Stimulating Hematology Investigation: New Endeavors (SHINE) (R01 Clinical Trial Not Allowed) | PAS 25 205

Opportunity Information: Apply for PAS 25 205

The Stimulating Hematology Investigation: New Endeavors (SHINE) program (PAS 25-205) is an NIH funding opportunity that uses the R01 research project grant mechanism to grow and strengthen the nonmalignant hematology research portfolio. Its core aim is to stimulate innovative, high-quality basic and early translational research in hematology that aligns with the scientific missions of three participating NIH institutes: the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Aging (NIA), and the National Heart, Lung, and Blood Institute (NHLBI). The opportunity is positioned for investigator-initiated ideas, meaning applicants propose their own research questions and approaches, as long as they fit within the program's defined nonmalignant hematology scope and the currently highlighted priority areas.

A central feature of SHINE is that it targets specific emerging topics at the leading edge of the field, but those topics are not static. NIH indicates that the highlighted scientific areas will be updated annually and posted through the NIH Guide to Grants and Contracts, with links provided from the notice of funding opportunity (NOFO). In practical terms, that means prospective applicants need to check the most current linked topic list when they are planning an application, because the program emphasis can shift over time in response to new discoveries, technologies, and unmet needs in nonmalignant blood research.

This NOFO is explicitly labeled "Clinical Trial Not Allowed," so applications proposing independent clinical trials are not permitted under this announcement. The intent is to support foundational and early translational work rather than interventional clinical studies. Applicants typically interpret this as focusing on mechanistic biology, preclinical model development, discovery and validation work, and translational steps that do not cross into a clinical trial as defined by NIH. (NIH policy definitions matter here, so teams often confirm whether any human subjects work they propose would be considered a clinical trial.)

Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (both with and without 501(c)(3) status, excluding institutions of higher education when relevant); for-profit organizations (other than small businesses); small businesses; public housing authorities and Indian housing authorities; and Native American tribal governments (federally recognized) as well as other Native American tribal organizations that are not federally recognized. The opportunity also calls out a range of mission-relevant and capacity-building institutional categories as "other eligible applicants," including 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), along with eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

At the same time, the announcement draws a clear boundary around foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" as defined in the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain scientifically justified activities performed outside the U.S. under NIH rules, provided the application meets NIH requirements for foreign components and the work is well justified and appropriately managed.

From an administrative standpoint, SHINE is a discretionary grant opportunity from the National Institutes of Health, categorized under health-related funding activity areas (with CFDA numbers listed as 93.839, 93.847, and 93.866). The original closing date is listed as January 6, 2028, indicating a multi-year window during which applications can be submitted according to the standard NIH receipt dates or any special dates specified in the NOFO. The public summary does not specify an award ceiling or the expected number of awards, which usually means applicants should rely on typical NIH R01 budgeting rules and institute-specific guidance, and plan budgets that are well justified for the proposed scope.

Overall, SHINE is best understood as an NIH pathway designed to bring new energy and capacity into nonmalignant hematology by inviting strong R01 proposals in prioritized, fast-moving scientific areas, while keeping the focus on basic and early translational work rather than clinical trials. The program's annual refresh of emerging topics is also a signal that NIH wants applications to be timely, forward-looking, and closely aligned with where the field is headed.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Stimulating Hematology Investigation: New Endeavors (SHINE) (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): 93.839, 93.847, 93.866.
• This funding opportunity was created on 2024-11-06.
• Applicants must submit their applications by 2028-01-06.
• 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 PAS 25 205

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