A Porcine Blueprint for Agriculture, Life and Biomedical Sciences BIOMEDICAL SCIENCES: Designing Cancer Models
The TJ Tabasco Genome Story: A Porcine Blueprint for Agriculture, Life and Biomedical Sciences LIFE SCIENCES: Mechanisms of Mammalian, Evolution and Diversity
The TJ Tabasco Genome Story: A Porcine Blueprint for Agriculture, Life and Biomedical Sciences DNA-based Models
Multi-PI, Multi-Institutional, Multi-National
Co-Clinical Trials: Oncopig Cancer Model Tumor Number of nodules Location Size Patient Co-morbidity (cirrhosis, NASH, obesity) Performance status (ECOG) Gender/age
Roles and Responsibilities Pathway of regulations The Who? Form follows function- defining roles and responsibilities Oversight- funders require specific statements, tremendous professional oversight; difference between making rules and enforcing Research Community
Demystifying Myths Researchers don t care about their animals Policing is necessary or people will never follow the rules Punishment is a strong motivator for ensuring quality welfare and care. Standards are critical to insuring
Building on Truths Animal facilities, housing and security have greatly advanced Quality of animals from breeding to health standards are unquestionable Monitoring of animals and their environments is exceptional People from IACUC to animal care to researchers provide the highest care for animals. Lead international vision discussion
Outcomes Reproducible robust results Progress Reducing costs through effectiveness Defining the what is broken Defining the who fixes and avoids
Defining the Right Path Forward Reducing patchwork of regulations Defining roles and responsibilities Funding agencies Compliance (FDA with GMO food animals) Host Institutions Researchers Defining outcomes
Streamlining: Authority and Risks Single office (reporting structure) All funding agencies request same Risk and complexity levels (like rdna BS levels) Standardized protocols for all to access (Wiki) Rules and Regulatory Process Efficiency to lower cost but reduce standards Like IRB, NCI has a IRB for all who receive funding to use
Animal Research Risk and Training Levels: Based on Pain, Complexity
Colleagues Extraordinaire Harris Lewin & Jon Beever Schook Laboratory Chuck Ray, Regina Schwind & Ron Gaba Greger Larsen & Martien Groenen