Last month, HR 5585, a bill that would establish the Advanced Research Projects Agency for Health (ARPA-H), passed in the US House of Representatives and is now heading to the Senate.
The Physicians Committee has been working hard to ensure this new agency prioritizes human-specific, nonanimal research. While new text was added to the bill in support of predictive model development and animal welfare, there are still many areas where it can be improved to strengthen its transformative potential for patients and animals.
ARPA-H is modeled after the Defense Advanced Research Projects Agency (DARPA), which funds high-risk, high-rewardprojects. National Institutes of Health (NIH) grants typically aim for more incremental progress over a longer timeframe, whereas the ARPA-H framework aims to help develop promising biomedical technologies more rapidly and at a larger scale. This model of administration equips the new agency for robust health research innovation that our country badly needs in the face of pressing public health concerns like COVID-19 and growing rates of dementia. However, it’s crucial that we use this exciting opportunity to overcome barriers to clinical translation caused by outdated and unreliable animal studies.
For ARPA-H to succeed in its goal of driving transformational health breakthroughs, the agency must put forth significant investment in disease models and technologies based on human, not animal, biology. For instance, microphysiological systems, or “tissue chips,” use human-derived cells in a chip the size of a thumb drive to mimic the structure and function of human tissues. In 2012, DARPA began investing in this technology because of their potential to develop and test countermeasures to biological threats at greater speed and accuracy than typical animal-based approaches. Nearly ten years later, tissue chip technologies are commercialized and readily available as predictive tools for use in drug development, disease modeling, and personalized medicine. They can emulate a wide variety of human organs, including the brain, lung, heart, liver, and intestine, and cell types from multiple organs can be configured together to observe complex inter-organ effects.
Inside the Bill
Also called the ARPA-H Act, HR 5585 importantly establishes the new agency in the Department of Health and Human Services, not in the NIH, as laid out in some previous versions of the bill. The NIH has a poor track record on reducing and replacing animal experimentation. The Physicians Committee has consistently advocated for establishing ARPA-H independently from the NIH to ensure a culture of innovation that moves medical research away from its reliance on animals.
The final House version of the ARPA-H Act states that the new agency should achieve its goals by “developing new capabilities, advanced computational tools, predictive models, or analytical techniques.” This language, which wasn’t included in previous versions of the bill, is important because human-specific, nonanimal models are more predictive of human outcomes than the use of animals, and they include computational tools. But the bill fails to specify that ARPA-H should achieve its goals by developing human-specific, nonanimal models. Thus, the Physicians Committee urges the Senate to strengthen the bill here by being explicit about the use of nonanimal models.
The ARPA-H Act describes the duties of program managers—staff in charge of establishing agency goals and selecting which projects to fund. In previous versions of the bill, there was no mention of animals, but here, program managers are assigned with ensuring that animal studies meet the same federal animal research requirements that govern research at the NIH and that proposals appropriately justify the number of animals used. Again, this is a step in the right direction as it implicitly acknowledges researchers’ moral obligation to protect animals. The Physicians Committee will continue to advocate for ARPA-H program managers to select projects based on their relevance to human biology and their minimization or elimination of animal use.
Other promising language in the ARPA-H Act includes efforts to recruit and retain a diverse workforce. Prioritizing human research would not only reduce animal use but would also help address funding biases that disadvantage Black scientists, who are more likely to propose research on topics with lower award rates, such as research involving human subjects.
Taken together, the House version of the ARPA-H Act makes some promising advances, including independence from the NIH, explicit mention of predictive and computational models, animal welfare, and workforce diversity. The Senate now has the opportunity to strengthen the bill even more by including provisions that prioritize nonanimal, human-based research. If it can do so, this exciting new agency holds great potential for improving human health research and reducing the research enterprise’s reliance on animals. The Physicians Committee will continue to urge Congress to make these important changes.