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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 how investigators, institutions, and animals interact. 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, the exact numbers of animals used in research and testing are unknown, but their impact must be recognized and addressed. 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 animals excluded from the AWA, it does not require facilities to report the number of animals used, and it applies to fewer facilities than the AWA. This lack of transparency, along with differing definitions of what constitutes an animal and varying applicability, raises ethical concerns. These concerns have led many animal advocates to work towards welfare improvements for research animals, argue for greater visibility into the numbers of animals 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. Ethics must always be a priority when considering the use of animals in research
Animal Testing Regulations and Policies
Two federal agencies 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 either law are legally required to have Institutional Animal Care and Use Committees (IACUCs) to monitor animal care and use 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 rarely available to the public. Research institutions are also guided by the “3 Rs,” which call for replacement, reduction, and refinement of animal testing, and by a standard of care 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. There is still significant progress to be made.
Law & Ethics of Animal Testing Course
Advocates argue for the protection of animals used in research or testing. They take a number of approaches, including lobbying for changes in federal and state laws, garnering public support through education and outreach, and building coalitional support amongst scientists and researchers. Understanding the legal protections, ethical considerations, and societal implications of animal testing is essential for informed advocacy and decision-making. The Center for Animal Law Studies (CALS) at Lewis & Clark Law School offers a course in the Law & Ethics of Animal Testing that explores these issues in depth. It explores the laws and policies governing the use of animals in research and testing; topics include bioethics, developments in animal-research legislation and regulation, and more human-relevant methods.
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 the JHU Toxicology Policy Program, which is dedicated to supporting the development and utilization of non-animal, human-relevant 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 Law School. 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 an Assistant Professor at Johns Hopkins, where she specializes in FDA oversight of animal research and state-based laboratory animal laws. 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 and participated in a panel moderated by Dr. Locke.
Scholarship Opportunities
Now is the time 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 the William C. Borst Trust, CALS offers two unique scholarship opportunities for advocates passionate about reforms benefiting 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. Learn more, including how to apply, here for the MSL and here for LLM.
Second, CALS offers a limited number of full-tuition and partial-tuition Scholarships for our 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.