Investigations on Primary Immunodeficiency Diseases/Inborn Errors of Immunity (R03 Clinical Trial Not Allowed) | PAR 19 347

Opportunity Information: Apply for PAR 19 347

The National Institutes of Health (NIH) funding opportunity titled "Investigations on Primary Immunodeficiency Diseases/Inborn Errors of Immunity (R03 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-19-347) is a discretionary grant program designed to support small, focused research projects that advance knowledge of primary immunodeficiency diseases (PIDs), also commonly referred to as inborn errors of immunity (IEI). The central aim is to encourage studies that discover new immunodeficiency disorders and better characterize known ones, with an emphasis on understanding underlying causes and disease mechanisms. The FOA is oriented toward generating insights that can improve early detection, strengthen molecular diagnosis, and ultimately contribute to strategies that treat and, over time, potentially cure these disorders. Because this mechanism is an NIH R03, it is typically well-suited for pilot studies, feasibility work, early-stage hypothesis testing, or targeted projects that can produce clear, discrete outcomes without requiring the scale of a larger multi-year research award.

Scientifically, the opportunity prioritizes research that clarifies why and how these immune disorders occur and progress. Projects might focus on identifying genetic contributors, mapping how specific variants disrupt immune pathways, describing immune cell dysfunction in detail, or linking molecular abnormalities to clinical features. A major theme is translation-enabling knowledge: improving the ability to recognize these conditions earlier, refining diagnostic approaches through molecular and immunologic characterization, and building foundations for rational therapeutic strategies. While the FOA language highlights eventual treatment and cure as long-term goals, the supported work under this mechanism is primarily discovery and characterization oriented, meaning applicants are expected to produce data or mechanistic understanding that can be leveraged later for therapeutic development rather than running clinical interventions themselves.

A key boundary is spelled out in the title: clinical trials are not allowed. In practice, that means applicants cannot propose prospective studies in which human participants are assigned to an intervention to evaluate health-related outcomes. Research involving human samples or observational human studies may be possible if they fit NIH definitions for non-trial human subjects research, but anything that meets the NIH definition of a clinical trial would be out of scope for this FOA. Applicants typically need to be careful in how they design and describe human-related aims to avoid inadvertently proposing a trial-like structure.

From an eligibility standpoint, the FOA is broadly open across the U.S. research ecosystem. Eligible applicants include a wide range of public entities (state, county, city or township governments; special district governments; and certain public housing authorities), educational organizations (independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education), tribal entities (federally recognized Native American tribal governments and other Native American tribal organizations), and nonprofit organizations (both 501(c)(3) and non-501(c)(3) nonprofits, as long as they are not institutions of higher education). For-profit organizations (other than small businesses) and small businesses are also listed as eligible, along with an "Other" category that NIH sometimes uses to accommodate additional applicant types consistent with federal policy. The FOA also explicitly calls out additional categories of eligible applicants, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, the FOA places firm limits on foreign involvement. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. In addition, foreign components, as NIH defines them in the NIH Grants Policy Statement, are not allowed under this announcement. In practical terms, this means the applicant organization must be domestic, the work cannot be carried out through a foreign component arrangement, and the project should not rely on a formal foreign component to conduct significant elements of the research.

Administratively, the opportunity is a grant (Funding Instrument Type: Grant) within the health research activity category, associated with CFDA number 93.855. The source information lists an award ceiling of $50,000, reflecting the small grant nature of the R03 mechanism, which is typically intended to support narrowly scoped, time-limited research aims. The announcement was created on 2019-08-16, with an original closing date listed as 2021-03-23. Even when a specific closing date is provided in a summary like this, NIH opportunities sometimes run on recurring receipt dates or may be reissued or expired, so applicants generally need to confirm the current status and applicable receipt dates in the live NIH posting and associated application instructions.

Overall, this FOA is best viewed as an NIH small-grant pathway for researchers who want to generate focused, high-value data on inborn errors of immunity: finding new disease entities, explaining mechanisms, improving diagnostic precision, and laying practical groundwork for better clinical management and future therapeutic advances, all while staying clearly on the non-clinical-trial side of NIH policy and keeping the project fully domestic in terms of applicant eligibility and project components.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigations on Primary Immunodeficiency Diseases/Inborn Errors of Immunity (R03 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): 93.855.
• This funding opportunity was created on 2019-08-16.
• Applicants must submit their applications by 2021-03-23. (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 $50,000.00 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 PAR 19 347

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