Integrating Health Disparities into Immuno-Oncology (HDIO) (P20 Clinical Trial Not Allowed) | RFA CA 23 038

Opportunity Information: Apply for RFA CA 23 038

The National Institutes of Health (NIH) funding opportunity titled "Integrating Health Disparities into Immuno-Oncology (HDIO) (P20 Clinical Trial Not Allowed)" (Funding Opportunity Number: RFA-CA-23-038; CFDA: 93.393) is a discretionary grant program designed to help research teams lay the groundwork for future, larger immuno-oncology projects that directly incorporate cancer health disparities. The core purpose is not to fund full-scale clinical trials, but to support planning activities and early-stage feasibility or pilot studies that test whether new ideas, methods, collaborations, and study approaches are realistic and promising. In practice, this mechanism is meant to help groups generate early data, refine study designs, and build the partnerships and infrastructure needed to pursue subsequent, more definitive funding focused on immuno-oncology while explicitly addressing disparity-related questions.

The scientific focus is on integrating cancer health disparities into immuno-oncology research, meaning applicants are expected to consider how unequal cancer burden and outcomes across populations can be built into the conceptual models, research questions, methods, and interpretation of immuno-oncology studies. The opportunity emphasizes multi-disciplinary and inter-disciplinary teamwork, reflecting the reality that disparities in cancer and the immune response are rarely explained by a single factor. Strong applications would typically involve complementary expertise across areas such as tumor immunology, oncology, epidemiology, population sciences, behavioral and social sciences, implementation science, health services research, biostatistics, genetics/genomics, computational biology, pathology, community engagement, and clinical oncology. The FOA highlights that these P20 projects are intended to enable teams to take on novel or higher-risk hypotheses that may not yet be ready for larger mechanisms, but could open up new directions if feasibility can be demonstrated.

Because this is a P20 planning and feasibility mechanism, the work is generally expected to concentrate on activities like developing and validating disparity-informed biomarkers or immune profiling approaches, assessing feasibility of recruitment and retention strategies in underserved populations, testing data collection pipelines that capture both immunologic and social/structural determinants, piloting analytic strategies to disentangle biological and non-biological contributors to outcome differences, and establishing shared resources or protocols that allow disparate data types (clinical, molecular, immunologic, geographic, and social) to be integrated. The "Clinical Trial Not Allowed" designation signals that the proposed research should not be structured as a clinical trial as defined by NIH, so applicants need to ensure they are not proposing prospective interventional studies that assign human participants to interventions to evaluate health-related outcomes. Instead, the emphasis is on preparatory and feasibility work that can de-risk later clinical and translational efforts, including observational, methodological, and planning components consistent with NIH policy for non-clinical-trial FOAs.

Eligibility is broad and includes many types of U.S.-based organizations and governmental 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; federally recognized Native American tribal governments; public housing authorities and Indian housing authorities; Native American tribal organizations that are not federally recognized governments; nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also explicitly calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions. At the same time, it clearly restricts non-U.S. applicants: non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which typically means a U.S. applicant can include certain foreign collaborations or work elements if they are justified and meet NIH requirements, even though the main applicant organization must be domestic.

From a funding standpoint, the opportunity lists an award ceiling of $250,000, indicating a cap on the maximum award amount per project under this announcement. The opportunity was created on 2023-04-27 and had an original closing date of 2023-06-30. While the listing does not specify the expected number of awards in the provided text, applicants generally should plan as though this is a competitive program and focus on clearly articulated, feasible aims that can be completed within the scope of a planning/pilot mechanism and that convincingly position the team for follow-on funding. Overall, this FOA is best understood as a structured on-ramp for research groups that want to bring health disparities to the center of immuno-oncology research, using targeted pilot and feasibility work to build the evidence, collaborations, and study designs needed for larger-scale translational and population-relevant immuno-oncology efforts.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Integrating Health Disparities into Immuno-Oncology (HDIO) (P20 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): 93.393.
• This funding opportunity was created on 2023-04-27.
• Applicants must submit their applications by 2023-06-30. (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 $250,000.00 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.

Apply for RFA CA 23 038

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