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Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs (2020)

Chapter: 2 Legal, Social, and Ethical Considerations

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Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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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2

Legal, Social, and Ethical Considerations

This chapter begins with a brief history of the use of dogs in research and of efforts to obtain legal protections for dogs as research subjects. This is followed by synopses of the regulatory requirements that govern the use of dogs at the U.S. Department of Veterans Affairs (VA) and of the currently accepted standards for the use, care, and welfare of dogs in biomedical research. Reflections on social and ethical considerations regarding the use of laboratory dogs in biomedical research are followed by the committee’s conclusions with respect to the role of societal preferences in considering the use of dogs for biomedical research at the VA.

HISTORICAL OVERVIEW OF RESEARCH USING DOGS

From antiquity through the 18th century, experimentation on living creatures was used to obtain basic knowledge about anatomy and physiology as well as to develop surgical procedures. Humans—typically slaves, condemned criminals, the dead, or the investigators themselves—were the most frequently used species for these investigations. Non-human animals were also used at least as far back as Aristotle (Altman, 1998; Appleman, 2020; Kinter and DeGeorge, 2016; Lairmore and Ilkiw, 2015; Moore, 2006; Weisse, 2012; West, 2015).

Until the mid-20th century, investigations continued to be conducted in humans, including felons, the disabled and infirm, and orphans (Appleman, 2020). By the end of this period, incidents of unethical human research led to growing concern regarding the use of humans without their explicit and informed consent (Dankar et al., 2019). The Nuremberg Code, a product of the 1946–1947 trial of Nazi doctors for horrific medical war crimes, established 10 ethical principles for conducting legitimate (human) clinical research. These principles emphasize the need for informed consent and include a prerequisite for conducting animal research prior to human experimentation (Weindling, 2001). The Nuremberg Code prompted the World Medical Association to create the Declaration of Helsinki, which articulates similar principles. Since its adoption in 1964, the Declaration of Helsinki has undergone several revisions (WMA, 2018). By largely recapitulating and extending the themes raised by the original Declaration of Helsinki, the United States developed the Code

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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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of Federal Regulations Title 45 Part 46, which was issued by the U.S. Department of Health and Human Services to lay out requirements for the ethical treatment of human subjects.1

Notwithstanding ethical and legal imperatives to conduct animal studies prior to engaging in human subjects research, most of the increase in animal use in the early to mid-20th century can be traced to developments in pharmacology, medicinal chemistry, and toxicology (Kinter and DeGeorge, 2016). With the explosion in pharmaceutical research and large-scale product development in the late 19th and early 20th centuries came periodic public health disasters, such as the death of 13 children from a commercial diphtheria antitoxin contaminated with tetanus in 1901, which led to adoption of the U.S. Biologics Control Act of 1902 (DeHovitz, 2014). This was followed by the Elixir Sulfonilamide disaster in 1937, in which (absent a requirement for toxicity testing) 105 people died of kidney failure after receiving an antibiotic that had been formulated in a toxic solvent, and thalidomide in the 1950s (Caron et al., 2016; Wax, 1995). In response to these episodes, the U.S. Congress passed the 1938 U.S. Food, Drug, and Cosmetic (FD&C) Act, followed by the 1962 Kefauver Harris Amendment, which required sponsors to demonstrate that their regulated products be both effective and safe before being granted marketing approval (Kinter and DeGeorge, 2016). The 1938 FD&C Act and the 1962 Kefauver Harris Amendment (also known as Drug Efficacy Amendment) birthed a new sub-discipline, regulatory science, for carrying out efficacy and safety evaluations of new regulated products (FDA, 2017). Subsequent regulatory guidance introduced new standard practices, including the requirement for testing in multiple (rodent and non-rodent) species (Kinter and DeGeorge, 2016). These regulations helped establish confidence among regulators, patients, and the public that new regulated products would be effective and safe, although at the cost of increased animal testing (Kinter and DeGeorge, 2016).

Dogs as Research Subjects

There is evidence that dogs were the first animal to be domesticated, having been derived from the grey wolf at least 14,200 and perhaps as long as 36,000 years ago (Ovodov et al., 2011). Unlike other domesticated species such as pigs and cows, which were primarily selected for traits related to food production, the ancestors of dogs were initially selected for their behaviors (Serpell and Duffy, 2014). The development of the human–dog relationship is often described as “co-evolution,” emphasizing a theory of human–wolf cooperation that finds support in a recent study of modern-day indigenous populations (Pierotti and Fogg, 2017).

Genetic evidence indicates that the integration of dogs into human society amounted to a form of natural selection (independent of later selections aimed at generating specific breeds). That is, as a result of an increased role in human society, domestic dogs have evolved genetically to display behaviors—such as hypersociability—that make them well-suited to partnerships with humans (Cagan and Blass, 2016; Hecht et al., 2019; vonHoldt et al., 2017). Some of these same traits have, on the one hand, made dogs an attractive species for laboratory research, while on the other hand engendered strong public reactions to their use as laboratory animals.

While records are incomplete, it is probable that dogs were used as research subjects from antiquity because they, like people, were available and tractable. It is known that animals were used by 16th-century scientists to elucidate the structure and function of body systems, with dogs preferred for studies of anatomy, surgery, circulation, and cardiac, pulmonary, and renal functions. Dogs and other animals were also used as surrogates for humans when the use of cadavers was banned (Kinter and DeGeorge, 2016; Lairmore and Ilkiw, 2015; Moore, 2006).

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1 CFR Title 45, Part 46: Protection of human subjects. Available at https://www.govinfo.gov/app/collection/cfr (accessed October 7, 2019).

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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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Beginning in the 19th century, aided by the growth of technologies to measure experimental endpoints, animal experimentation became increasingly sophisticated, addressing questions of organ morphology, physiology, and pathophysiology (Kinter and DeGeorge, 2016). Photographic images of a bulldog standing for the first electrocardiogram recordings helped ensconce dogs as the favored non-human model for cardiovascular research (Burchell, 1987; Nishida et al., 2010). Anatomical and physiological similarities between dog and human cardiovascular systems, elucidated over a century and a half, bolstered that perception (e.g., Hayashi et al., 1995).

Most current dog use in the United States is to fulfill safety testing requirements for regulated pharmaceutical and medical devices (Kinter and DeGeorge, 2016). Some of the documents that provide guidance to investigators, including the U.S. Food and Drug Administration (FDA) Redbook 2000, specifically reference dogs as a preferred non-rodent species (FDA, 2007). Addressing the two-species requirement for animal toxicity studies, the Redbook comments that the non-rodent species is “usually dogs” or, in screening for neurotoxicity, “preferably dogs” (FDA, 2007).

With the rise in new cellular and molecular disciplines and gene-manipulation technologies that favor the use of rodents, the late 20th century saw a precipitous decline in dog use in the United States, as described in Chapter 3 and Appendix B. The precise nature of this decline is discussed in greater detail in Chapter 3, which addresses the current use of dogs for biomedical research. While most laboratory dog use is carried out to satisfy regulatory requirements related to product development by private industry, investigators in a limited number of biomedical fields continue to perform research using laboratory dogs, based on familiarity, equipment, training and experience, access to historical data, biological factors that cannot be modeled effectively in other systems, or a combination of these reasons, as will be described in Chapter 3.

LEGAL CONTEXT FOR USING LABORATORY DOGS IN BIOMEDICAL RESEARCH

In the United States, the 1965 exposure of abuses by “Class B” unregulated dog dealers was a flashpoint in the evolution of attitudes toward the treatment of dogs and other animals, contributing, in part, to the passage of the Animal Welfare Act of 1966 (AWA) and subsequent amendments (Adams and Larson, 2016; Engber, 2009). The AWA established the basis for regulation of animal research involving selected warm-blooded animal species in the United States.2

For the past half-century, a set of principles known as the Three Rs (replace, reduce, refine) has guided the ethical use of animals in research (Russell and Burch, 1959; Tannenbaum and Bennett, 2015), and these principles are endorsed or incorporated into various regulations, policies, and laws, including the Guide for the Care and Use of Laboratory Animals (the Guide) (Griffin and Locke, 2016). The Three Rs require researchers to employ methods that replace the use of animals wherever possible, reduce the number of animals used, and refine procedures to minimize pain, suffering, distress, or lasting harm and improve animal welfare (Russell and Burch, 1959). Multiple U.S. and international organizations exist to advance the Three Rs and to enable scientific practice to draw ever closer to an ideal expression of these principles (Anestidou et al., 2017; EURL-ECVAM, 2019; ILAR, 2019; NC3Rs, 2019). Some ethicists and animal welfare scientists have proposed revisions to the Three Rs to reflect society’s evolving understanding of animal welfare (see Beauchamp and DeGrazia, 2019; Brønstad and Berg, 2011; DeGrazia, 2019; Kirk, 2018; Mellor, 2016).

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2 U.S. Code Title 7, Chapter 54: Transportation, sale, and handling of certain animals. “Animal Welfare Act.” Available at https://www.nal.usda.gov/awic/animal-welfare-act (accessed December 30, 2019).

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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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Requirements for the Use of Dogs in VA Biomedical Research

Like most institutions that conduct animal research in the United States, the VA is required by law to comply with federal regulations under the AWA. Additionally, VA policy requires compliance with the U.S. Public Health Service (PHS) Policy, which includes adherence to American Veterinary Medical Association (AVMA) euthanasia guidelines and the provisions of the Guide. The VA recognizes that for each of these, the authority to interpret the requirements rests with the entity that published and oversees compliance with it. The VA also requires all VA animal research programs to maintain full accreditation by AAALAC International and to comply with internal VA policies and reporting requirements.

The Animal Welfare Act and Regulations

The U.S. Department of Agriculture (USDA) enforces federal regulations governing the care and use of dogs in biomedical research in accordance with the AWA, which aims “to insure that animals intended for use in research facilities or for exhibition purposes or for use as pets are provided humane care and treatment,” and with the corresponding Animal Welfare Regulations (AWR).3 Under the AWA/AWR, all institutions using dogs for research must register with the Secretary of Agriculture and procure dogs in accordance with the regulations. Minimum standards are established for the transportation, handling, housing, feeding, watering, sanitation, ventilation, and veterinary care of all research animals covered by the AWR, with additional requirements for exercising dogs. For animals involved in experimental procedures, standards include requirements to minimize pain and distress and to consider alternatives to procedures that may cause pain or distress.

Institutions registered under the AWA/AWR are required to keep records which are examined during annual unannounced inspections by the USDA veterinary medical officer. The VA’s animal research programs are generally not visited by USDA inspectors but are still required to file a USDA annual report of animal usage and pain category for species regulated by the USDA (including dogs).

Institutional Animal Care and Use Committee

Each research institution must establish an oversight and ethical review committee, the institutional animal care and use committee (IACUC), which is required to inspect the institution’s “program for humane care and use of animals” and “animal facilities, including animal study areas” at least semi-annually. For any activity involving animals, the IACUC must review those components relating to animal care and use for compliance with the AWA. Research with animals, including dogs, may be conducted only after the IACUC (1) reviews the protocol describing what is to be done, and why, and how discomfort, pain, and distress to the animals will be avoided or minimized; (2) determines that the protocol is in compliance with AWA/AWR, PHS Policy, and AAALAC International and VA requirements; and (3) grants approval for it to proceed. The IACUC must be made up of no fewer than five voting members, appointed by the chief executive officer of the institution, which for VA stations is the local medical center director. The IACUC is required to include at least “one Doctor of Veterinary Medicine with training or experience in laboratory animal science and medicine, who has program authority and responsibility for activities involving animals at the institution,”4 one practicing scientist experienced in research with animals, one

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3 CFR Title 9, Subchapter A: Animal welfare. “Animal Welfare Regulations.” Available at https://www.nal.usda.gov/awic/animal-welfare-act (accessed December 30, 2019).

4 CFR Title 9, Chapter 1, Subchapter A, § 2.31(b)(3)(i) and PHS Policy, par IV.A.3.b(1).

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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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member whose concerns are primarily nonscientific, and one member who is otherwise unaffiliated with the research institution.

Work on any research with animals may begin only after the IACUC determines that the proposed activities are in accordance with regulatory requirements. Those requirements focus on “avoid[ing] or minimize[ing] discomfort, distress, and pain to the animals, consistent with sound research design,”5 which implies a responsibility to weigh study objectives against animal welfare concerns. The standard VA animal protocol form, the animal component of research protocol, approaches this responsibility in several ways, including requiring documentation of (1) harm–benefit analysis, (2) justification for the number of animals requested, (3) justification for the species requested, (4) endpoint criteria, and (5) a database search for appropriate alternatives, in accordance with the tenets of the Three Rs, to replace animals, reduce the number of animals used, or refine procedures to better minimize pain or distress. The IACUC has the authority to withhold approval from any research proposal and to stop work on any project it determines to have failed to meet proper standards, and the IACUC is required to report noncompliance to the VA’s facility director and the associate chief of staff for research and development. The IACUC does not itself evaluate the scientific merit of a study but rather relies on the judgment of the committees of scientific subject-matter experts that carry out scientific review of the research proposal.

The Office of the Chief Veterinary Medical Officer provides in-person animal research and IACUC training for VA personnel once or twice per year at major national meetings and also in customized station-specific training workshops for IACUC members conducted at individual stations as needed. IACUC training exercises are developed about four times per year to help local IACUCs maintain expertise and stay abreast of emerging issues (NRC, 2011).

The U.S. Public Health Service Policy on the Humane Care and Use of Laboratory Animals

PHS Policy, administered by the National Institutes of Health’s (NIH’s) Office of Laboratory Animal Welfare (OLAW), is specifically designed to apply to the care and use of animals involved in research, research training, and biological testing activities conducted or supported by PHS (PHS Policy, par. I), which includes institutions receiving research funds from NIH, FDA, or the Centers for Disease Control and Prevention. The VA has a longstanding arrangement for OLAW to oversee all VA research with animals, so any VA research with animals must be covered by a PHS animal welfare assurance (statement of compliance) approved by OLAW, regardless of whether the activities use PHS funds. OLAW recently began overseeing animal activities funded by the National Science Foundation and the National Aeronautics and Space Administration as well. Compliance with PHS Policy requires adherence to the recommendations in the Guide (NRC, 2011) and relies on the guidance about the PHS Policy provided in the Frequently Asked Questions guidance section of the OLAW website (OLAW, 2019).

The Guide is intended to assist institutions and investigators in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate in accord with scientific, humane, and ethical principles. The Guide highlights a commitment to the Three Rs and provides detailed recommendations regarding the composition and responsibilities of the IACUC, including guidelines for protocol review and post-approval monitoring (NRC, 2011). The Guide also includes detailed recommendations for housing and environment (including the importance of social housing), veterinary care, and the physical plant. Its recommendations are presented as “must,” “should,” or “may,” indicating practices deemed mandatory, strongly recommended, or suggested for consideration. Any deviation in practice from a “must” statement requires written justification and inclusion in a semi-annual report to the institutional official, typically the medical facility

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5 PHS Policy IV.C.1.a and CFR Title 9, Chapter 1, Subchapter A, § 2.31(d)(1)(i).

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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.
×

director. The Guide stipulates that primary oversight responsibilities for an animal care and use program rest with the institutional official, the attending veterinarian, and the IACUC.

The American Veterinary Medical Association’s Guidelines for the Euthanasia of Animals

AVMA’s Guidelines for the Euthanasia of Animals (AVMA, 2013) provides veterinarians with guidance for relieving the pain and suffering of animals that are to be euthanized, consistent with the obligations of the Veterinarian’s Oath. Methods for measuring consciousness, pain, stress, and distress are discussed, as are principles governing the administration of inhaled, non-inhaled, and physical agents. Intravenous injection of a barbituric acid derivative is the preferred method of euthanasia for dogs. Euthanasia for dogs in laboratory settings must be approved by the IACUC.

AAALAC International

AAALAC International is an internationally recognized accreditation organization that evaluates institutions that voluntarily apply for accreditation. VA policy requires all facilities where VA animal research is conducted to be in programs that maintain full accreditation. AAALAC International performs site visits of every accredited program once every 3 years, using a peer-review process and site visits by teams selected for their professional expertise. Each VA program that conducts dog research receives an additional AAALAC International interim site visit in between the usual triennial visits. AAALAC International uses the Guide (NRC, 2011) as a primary standard for accreditation.

Internal VA Policy Documents

In addition to the external requirements listed above, VA animal research programs are required to comply with the following internal VA policy documents:

  • Veterans Health Administration (VHA) handbook 1200.07, Use of Animals in Research (VHA, 2016), sets forth principles and procedures that govern research, testing, and teaching activities involving laboratory animals at the VA, including detailed requirements for the composition and responsibilities of the IACUC. Training is required for all individuals involved in animal research and husbandry; the American Association for Laboratory Animal Science provides web-based training tools for VA husbandry staff (AALAS, 2020). The current forms required by the VA for animal research programs and detailed instructions for their use are available online.6
  • The animal component of research protocol is the form required for protocols submitted for IACUC review, for projects that are to be supported by VA funding. The forms for VA IACUC semi-annual evaluations of the animal research program and facilities provide checklists as well as tables for documenting the significance of deficiencies noted and how the IACUC determines they are to be addressed as well as a framework for summarizing the findings as a meaningful guide for improving the program and moving forward.
  • VHA handbook 1058.01, Research Compliance Reporting Requirements (VHA, 2015), sets forth the requirements for reporting non-compliance events in VA research to research review committees, facility officials, and the Office of Research Oversight (ORO). According to the handbook,

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6 See https://www.research.va.gov/programs/animal_research/documents.cfm (accessed August 20, 2020).

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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.
×

VA personnel … must ensure written notification of the IACUC within 5 business days after becoming aware of any apparent unanticipated death(s) of animals used for research, including deaths due to physical plant deficiencies, engineering failures, worker errors, test article toxicity, anesthetic or surgical complications, and other mishaps…. The IACUC must notify the VA facility director and the ACOS/R&D [associate chief of staff for research and development] within 5 business days after reaching a determination that a reportable incident has occurred…. The VA facility director must report the incident to ORO within 5 business days after receiving the IACUC’s notification.

STANDARDS FOR THE USE AND WELFARE OF DOGS IN BIOMEDICAL RESEARCH

AWR (Part 3, Subpart A) set specific standards for dogs used in research with regard to identification, transportation, emergency planning, housing, and husbandry.7 Dogs must be individually identified and provided with safe containment, temperature control, and adequate food and water during transportation. Dog enclosures must be of an adequate size (based on dog size) and constructed of sanitizable materials that are regularly cleaned and safe for the animals. Ventilation, temperature, and humidity must fall within prescribed parameters, and lighting must be diurnal and not excessive. Though laboratory dogs are rarely housed outdoors, there is a separate set of standards that must be met to provide for their comfort and safety in this circumstance. Health and husbandry standards stipulate the need for the compatibility of dogs housed together, the regular exercise of dogs housed in individual enclosures, daily feeding and twice-daily watering, daily cleaning of primary enclosures, biweekly sanitization of used primary enclosures and food and water receptacles, housekeeping, and pest control. Medical care must be provided and overseen by an attending veterinarian. Employees must be adequately supervised and trained to carry out the required level of animal husbandry and care.

The Guide (NRC, 2011) provides detailed recommendations regarding the dogs’ environment, adding noise and vibration to the factors mentioned above along with a consideration of their socialization needs. Recommendations for medical care place a strong emphasis on the need to minimize pain and distress. Unlike the AWA/AWR, most recommendations in the Guide fall in the categories of “should” or “may” rather than “must.”

Conclusion 2-1: Based on the documentation provided by the U.S. Department of Veterans Affairs (VA) and other organizations (e.g., confirmation of AAALAC International accreditation) as well as site visits, the committee concludes that the VA’s biomedical research programs involving laboratory dogs appear to adhere to all relevant policies surrounding animal research.

SOCIAL AND ETHICAL CONSIDERATIONS

The committee was convened specifically to assess the use of dogs within the United States, and it is reasonable to ask why public and political pressure is being placed on the VA to curtail dog research in particular. The perceived mistreatment of dogs elicits an intense emotional reaction that resonates in the public sphere. As noted previously, it was this dynamic that led to passage of the AWA. The U.S. Congress passed the AWA in response to public pressure triggered in part by a Life

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7 CFR Title 9, Subchapter A: Animal welfare. “Animal Welfare Regulations.” Available at https://www.nal.usda.gov/awic/animal-welfare-act (accessed December 30, 2019).

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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.
×

magazine article exposing the neglect of dogs housed by unlicensed animal dealers—an article that stimulated more letters to Life magazine than any story on Vietnam or civil rights (Stevens, 1990).

The committee did not investigate the basis for valuing dogs differently from the many other species that share humans’ lives, habitats, and research activities. Pigs, cats, birds, horses, livestock, and an array of other species have their proponents. The idea that dogs should receive preferential treatment over other domesticated species is not supported by the current understanding of ethics as it applies to animals (DeGrazia, 1996). In other words, from an ethical standpoint—discussed in greater detail later in this chapter—dogs are not intrinsically more valuable than other large mammals.

ETHICAL CONSIDERATIONS ON THE USE OF DOGS IN VA RESEARCH

Dogs are valued by members of the public, including many veterans, and they tend to receive privileged treatment relative to other non-human species. This is evidenced in the amount that Americans spend on companion animals as well as by some of the evolutionary evidence suggesting that dogs have been bred and that perhaps in ancient times Homo sapiens selected dogs for preferential treatment.

However, the prevalence and intensity of such preferences (and their biological basis) has less than obvious implications for the ethics of using laboratory dogs in research. On the one hand, it is tempting to honor such dominant societal preferences by privileging dogs and enacting unusually restrictive policies for conducting research using them. On the other hand, cultural preferences sometimes lead society astray in terms of ethical decision making. One need not look far back in U.S. history to find moral mistakes where dominant social preferences supported policies that privileged members of certain groups. A more developed model of the ethics of using laboratory dogs in VA research requires an analysis of how the interests of veterans, laboratory animals, members of society, and others are implicated by conducting such research and what duties the VA has to members of those various groups.

Research involving laboratory dogs implicates the interests of laboratory dogs; knowledge users like patients, physicians, and veterinarians; non-canine laboratory animals that might be substituted for or replaced by laboratory dogs; working, service, military, and companion dogs that may derive benefit from research using laboratory dogs; members of society who place a high value on dogs; and individuals who depend on the institution under whose auspices the research is conducted—in this case, the VA. An ethical framework for biomedical research with laboratory dogs should explain how the interests of each articulate with each other, which interests should drive decisions and policy, and how interests and preferences might be accommodated or respected without violating obligations.

There is widespread consensus within the field of bioethics that many non-human animals have moral status. Though the views of different commentators often originate from different ethical theories, they generally converge on the position that members of any non-human animal species that has sentience deserve protection and respect (DeGrazia, 1996; Regan, 1983; Singer, 1975). Another way this is commonly articulated is that the suffering endured by a member of one species does not, by virtue of its species membership alone, deserve greater or lesser regard than the equivalent amount of suffering in another species.

Dogs clearly qualify as having sentience and various mental states that entitle them to respect and protections in biomedical research. For example, they have interests in their own welfare. They feel pain, anxiety, fear, and depression, and they have preferences for being treated in certain ways. Dogs also have the capacity to flourish in a life. In these respects, dogs are not different from other sentient species such as human beings, non-human primates, cats, pigs, and mice. Where species vary is in their particular needs—that is, what they need to flourish and avoid suffering. For

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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.
×

example, whereas dogs might need social stimulation with other dogs or human beings in order to thrive, pigs might require a different type of social stimulation or none at all.

Some ethicists and anti-vivisectionists would advocate a ban on any invasive research involving members of sentient non-human animal species. However, the present report is working within assumptions grounding the Statement of Task, one of which is that animal research can be conducted ethically. To that end, policy and regulations have established several ethical conditions for conducting animal research. These include the following:

  • Any experiment should minimize compromises to the welfare of a non-human animal by using the smallest number of animals possible, by using the least invasive and burdensome approaches possible (including using companion dogs instead of laboratory-housed dogs where feasible), or by substituting species that are expected to have their welfare less compromised (or using in vitro or in silico methods);
  • All animals used in research must be treated humanely. Specifically, non-human animals must receive competent veterinary care, must be given proper analgesia and must be euthanized if in extreme duress, and must be housed under conditions that are suitable and enriched for that species;
  • Any experiment involving non-human animals should be conducted according to high scientific standards;
  • The burdens of any experiment involving non-human animals must be justified by the value of the knowledge acquired from the experiment; and
  • Judgments regarding the fulfillment of each of the requirements above should be independently and expertly refereed.

In recent years, various commentators have sought to extend these standards—for example, by requiring that non-human animals used in research should have “lives worth living” (DeGrazia and Sebo, 2015). Of course, having standards does not mean that the application of those standards is done easily or without controversy. For example, quantifying the value of the knowledge to be attained from a study is contentious. For instance, must it be directly translatable to human (or veterinary) use, or is an expansion of a body of knowledge sufficient? Most of these questions lie outside the scope of this committee’s task. Dogs, nonetheless, have unique needs and interests in being treated humanely in the context of research. Chapter 5 contains a detailed discussion of the care and welfare of laboratory dogs.

Substitute Species

Policies and practices surrounding dog research also have implications for members of other species that might be substituted for, or replace, laboratory dogs. Policies that restrict research on dogs would in many instances transfer the burden to other large animal models, such as pigs, sheep, and non-human primates. Therefore, any ethical policy must address the ethics of substitution. The use of any animal model presupposes that a human model is not ethically appropriate because the best model for human research is, of course, a human. It must also be determined that in vitro and in silico methods are insufficient and that conducting clinical studies in companion dogs (where the veterinarian bears care obligations and the owner can provide a type of surrogate consent) rather than laboratory dogs is not feasible or scientifically appropriate.

In determining whether to use a dog or other animal, the committee believes that the most important consideration is whether their biological characteristics make them the most suitable model for the question being addressed. For example—and as discussed in detail later in this report—while the coronary anatomy of the pig makes this species a favored model for studying

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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.
×

atherosclerosis, the pig may be unsuitable for studying electrophysiological aspects of arrhythmia due to significant physiological differences in the Purkinje fiber networks between pigs and humans.

But physiological and anatomical characteristics are not the only criteria that should be considered. Behavioral or cognitive characteristics may make an animal more or less suitable for use in research. A non-human primate’s superior cognitive ability may cause it to react differently than a non-primate, and in that context an animal that is likely to experience less harm may be a superior model, provided that the model’s biological characteristics are sufficiently similar to those of humans to address the research question. A sheep may be more docile than a goat and therefore better for one study, while it may be less trainable and therefore worse for another. Even if an animal is biologically and behaviorally appropriate, if members of the species cannot be housed and handled in a way that does not induce undue suffering, they are not suitable models. Moreover, some animals may pose hazards to the research team that make them inappropriate models.

Another criterion is which species has provided the best, most relevant historical data. Past experience with a given species may support linking data from an experiment to historical data and thus allow for fewer animals to be used than would be needed in the transition to a new model. Nonetheless, this argument is potentially problematic, as it may be employed to justify the continued use of a less suitable model because the latter was used first.

There are no clear moral grounds for arguing that dogs have a “higher” moral status than other large animal species such as pigs or that scientists ought to be more restrictive about research on dogs than pigs because the former have greater moral value. What matters most in selecting a particular species, from an ethical standpoint, is that (1) the biological characteristics of the non-human animal indicate that the model will provide valuable knowledge; and (2) the harm experienced by the animals is minimized (Rachels, 2004). Some animal research protocols may be less harmful when conducted in dogs than in other species such as pigs. Others might be the reverse. For example, anxiety associated with blood draws, ureteral catheterizations, or other procedures might be less burdensome for trained dogs than for pigs. On the other hand, pigs might fare better than dogs in studies that require prolonged isolation.

Rights and Interests of Patients

Much of the biomedical research conducted with laboratory dogs is aimed at human clinical applications (exceptions include research on veterinary applications, application of human therapies in veterinary patients, and, to a lesser extent, basic research). Which research uses dogs—and how the research is performed—has clear implications for the interests and welfare of patients who might ultimately benefit from the information gathered in dog studies. In this respect, patients and other information users have interests that rival those of dogs or substitutable species.

There are several features of patient interests, however, that can be contrasted with those of dogs or substitutable species. First, whereas harms to laboratory dogs associated with a given research protocol are immediate and certain, benefits to patients are prospective and probabilistic. Not all studies advance patient care, and even when they do, many years can elapse between an experiment and its clinical application. Second, whereas harms to laboratory dogs are unconditional (they are, in a sense, hard-wired into the protocol), benefits to patients are conditioned on several factors. For example, the research needs to be designed and conducted in a way that supports valid clinical generalization, minimizing bias and confound. In order for research to advance patient care it must be disseminated in a timely manner, through complete and unbiased reporting. And there must be a community of researchers who are able to invest the time and resources in further developing a treatment approach.

There is also the circumstance in which the patient is the dog and the research using dogs supports therapeutic opportunities for both human and veterinary patients. For example, VA

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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.
×

investigations using laboratory dogs to find new treatments for human arrhythmias and cardiac failure also benefit veterinary treatments for arrhythmias and cardiac failure in dogs.

The Role of Societal Preferences in Establishing Ethical Animal Care Standards

Humans and dogs evolved symbiotically over tens of thousands of years. Approximately 38 percent of American households owned a dog in 2016 (AVMA, 2018). Many members of the public have an emotional aversion to the use of dogs in research that is different than their reaction to the use of other animals. While most Americans favor humane research practices for all animals in research, many would likely oppose using dogs in research. This is not surprising; many Americans love their dogs and consider them to be family members. Perhaps because farm animals are a dietary staple for many, and most Americans have very limited interactions with them, a close attachment is not common.

The extent to which societal preferences translate into ethical guidance for research policy is not entirely clear. These preferences find expression in laws that restrict and regulate the use of dogs in research (see Chapters 1 and 3 for recent legislation regarding VA research using dogs). Beyond that, it might be argued that the unique relationship with dogs obliges humans to create exceptions that favor the use of other animals over dogs when all (or most) other considerations are equal. It might also be argued that federal agencies such as the VA could show respect for views that are prevalent among the taxpayers that fund them.

On the other hand, the preference for dogs can also be viewed as prejudicial. That is, insofar as honoring such a preference would substitute other species for dogs, it discounts the welfare and interests of other species merely because many individuals prefer dogs. Most accounts of animal ethics reject “speciesism” (i.e., the notion that it is acceptable to discriminate against some animals based on their species membership), or at least they place strong constraints on it. By analogy, many people have strong bonds with members of their own culture or religion, and this finds expression in contributions to various cultural or religious charities. Few would argue that such preferences—however justified—would provide a sound basis for establishing policies that discount the welfare of members of non-majoritarian cultures or religions in terms of hiring, access to medical care, or use in research. Similarly, the moral relevance of the human–dog unique relationship is highly debatable.

Individual relationships entail special obligations, such as those owed by parents to their children, teachers to pupils, or physicians to patients. A dog owner has a stronger moral obligation to his or her own dog than to the sheep (or dog) on a neighbor’s farm. It is entirely unclear, however, whether the entire population of a species (e.g., human beings) bear such moral duties. It is not clear that people in general are morally justified in discounting the welfare and interests of sheep. Nor is it clear that the entire population of a species (e.g., dogs) have moral status per se or that they have special claims that oblige humans to protect or prioritize the interests of dogs over those of other species.

According to prevailing accounts of animal ethics in the scholarly literature, there is no basis for discounting the interests and welfare of animals like sheep or pigs relative to dogs. Various commentators have derived a rejection of such speciesism in different ways. Utilitarians note that animals have interests and a capacity for suffering and there are no a priori reasons to posit that the welfare of animals counts less than that of human beings (Singer, 1975). Some argue that animals have inherent value, owing to their interest in avoiding pain and satisfying preferences (Korsgaard, 2011). Others argue that from an evolutionary standpoint, there are no principled ways to draw a moral boundary around species, because mental traits in human beings that are believed to confer moral status are present to some degree in at least some non-human animals (Beauchamp and Frey, 2011; Bekoff, 1998; Rachels, 1990). In all of these frameworks the animal’s moral value is

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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.
×

intrinsic—it is not determined by the extent to which others assign value to the animal. In this view, the fact that members of one species are loved more than members of another species is irrelevant with respect to the duties we owe to a given animal (Regan, 1983).

The rejection of speciesism is also implicit in the pragmatic framework for animal research ethics offered by DeGrazia and Sebo (2015). One of the conditions they stipulate is the notion that no experiment should entail unnecessary harm, where necessity is dictated by the purpose of the experiment. On this view, using a species that would experience greater welfare loss for a given research objective would count as unnecessary harm. Just as the decline in welfare of one human being ought to have equal weight to the decline in welfare of another human being when considering whether an act is ethical, a decline in welfare of one animal (a human being, or a dog) ought to have identical weight to the equivalent decline in welfare in another animal (e.g., another dog, or a sheep).

Rejecting speciesism does not logically imply that all animals should be treated exactly the same. Different animals require different things to flourish. Some animals need certain kinds of bedding, others need certain forms of mental stimulation, and others need space to roam. A rejection of speciesism implies that equal consideration be given to the equivalent interests of different animals and members of different species (DeGrazia, 1996).

Institutional Considerations

As described earlier in this chapter, the use of dogs in biomedical research remains controversial. Therefore, the mission of any institution that sponsors dog research is potentially threatened by the political fallout associated with conducting such research. If negative publicity leads to diminished budgetary support or reputational harm, it can set back all parties that depend on the VA. On the one hand, every dollar that the VA spends on public relations to shore up support for dog research is one less dollar available to advance the health of veterans. On the other hand, the use of dogs to develop effective treatments can improve the VA’s reputation and support while serving its core mission.

To what extent should reputational considerations drive policy at an institution like the VA? As argued above, the substitution of laboratory dogs with alternative species that would experience greater welfare loss would be unethical. In this case, any reputational benefit accruing to the VA as a result of privileging dogs would be at the expense of ethical integrity, insofar as alternative species were used. Institutions that conduct research on dogs would seem to have special obligations to employ active and effective public communication strategies aimed at educating the public to secure the necessary support and minimize reputational risk.

Synthesis

Because of the unique bond that many human beings have with dogs, it is tempting to infer that dogs bear a higher moral status and therefore deserve greater protection than other species like rabbits or pigs. However, it is important to look closely at the basis for these preferences and to ask whether they are prejudicial. Pigs, sheep, and cows—and mice and rats, for that matter—all have moral status; they have feelings, preferences, interests in their own welfare, and the ability to suffer. In varying ways, all can experience a flourishing life. A human preference for dogs does not of itself justify a lower regard for the welfare of non-dog species. By analogy, all parents have a special relationship with their own children. However, that does not make it permissible for them to mistreat other children. The welfare of all children should be held in equal regard, regardless of parentage.

If dogs should be afforded greater protection, it is not because of their superior moral status but because of how humans perceive them. Current societal preferences in the United States implicate

Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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.
×

multiple stakeholders, and while moral status may not dictate preferential treatment for dogs, other interests may.

There was division among committee members as to whether and the extent to which dogs should receive preferential treatment in research. A majority of the committee members believe that moral status should be the principal concern and that societal interests should serve, at most, as a tie-breaker. For example, imagine that a proposed study could be conducted in pigs as well as in dogs, a careful risk–benefit assessment concludes that either would produce an equivalent gain in knowledge, and both would entail roughly the same degree of burden on the animals. In this circumstance, societal preferences could serve as a tie-breaker and justify the use of the alternate species (i.e., the pig) in research, instead of the dog. The full committee believed that such equivalences are likely to be uncommon.

In contrast, a minority of committee members do not believe that such an approach sufficiently recognizes the societal preferences at play. While they recognize the importance of the moral status of all animals, they support a position that uses dogs only when no other animal model can be used to answer the scientific question posed, even if that model is associated with much greater impact in a non-dog species.

Conclusion 2-2: Many people have a unique relationship with dogs. This relationship stems from tens of thousands of years of joint history and the cultural value of the role of dogs as service, military, law enforcement, and working partners as well as companion animals. This cultural preference for dogs is not universal, nor does it necessarily constitute a reliable guide to ethical action. The majority of the committee concludes that it is valid to consider the societal preference for dogs only in situations where expected burden for substitute species is anticipated to be equivalent to that projected for the laboratory dog.

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Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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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Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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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Suggested Citation:"2 Legal, Social, and Ethical Considerations." 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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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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