NIH Directors Emergency Transformative Research Awards (R01 Clinical Trial Optional) | RFA RM 20 020

Opportunity Information: Apply for RFA RM 20 020

The NIH Directors Emergency Transformative Research Awards (R01 Clinical Trial Optional), funding opportunity number RFA-RM-20-020, was a National Institutes of Health (NIH) grant solicitation created specifically as an emergency response to the COVID-19 public health crisis, using funding provided through the CARES Act. The key point of this announcement is that it was limited to proposals addressing SARS-CoV-2 and COVID-19; applicants with transformative ideas not tied to the COVID-19 emergency were directed to submit instead under the standard Transformative Research Award announcement (RFA-RM-20-013). In other words, this was a targeted, time-sensitive version of a broader NIH high-innovation mechanism, aimed at accelerating unusually bold ideas that could materially change prevention, preparedness, or response efforts related to the pandemic.

At its core, this program sits within the NIH Common Fund High-Risk, High-Reward Research (HRHR) portfolio and is built to back research that is genuinely unconventional and potentially paradigm-shifting. NIH described the aim as supporting individual scientists or teams proposing groundbreaking, exceptionally innovative, original, and/or nontraditional work with the potential to open new scientific directions, produce entirely new and improved clinical approaches, or create transformative technologies. A major feature of HRHR-style opportunities is that they prioritize the strength of the concept and rationale rather than extensive prior evidence, and this FOA explicitly stated that no preliminary data were required. Instead, applicants were expected to make a compelling, logic-driven case that the proposed work could produce major impact for SARS-CoV-2 prevention, preparation, or response.

The scientific scope was intentionally broad as long as it was clearly relevant to coronavirus work. NIH welcomed proposals across essentially any relevant domain, including behavioral and social science research, research addressing health disparities, development of novel therapeutics, and other COVID-19 related topics. Innovation was framed broadly as well: it could be technological (new tools, platforms, diagnostics, devices, or computational methods) or conceptual (new models of disease control, new intervention strategies, or unconventional hypotheses that, if correct, would reshape the field). The overall emphasis was on ideas that might be too early, too different, or too cross-cutting to fare well in traditional funding streams, but that could deliver outsized public health benefits if successful.

In terms of anticipated funding outcomes, NIH stated that, because of the emergency, the Common Fund would use CARES Act resources to support a total of about 5 to 10 awards across two related emergency FOAs: this Transformative Research Awards FOA and the Early Independence Awards FOA (RFA-RM-20-021). That detail matters because it signals a highly competitive environment and a strong focus on standout proposals that bring genuinely new perspectives or methods to COVID-19 challenges, whether in the United States or in international contexts.

Eligibility was broad and included many categories of U.S.-based organizations and public entities typically eligible for NIH grants. The listed eligible applicants included state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education when applicable); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The FOA also highlighted additional eligible applicant types that NIH especially encouraged, reflecting a strong diversity and inclusion emphasis: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); faith-based or community-based organizations; Hispanic-serving institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); certain tribal governments and regional organizations; U.S. territories or possessions; and eligible federal agencies. NIH underscored that it sought applications reflecting the full diversity of the nation’s research workforce and encouraged individuals from diverse backgrounds and institutions across all geographic regions to apply.

Foreign eligibility was handled in a nuanced way. Non-domestic (non-U.S.) entities (foreign organizations/institutions) were stated as not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations were also not eligible to apply. However, “foreign components” as defined in the NIH Grants Policy Statement were allowed, meaning U.S. applicant organizations could include certain internationally located elements of the project when justified and compliant with NIH policy, even though a foreign institution could not serve as the primary applicant.

Administratively, this was a discretionary grant opportunity in the health area (CFDA 93.310) administered by NIH. The opportunity was posted in May 2020 (creation date 2020-05-21) and had an original closing date of September 30, 2020, aligning with the urgent timeframe of early pandemic research mobilization. The FOA title indicates an R01 mechanism with clinical trial optional, meaning applicants could propose studies that did or did not include a clinical trial component, as appropriate to the scientific approach, while still being reviewed under the high-risk, high-reward, transformative expectations of the program.

Overall, the opportunity can be summarized as an emergency, CARES Act-funded call from NIH for exceptionally innovative, high-impact COVID-19 research ideas, evaluated primarily on the transformative potential and strength of reasoning rather than extensive preliminary results, with broad topical latitude across SARS-CoV-2 prevention, preparedness, and response, and with explicit encouragement for participation from a diverse range of investigators and institutions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH Directors Emergency Transformative Research Awards (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
• This funding opportunity was created on 2020-05-21.
• Applicants must submit their applications by 2020-09-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA RM 20 020

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: