Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed) | PAR 21 038

Opportunity Information: Apply for PAR 21 038

The Stephen I. Katz Early Stage Investigator Research Project Grant is an NIH R01 funding opportunity (PAR-21-038) designed specifically for early stage investigators (ESIs) who want to pursue a genuinely new and potentially high-impact research direction. The core idea is to create space for bold, creative projects that do not yet have the usual foundation of pilot results. Unlike many R01 opportunities where applicants are expected to demonstrate feasibility through preliminary findings, this program explicitly requires that applications not include preliminary data at all. In practice, that means the proposal must stand on the strength of its scientific rationale, originality, approach, and potential significance rather than on prior experimental proof generated by the applicant.

A defining feature of this opportunity is that it supports a change in research direction for the ESI. The project is expected to be innovative and distinct from what the investigator has already been doing, emphasizing new concepts, methods, or areas of inquiry. Even though preliminary data are not allowed, the project still needs to be well-reasoned and methodologically sound. Applicants are essentially expected to make a compelling case that the question is important, the approach is rigorous, and the work is feasible based on strong logic, existing knowledge in the field, and careful planning rather than internal pilot datasets.

The scientific scope is broad but not unlimited: the proposed research must align with the programmatic interests and mission areas of one or more participating NIH Institutes and Centers. NIH covers a wide range of biomedical, behavioral, and health-related research areas, and this FOA is intended to fund projects that fit within those mission-driven priorities. Applicants generally need to pay close attention to which NIH Institute or Center is the best match for their topic and frame the significance of the work in a way that clearly connects to that Institute or Center's goals.

This FOA does not allow clinical trials. That means an application cannot propose a study in which human participants are prospectively assigned to one or more interventions (including placebo or other controls) to evaluate effects on health-related biomedical or behavioral outcomes. Applicants can still potentially propose other forms of human research depending on NIH definitions and the specific study design, but anything that meets the NIH definition of a clinical trial would be out of scope for this particular announcement. The intent is to keep the focus on non-clinical-trial research while still enabling ambitious early-stage science.

Eligibility is broad across many types of U.S.-based organizations. Eligible applicants 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; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly notes eligibility categories that are often highlighted to encourage broad participation, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments other than federally recognized ones, and U.S. territories or possessions.

Foreign institutions are not eligible to apply as applicant organizations, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components are allowed under NIH policy (as defined in the NIH Grants Policy Statement). In practical terms, that means the main applicant organization must be domestic and eligible, but certain well-justified parts of the work may be carried out in collaboration with foreign entities or at foreign sites when permitted and appropriately described.

Administratively, this is a discretionary grant program run by the National Institutes of Health. The funding instrument is a grant, and the activity is an R01 research project mechanism, which typically supports a defined research project with a multi-year plan and budget consistent with NIH R01 expectations (specific budget limits are not provided in the source text you supplied). The FOA is associated with multiple CFDA numbers, reflecting the fact that different NIH Institutes and Centers may participate and fund awards under their respective program authorities. The source information lists an original closing date of 2023-12-28 and a creation date of 2020-11-09, indicating the announcement has been active over a multi-year period with defined due dates.

Overall, this opportunity is best understood as an NIH-supported on-ramp for early stage investigators to take a serious scientific risk: to pivot into a new research direction and pursue an idea that is compelling enough to merit R01-level support even without preliminary results. The strongest applications are likely to be those that clearly articulate a major problem, explain why the new direction is promising and timely, present a rigorous and realistic research strategy, and demonstrate clear alignment with an NIH Institute or Center mission, all while staying strictly outside the clinical trial space and adhering to the no-preliminary-data rule.

• The National Institutes of Health in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.313, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.865, 93.866, 93.867, 93.879.
• This funding opportunity was created on 2020-11-09.
• Applicants must submit their applications by 2023-12-28. (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 PAR 21 038

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