Each year, tens of millions of animals are used in scientific and commercial research in the U.S. There are two federal statutes that cover these animals – the Animal Welfare Act (AWA) and the Health Research Extension Act (HREA). Together they form a complex, and often counterintuitive, system that governs the way that investigators, institutions and animals interact.
Ethics of Animal Testing
In the United States, precise numbers of animals involved in research and testing are unknown. The vast majority of animals used in research (such as mice, rats, and birds bred for research) are not covered by the AWA. While the HREA covers many of the animals that are excluded from the AWA, it does not require that facilities report the number of animals they use, and applies to a smaller number of facilities than the AWA. This lack of transparency, along with different definitions of what constitutes an animal, and differences in applicability, raise ethical concerns that have led many animal advocates to work towards welfare improvements for research animals, argue for more visibility about the numbers of animals that are used and how they are used, and advocate for the development of alternatives to animals in research and testing.
There are several ethical theories that can be applied to the use of animals in research and testing. These include deontology, virtue ethics, and utilitarianism. Understanding the ethical principles that underlie federal laws is important, especially for attorneys and other advocates who seek changes to the current system.
Animal Testing Regulations and Policies
There are two federal agencies that are responsible for implementing the federal laws that cover animals in research and testing.
The U.S. Department of Agriculture (USDA) houses the Animal and Plant Health Inspection Service (APHIS), the agency responsible for enforcing the AWA. The US National Institutes of Health houses the Office of Laboratory Animal Welfare (OLAW), which administers the HREA. Facilities covered by both laws are legally required to have Institutional Animal Care and Use Committees (IACUCs) to monitor the animals’ standard of care and review protocols. IACUCs are central to the system of self-enforcement that is embedded in both the AWA and the HREA. The scope of what IACUCs can do, who serves on them, and their decision-making is of great importance to the system of laboratory animal law. IACUC deliberations and decisions are almost never available to the public. Research institutions are also guided to follow the “3 Rs,” which call for replacement, reduction, and refinement of animal testing and a standard of care, which is set out in The Guide for the Care and Use of Laboratory Animals.
In the past decade, significant progress has been made in the development and use of non-animal methods that are based on human biology. A focus on seeking alternatives to animal testing has gained greater attention and is evolving rapidly. In 2023, the U.S. eliminated its previous requirement that all drugs be tested on animals before being given to human subjects. And in 2024, the American Bar Association adopted a resolution urging Congress and federal agencies to promote the development and use of methods that aim to replace, reduce and refine the use of animal models in research and testing. These developments reflect shifting public and scientific sentiment regarding the use of animals in research and testing and the need to support the growing use of these new methods.
Law & Ethics of Animal Testing Course
Advocates arguing for the protection of animals used in research or testing take a number of approaches, including passing legislation, garnering public support, and advocating among scientists and researchers. For those interested in the legal and ethical landscape surrounding research animals, the Center for Animal Law Studies (CALS) at Lewis & Clark Law School offers a course in the Law & Ethics of Animal Testing. It explores the regulations and policies that govern the use of animals in research and testing, and topics include bioethics and contemporary developments in animal-research litigation and legislation.
Alongside guest speakers who offer unique insights into the multifaceted issue of animal testing, the course is taught by two leaders in the field: Dr. Paul Locke, Distinguished Visiting Professor of Animal Law and Science at Lewis & Clark Law School, and Professor Rebecca Critser, Adjunct Professor and CALS LLM alum.
Dr. Locke is a professor at the Johns Hopkins Bloomberg School of Public Health, where he researches radiation policy and toxicity testing. He holds a J.D. as well as master’s and doctorate degrees in public health. He leads a toxicology policy team at Hopkins that is dedicated to supporting the development and utilization of non-animal, human inspired biological methods in testing and research. Informed by his background, Dr. Locke takes an interdisciplinary approach to the course, incorporating law, public health, and science to ground discussions in practical examples. Dr. Locke is a member of the ABA and testified in support of the ABA 3Rs resolution.
Professor Critser took the Law & Ethics of Animal Testing course as an Animal Law LLM student at Lewis & Clark. Professor Critser, who also teaches Animal Legal Philosophy in the online advanced degree program, balances her own science background in animal behavior and biotechnology with her legal background and a deep understanding of bioethics and philosophy. Professor Critser is now a postdoctoral fellow at Johns Hopkins, where she specializes in studying animals used in science, and she chairs the ABA TIPS Animal Law Committee’s Science & Technology Subcommittee. Professor Critser presented on Laboratory Animal Legislation, Litigation, and Care Standards at the 32nd Animal Law Conference, participating in a panel moderated by Dr. Locke.
Scholarship Opportunities
If you would like to learn more about the ethics of animal testing and how you can protect animals used in research, consider an MSL or LLM in animal law through Lewis & Clark Law School’s Center for Animal Law Studies (CALS). Both programs are offered on campus in Portland, Oregon, and online in an asynchronous learning environment.
Through the generosity of William C. Borst Trust, CALS offers two unique scholarship opportunities for advocates passionate about reform that benefits laboratory animals:
First, the William C. Borst Anti-Vivisection Scholarship provides a full-tuition scholarship for an incoming Animal Law LLM or MSL student who is interested in anti-vivisection work, including through policy development, scholarship, or advocacy. Priority is given to applicants passionate about ending the use of companion dogs in research. All applicants to the MSL and LLM programs are considered for the scholarship. Please note and explain your interest and experience in the personal statement provided as part of the admissions process. Applications are due by May 1, 2025, for Fall 2025 start in the advanced degree program. Learn more, including how to apply, here for the MSL and here for LLM.
Second, CALS also offers a limited number of full-tuition Visiting and Auditing Student Scholarships to take our Summer 2025 online course—The Law & Ethics of Animal Testing. Applications are due by May 5, 2025. Applicants must meet the requirements to take the course as a Visiting Student or Auditing Student with a Certificate, with priority given to those passionate about ending the use of companion dogs in research. Learn more and apply here.