Opportunity Information: Apply for RFA RM 23 006
The NIH Directors Transformative Research Awards (R01 Clinical Trial Optional), Funding Opportunity Number RFA-RM-23-006, is a National Institutes of Health grant opportunity designed to back research that is intentionally high-risk and high-reward. The program is aimed at bold ideas that could reshape how a field thinks, open up entirely new lines of investigation, create new scientific paradigms, lead to radically improved clinical approaches, or produce genuinely transformative technologies. NIH is looking for projects that are exceptionally innovative, original, unconventional, and likely to have outsized impact if they work, rather than incremental extensions of existing work.
A key feature of this opportunity is that it welcomes proposals across the full breadth of NIH-relevant science and does not restrict applicants to specific disease areas or narrow topic lists. Projects can come from behavioral, social, biomedical, applied, and formal sciences, and they can be basic, translational, or clinical in nature. Clinical trials are allowed but not required, which is reflected in the "Clinical Trial Optional" designation. Importantly, no preliminary data are required, which lowers the barrier for pursuing ideas that are too early-stage or too unconventional to have a standard evidence base yet. Even without preliminary data, the application still needs to make a strong, logically compelling case that the approach is sound and that success would produce a major impact in a broad area relevant to NIH.
This award sits within NIH's Common Fund as part of the High-Risk, High-Reward Research program. That context matters because the review expectations tend to prioritize potential for transformation and the strength of the underlying rationale over traditional indicators like extensive prior results. The program is explicitly trying to identify work that could change the direction of a research area, rather than simply improve it at the margins.
NIH also emphasizes broad participation and encourages applications that reflect the full diversity of the national research workforce. Individuals from groups that are underrepresented in the biomedical and behavioral research enterprise are strongly encouraged to apply, consistent with the Notice of NIH's Interest in Diversity (NOT-OD-20-031). In practice, this means the opportunity is not only open to a wide range of scientific topics, but is also intentionally trying to attract a broad range of investigators and perspectives, on the premise that transformative ideas are more likely to emerge when the applicant pool is as wide and diverse as possible.
Another notable aspect is the pilot review process intended to reduce bias in early-stage evaluation. For the initial peer review phases, the identities of investigators and institutions are withheld until the last phase of review. Applicants must follow specific instructions for anonymizing parts of the application, and those instructions are not optional; they are part of the submission requirements. The goal is to focus reviewers first on the idea, logic, and potential impact, rather than on reputation, institutional prestige, or prior track record cues.
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, and local governments; 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; Native American tribal organizations that are not federally recognized; 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; and small businesses. The announcement also highlights additional eligible 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, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, certain eligible federal agencies, regional organizations, and U.S. territories or possessions.
On the foreign participation side, there are important limits. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may be able to include certain foreign activities or collaborations if they meet NIH policy requirements and are justified within the project.
Administratively, this is a discretionary grant opportunity in the health area (CFDA 93.310) offered by the National Institutes of Health. The original closing date listed for this specific announcement is September 1, 2023, and the opportunity was created on March 27, 2023. The award ceiling and expected number of awards are not specified in the provided listing, which typically means applicants need to consult the full FOA text and NIH budget guidance for allowable costs, project period expectations, and any program-specific budgeting norms.Apply for RFA RM 23 006
- 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 2023-03-27.
- Applicants must submit their applications by 2023-09-01. (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-23-006
What is this funding opportunity?
This opportunity is the NIH Director's Transformative Research Awards (R01 Clinical Trial Optional), Funding Opportunity Number (FOA) RFA-RM-23-006. It is an NIH grant program designed to support intentionally high-risk, high-reward research with the potential to be truly transformative.
What kinds of projects is NIH trying to fund?
NIH is looking for projects that are bold and unconventional, with the potential to reshape how a field thinks, open entirely new lines of investigation, establish new scientific paradigms, produce radically improved clinical approaches, or create genuinely transformative technologies. The emphasis is on exceptionally innovative ideas rather than incremental extensions of existing work.
Is this opportunity limited to specific diseases or topic areas?
No. A defining feature is that proposals are welcomed across the full breadth of NIH-relevant science, without restriction to specific disease areas or narrow topic lists.
What scientific areas are considered appropriate for this award?
The program is open to NIH-relevant research from behavioral, social, biomedical, applied, and formal sciences. Projects may be basic, translational, or clinical in nature.
Are clinical trials required?
No. Clinical trials are allowed but not required, consistent with the "Clinical Trial Optional" designation in the opportunity title.
Are clinical trials allowed under this FOA?
Yes. Clinical trials may be proposed, but they are not mandatory for the application to be responsive to the opportunity.
Is preliminary data required to apply?
No. The opportunity explicitly states that no preliminary data are required. This is intended to lower barriers for ideas that are early-stage or too unconventional to have a standard evidence base.
If preliminary data are not required, what does NIH expect instead?
Even without preliminary data, the application is expected to present a strong and logically compelling rationale showing that the approach is sound and that success would yield major impact in a broad area relevant to NIH.
How is this program positioned within NIH?
This award sits within NIH's Common Fund as part of the High-Risk, High-Reward Research program. That context signals a focus on potentially field-changing work rather than incremental advances.
What does "high-risk, high-reward" mean in the context of this FOA?
It means NIH is intentionally prioritizing projects that may be more uncertain or unconventional than typical proposals, but that could have outsized impact if successful. Review expectations tend to emphasize transformative potential and the strength of the rationale.
Does NIH encourage applications from underrepresented groups?
Yes. NIH emphasizes broad participation and strongly encourages individuals from groups underrepresented in the biomedical and behavioral research enterprise to apply, consistent with NIH's interest in diversity (NOT-OD-20-031).
What is the purpose of the anonymized review process mentioned in the opportunity?
The pilot review process is intended to reduce bias in early-stage evaluation. For initial peer review phases, the identities of investigators and institutions are withheld until the last phase, so reviewers can focus first on the idea, logic, and potential impact rather than reputation or institutional prestige.
Do applicants have to anonymize parts of the application?
Yes. Applicants must follow specific instructions for anonymizing parts of the application, and those instructions are described as not optional. They are part of the submission requirements for this opportunity.
When are investigator and institution identities revealed during review?
Based on the information provided, identities are withheld until the last phase of review.
Who can apply (in general terms)?
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities, as well as certain other eligible categories specifically highlighted in the listing.
Which U.S. government entities are eligible to apply?
Eligible applicants include state, county, and local governments, as well as special district governments.
Are public and private colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are nonprofit organizations eligible?
Yes. Nonprofits with or without 501(c)(3) status (other than institutions of higher education) are listed as eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible. Small businesses are also listed as eligible.
Are Native American tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments are eligible, and Native American tribal organizations that are not federally recognized are also listed as eligible.
Are public housing authorities eligible to apply?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
Are Historically Black Colleges and Universities (HBCUs) eligible?
Yes. HBCUs are specifically highlighted among additional eligible categories.
Are Hispanic-serving Institutions eligible?
Yes. Hispanic-serving Institutions are specifically highlighted among additional eligible categories.
Are Tribally Controlled Colleges and Universities (TCCUs) eligible?
Yes. TCCUs are specifically highlighted among additional eligible categories.
Are Alaska Native and Native Hawaiian Serving Institutions eligible?
Yes. These institutions are specifically highlighted among additional eligible categories.
Are Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) eligible?
Yes. AANAPISIs are specifically highlighted among additional eligible categories.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are specifically highlighted among additional eligible categories.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are specifically highlighted among additional eligible categories.
Can a foreign (non-U.S.) institution apply as the applicant organization?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Are foreign components allowed at all?
Yes. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. This means a U.S. applicant may be able to include certain foreign activities or collaborations if they meet NIH policy requirements and are appropriately justified in the project.
What is the CFDA number and general funding area?
The opportunity is a discretionary grant in the health area, with CFDA 93.310.
When was this opportunity created?
The listing indicates the opportunity was created on March 27, 2023.
What was the closing date for this announcement?
The original closing date listed for this specific announcement is September 1, 2023.
Is the award ceiling listed?
No. The award ceiling is not specified in the provided listing.
Is the expected number of awards listed?
No. The expected number of awards is not specified in the provided listing.
Where should applicants look for budget limits, allowable costs, and project period expectations?
Because the award ceiling and expected number of awards are not provided in the listing, applicants typically need to consult the full FOA text and NIH budget guidance for allowable costs, expected project period, and any program-specific budgeting norms.
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| Understanding Neurological Effects of COVID-19 and Post-Acute Sequelae of SARS-CoV-2 Infection (R01 Clinical Trial Optional) Apply for RFA NS 23 021 Funding Number: RFA NS 23 021 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| NIH Directors New Innovator Award Program (DP2 Clinical Trial Optional) Apply for RFA RM 23 005 Funding Number: RFA RM 23 005 Agency: National Institutes of Health Category: Health Funding Amount: $900,000 |
| NIDCR Small Research Grants for Analyses of Existing Genomics Data (R03 Clinical Trial Not Allowed) Apply for PAR 23 132 Funding Number: PAR 23 132 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Animal Models for Hepatitis B and C (R01 Clinical Trial Not Allowed) Apply for RFA AI 23 022 Funding Number: RFA AI 23 022 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCR Research Grants for Analyses of Existing Genomics Data (R01) (Clinical Trial Not Allowed) Apply for PAR 23 133 Funding Number: PAR 23 133 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Understanding Neurological Effects of COVID-19 and Post-Acute Sequelae of SARS-CoV-2 Infection (R21 Clinical Trial Optional) Apply for RFA NS 23 022 Funding Number: RFA NS 23 022 Agency: National Institutes of Health Category: Health Funding Amount: $275,000 |
| Pulmonary Outcomes and Sequelae after Treatment-TB (POST-TB) (R01 Clinical Trial Optional) Apply for PAR 23 148 Funding Number: PAR 23 148 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Developing Measures to Advance Access and Quality in Global Mental Health Services (R34 Clinical Trial Not Allowed) Apply for RFA MH 23 300 Funding Number: RFA MH 23 300 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Implementing and Evaluating New Models for Delivering Comprehensive, Coordinated, Person-Centered Care to People with Long COVID (U18) Apply for RFA HS 23 012 Funding Number: RFA HS 23 012 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: Case Dependent |
| Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Collaborative Research Centers (CRCs) (U54 Clinical Trial Optional) Apply for RFA NS 24 022 Funding Number: RFA NS 24 022 Agency: National Institutes of Health Category: Health Funding Amount: $1,200,000 |
| Limited Competition: NEI - DOD Vision Research Collaborative (R01 Clinical Trial Optional) Apply for PAR 23 141 Funding Number: PAR 23 141 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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| Core Centers for Clinical Research (CCCR) (P30 Clinical Trial Not Allowed) Apply for RFA AR 24 003 Funding Number: RFA AR 24 003 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Developing Measures to Advance Quality in Mental Health Care Services (R01 Clinical Trial Not Allowed) Apply for RFA MH 23 265 Funding Number: RFA MH 23 265 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Fundamental Research to Understand the Mechanisms of Neurotropic Virus-mediated Disease (R01 Clinical Trial Not Allowed) Apply for RFA AI 23 028 Funding Number: RFA AI 23 028 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Understanding Persistent Oral Human Papillomavirus and Human Immunodeficiency Virus Co-infection and Its Role with Oropharyngeal Cancer Induction (R21 Clinical Trial Not Allowed) Apply for RFA DE 24 002 Funding Number: RFA DE 24 002 Agency: National Institutes of Health Category: Health Funding Amount: $275,000 |
| Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01 Clinical Trial Not Allowed) Apply for PAR 23 165 Funding Number: PAR 23 165 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01 Clinical Trial Optional) Apply for PAR 23 164 Funding Number: PAR 23 164 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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