Moving Toward Nonanimal Approaches in Medical Research and Testing

Gail A. Van Norman is a Professor Emeritus of the Department of Anesthesiology and Pain Medicine at the University of Washington in Seattle. She is an academic clinician/ethicist who has spent over 35 years in clinical practice and published a number of articles regarding the ethics and background of animal research as well as regulatory issues in pharmaceutical research and the failure of animal studies to provide effective scientific translation to human medicine. Her reviews of animal and nonanimal research published in JACC Basic to Translational Science have been among the most highly read, downloaded, and cited articles throughout the journal’s history. She has been an invited speaker at national and international meetings regarding the issues of animal research and translational science failures. Catharine E. Krebs is a medical research specialist at the Physicians Committee for Responsible Medicine, a United States-based organization of physicians and laypersons that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in research and medical training. Her biomedical research training is in human genetics, but she has worked in animal research advocacy and policy for years. In her work, she advocates for the National Institutes of Health to fund and conduct the most responsible and effective biomedical practices and has authored numerous public comments and Congressional statements for the record. She also leads an effort to address animal methods bias in publishing by developing resources for authors and by engaging with journal editors and peer reviewers. She has been an invited speaker at national and international meetings regarding research policy and advancing nonanimal research approaches.

• PART 1: THE NEED TO MOVE AWAY FROM ANIMAL-BASED RESEARCH AND TESTING: HISTORICAL, ETHICAL, LEGISLATIVE, AND SCIENTIFIC CONTEXT1. Philosophical and religious foundations of animal-based research2. Legislative history of animal-based research3. Lack of reliability, validity, translatability of animal-based research4. Animal, financial, and human costs of animal research5. The individual and systemic preference for animal-based methods: Animal methods bias in publishing and fundingPART 2: ADVANCES IN NONANIMAL METHODS FOR RESEARCH AND TESTING6. Organoids7. Microphysiological systems8. In Silico modeling, supercomputing9. Bioprinting10. Other potential topics11. Human subjects as alternatives to animal subjects in medical researchPART 3: ACHIEVING A PRACTICAL SHIFT TOWARD NONANIMAL-BASED RESEARCH AND TESTING12. Mitigation efforts in the United States: Overcoming the inertia against nonanimal research13. International Mitigation efforts: Overcoming the inertia against nonanimal research14. The industry perspective15. Getting grants for nonanimal studies16. Publishing nonanimal studies17. Building trust in nonanimal methods through standardization, validation, benchmarking, reporting