Moving Toward Nonanimal Approaches in Medical Research and Testing pioneers a single-source guide for researchers regarding nonanimal research tools and methodology, funding opportunities for nonanimal studies, advocacy for regulatory change regarding approval of human therapeutics through nonanimal studies, and how to overcome the publication bias against nonanimal studies. This book is presented in three parts: 1) historical, ethical, legislative, regulatory, and scientific contexts to animal-based research and testing, 2) the latest advances in nonanimal tools and methods for research and testing of human therapeutics, and 3) achieving a practical shift toward nonanimal-based research and testing requirements. This book, primarily directed to researchers in biomedicine and human medical therapeutics, will also appeal to researchers in industry, providing overview and insights about the latest applications of nonanimal research tools and methods. Clinicians who wish to understand the methods and reliability of nonanimal versus animal-tested therapeutics as well as advocacy groups seeking to present up-to-date understanding of the reliability of animal versus nonanimal testing methods will also find significant value in this text. Finally, regulators and those involved in regulatory review and legislative oversight will benefit from this single comprehensive source for developing a basic understanding of nonanimal research and human safety.
Table of Contents
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 research
2. Legislative history of animal-based research
3. Lack of reliability, validity, translatability of animal-based research
4. Animal, financial, and human costs of animal research
5. The individual and systemic preference for animal-based methods: Animal methods bias in publishing and funding
PART 2: ADVANCES IN NONANIMAL METHODS FOR RESEARCH AND TESTING
6. Organoids
7. Microphysiological systems
8. In Silico modeling, supercomputing
9. Bioprinting
10. Other potential topics
11. Human subjects as alternatives to animal subjects in medical research
PART 3: ACHIEVING A PRACTICAL SHIFT TOWARD NONANIMAL-BASED RESEARCH AND TESTING
12. Mitigation efforts in the United States: Overcoming the inertia against nonanimal research
13. International Mitigation efforts: Overcoming the inertia against nonanimal research
14. The industry perspective
15. Getting grants for nonanimal studies
16. Publishing nonanimal studies
17. Building trust in nonanimal methods through standardization, validation, benchmarking, reporting
Authors
Gail Van Norman Professor Emeritus, Department of Anesthesiology and Pain Medicine, University of Washington, USA.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 Krebs Medical Research Specialist, Physicians Committee for Responsible Medicine, USA. 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 over four 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 over 20 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.
