By Soumya Somani
Student intern, Science and Technology Policy Program
How were scientists able to make the COVID-19 vaccine within one year? Can scientists similarly accelerate other such breakthroughs for diseases like cancer, Alzheimer’s and diabetes? The National Institutes of Health’s (NIH) new research agency, the Advanced Research Projects Agency for Health (ARPA-H), offers a unique opportunity to advance high-risk, high-reward research typically underfunded in NIH’s traditional focus on incremental, basic research.
Modeled after the Defense Advanced Research Projects Agency (DARPA) — a federal agency credited with the creation of the internet, GPS, self-driving cars and mRNA vaccines — ARPA-H is designed to be a nimble organization with a flat bureaucratic structure composed of project managers who report directly to the agency director. These project managers will have the flexibility to determine what projects to pursue and evaluate under a time-bound, metric-driven system that incentivizes bold ideas and normalizes failures. Under this model, the agency will identify investable projects rather than relying on NIH’s peer review system, thereby mitigating historical conservatism that stifles innovative proposals, inconsistency between peer reviewers and high external costs (i.e., time) for applicants.
While the NIH has successfully managed large, user-focused research projects in the past — such as the Human Genome Project, the Rapid Acceleration of Diagnostics (RADx), and the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) — it lacks the framework to regularly support such accelerated breakthroughs. In fact, in the period after the original 2003 SARS outbreak to the start of the COVID-19 pandemic, researchers working on coronavirus vaccines, treatments and diagnostics struggled to acquire funding from agencies like the NIH, which cited concerns such as irrelevance and low monetary returns. Even though the U.S. spends nearly $178 billion — a mere 20% of its non-defense discretionary budget—on health, very little of that funding ends up tackling society-wide challenges, especially related to diseases that primarily affect marginalized populations.
To that end, ARPA-H emphasizes equity and inclusion in health care access and outcomes in its core mission — an issue often overlooked by federal research agencies — enabling it to tackle the root causes of diseases. Without interweaving a focus on disparities in research innovations and technological development, health inequities would not only be perpetuated but also potentially exacerbated, as effective interventions would fail to reach those most in need. ARPA-H corrects this by funding projects focused on health equity. This is a stark departure from the NIH’s inability to involve community stakeholders in the research process and the racial biases embedded in its grant funding process.
ARPA-H aims to remediate these failures by broadening participation in the research ideation process. More specifically, the agency plans on engaging key stakeholders and end users (e.g., patients, clinicians, targeted marginalized populations) and prioritizing research projects that solve community health challenges. At the organizational level, ARPA-H plans on recruiting leaders and project managers from diverse disciplinary and demographic backgrounds to promote an atmosphere free of barriers to collaboration and inclusion. Such diversity would not only counter systemic biases in federal grant funding but also contribute to the agency’s mission to foster creativity and synergize the strengths and experiences of various agency leaders and project managers.
Some critics argue that ARPA-H’s mission is too broad; Francis Collins, President Biden’s chief scientific advisor and former NIH Director, recently stated that ARPA-H will not ignore any disease. However, it is precisely ARPA-H’s broad mission that enables its network of program managers the intellectual freedom to prioritize what research to pursue. Nonetheless, this criticism underscores how vital program managers are, as they form the backbone of the ARPA model. Risk-averse or irresponsible project managers could work against the agency’s bold mission and needed accountability for the ARPA-H mission to succeed. To avoid this, the ARPA model has an inbuilt turnover system that limits the term of project managers to 3-5 years.
Another major criticism of ARPA-H in its current form is its establishment within the NIH. Proponents of this arrangement — including the Biden White House — have pointed to the benefits of sharing administrative costs and the mitigation of duplicative research. However, housing ARPA-H within the NIH raises concerns about a lack of the agency’s autonomy, limiting its ability to operate beyond the NIH’s culture of conservatism. Establishing ARPA-H within the NIH has also brought it into competition with the NIH and could divert future funding away from the NIH.
Nonetheless, the opportunities ARPA-H offers far outweigh the challenges to implementation. An ARPA-H system is necessary to supplement existing NIH practices and diversify the United States’ biomedical research strategy. Congress must continue to support ARPA-H and push for its establishment as a separate entity from the NIH to alleviate current concerns. With adequate funding and full independence from NIH, ARPA-H can accelerate promising breakthroughs, promote equity in health outcomes, and ultimately, transform the biomedical research ecosystem within the United States.