Opportunity Information: Apply for RFA RM 19 007
The NIH Directors Transformative Research Awards (R01 Clinical Trial Optional), Funding Opportunity Number RFA-RM-19-007, is a discretionary NIH grant opportunity designed to back research that is intentionally bold and unconventional. The program is aimed at individual investigators or teams proposing projects that are genuinely high-risk but also high-reward, meaning the ideas may challenge current assumptions, open up entirely new directions in a field, or produce step-change advances rather than incremental progress. NIH is looking for work that could create new scientific paradigms, lead to fundamentally new or substantially improved clinical approaches, or generate transformative technologies that reshape how research or healthcare is done.
A key feature of this opportunity is that it welcomes applications across the full breadth of NIH-relevant science. Proposed projects can fall within behavioral, social, biomedical, applied, or formal sciences, and they may be basic, translational, or clinical in nature. As the title indicates, clinical trials are optional, so applicants can propose studies with or without a clinical trial component as appropriate to the transformative concept. NIH emphasizes that proposals should make a strong, logically compelling case for major potential impact in an area broadly relevant to NIH, even if the approach is novel and not yet widely validated.
Unlike many standard research funding mechanisms, this program explicitly states that no preliminary data are required. That policy is meant to remove a common barrier for truly innovative ideas that may be difficult to de-risk using traditional pilot work. Instead, the burden is on the strength of the rationale: reviewers are expected to weigh whether the idea, if successful, would substantially change scientific understanding or practice, and whether the proposed strategy is coherent and capable of testing the transformative concept.
The program is also explicitly focused on supporting excellence through the full diversity of the research workforce and the wide range of institutions across geographic regions. NIH strongly encourages applications from individuals with diverse backgrounds and from all eligible institution types, including organizations that have historically been underrepresented in certain funding streams. This emphasis is framed as essential to finding the best ideas and the best people to pursue them, especially when the goal is disruptive innovation.
Eligible applicants span a broad set of U.S.-based organizational types typical of NIH funding, including state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) and small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as other Native American tribal organizations. The announcement also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
On the foreign eligibility side, the opportunity draws a clear line: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as applicant organizations. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant can include certain international elements when they are justified and meet NIH policy requirements.
Administratively, the opportunity is run by the National Institutes of Health under CFDA 93.310, and it is part of the NIH Common Fund High-Risk, High-Reward Research program. The original posting date (creation date) is March 28, 2019, with an original closing date of September 20, 2019. The publicly provided summary does not specify an award ceiling or expected number of awards in the included source text, but the overall intent is clear: NIH is using this mechanism to fund unusually innovative research proposals that could have outsize impact if they succeed.Apply for RFA RM 19 007
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH Directors 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 2019-03-28.
- Applicants must submit their applications by 2019-09-20. (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.
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FAQs: NIH Director's Transformative Research Awards (R01 Clinical Trial Optional) - RFA-RM-19-007
What is this funding opportunity?
The NIH Director's Transformative Research Awards (R01 Clinical Trial Optional), Funding Opportunity Number (FOA) RFA-RM-19-007, is a discretionary NIH grant opportunity intended to support research that is intentionally bold, unconventional, and potentially transformative.
What kind of research is NIH trying to fund through this program?
NIH is looking for projects that are genuinely high-risk and high-reward. The emphasis is on ideas that could challenge existing assumptions, open entirely new research directions, create new scientific paradigms, enable fundamentally new or substantially improved clinical approaches, or produce transformative technologies that change how research or healthcare is conducted.
Is this program focused on incremental advances or major leaps?
This program is designed for step-change advances rather than incremental progress. The application should make a strong case that, if successful, the work would substantially alter scientific understanding or practice in an NIH-relevant area.
What does "high-risk, high-reward" mean in this FOA?
In this context, "high-risk" refers to ideas that may be unproven, unconventional, or not widely validated yet, and may be difficult to "de-risk" using traditional pilot work. "High-reward" refers to the potential for outsized impact, such as shifting paradigms, creating new directions, or enabling transformative technologies or approaches.
Do applications need to include a clinical trial?
No. The FOA is labeled "Clinical Trial Optional," which means applicants may propose projects with or without a clinical trial component, depending on what best fits the transformative idea.
What scientific areas are eligible?
The opportunity welcomes applications across the full breadth of NIH-relevant science. Proposed work may fall within behavioral, social, biomedical, applied, or formal sciences, and may be basic, translational, or clinical in nature.
Is preliminary data required to apply?
No. A key feature of this program is that no preliminary data are required. Instead of relying on pilot data, reviewers are expected to focus on the strength of the rationale and whether the proposed strategy is coherent and capable of testing the transformative concept.
If preliminary data are not required, what is the application expected to emphasize?
Applications should emphasize a logically compelling case for major potential impact, along with a coherent approach that can test the transformative concept. The central question is whether success would substantially change understanding or practice, even if the idea is novel and not yet broadly validated.
Who can apply (in general terms)?
The program is aimed at individual investigators or teams proposing transformative, high-risk/high-reward projects. Organizational eligibility spans a wide range of U.S.-based institution types typical of NIH funding, including academic, nonprofit, for-profit, and government entities (as listed in the FOA summary).
What types of U.S. organizations are eligible to apply?
Eligible U.S.-based applicant organization types include:
- State, county, city/township, and special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations (other than small businesses) and small businesses
- Public housing authorities / Indian housing authorities
- Native American tribal governments (federally recognized) and other Native American tribal organizations
- Faith-based or community-based organizations
- Eligible federal agencies
- Regional organizations
- U.S. territories or possessions
Are minority-serving institutions specifically highlighted as eligible?
Yes. The FOA summary explicitly highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
Does NIH encourage applications from diverse investigators and institutions?
Yes. The program explicitly emphasizes supporting excellence through the full diversity of the research workforce and a wide range of institutions across geographic regions. NIH strongly encourages applications from individuals with diverse backgrounds and from all eligible institution types, including those historically underrepresented in certain funding streams.
Are non-U.S. (non-domestic) organizations eligible to apply as the applicant?
No. Non-domestic (non-U.S.) entities are not eligible to apply as applicant organizations under this opportunity.
Can a U.S. applicant include international work or partners?
Yes, to a point. While non-domestic entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization, foreign components (as defined in the NIH Grants Policy Statement) are allowed when they are justified and meet NIH policy requirements.
Which NIH program is this opportunity associated with?
This FOA is part of the NIH Common Fund High-Risk, High-Reward Research program.
What is the administering agency and CFDA number?
The administering agency is the National Institutes of Health (NIH). The CFDA number listed for this opportunity is 93.310.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-RM-19-007.
What activity code/mechanism is used?
The mechanism is an R01, and the FOA indicates "Clinical Trial Optional."
When was this opportunity posted and when did it close?
The original posting (creation) date is March 28, 2019, and the original closing date is September 20, 2019.
Does the provided summary list the award ceiling or the expected number of awards?
No. Based on the provided source text, an award ceiling and the expected number of awards are not specified in the public summary included here.
What is the main thing reviewers are expected to weigh?
Reviewers are expected to weigh whether the idea, if successful, would substantially change scientific understanding or practice, and whether the proposed strategy is coherent and capable of testing the transformative concept, even in the absence of preliminary data.
Is this opportunity limited to a specific scientific field or disease area?
No. The FOA summary describes it as open across the full breadth of NIH-relevant science, rather than limited to a narrow field or single disease area.
What is the overall goal of the award program?
The overall goal is to fund unusually innovative research proposals with the potential for outsize impact if they succeed, particularly ideas that are disruptive and could reshape research directions, scientific paradigms, technologies, or clinical approaches.
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