Investigations on Primary Immunodeficiency Diseases/Inborn Errors of Immunity (R01 Clinical Trial Not Allowed) | PAR 18 712

Opportunity Information: Apply for PAR 18 712

The grant opportunity titled "Investigations on Primary Immunodeficiency Diseases/Inborn Errors of Immunity (R01 Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) discretionary research grant (Funding Opportunity Number PAR-18-712) designed to support in-depth, hypothesis-driven studies on primary immunodeficiency diseases, also referred to as inborn errors of immunity. The central aim is to push the field forward by improving how these disorders are discovered and defined, clarifying their underlying biological causes, and mapping the mechanisms that drive disease. In practical terms, the FOA targets research that can strengthen the scientific foundation needed to recognize these conditions earlier, diagnose them more precisely at the molecular level, and build credible paths toward better treatments and, ultimately, cures. Because this is an R01 mechanism, it is generally intended for substantial projects with a clear scientific rationale, well-developed approach, and meaningful potential impact on immunology and human health.

A major emphasis of the announcement is on advancing discovery and characterization. That includes efforts to identify new genetic or molecular defects that lead to immune dysfunction, as well as work that more accurately defines disease subtypes that may currently be grouped together under broad diagnoses. Another focus is explaining causation and mechanism, meaning projects are expected to go beyond description and aim to show how specific variants, pathways, cell types, or immune processes contribute to immune deficiency, immune dysregulation, susceptibility to infection, autoinflammation, autoimmunity, allergy, lymphoproliferation, or other clinical features that can accompany inborn errors of immunity. The FOA also highlights early detection and molecular diagnosis, signaling NIH interest in research that improves diagnostic strategies, validates biomarkers, refines sequencing-based approaches, strengthens genotype-phenotype relationships, or otherwise helps clinicians and laboratories identify these diseases sooner and with greater confidence. Finally, the FOA encourages research that supports development of treatment strategies. While the notice does not promise support for late-stage testing in humans, it does support the kind of mechanistic and preclinical work that can rationally guide therapeutic development, such as identifying druggable targets, testing corrective approaches in relevant models, or clarifying which patients are most likely to benefit from specific interventions.

This specific FOA is labeled "Clinical Trial Not Allowed," which is an important boundary condition for applicants. It indicates the program is not intended to fund prospective interventional studies in humans where participants are assigned to receive an intervention to evaluate health-related outcomes. Applicants can still propose robust human-focused research that does not meet the definition of a clinical trial, such as observational studies, analyses of existing cohorts or biospecimens, deep immune profiling, genomic studies, natural history investigations without prospective assignment to interventions, and mechanistic studies using patient-derived samples, depending on NIH policy and the exact design. The key is that the proposed work must remain within the non-clinical-trial scope while still contributing directly to understanding, diagnosing, or enabling future treatment of primary immunodeficiency/inborn errors of immunity.

Eligibility for this FOA is broad, reflecting NIH's interest in supporting research capacity across many sectors. Standard eligible applicants include various levels of government (state, county, city or 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, and tribal organizations that are not federally recognized. The FOA also welcomes nonprofit organizations, including those with and without 501(c)(3) status (when they are not institutions of higher education), public housing authorities/Indian housing authorities, for-profit organizations other than small businesses, and small businesses, as well as other applicants meeting NIH requirements. In addition, it explicitly calls out several categories of "other eligible applicants," 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, and U.S. territories or possessions. Notably, the FOA also states that non-domestic (non-U.S.) entities (foreign organizations) may apply, which can be particularly relevant when rare immunodeficiency disorders are studied through international collaborations or when unique patient populations and expertise exist outside the United States.

From the funding classification details provided, the opportunity falls under the Health activity category and is associated with CFDA number 93.855. The funding instrument is a grant, and the mechanism is R01, which typically supports multi-year, investigator-initiated research projects of meaningful scope. The source data provided does not list an award ceiling or expected number of awards, so applicants would need to consult the full FOA and NIH funding policies for budget guidance, project period expectations, and program-specific constraints. The opportunity was created on 2018-03-15, and the original closing date listed is 2021-05-07, which suggests that the specific posted cycle referenced here has passed; however, NIH sometimes reissues, extends, or republishes related program announcements, so anyone interested should verify the current status and any active versions of the FOA on NIH or Grants.gov before investing in an application.

Overall, this FOA is aimed at strengthening the pipeline from discovery to actionable understanding in primary immunodeficiency and inborn errors of immunity. It prioritizes research that identifies new disease causes, explains how immune defects lead to clinical outcomes, improves diagnostic precision and early identification, and lays the groundwork for targeted therapeutic strategies, all while staying clearly outside the boundaries of NIH-defined clinical trials.

• 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 (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): 93.855.
• This funding opportunity was created on 2018-03-15.
• Applicants must submit their applications by 2021-05-07. (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 18 712

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