Report on Research Compliance 19, no. 7 (July, 2022)
NIH’s highest ranking external advisory committee had just heard a spirited, hour-long explanation about the agency’s Advanced Research Project Agency for Health (ARPA-H), punctuated by enthusiastic interjections from Adam Russell, ARPA-H’s acting deputy director, who’d been on the job barely two weeks.
Next up was Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, to give an update on COVID-19 to the Advisory Committee to the Director (ACD). After his presentation, an ACD member told Fauci she was concerned about the impact of COVID-19 on Native American and rural populations.
Could an ARPA-H effort help target the underserved, wondered Roberta Diaz Brinton, director of the University of Arizona’s Center for Innovation in Brain Science. Fauci responded that, since the start of the pandemic, NIH has had a task force addressing the adverse effects of COVID-19 on minority and other vulnerable groups.
“I’m not so sure we need an ARPA-H for it—whatever that is,” added Fauci, who was not present for the earlier discussion.
Still, talk of ARPA-H has been in the media and on the lips of Congress, the White House and HHS officials for more than a year. President Biden first proposed the agency as part of NIH in an April 9, 2021, memorandum to Congress in advance of his fiscal year (FY) 2022 budget, seeking $6.5 billion for the project.[1]
Modeled after the Defense Advanced Research Projects Agency (DARPA), it is to have “an initial focus on cancer and other diseases such as diabetes and Alzheimer’s” and represent an “investment in Federal research and development [to] drive transformational innovation in health research and speed application and implementation of health breakthroughs,” the budget memorandum explained at the time.
More recently, ARPA-H was approved by Congress in March as part of its final continuing resolution for FY 2022, which began in October. It was even the focus of some backlash. On March 31, Rep. Anna G. Eshoo, D-CA, chair of the Energy and Commerce Health Subcommittee, called HHS Secretary Xavier Becerra’s decision to place ARPA-H and “transfer funds to NIH…an opportunity squandered.”[2]
“I have consistently urged the Administration to set up ARPA-H for success on Day 1 by creating an independent, empowered, risk-taking agency. Regrettably, the HHS Secretary has chosen the opposite by relying on a bureaucratic structure, rather than a transformational one,” said Eshoo, who sponsored the bill to create ARPA-H.
Becerra announced Russell’s hiring on May 25, and two days later, HHS published a notice in the Federal Register outlining the structure of the agency.[3][4]
Russell joined ARPA-H after serving as chief scientist at the Applied Research Laboratory for Intelligence and Security at the University of Maryland. His role is to “help launch ARPA-H and “guide the early stages of building the administrative structure of the agency and oversee the hiring of initial operational staff to ensure the agency is stood up as effectively and efficiently as possible.”
The Federal Register said ARPA-H “provides leadership for high-risk, high-reward biomedical and health research to speed application and implementation of health breakthroughs equitably”; “creates, supports, and manages programs to catalyze the development of transformative, evidenced-based, use-driven capabilities, platforms, and technologies in a range of biomedical and health research areas”; “facilitates partnerships and collaboration among government, academia, industry, and other sectors to accelerate the translation of innovation into meaningful and measurable benefits for the nation”; and “converts use-driven research into tangible, sustainable solutions for patients.”
It will have a Treatment Innovation Office, Health Promotion and Disease Detection Office, and an Innovation and Entrepreneurship Office, among others.
ARPA-H Described in Glowing Terms
While ARPA-H may be new to Fauci, many of the ACD members also had questions, owing to the quick pace of recent developments, as Atul Butte, MD, told RRC after the meeting.
“I was glad to hear more about ARPA-H during the ACD meeting,” said Butte, pediatrics professor, director of the Bakar Computational Health Sciences Institute at University of California (UC), San Francisco, and chief data scientist for UC Health. “Everything I heard about ARPA-H today was absolutely new to me, and the presentation did highlight how its operations will be different from the usual way NIH operates. I had not heard of any of those details before, but I do think it’s still very early days for ARPA-H and there’s still a lot that is unclear about how exactly it’s going to work.”
Tara Schwetz, currently NIH’s acting principal deputy director, described ARPA-H to the ACD, frequently using the words bold, nimble, robust, dynamic, and synergistic.[5] She noted that Congress appropriated $1 billion available through Sept. 30, 2024. However, President Biden is also seeking an additional $5 billion in his FY 2023 request, which Congress has not yet acted on.
Among the other details she shared, are the following:
Leadership: President Biden will appoint a director, but the position does not require Senate confirmation. No timetable was given for when this would occur. Schwetz said the director will “set out the vision of the organization” and “outline the scientific foci of ARPA-H, at least as a starting point in the beginning.” The White House is seeking someone with ARPA experience who also is “an extraordinary leader with a proven track-record and a vision for driving transformative change in health or biomedicine,” she said. This position is among several related high-level posts the White House needs to fill. Former NIH director Francis Collins, who retired in December, has stepped in as acting director of the Office of Science and Technology Policy (OSTP); both the top NIH slot and the OSTP position require Senate confirmation. Larry Tabak, former principal deputy director, is acting NIH director.
Staffing: ARPA-H anticipates hiring approximately 100 full-time employees over the next year. It also will use contractors “for support systems, with a model similar to DARPA,” Schwetz said. Approximately 30 to 40 program managers will be hired, based in part on their ability to make a “pitch” for a program, she added. But hiring will “wait” until the director is on board. Program managers are expected to hold their posts for three-year terms, which could be renewable once.
Funding opportunities and decisions: ARPA-H will be “working toward” making its first broad agency announcement, or proposal solicitation, in the fall. Pending approval by the inaugural director, the agency plans to judge solicitations based on the Heilmeier Questions, named for a former DARPA director. These include describing the objectives without using jargon; explaining how something is done now, by whom and the “limitations of present approaches”; establishing what is “new”; and stating why the idea will succeed and what impact it could have. Proposers also need to identify the risks, costs and length of time to achieve the goal. ARPA-H may add questions about how equity would be achieved and whether the “solution” would be “applicable to other challenges.”
For his part, Butte had his own set of questions.
“What kind of institutions do you think are going to apply for ARPA-H?” he asked. “When you think about the institutions that apply for DARPA and ARPA, they’re not necessarily academic institutions. Do you see the traditional NIH applicants also playing a role here?”
“If we are doing things correctly, we’re hoping to see applicants, and hopefully then performers, who are coming from a variety of different areas and segments of the community,” said Schwetz, “from academic researchers to companies to small businesses and everything and everyone in between. Ideally…we're going to be promoting these large-scale challenges that will probably necessitate interdisciplinary, transdisciplinary approaches. We’re hoping that people will come together and form teams that are not the typical teams we'd put together necessarily or that would evolve organically. We’re going to try to encourage that formation.”
Butte also asked if officials “see dollars for translational research moving towards ARPA-H and moving away from NIH.”
“What we’re talking about here is an approach that is supplemental to NIH; it’s really meant to be complementary. The work that ARPA-H is going to do can’t be done without the work that NIH does, and so we wouldn’t want to see that sort of shift. We want to see dual growth for both entities and efforts,” she replied.
“So, if you can use phrases—and I apologize if this is too snarky—like dynamic and transformation for the way ARPA-H is going to pick projects to fund, why can’t we use those phrases for the rest of NIH-fund[ed] projects?” Butte asked.
Schwetz said NIH has funded and engaged in dynamic research, as demonstrated during the pandemic, and said ARPA-H’s approach will be “synergistic and collaborative.”
Russell added that ARPA-H might actually ban words like dynamic and innovation, saying “at the end of the day it comes down to” metrics researchers can show for their potential progress or programs, not descriptive words.
1 Young, Shalanda D., FY 2022 Discretionary Request, letter to Sen. Patrick Leahy, April 9, 2021, https://bit.ly/3N2SGiM.
2 Rep. Anna G. Eshoo, “Eshoo Statement on Becerra Placing ARPA-H in NIH,” press release. March 31, 2022, https://bit.ly/3N95yUq.
3 HHS, “HHS Secretary Becerra Establishes ARPA-H within NIH, Names Adam H. Russell, D.Phil. Acting Deputy Director,” May 25, 2022, https://bit.ly/3HCX8n7.
4 Establishment of the Advanced Research Projects Agency for Health, 87 Fed. Reg. 32,174, May 17, 2022, https://bit.ly/3n2bNPq.
5 Tara A. Schwetz, “Advanced Research Projects Agency for Health (ARPA-H) A, New Paradigm for Propelling Use-Driven, High Impact Biomedical and Health Research,” meeting of the Advisory Committee to the Director, June 9, 2022, https://bit.ly/3OoH4aL; NIH “Advisory Committee to the Director – June 9, 2022 (Day 1), Videocast, 1:39:00, June 9, 2022, https://bit.ly/3aZOSBl.
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