NIH embraces the human-first research revolution

Amid a major shift in biomedical science in the U.S., the National Institutes of Health is launching an initiative to reduce animal testing while expanding innovative research technologies based on humans, a move similar to the latest FDA efforts and could fundamentally change the way medical discovery reaches patients.

The program establishes a new research innovation, validation and application (ORIVA) responsible for developing and expanding non-animal research methods across the agency’s broad portfolio. This organizational change shows an increasing recognition that traditional animal models, while valuable, often face serious limitations when predicting human outcomes.

“For decades, our biomedical research systems have relied heavily on animal models. Through this initiative, NIH is ushering in a new era of innovation,” said Dr. Jay Bhattacharya, director of NIH. “By combining advances in data science and technology with an increasing understanding of human biology, we can fundamentally reimagine the way research is developed from clinical development to real-world applications.”

Part of the reason for moving towards human-based methodology is the disappointing translation rate in key research areas. Studies on Alzheimer’s disease and various cancers often show promising results in animals, only failing in human trials, a pattern that attributes this pattern to fundamental differences in physiology, disease progression and genetic function between species.

Researchers at institutions such as the Wyss Institute at Harvard University have demonstrated the potential of alternative approaches. Their “pulmonary lung chip” technology combines microbial engineering with tissue engineering to mimic human lung behavior for drug screening, the type of innovation that NIH is now seeking priority.

In addition to organ and tissue chips, the program will also promote computational models to simulate complex biological systems and encourage real-life health data analysis of human populations. The strategic shift represents the necessary evolution in research methods that many scientists believe.

Dr. Bhattacharya highlights the potential implications: “This human-based approach will accelerate innovation, improve healthcare outcomes and provide life-changing treatments. This marks an important leap in science, public trust and patient care.”

For researchers accustomed to traditional animal models, the transition may require significant adjustments. The NIH plans to address this issue through expanded funding opportunities specifically targeting non-animal approaches and adopt new assessment criteria to assess methods based on human relevance and translational potential rather than conforming to established animal protocols.

The agency also acknowledges potential institutional biases favoring traditional methodology. Grant reviewers will receive training to identify and mitigate animal research preferences, while experts on alternative approaches will increasingly be involved in the research sections that evaluate research recommendations.

Perhaps most importantly, the NIH plans to implement accountability by publicly reporting annual research expenditures, thereby tracking progress in reducing animal research while increasing investment in human-based approaches. This commitment to transparency suggests that the program extends to the scope of measurable institutional changes.

For animal welfare advocates, the announcement represents a welcome turnaround, although many point out that traditional animal models remain critical to certain research questions where alternatives do not exist yet. The initiative seems to balance moral considerations with pragmatic scientific assessments, which methodology is best to answer specific questions.

With the improvement of computing power and tissue engineering technology, researchers are expected to create increasingly complex human-related models. Early successes, such as chip-on-pulmonary technology, demonstrate how emerging methods capture complex mechanical and biochemical behaviors that were previously observed only in organisms.

The transition doesn’t happen overnight. Developing, validating and expanding human-based alternatives requires significant investment and expertise. However, by establishing Oriva as a dedicated office in the board office, NIH expresses the agency’s commitment to this scientific evolution.

For patients waiting to treat diseases with poorly modeled models through animal studies, the program offers new hope that the findings can be translated more reliably into effective therapies. As the country’s major medical research institution oversees 27 institutions and centers, NIH’s methodological priorities significantly affect the wider biomedical research ecosystem.

Whether this shift represents a paradigm change or is merely an expansion of available research tools remains to be seen, but the direction is clear: tomorrow’s medical discoveries will increasingly rely on technologies designed to reflect human biology from the outset.