The National Institutes of Health announced on Monday that the biomedical agency will no longer award funding to new grant proposals solely relying upon animal testing and will require that applicants use some form of computational modeling or artificial intelligence to determine how a particular product or treatment will affect human health.

The new policy marks an incremental shift in the biomedical agency’s overall trajectory toward embracing the data capacity of artificial intelligence, but animal rights groups say the rejection of animal testing is not happening fast enough.

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Nicole Kleinstreuer, the NIH deputy director for programs and strategic innovation, made the policy announcement Monday afternoon during a joint workshop with the Food and Drug Administration about using the power of AI and other emerging technologies to replace animal testing in biomedical research.

“NIH is fully committed to this shift, to reprogramming funding, to modernizing policy, and to prioritizing sustainable, scalable, human-centered research,” Kleinstreuer said.

Kleinstreuer said Monday that all new NIH grant applicants will have to include an outline for New Approach Methodologies using AI or some other form of computational modeling to project how a particular intervention will affect human health.

“All new NIH funding opportunities moving forward should incorporate language on consideration of NAMs,” Kleinstreuer said. “NIH will no longer seek proposals exclusively for animal models.”

The change marks what Kleinstreuer said is a systemwide shift to strengthening the NIH’s ability to use real-world data to study health outcomes in real time and train AI to have better predictive capacity.

“This is where big data and AI and NAMs really can converge to deliver truly predictive science for human health,” she said.

Biomedical research testing on animals became a renewed flashpoint in political discourse during the COVID-19 pandemic, when news broke regarding painful experiments on beagle puppies that were approved by Dr. Anthony Fauci, then the director of the National Institute of Allergy and Infectious Diseases.

Shifting away from reliance on animal testing has been a priority for Dr. Jay Bhattacharya, President Donald Trump’s NIH director, who was confirmed by the Senate on April 1.

On April 29, the agency announced that it would create a new Office of Research Innovation, Validation, and Applications within the director’s office to advance the use of computational modeling and real-world data analysis. One of the new office’s founding goals was to reduce the need for animal testing.

Anthony Bellotti, the founder and president of advocacy group White Coat Waste Project that exposed Fauci’s beagle experiments, told the Washington Examiner that he was “not impressed” with Kleinstreuer’s announcement, saying it ought to have gone further by prohibiting all animal testing.

Although the Defense Department, the Environmental Protection Agency, and the FDA have either banned or released a phase-out timeline for animal testing, Bellotti said Bhattacharya’s NIH “is the black sheep and a big disappointment.”

Kleinstreuer said last month that the biomedical agency would not be phasing out animal studies overnight.

But on Monday, she said the shift toward using computer-generated models to predict human health outcomes is “a very high priority for the NIH director, for the HHS secretary, and for the White House.”

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She noted that the scientific and regulatory apparatus has operated on animal-based models for decades, making the shift all the more important.

“Our responsibility now is to build an even more robust system around NAMs so that we don’t ever have to go backwards relying upon animal models and we can instead go forwards to relying on human biology-based methods,” she said.