Opportunity Information: Apply for RFA RM 18 009
The NIH Directors Transformative Research Award (R01 - Clinical Trial Optional), Funding Opportunity Number RFA-RM-18-009, is a National Institutes of Health (NIH) grant designed to back research ideas that are genuinely bold and unconventional, where the payoff could be a major leap forward for biomedicine or behavioral science. It is part of the NIH Common Fund High-Risk, High-Reward Research program, which is specifically meant to support work that might be too novel, too early, or too paradigm-challenging to fare well in more traditional funding mechanisms. The core emphasis is on proposals that could reshape how a field thinks, open up entirely new areas of inquiry, create transformative technologies, or lead to dramatically improved clinical approaches. The "clinical trial optional" label means applicants may propose studies that include clinical trials, but a clinical trial is not required.
A defining feature of this opportunity is its explicit encouragement of exceptionally innovative and original research, including projects that might seem unconventional by standard peer review expectations. NIH signals that little or no preliminary data are expected, which is important because it lowers the barrier for pursuing high-risk concepts that have not yet accumulated extensive proof-of-concept evidence. That said, applicants still need to make a convincing case that the idea is scientifically sound in its rationale and, most importantly, that it has clear potential for major, broad impact. In other words, the program is not simply funding speculative ideas; it is funding ideas that, if they work, would change the landscape in a meaningful way across a broad area of biomedical or behavioral research.
The award uses the R01 grant mechanism (a standard NIH research project grant), but the spirit and selection criteria are aligned with transformative, high-impact outcomes rather than incremental advances. NIH welcomes applications from individual investigators as well as groups of scientists, and it is open to any topic that fits within the broad NIH mission. The opportunity also explicitly welcomes applicants with diverse backgrounds, reinforcing that NIH is looking for a wide range of perspectives and approaches, which often fuels the kind of creative thinking this program is meant to reward.
In terms of eligibility, the program is broadly accessible across many organization types. Eligible applicants include state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other applicants as allowed under NIH policy (with the notice indicating to consult the funding announcement text for any special clarifications). The sponsoring agency is the U.S. Department of Health and Human Services (HHS), National Institutes of Health.
Key administrative details from the posted opportunity include a creation date of May 23, 2018, and an original closing date of September 21, 2018. The listing indicates an expected number of awards of 7. The "Award Ceiling: 0" entry typically reflects that a single fixed cap is not stated in that field in the source record rather than implying no funds are available; applicants normally need to rely on the full funding announcement and NIH budget policies for allowable budgets and project periods. Overall, the program is best understood as a competitive, prestige-oriented NIH mechanism aimed at enabling researchers to pursue potentially field-changing ideas that could be too risky or unconventional for standard grant pathways, with success measured by the magnitude and breadth of the potential scientific or clinical transformation.Apply for RFA RM 18 009
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH Directors Transformative Research Award (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 May 23, 2018.
- Applicants must submit their applications by Sep 21, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 7 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: NIH Director's Transformative Research Award (R01 - Clinical Trial Optional) - RFA-RM-18-009
What is the NIH Director's Transformative Research Award (R01 - Clinical Trial Optional)?
It is an NIH grant opportunity designed to support research ideas that are unusually bold, unconventional, and potentially capable of producing a major leap forward in biomedical or behavioral science. The award uses the R01 mechanism, but the emphasis is on transformative, high-impact outcomes rather than incremental advances.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number (FON) is RFA-RM-18-009.
Which agency sponsors this opportunity?
The sponsoring agency is the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH).
What larger NIH program is this award part of?
This opportunity is part of the NIH Common Fund High-Risk, High-Reward Research program, which is intended to support ideas that may be too novel, too early, or too paradigm-challenging for traditional funding mechanisms.
What kinds of projects is NIH looking to fund through this award?
NIH is looking for exceptionally innovative and original research that could reshape how a field thinks, open entirely new areas of inquiry, create transformative technologies, or lead to dramatically improved clinical approaches. The key is the potential for major, broad impact if the approach succeeds.
Does this program require preliminary data?
NIH signals that little or no preliminary data are expected, which is intended to lower the barrier for proposing high-risk concepts that may not yet have extensive proof-of-concept evidence.
If preliminary data are not expected, how should an application still make a strong case?
Even without extensive preliminary data, applicants are expected to provide a scientifically sound rationale and clearly explain why the idea has the potential for major, broad impact. The program is not aimed at purely speculative ideas; it is focused on ideas that could meaningfully change the landscape if they work.
What does "Clinical Trial Optional" mean for this opportunity?
"Clinical Trial Optional" means applicants may propose studies that include clinical trials, but proposing a clinical trial is not required to apply.
Is this award limited to specific research topics or disease areas?
The opportunity is open to any topic that fits within the broad NIH mission.
Is this opportunity intended for incremental research projects?
No. While it uses the R01 grant mechanism, the stated spirit and selection criteria are aligned with transformative, high-impact outcomes rather than incremental advances.
Can teams apply, or is it only for individual investigators?
NIH welcomes applications from both individual investigators and groups of scientists.
Does NIH encourage applications from investigators with diverse backgrounds?
Yes. The opportunity explicitly welcomes applicants with diverse backgrounds, reflecting an interest in a wide range of perspectives and approaches.
What types of organizations are eligible to apply?
Eligibility is broad and includes: state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other applicants as allowed under NIH policy (with the notice indicating applicants should consult the funding announcement text for any special clarifications).
Are for-profit organizations eligible to apply?
Yes. The eligibility list includes for-profit organizations other than small businesses, as well as small businesses.
Are tribal governments included in the eligible applicant types?
Yes. Federally recognized Native American tribal governments and certain tribal organizations are listed as eligible applicants.
Are colleges and universities eligible to apply?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are included as eligible applicants.
What is the expected number of awards for this opportunity?
The listing indicates an expected number of awards of 7.
What are the key dates listed for this opportunity?
The posted opportunity includes a creation date of May 23, 2018, and an original closing date of September 21, 2018.
Is there an award ceiling (maximum award amount) listed?
The listing shows "Award Ceiling: 0," which typically indicates that a single fixed cap is not stated in that field in the source record, rather than implying that no funds are available. Applicants are expected to rely on the full funding announcement and NIH budget policies for allowable budgets and project periods.
What does the use of the R01 mechanism imply here?
The award uses the NIH R01 mechanism (a standard research project grant), but it is positioned as a competitive, prestige-oriented opportunity aimed specifically at enabling potentially field-changing ideas that might be too risky or unconventional for standard grant pathways.
How does NIH describe success for projects funded through this award?
Based on the program description, success is tied to the magnitude and breadth of potential scientific or clinical transformation, meaning the work could produce major advances across a broad area of biomedical or behavioral research.
Where should applicants look for any special eligibility clarifications or detailed requirements?
The notice indicates that applicants should consult the full funding announcement text for any special clarifications, as well as NIH policies for budget and project period details.
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