HLA and KIR Region Genomics in Immune-Mediated Diseases (U01 Clinical Trial Not Allowed) | RFA AI 19 041

Opportunity Information: Apply for RFA AI 19 041

The NIH funding opportunity RFA AI 19 041, titled "HLA and KIR Region Genomics in Immune-Mediated Diseases (U01 Clinical Trial Not Allowed)," supports participation in a coordinated research consortium known as the HLA and KIR Region Genomics in Immune Mediated Diseases Consortium (HLARGC). The main scientific goal is to deepen understanding of how genetic variation in two highly important immune system regions, the human leukocyte antigen (HLA) region (also called the Major Histocompatibility Complex, or MHC) and the killer cell immunoglobulin-like receptor (KIR) region, influences the risk, biology, and outcomes of immune-mediated diseases. A key emphasis is on clarifying genetic associations in these regions and how they relate not only to classic immune-mediated conditions but also to outcomes after cell, tissue, and organ transplantation, where HLA and KIR biology can strongly affect graft acceptance, rejection, immune complications, and overall patient outcomes.

This is a cooperative agreement (U01), which generally means the funded projects are expected to operate as part of a larger NIH-supported team effort rather than as completely independent investigator-driven awards. In practice, this type of mechanism typically involves substantial coordination across awardees, shared consortium activities, and active programmatic involvement from NIH staff to keep methods, data practices, and scientific goals aligned across the group. The FOA is explicitly labeled "Clinical Trial Not Allowed," signaling that the supported work should not include prospective interventional studies that meet the NIH definition of a clinical trial. The research focus is instead on genomics, genetic association, and related analyses that can be conducted through observational cohorts, existing datasets, biorepositories, transplantation registries, laboratory-based genomic methods, and other non-interventional designs consistent with NIH policy.

The opportunity is offered by the National Institutes of Health and is listed under CFDA numbers 93.399, 93.853, and 93.855, reflecting involvement across NIH programs that support allergy, immunology, infectious disease, and related biomedical research. The activity category is listed broadly under education and health, but the substance of the announcement is biomedical genomics and immunogenetics. The original closing date shown for the announcement was September 4, 2019, and the source information does not provide an award ceiling, expected number of awards, or other budget and volume details in the excerpt provided.

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; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories 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; and certain regional organizations and eligible federal agencies. At the same time, it draws clear lines around non-U.S. applicants: non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant organization can propose specific, justified elements of the project to be carried out by foreign collaborators or at foreign sites if it meets NIH’s policy definition and is appropriately documented and approved.

Overall, the opportunity is designed to build and sustain a collaborative immunogenomics effort focused on the HLA/MHC and KIR regions, two of the most complex and clinically relevant parts of the human genome for immune function. By funding coordinated projects within the HLARGC, NIH aims to improve how the field maps genetic variation in these regions, links that variation to immune-mediated disease mechanisms and outcomes, and potentially strengthens the evidence base that later informs diagnostics, risk prediction, donor-recipient matching strategies in transplantation, and future therapeutic approaches, while staying within a non-clinical-trial research scope.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HLA and KIR Region Genomics in Immune-Mediated Diseases (U01 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): 93.399, 93.853, 93.855.
• This funding opportunity was created on 2019-05-02.
• Applicants must submit their applications by 2019-09-04. (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 RFA AI 19 041

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