The 3Rs and Non-Human Animals in Biomedical Research: The Next 65 Years

It has been 65 years since the publication of Russell and Burch’s “The Principles of Humane Experimental Technique,” which established the ‘3Rs’—refinement, reduction, and replacement—as the key principles applicable to decision making about, and the use of, non-human animals in laboratory settings. The 3Rs are universally accepted by responsible scientists throughout the world and form the basis for many national legal and regulatory systems governing animal use in laboratories. This Article will discuss broadly how the 3Rs have evolved over the past seven decades since the publication of Russell and Burch’s seminal work, and examine the 3Rs in light of the needs of the biomedical research challenges today and into the future. The Article also evaluates recent critiques of the 3Rs and assesses whether such critiques are warranted considering current research practices and societal concerns.

To make the 3Rs maximally useful for the 21st century and beyond, additional principles should be added that take into consideration (1) the need to strengthen reproducibility and predictivity of animalbased research; (2) the recognition that animals are sentient beings whose basic needs must be met; and (3) the importance of a harm-benefit evaluation that addresses the benefits, risks, and harms to humans as well as animals. The 3Rs must evolve in these ways so that science can continue to develop, and laboratory animal use can be reduced or replaced. An earlier draft of this Article was discussed at George Washington University School of Law’s “Animals and the Antropocene: A Legal Scholarship Symposium” on March 24th, 2023. A small portion of the work discussed in this Article was supported by a NIEHS Training Grant.