Press release
Tuesday, April 29, 2025
A new initiative aims to reduce the use of animals in NIH-funded research.
Combining microfabrication techniques with modern tissue engineering, the lung-on-a-chip, designed by Harvard University's Wyss Institute, offers a new in vitro approach to drug screening by mimicking the complex mechanical and biochemical behaviors of a human lung. The work on the lung-on-a-chip was supported by the NIH Common Fund and the FDA. Wyss Institute, Harvard University
The National Institutes of Health (NIH) is adopting a new initiative to expand innovative human-based science while reducing the use of animals in research. The development and use of cutting-edge alternative non-animal research models aligns with the recent initiative. of the United States Food and Drug Administration (FDA) aimed at reducing animal testing. While traditional animal models remain essential to the advancement of scientific knowledge, the use of new and emerging technologies can offer unique advantages that, when used correctly or in combination, can expand researchers' tools to answer previously difficult or intractable biomedical research questions.
“For decades, our biomedical research system has relied heavily on animal models. With this initiative, the NIH is ushering in a new era of innovation,” said Dr. Jay Bhattacharya, NIH Director. “By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally rethink how research is conducted, from clinical development to real-world application. This human-centered approach will accelerate innovation, improve health care outcomes, and deliver breakthrough treatments. It marks a critical leap forward for science, public trust, and patient care.”
Some research has been inconclusive regarding the effectiveness of translating findings from animal models to human diseases, such as Alzheimer's disease and cancer. These difficulties in translating to humans may be due to differences in anatomy, physiology, lifespan, and disease characteristics. Although humans and animals may share genes, some studies have shown that there may be functional differences between organs and body systems that could lead to certain translational limitations.
New and emerging technologies have begun to enable researchers to study health and disease using human information, making it an alternative route to produce reproducible, translatable, and effective results, either alone or in combination with animal models. These technologies include:
- Organoids, tissue chips, and other in vitro systems that allow scientists to model human diseases and capture human variability and patient-specific characteristics.
- Computer models that simulate complex human biological systems, disease pathways, and drug interactions.
- Real-world data that allows scientists to study health outcomes in humans at the community and population levels.
To integrate innovative human-based science, the NIH intends to create the Office of Research Innovation, Validation, and Translation (ORIVA) within the Office of the NIH Director. The new office will coordinate NIH-wide efforts to develop, validate, and expand the use of non-animal approaches across the agency's biomedical research portfolio and serve as a hub for interagency coordination and regulatory translation for the protection of public health.
ORIVA will increase funding and training for non-animal approaches and raise awareness of their value for translational success. New funding opportunities will include evaluation criteria that assess methods based on their fit to the research question, context of use, translatability, and human relevance. The infrastructure for non-animal approaches will also be expanded to make these methods more accessible to researchers.
Additionally, grant review staff will participate in mitigation training to eliminate potential bias toward animal studies and integrate alternative methods experts into study sections. The NIH will also publicly report research spending annually to measure progress toward reducing funding for animal studies and increasing funding for human-based approaches.
About the National Institutes of Health (NIH): The NIH, the nation's medical research agency, comprises 27 institutes and centers and is a component of the U.S. Department of Health and Human Services. The NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research. It studies the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.
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