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The Necessity of the Use of Non-Human Primate Models in Research

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The Necessity of the Use of Non-Human Primate Models in Research THE NECESSITY OF THE USE OF NON-HUMAN PRIMATE MODELS IN RESEARCH Working Group April 18-19, 2017 Johns Hopkins Berman Institute of Bioethics 1809 Ashland Ave Baltimore, MD 21205 CONTENTS 1. GOALS AND APPROACH 2. MEMBERS 3. AGENDA FOR APRIL 2017 MEETING 4. LOGISTICAL INFORMATION 5. RECOMMENDED READINGS A. REPORTS (EXECUTIVE SUMMARIES) B. ON NECESSITY C. ON THE STATUS OF THE USE OF NHPs IN RESEARCH D. THE USEFULNESS OF NHP MODELS 1. GOALS AND APPROACH GOALS AND APPROACH The use of animals in biomedical research continues to be a topic of intense interest as well as a focus of discussion in the scientific community, among government regulators, and by interested groups and organizations. In particular, the use of non-human primates (NHPs) continues to receive intense attention, with both strong defense of the importance of such research as well as fierce opposition to the use of NHPs as research models. The use of these animals also presents some unique ethical issues, particularly in light of more recent studies of animal behavior and cognition that reveal more information about how animals think, communicate and function in social groups. To help address the issues of the use of NHPs in research, we are convening this working group to examine the science, ethics, and policy aspects of the use of NHPs in biomedical and behavioral research and testing, with the goal of identifying consensus findings, conclusions, and recommendations. The focus of the working group will be to evaluate the current and potential future uses of NHP models, drawing on the approach used in the 2011 IOM Report “Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity” (IOM, 2011). The product(s) of the working group process will be a report or series of reports based on the working group’s expert analysis, which will include principles and criteria for assessing the necessity of the use of NHPs in research. The working group process will include multiple meetings over time, with a workplan, timeline, and potential additional funding sources to be discussed at the first working group meeting. 2. MEMBERS Members - List Tom Beauchamp, PhD Jeff Kordower, PhD Professor Emeritus Professor Dept. of Philosophy and Kennedy Institute of Department of Neurological Sciences Ethics Rush Medical College Georgetown University Margaret Landi, DVM John Capitanio, PhD Chief of Animal Welfare, Ethics, and Strategy Research Psychologist Veterinary Medicine Department of Psychology GlaxoSmithKline University of California, Davis David Peña-Guzmán, PhD Larry Carbone, DVM, PhD Hecht-Levi Postdoctoral Fellow Director Johns Hopkins Berman Institute of Bioethics Animal Care and Use Program Office University of California, San Francisco Eugene Redmond, MD Professor Kathleen Conlee, MPA Departments of Psychiatry and Neurosurgery Vice President of Animal Research Issues Yale University The Humane Society of the United States Jonathan Richmond, MB ChB, FRCSEd Lori Gruen, PhD Formerly Chief Inspector William Griffin Professor Home Office, United Kingdom Department of Philosophy Wesleyan University Steven Schapiro, PhD Associate Professor Kathy Hudson, PhD Department of Veterinary Sciences, MD Anderson Formerly Deputy Director, Science, Outreach, and Cancer Center Policy The University of Texas NIH Jerrold Tannenbaum, JD Eric Hutchinson, DVM Professor Emeritus Associate Director of Research Animal Resources Department Population Health and Reproduction and Assistant Professor University of California, Davis Department of Molecular and Comparative Pathobiology Joanne Zurlo, PhD Johns Hopkins University Director of Science Strategy and Senior Scientist Department of Environmental Health and Jeffrey Kahn, PhD, MPH Engineering Andreas C. Dracopoulos Director Johns Hopkins University Johns Hopkins Berman Institute of Bioethics Members – Biographical Sketches Tom L. Beauchamp, Ph.D. is Professor of Philosophy and Senior Research Scholar, Kennedy Institute of Ethics, Georgetown University. He was born in Austin, Texas. He took graduate degrees from Yale University and The Johns Hopkins University, where he received his Ph.D. in 1970. He then joined the faculty of the Philosophy Department at Georgetown University and in the mid-1970s accepted a joint appointment at the Kennedy Institute of Ethics. In late 1975, he joined the staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, where he wrote the bulk of The Belmont Report (1978). Dr. Beauchamp's research interests are in the ethics of medicine and human-subjects research, the ethics of animal-subjects research and human uses of animals, the place of universal principles and rights in biomedical ethics, methods of bioethics, Hume and the history of modern philosophy, and business ethics. Publications include the co-authored works Principles of Biomedical Ethics (OUP, 7th edition, 2013, coauthor James Childress), A History and Theory of Informed Consent (OUP, 1986, coauthor Ruth Faden), and The Human Use of Animals (OUP, 2nd edition, 2008, with four coauthors). His Philosophical Ethics (McGraw-Hill, 3rd edition, 2001) is a work in ethical theory. Publications also include a number of edited and co-edited anthologies and over 170 scholarly articles in journals and books. Many of his articles on biomedical ethics were collected and republished early in 2010 by the Oxford University Press under the title Standing on Principles: Collected Works. Beauchamp has recently co-edited (with R. G. Frey) The Oxford Handbook of Animal Ethics--a comprehensive, state-of-the-art presentation of the field—and he has also coedited (with George G. Brenkert) The Oxford Handbook of Business Ethics, a similarly comprehensive volume on the subject. Dr. Beauchamp is one of three editors of the Clarendon Hume, a critical edition of the works of David Hume under continuous publication by Clarendon Press, Oxford. Beauchamp has himself issued three volumes in the Clarendon Hume and is currently completing his fourth and final volume. They deal with Hume's theories of human nature, the limits of knowledge, moral philosophy, moral psychology, philosophy of religion, and political theory—based on Hume's works An Enquiry concerning the Principles of Morals, An Enquiry concerning Human Understanding, A Dissertation on the Passions, The Natural History of Religion, and Essays, Moral, Political, and Literary. Beauchamp's co-authored book (with Alexander Rosenberg), Hume and the Problem of Causation (Oxford University Press, 1981) has been widely discussed in the Hume literature. In 2011 Dr. Beauchamp was given the Lifetime Achievement Award for Excellence in Research Ethics by Public Responsibility in Medicine and Research (PRIM&R). In 2010 he was presented the Henry Beecher Award of the Hastings Center, New York, for a lifetime of contributions to research ethics and other areas of bioethics. In 2004, he was given the Lifetime Achievement Award of the American Society of Bioethics and Humanities (ASBH) in recognition of outstanding contributions and significant publications in bioethics and the humanities. In 2003, he was presented Georgetown University's Career Recognition Award, which is awarded to a faculty member in the University each year for distinguished research across a career. In 1994, Indiana University made Beauchamp the first award winner of its "Memorial Award for Furthering Greater Understanding and Exchange of Opinions between the Professions of Law and Medicine." In 2004 the College of William and Mary School of Law awarded Tom and Jim Childress the Benjamin Rush Medal, which is bestowed by vote of scholarship students for distinguished contribution to the field of health law and policy. John Capitanio, Ph.D. is a Research Psychologist in the Department of Psychology at the University of California, Davis, and a Core Scientist at the California National Primate Research Center. I received my Ph.D. in Comparative Psychology from the University of California at Davis in 1982, and was a postdoctoral researcher in Developmental Psychobiology in the Dept. of Psychiatry at the University of Colorado Health Sciences Center. My research interests include understanding the causes, correlates, and consequences of individual variation in biobehavioral organization in nonhuman primate species. Biobehavioral organization reflects patterns of personality, behavioral and emotional responsiveness, and physiological organization that are stable within individuals and across situations, but which can differ between individuals. My research focus has been in two areas. The first area emphasizes personalized medicine. In former NIH Director E. Zerhouni’s testimony before Congress in 2006, he stated “Because we now know that individuals respond differently to environmental changes according to their genetic endowment and their own behavioral responses, we can envision the ability to precisely target treatment on a personalized basis.” Our efforts in this area have focused on understanding the mechanisms whereby variation in personality/temperament factors (ie, organism-level variables) such as sociability and behavioral inhibition create risk for disease. The second area of focus has been on identifying how stable individual difference factors can influence adaptation in captive management of nonhuman primates: a “personalized,” one-size-does-not-fit-all, approach to colony management. My development of a BioBehavioral Assessment program in 2001 has enabled us to identify temperament dimensions that
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