Significance of Clonal Hematopoiesis (CH) in Aging Humans (R01 Clinical Trial Not Allowed)? | RFA AG 24 038

Opportunity Information: Apply for RFA AG 24 038

The National Institutes of Health (NIH) is soliciting R01 grant applications under the Notice of Funding Opportunity (NOFO) titled "Significance of Clonal Hematopoiesis (CH) in Aging Humans (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number: RFA-AG-24-038; CFDA/Assistance Listing: 93.866). The central aim is to push the field forward by supporting secondary analyses that use existing human biospecimens and/or existing datasets to clarify what clonal hematopoiesis mutations mean clinically as people age. The NOFO is specifically framed around improving understanding of the clinical significance of CH, including whether CH plays a causal role in age-related outcomes, the direction of relationships (for example, whether CH contributes to particular aging phenotypes or arises as a consequence of them), how CH relates to multiple human aging phenotypes, and what biological mechanisms might explain these associations.

A key feature of this opportunity is the emphasis on leveraging resources that already exist rather than building new cohorts from scratch. Applicants are expected to make strong use of previously collected specimens (such as blood-derived samples suitable for genomic analysis) and/or datasets (for example, longitudinal aging studies, biobanks, electronic health record-linked cohorts, or other well-annotated research cohorts). The goal is to extract more value from established collections by applying modern analytic approaches to evaluate CH mutations in relation to aging-relevant clinical endpoints and biological readouts. Projects responsive to this NOFO would typically focus on rigorous study design for observational/secondary data, careful handling of confounding and bias, and thoughtful strategies to evaluate causality and directionality where possible (for instance through longitudinal modeling, genetic epidemiology approaches, or other robust inferential frameworks that can be applied to existing data).

The NOFO uses the R01 mechanism, which is intended for mature, hypothesis-driven research programs with a clear plan and strong analytic rigor. It is labeled "Clinical Trial Not Allowed," which generally means applications should not propose prospective interventional studies where participants are assigned to receive an intervention to evaluate health outcomes. Instead, the work should be grounded in analyses of existing data and specimens, potentially including retrospective and/or observational investigations, mechanistic inference using human data, and integrative analyses that connect CH status to clinical phenotypes of aging. In practice, that restriction steers applicants toward computational, statistical, epidemiologic, and translational analyses that do not involve initiating a new clinical trial.

In terms of who can apply, eligibility is broad and includes many types of U.S. organizations and governmental units, such as state, county, city/township, and special district governments; independent school districts; and public housing authorities/Indian housing authorities. Academic eligibility includes public and state-controlled institutions of higher education as well as private institutions of higher education. The NOFO also allows nonprofit organizations both with and without 501(c)(3) IRS status (other than institutions of higher education). For-profit organizations (other than small businesses) and small businesses are also eligible, along with federally recognized Native American tribal governments and Native American tribal organizations that are not federally recognized tribal governments. In addition, the announcement highlights an expanded set of "other eligible applicants," explicitly naming Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-domestic (non-U.S.) entities/foreign organizations. Taken together, the eligibility language indicates NIH is open to a wide range of applicants who can credibly conduct high-quality secondary research on CH and aging, including organizations serving historically underrepresented populations and institutions outside the continental U.S.

Administratively, this is a discretionary grant opportunity offered by NIH in the health funding activity category. The original closing date listed for applications was October 23, 2023, and the NOFO was created on May 17, 2023. The listed award ceiling is $1,000,000, indicating the maximum funding level per award under this opportunity (with actual budgets expected to align with the scope and needs of the proposed analyses). The number of expected awards is not specified in the provided source information, which often means applicants should not assume a particular success rate and should focus instead on responsiveness to the scientific priorities, feasibility, and the strength of the analytic plan.

Overall, the opportunity is designed for research teams that can take advantage of existing biospecimen collections and datasets to answer pressing questions about how clonal hematopoiesis fits into human aging: whether it is merely correlated with aging-related decline or actively contributes to it, which aging phenotypes are most strongly linked to CH, and what mechanisms might connect CH mutations to downstream health outcomes. The emphasis on secondary analysis, coupled with the prohibition on clinical trials, positions this NOFO for investigators with strong expertise in human genetics/genomics, aging biology, epidemiology, biostatistics, and data integration who can make definitive progress using resources that are already available.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Significance of Clonal Hematopoiesis (CH) in Aging Humans (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): 93.866.
• This funding opportunity was created on 2023-05-17.
• Applicants must submit their applications by 2023-10-23. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
• 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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