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National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Division on Earth and Life Studies; Institute for Laboratory Animal Research; Committee on Assessment of the Use and Care of Dogs in Biomedical Research Funded by or Conducted at the U.S. Department of Veterans Affairs. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington (DC): National Academies Press (US); 2020 Jul 1.

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Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs.

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Appendix AMethods

This 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
  • 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

Rodney White, Committee Member, Long Beach MemorialCare Heart & 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

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

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
  • Webinar 2
  • Tuesday, May 28, 2019
10:30 a.m.Welcome, Introductions, Process for Webinar

Greg Symmes, Executive Director, Division on Earth and Life Studies, 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

Elisa Passini, Senior Researcher, Department of Computer Science, University of Oxford

11:00 a.m.Modeling Atrial Fibrillation Using Human Embryonic Stem Cell–Derived Atrial Tissue

Zachary Laksman, Director, St. Paul's Hospital Atrial Fibrillation Clinic 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

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, responsibilities of the Chief Veterinary Medical Officer (CVMO) at the VA central office, organization 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 disappearance in animal research and death/accident/illness/injury/exposure of humans working 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 regulations (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 nonhuman primates that are conducted at any VA property.
  • 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 committee 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)

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.

Footnotes

1
2

Copies of documents in the public access file may be requested by contacting the National Academies' Public Access Records Office (PARO@nas​.edu).

Copyright 2020 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK562726

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