NIH’s Commitment to Human-Based Research Applauded as a Major Milestone for Science and Animal Welfare
The Physicians Committee for Responsible Medicine, a nonprofit organization committed to advancing ethical medical research and improving public health, is celebrating what it calls a “historic step forward” by the U.S. National Institutes of Health (NIH). The agency’s newly announced initiative to prioritize human-based research methods over traditional animal testing is being hailed not only as a monumental win for laboratory animals, but also as a critical pivot toward more effective and humane science.
The announcement, made by NIH Director Jay Bhattacharya, outlines a bold new direction for the agency, emphasizing the development and application of innovative, nonanimal methodologies. These include cutting-edge tools such as organoids (miniature organs grown in vitro), tissue chips that mimic organ systems, advanced computational models, and large-scale analyses of real-world health data. All of these techniques rely on human biology and data, aiming to increase the relevance, efficiency, and reliability of scientific findings.
“This is a big win for animals, but also for human health,” said Dr. Catharine E. Krebs, medical research program manager at the Physicians Committee. “We’ve known for years that animal models often fail to predict how treatments will work in humans. This continued reliance on outdated methods not only puts patients at risk but also wastes valuable resources that could be invested in more innovative, accurate approaches.”
The Cost of Animal Research
The current biomedical research paradigm heavily depends on the use of animals—ranging from mice and rats to dogs, monkeys, and pigs—for drug development, toxicity testing, and disease modeling. Yet, study after study has shown that results from animal experiments often do not translate to human outcomes. This poor predictability contributes to the notoriously high failure rate in clinical drug development, where more than 90% of drugs that appear promising in preclinical stages fail during human trials.
According to the Physicians Committee, this disconnect not only delays medical breakthroughs but also costs the U.S. economy billions of dollars each year. Moreover, it leads to the suffering and death of over 100 million animals annually in the United States alone—animals that are often subjected to painful and invasive procedures with little scientific return.
A Shift Toward Modern Science
In contrast, a new generation of tools—known collectively as new approach methodologies (NAMs)—is changing the landscape of biomedical research. These techniques are grounded in human biology and provide far more accurate representations of human physiology and disease. Tissue chips, for instance, can model complex organ systems and allow researchers to study drug metabolism, toxicity, and disease progression in a controlled, replicable environment. Organoids are increasingly being used to study diseases like cancer and Alzheimer’s at a cellular level, using patient-derived cells.
Advancements in computational biology and artificial intelligence have also enabled researchers to simulate disease mechanisms, predict drug responses, and identify potential therapeutic targets using real-world data sets drawn from clinical records, genomic databases, and public health repositories.
“These modern tools are not just alternatives—they’re superior,” said Dr. Krebs. “They offer the potential to conduct more accurate and reproducible science while upholding ethical standards.”
The NIH’s New Framework for Progress
In its announcement, the NIH laid out a comprehensive strategy for integrating these human-focused technologies into the mainstream of biomedical research. One of the centerpieces of the plan is the creation of the Office of Research Innovation, Validation, and Application (ORIVA). This office will be responsible for driving cross-agency coordination, developing validation frameworks for NAMs, and helping transition promising technologies into regulatory and clinical practice.
To support the growth of nonanimal research, the NIH will also expand its funding mechanisms, training programs, and infrastructure for human-based science. Importantly, new grant application criteria will emphasize the relevance and suitability of proposed methods for addressing the specific research question at hand. Review panels will include experts in nonanimal methodologies, and NIH staff will undergo training to reduce biases that have historically favored animal-based proposals—what experts term “animal methods bias.”
The agency also committed to greater transparency in how it allocates research funding. Annual reports will now include detailed breakdowns of investments in animal versus nonanimal studies, allowing the public and the scientific community to monitor progress.
Building on Momentum
The NIH’s announcement follows a series of recent developments that signal growing institutional support for a transition toward human-relevant science. In 2024, the agency received a set of forward-looking recommendations from an expert advisory group, many of which have now been adopted. These included calls for more robust infrastructure, expanded training for researchers, and efforts to shift the research culture away from animal models.
In parallel, the NIH also launched a new initiative called Complement-ARIE, designed to accelerate the development, validation, and deployment of NAMs. This program aims to fill technical and regulatory gaps that have previously hindered widespread adoption of nonanimal methods.
The Physicians Committee has played a central role in shaping these policy changes. The organization has long advocated for the prioritization of human-based science, public accountability in research funding, and the elimination of barriers to innovative methodologies. In early April, the group coordinated a letter to Director Bhattacharya signed by 324 physicians, scientists, and healthcare professionals, urging the NIH to lead the scientific community toward a more humane and effective research model.
“This is not just about compassion for animals, though that is important,” said Dr. Krebs. “It’s about saving lives—human lives—by doing better science.”
A Broader Cultural Shift
The NIH’s initiative also aligns with recent regulatory reforms at the U.S. Food and Drug Administration (FDA), which announced plans earlier this year to phase out mandatory animal testing for certain drug categories, including monoclonal antibodies. This decision reflects a broader acknowledgment by federal agencies that modern science requires modern methods.
Public sentiment is also strongly behind these changes. A recent national poll found that 85% of Americans support phasing out animal experimentation in favor of more advanced, human-relevant technologies. This growing consensus among scientists, regulators, and the public signals that the time for change has arrived.
While today’s announcement represents a landmark shift, experts caution that fully replacing animal models will require sustained effort and investment. Challenges such as regulatory inertia, entrenched academic practices, and funding imbalances must still be addressed.
Nevertheless, the NIH’s commitment offers a clear roadmap. By embedding human biology at the core of its research strategy, the agency is laying the foundation for a future in which science is not only more ethical, but also more predictive, efficient, and aligned with the needs of patients.
“This moment marks a turning point,” said Dr. Krebs. “With leadership from the NIH, we can finally move beyond animal models and usher in an era of research that respects both scientific rigor and ethical responsibility.”
