Appendix A

Methods

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

Meeting 2
Thursday, February 14, 2019
National Academies Keck Center, Washington, DC

Meeting 3 and Workshop on the Uses of Dogs in Biomedical Research
Wednesday, March 27, 2019
National Academies Keck Center, Washington, DC

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.

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.

Meeting 4
Thursday, March 28, 2019
National Academies Keck Center, Washington, DC

Webinar 1
Tuesday, May 7, 2019

Webinar 2
Tuesday, May 28, 2019

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.

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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 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.