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Suggested Citation:"Appendix A: Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Page 135
Suggested Citation:"Appendix A: Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Page 136
Suggested Citation:"Appendix A: Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
×
Page 137
Suggested Citation:"Appendix A: Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
×
Page 138
Suggested Citation:"Appendix A: Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
×
Page 139
Suggested Citation:"Appendix A: Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
×
Page 140
Suggested Citation:"Appendix A: Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
×
Page 141
Suggested Citation:"Appendix A: Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Page 142

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Appendix A Methods T his appendix includes public meeting agendas, a list of materials supplied to the committee by the U.S. Department of Veterans Affairs (VA), and the literature search criteria used by the committee. The information-gathering sessions included in-person, public meetings and webinars held by the committee from December 2018 to May 2019, and they are listed in chronological order. PUBLIC MEETING AGENDAS Meeting 1 Sunday, December 9, 2018 National Academy of Sciences Building, Washington, DC 1:00 p.m. Welcome, Introductions, Process for Open Session – Rhonda Cornum, Committee Chair 1:10 p.m. The National Academies of Sciences, Engineering, and Medicine Study Process Overview – Lida Anestidou, Study Director 1:20 p.m. Study Context and Expectations for the Study – Michael Fallon, U.S. Department of Veterans Affairs – Alice Huang, U.S. Department of Veterans Affairs – Joan Richerson, U.S. Department of Veterans Affairs 3:00 p.m. Public Comment Session 3:20 p.m. Closing Remarks and Adjournment of Open Session 135

136 NECESSITY, USE, AND CARE OF LABORATORY DOGS AT THE VA Meeting 2 Thursday, February 14, 2019 National Academies Keck Center, Washington, DC 8:30 a.m. Welcome, Introductions, Process for Open Session – Rhonda Cornum, Committee Chair 8:45 a.m. Study Context and Expectations for the Study – Michael Fallon, U.S. Department of Veterans Affairs – Alice Huang, U.S. Department of Veterans Affairs (remote) – Joan Richerson, U.S. Department of Veterans Affairs (remote) 10:15 a.m. Public Comment Session 10:30 a.m. Closing Remarks and Adjournment of Open Session Meeting 3 and Workshop on the Uses of Dogs in Biomedical Research Wednesday, March 27, 2019 National Academies Keck Center, Washington, DC 8:00 a.m. Welcome, Introductions, Process for Open Session – Rhonda Cornum, Committee Chair Panel on Comparative Modeling in Cardiovascular Research Cardiovascular research is a key priority for the VA and one of the areas in which dogs serve as models of disease. This panel will examine various approaches to modeling diseases of the heart for research and translational purposes. 8:10 a.m. Panel Introduction – Donna K. Arnett, Committee Member 8:15 a.m. Modeling Cardiovascular Disease Using Canine Models –  odney White, Committee Member, Long Beach MemorialCare Heart & R Vascular Institute 8:35 a.m. Translational Approaches in Cardiovascular Disease Research Using Rodent Models – David Harrison, Vanderbilt University Medical Center 8:55 a.m. Modeling Cardiovascular Disease Using Swine Models – Daniel D. Myers, University of Michigan 9:15 a.m. Break 9:25 a.m. Using Human Hearts to Study Arrhythmogenesis – Igor Efimov, The George Washington University

APPENDIX A 137 9:45 a.m. CiPA: Evaluating Risk Using Mechanistic Electrophysiologic Understanding of Proarrhythmia – Alexandre Ribeiro, U.S. Food and Drug Administration 10:05 a.m. Cardiovascular Research in Humans: The Clinician’s Perspective – Scott A. Bernstein, NYU Langone Health 10:25 a.m. Discussion with Panelists 10:55 a.m. Break Panel on Ethical and Societal Issues Regarding the Use of Dogs in Biomedical Research 11:10 a.m. Panel Introduction – Margaret (Mimi) Foster Riley, Committee Member 11:15 a.m. Establishing a Necessity-Based Approach to the Use of Chimpanzees in Research – Jeffrey Kahn, Johns Hopkins University 12:00 p.m. Lunch 1:00 p.m. An Ethical Framework for the Use of Animals in Research – David DeGrazia, The George Washington University  1:30 p.m. The Unique Role of Dogs in Society – James A. Serpell, University of Pennsylvania 2:00 p.m. Discussion with Panelists 2:30 p.m. Break Panel on Comparative Modeling in Spinal Cord Injury Research Spinal cord injury (SCI) research is a key priority for the VA and one of the areas in which dogs serve as models of disease. This panel will examine various approaches to modeling SCI for research and translational purposes. 2:45 p.m. Panel Introduction – Warren Casey, Committee Member 2:50 p.m. An Overview of Large Animal Models of Spinal Cord Injury – Candace L. Floyd, University of Utah Health 3:10 p.m. Rodent Models of Spinal Cord Injury – Warren J. Alilain, University of Kentucky College of Medicine 3:30 p.m. The Natural SCI Model of Canine Intervertebral Disk Herniation Clinical Trials of Novel Therapies – Nicholas Jeffery, Texas A&M College of Veterinary Medicine

138 NECESSITY, USE, AND CARE OF LABORATORY DOGS AT THE VA 3:50 p.m. The Natural SCI Model of Canine Intervertebral Disk Herniation Clinical Trials of Novel Therapies (Continued) CANSORT-SCI and the International Canine SCI Registry: Tools for Identifying and Assessing the Impact of Therapeutic Strategies – Sarah Moore, The Ohio State University College of Veterinary Medicine 4:10 p.m. Discussion with Panelists 4:40 p.m. Public Comments 4:55 p.m. Adjourn Open Session Meeting 4 Thursday, March 28, 2019 National Academies Keck Center, Washington, DC 8:30 a.m. Welcome, Introductions, Process for Open Session – Rhonda Cornum, Committee Chair 8:40 a.m. Establishing Research Priorities at the VA – Rachel Ramoni, Veterans Health Administration – Karen Lohmann Siegel, Veterans Health Administration – Chris Bever, Veterans Health Administration 9:30 a.m. Adjourn Open Session Webinar 1 Tuesday, May 7, 2019 9:30 a.m. Welcome, Introductions, Process for Webinar – Rhonda Cornum, Committee Chair 9:40 a.m. Panel Introduction – Nancy Figler Marks, Committee Member 9:45 a.m. Spinal Cord Injury Research in Humans: The Clinician’s Perspective – James Guest, University of Miami 10:05 a.m. Modeling Infectious Disease Research Using Canine Models – Christine Petersen, The University of Iowa 10:25 a.m. Committee Discussion with Panelists 11:00 a.m. Adjourn Webinar

APPENDIX A 139 Webinar 2 Tuesday, May 28, 2019 10:30 a.m. Welcome, Introductions, Process for Webinar –  reg Symmes, Executive Director, Division on Earth and Life Studies, G National Academies of Sciences, Engineering, and Medicine 10:35 a.m. Panel Introduction – Warren Casey, Committee Member 10:40 a.m. Development of Human-Based Computer Model of the Heart to Predict Drug Safety and Efficacy –  lisa Passini, Senior Researcher, Department of Computer Science, E University of Oxford 11:00 a.m.  Modeling Atrial Fibrillation Using Human Embryonic Stem Cell–Derived Atrial Tissue –  achary Laksman, Director, St. Paul’s Hospital Atrial Fibrillation Clinic Z and Director, Inherited Arrhythmia Clinic, University of British Columbia, Vancouver, Canada 11:20 a.m. Committee Discussion with Panelists 12:00 p.m. Adjourn Webinar

140 NECESSITY, USE, AND CARE OF LABORATORY DOGS AT THE VA OVERVIEW OF DOCUMENTS PROVIDED BY THE VA The documents below were provided or submitted by the VA to the committee during the course of the study. Copies of the documents can either be found at the VA website1 or are deposited in the study’s public access file.2 • Overview of VA animal research and canine studies1 Includes VA research overview, organizational structure, collaborative relationships, research regulatory environment, animal research conduct and review, and past and current research using dogs. • Appendix 1: Veterans Health Administration (VHA) handbook 1200.07, Use of Animals in Research2 Includes the rationale for and principles governing use of animals in research, responsibili- ties of the Chief Veterinary Medical Officer (CVMO) at the VA central office, organiza- tion at VA medical facilities, veterinary medical unit operations at VA medical facilities, institutional animal care and use committees (IACUCs), visits to VA animal facilities by non-VA federal regulators, and requirements for occupational health and safety program. • Appendix 2: VHA handbook 1058.01, Research Compliance Reporting Requirements2 Includes a summary of major changes to reporting requirements; systemic requirements and responsibilities; reporting guidance for death (unanticipated or related to the research) in human research; reporting guidance for unanticipated animal death, theft, escape, or disap- pearance in animal research and death/accident/illness/injury/exposure of humans work- ing with animals; and reporting guidance on incidents related to research safety, research laboratory security, and research information security. • Appendix 3: Animal component of research protocol (ACORP), version 42 Copy of the ACORP, a form that contains the justification for proposed animal research at the VA. The ACORP is used by the local IACUC to assess harm–benefit. • Appendix 4: VA semiannual evaluation of the institutional animal care and use program and facilities2 Copy of the form that the VA requires for the semi-annual review of all of the policies, plans, standard procedures, and systems for ensuring humane animal care and use. The form has three parts: Part 1—Checklist; Part 2—Table of Deficiencies and Departures; Part 3—Post-Review Documentation. • Appendix 5: Adoption of research animals covered by the Animal Welfare Act regula- tions (Guidance Document AR2018-001) 2 Guidance document used to assist VA animal research programs in arranging adoptions for laboratory animals as pets. • Appendix 6: Selected VA research accomplishments with dogs1 Information on past projects that used dogs to address veterans’ health issues from 1960 to the current decade. • Appendix 7: Canine, Feline, and Non-Human Primate Research Protocols (Guidance Document: AR2017-001, rev. 2) 2 Information on the reviews required for research protocols involving dogs, cats, and non- human primates that are conducted at any VA property. 1 See https://www.research.va.gov/programs/animal_research/canine_research/nas_assessment.cfm (accessed June 16, 2020). 2 Copies of documents in the public access file may be requested by contacting the National Academies’ Public Access Records Office (PARO@nas.edu).

APPENDIX A 141 • Appendix 8: Current VA research using canines1 Information about research protocols as of June 1, 2017; March 28, 2018; and November 15, 2018: animal protocol form approved by the local IACUC and the CVMO’s office; feedback document from the CVMO’s office used by the local IACUC to develop the final approved version of the animal protocol form; and a summary of the literature search done by the CVMO’s office as part of the review. • Appendix 9: Disclosure of animal research documents pursuant to FOIA request • Completed ACORP for a companion dog study2 This study became active in 2019; this was the first protocol approved through the new review process (AR-2017). • Publications related to Appendix 81 A list of peer-reviewed publications related to each of the protocols in Appendix 8 (current VA dog projects). • Appendix 9: Veterans Health Administration Freedom of Information Act (FOIA) guidance on animal research requests1 Memo from the VHA FOIA office to VHA field FOIA officers on how to respond to FOIA requests for information on VA animal research. • Canine research in the Department of Veterans Affairs (PowerPoint presentation)1 • Publications from the past 10 years stemming from VA research with dogs1 List of all peer-reviewed, full-length reports of research with dogs that indicated author affiliation with a VA facility, support by VA funding, or other use of VA resources. • VA response to follow-up questions of the National Academies committee1 The committee asked for clarification on the information provided by the VA. The commit- tee was interested in connections and relationships between past projects, current projects, and accomplishments. This document contains the VA’s response to the committee. • Report on the National Institutes of Health Office of Laboratory Animal Welfare (NIH-OLAW) site visits to the Veterans Affairs medical centers with focus on canine care and use in research (January 3, 2019). • Grant applications of four active protocols2 ° Protocol 1 (High-frequency spinal cord stimulation to restore cough) ° Protocol 5 (Mechanistic insight of premature bentricular contractions-induced cardiomyopathy) ° Protocol 6 (Autonomic nerve activity and cardiac arrhythmias) ° Protocol 7 (Effect of chronic premature ventricular contractions on the remodeled ischemic heart)

142 NECESSITY, USE, AND CARE OF LABORATORY DOGS AT THE VA LITERATURE SEARCH CRITERIA (CHAPTER 3) A literature search, which was performed using the Scopus database, employed the following approach: “dog” and “cardi” were the standard spine, and modifiers were then added. The modifiers and numbers of citations obtained were as follows: arrhythmia (219), atrial fibrillation (144), aneurysm (19), congestive heart failure (34), ventricular premature contraction (6), device (95), gene therapy (10), graft (49), instrument (52), pacemaker (37), stent (169), surgical technique (77), thrombosis (21), tissue engineering (3), and vascular disease (120). Many papers were duplicated among the search subsections. A subsequent PubMed search turned up additional articles. A subset of the articles obtained from both searches is referenced in this section of the report, with an effort to cite only papers that describe dog use in hypothesis-testing research or proof-of-principle applications. To gain an understanding of dog use in pharmacological research over the past decade, a literature search was performed using Scopus and PubMed databases in April 2019 to identify published scientific literature (2009–2019) having the words “dog” and “pharmacol” in the title or abstract. Citations were characterized as either (1) basic research or preclinical research/ development of human therapeutics; (2) veterinary research/product development; (3) companion/ therapeutic animal research; or (4) other, unrelated to any of the above.

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For many years, laboratory dogs have served as important animal models for biomedical research that has advanced human health. Conducted at the request of the U.S. Department of Veterans Affairs (VA), this report assesses whether laboratory dogs are or will continue to be necessary for biomedical research related to the VA's mission. The report concludes that using laboratory dogs in research at the VA is scientifically necessary for only a few areas of current biomedical research. The report recommends that the VA adopt an expanded set of criteria for determining when it is scientifically necessary to use laboratory dogs in VA biomedical research; that the VA promote the development and use of alternatives to laboratory dogs; and highlights opportunities for the VA to enhance the welfare of laboratory dogs that are being used in biomedical research areas for which they have been deemed necessary.

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