Regulation of Animal Subjects Research

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Scholars discuss whether the Animal Welfare Act achieves its aim of protecting animal research subjects.

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Biomedical and behavioral researchers use animals as research subjects to improve human health. For example, physicians used cats and dogs to develop the medical technology that would eventually make open heart surgery possible. Today, scientists developing coronavirus vaccines  first tested on animals before moving to human subjects.

In the United States, the Animal Welfare Act (AWA) is the primary regulatory instrument to protect animal research subjects. The AWA protects warm-blooded animals used in research, commercial sale, public exhibition, or commercial transport. The law contains standards for the treatment of animals in research and requires institutional oversight of all animal subjects research. The U.S. Department of Agriculture enforces the AWA through routine inspections of research facilities.

Scholars differ on whether the AWA does enough to protect animal welfare. Some organizations oppose using any form of animal research, but others maintain that animal research is necessary for the continued improvement of medical techniques and treatments.

This week’s Saturday Seminar focuses on the AWA and protections for the use of animals as test subjects in scientific research.

  • In an article published in Mitchell Hamline Law Review, Jane Kotzmann of Deakin University and Nick Pendergrast of The University of Melbourne explain that animal activism exists on a spectrum between two main ideologies: animal welfare theory and animal rights theory. Animal welfare theory focuses on limiting the harm done to animals when used to benefit humans. Animal rights theory argues that animals are entitled to certain fundamental rights that protect them from human use. According to Kotzmann and Pendergrast, animal welfare theory, which frames the AWA, has failed to prevent or slow exploitation of and cruelty toward animals. Instead, they argue that creating a legal framework based on animal rights theory will provide a more effective protection scheme.
  • In a Hastings Law Journal article, Justin Marceau of the University of Denver Sturm College of Law claims that the AWA has “caused more harm than good.” Marceau claims that the structure of the AWA—which only applies to warm-blooded animals—acts as a conceptual barrier to animal protection by confirming the belief that “not all animals count as animals.” Marceau also argues that opponents of animal protection use the AWA to prevent additional regulation of animal welfare. For example, opponents of animal protection often invoke the AWA “to justify deference” to AWA-licensed businesses regardless of whether their practices actually preserve animal welfare.
  • In an article published in the Nebraska Law Review, McGeorge School of Law’s Courtney G. Lee argues that the AWA does not adequately protect animals used in laboratory testing. In 2002, she explains, Congress excluded certain species from AWA protection—including rats and mice, which make up about 95 percent of laboratory tests involving animals. Although Lee acknowledges the medical benefits of animal testing, she suggests that the AWA needs updating to provide more humane treatment for the animals used in these studies. She proposes broadening the definition of “animal” to cover more species capable of feeling pain, requiring researchers to consider alternatives to animal testing, and encouraging facilities to rehome animals rather than kill them after testing.
  • Although strong ethical guidelines cover human test subjects, no comparable guidelines protect animals used in research, according to Hope Ferdowsian and her coauthors in a recent article. They explain that the AWA was originally passed to prevent researchers from illegally obtaining dogs and cats for research but suggest that the law falls short in its protections of other animals used in research. Ferdowsian and her coauthors argue that moral distinctions between the treatment of animal and human test subjects are arbitrary, and so the stricter ethical guidelines that apply to human subjects should also apply to animals. Some of the guidelines they recommend extending include: banning the use of “punishment, coercion, restraint, or confinement” on animals; requiring the expected benefits of the research to outweigh the risk of harm to animals; and guaranteeing that the risk of harm to animals is almost nonexistent.
  • Proposals to reform the AWA typically fall into two schools of thought, Harvard Law School’s Jessica Eisen writes in a University of Michigan Journal of Law Reform article. Eisen notes that proponents of the animal welfare theory argue that animals should be treated in ways that reduce their suffering. On the other hand, followers of the animal rights theory think that animals have inalienable rights and promote treatment of animals that respects those rights. To advance animal protections, however, Eisen argues that public discourse should instead focus on a new perspective, which she calls “evolving ethic.” According to Eisen, this perspective considers other aspects of animal legal protection—such as storytelling of animals’ experiences—and provides a better framework to regulate animal experimentation.
  • In a North Carolina Law Review article, Mayo Clinic’s Karen M. Meagher and Michigan State University’s Paul B. Thompson detail the regulatory history of biotechnology research involving animal subjects. Noting the importance of hog farming in North Carolina, they then discuss how genetic bioengineering will face legal and social challenges—such as environmental justice and food ethics issues—within the state in the future. Borrowing from the lessons learned from genetically engineered mosquitoes, Meagher and Thompson suggest ways that farmers incorporating genetically bioengineered hogs can navigate North Carolina’s farming policies and animal protection legislation.

The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week, The Regulatory Review publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.