The nonprofit Physicians Committee for Responsible Medicine, which promotes the use of human-based research to improve health and replace animal use, has welcomed the U.S. National Institutes of Health’s “landmark” commitment to prioritize innovative, human-based methods, like organoids, tissue chips, computational models, and real-world data analyses, while reducing animal use.
“NIH Director Jay Bhattacharya’s historic announcement that the NIH will prioritize human-based science is not only a big win for animals, but also for human health,” says Catharine E. Krebs, PhD, medical research program manager for the Physicians Committee for Responsible Medicine.
“We’ve known for a long time that animal experiments don’t reliably translate to human health outcomes, coming at a grave cost to patients in need of better treatments, to innovation, and to animal lives.”
A poor representation
Animal experiments are poorly representative of human health and disease and rarely predictive of drug efficacy, safety, and toxicity in humans. The reliance on animals is a direct contributor to high failure rates in the drug development pipeline, wasting billions of dollars each year and putting trial participants and patients at risk by failing to capture unsafe or ineffective products.
As a result, untold numbers of dogs, cats, monkeys, mice, rats, and other animals are bred and used in painful and deadly research and testing procedures—estimated to be greater than 100 million per year in the United States.
Innovative 3d in vitro technologies like tissue chips, organoids, and bioprinting, as well as advanced computational modelling and real-world data analyses, are already being used to replace animals in a variety of applications, including disease modelling, precision medicine, and regulatory toxicology.
These pioneering methods, also called new approach methodologies (NAMs), use human cells, tissue, and data to replicate human-specific biology and disease characteristics and have enormous potential to revolutionize medical research and testing.
The announcement details several agency actions to better prioritise innovative human-centred research, including the establishment of the Office of Research Innovation, Validation, and Application (ORIVA) to coordinate NIH-wide efforts to develop, validate, and scale up the use of non-animal approaches and serve as a hub for interagency coordination and regulatory translation.
Funding expansion
To promote the broader use of non-animal approaches, ORIVA will expand funding, training, and infrastructure and help raise awareness of their value in translational success. New funding opportunities will include evaluation criteria that assess methods based on their suitability for the research question, context of use, translatability, and human relevance—factors which should help improve review quality and ensure impartiality toward different methods.
To also aid in the review of non-animal research proposals, grant review staff will participate in mitigation training to address bias toward animal studies—a phenomenon called animal methods bias—and review groups will include non-animal method expertise. Lastly, the NIH will publicly report on research spending annually to measure progress toward reduction of funding for animal studies and increase for human-based approaches.
This significant shift builds on steady progress at the agency toward the broader development and use of non-animal, human-based methods. In 2024, the NIH accepted comprehensive recommendations on catalysing non-animal approaches made by an advisory group, including many measures reflected in the announcement, like supporting non-animal method infrastructure and training and raising awareness of the value of non-animal approaches. In conjunction, a new program called Complement-ARIE was launched, aimed at speeding up the development, standardisation, validation, and use of such methods.
More ethical science
“NIH investment in nonanimal alternatives has steadily increased over the last couple decades, but as much as half of the agency’s budget still goes toward animal use,” says Krebs. “Today’s announcement is exactly what the medical research enterprise needs to generate real change toward more ethical and effective science.”
This historic news comes on the heels of the groundbreaking April 10 announcement from the U.S. Food and Drug Administration to phase out animal testing requirements for monoclonal antibodies and other drugs. These changes are popular among the public: In a recent poll, 85% of Americans agreed that “animal experimentation should be phased out in favour of more modern research methods.”
Physicians Committee experts have been working toward these changes for many years, advocating for the prioritization of human-centered research and the public reporting of funds going toward animal- and nonanimal-based studies, providing critical feedback regarding challenges and investment opportunities for NAMs, and leading an international collaboration of researchers and advocates aimed at addressing animal methods bias.
Earlier this month, the Physicians Committee and 324 scientists, physicians, and other health professionals sent a letter to Director Bhattacharya, asking him to lead the agency in the important shift away from the use of animals in medical research in favour of human-based science.
