Human Islet Research Network - Consortium on Targeting and Regeneration (HIRN-CTAR) (U01 Clinical Trial Not Allowed) | RFA DK 18 014

Opportunity Information: Apply for RFA DK 18 014

The Human Islet Research Network - Consortium on Targeting and Regeneration (HIRN-CTAR) funding opportunity (RFA-DK-18-014) is a National Institutes of Health (NIH) cooperative agreement (U01) designed to accelerate research aimed at restoring or preserving functional human beta cell mass for people with Type 1 Diabetes (T1D). The central scientific goal is to support innovative, collaborative strategies that either increase the number of functional insulin-producing beta cells or protect remaining beta cells from destruction. The FOA is positioned within the broader Human Islet Research Network (HIRN), meaning awardees are expected to operate as part of a coordinated consortium rather than as fully independent, stand-alone projects, with substantial NIH involvement typical of cooperative agreements.

CTAR focuses on a few tightly related biological approaches to addressing beta cell loss in T1D. One major emphasis is controlled manipulation of beta cell replication, meaning research that investigates how to prompt existing human beta cells to divide and expand in a way that is effective and safe. A second emphasis is islet cell plasticity, which broadly refers to the ability of cells within the pancreatic islet to shift identity or function, potentially enabling new sources of beta-like cells. A third emphasis is reprogramming pancreatic non-beta cells into beta-like cells, which includes strategies to convert other pancreatic cell types into insulin-producing cells that resemble beta cells in function. In addition to regeneration and replacement concepts, the FOA also highlights shielding residual beta cell mass from the autoimmune environment, reflecting the reality that in T1D the immune system targets beta cells; therefore, even newly generated or spared beta cells may require protective strategies to survive and function.

Administratively, this opportunity is categorized as discretionary funding and uses the cooperative agreement mechanism, signaling an expectation of active coordination with NIH program staff and integration with HIRN consortium goals, standards, and collaborative activities. The activity area is health (CFDA 93.847). The FOA is explicitly labeled "Clinical Trial Not Allowed," which means applications should be centered on preclinical, mechanistic, translational, or technology-development research that does not include prospective assignment of human participants to an intervention to evaluate health-related outcomes. In practice, projects may still involve human tissues, human islets, or other human-derived biospecimens and may include observational or non-interventional human research where appropriate, but they cannot propose a clinical trial.

The listed award ceiling is $550,000, indicating the maximum budget level anticipated per award under the announcement. The original closing date for submissions was February 26, 2019, and the opportunity was created on October 31, 2018. While the posting notes "ExpectedAwards:" without a number provided in the source text, the intent is to fund a set of projects that collectively form the CTAR consortium and contribute complementary expertise toward the shared objective of improving beta cell mass and function in the context of T1D.

Eligibility is broad and includes many categories of U.S.-based organizations and government entities, reflecting NIH-wide openness to academic, nonprofit, and private-sector participation when scientifically justified. 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; Native American tribal governments (federally recognized); tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights 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, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth signals an interest in drawing on diverse institutional capabilities, including specialized research centers, community-linked organizations, and international expertise relevant to human islet biology and diabetes.

In short, HIRN-CTAR (U01) is a consortium-based NIH program supporting coordinated research to regenerate, replace, or protect human beta cells for T1D, with emphasis on beta cell replication, islet plasticity, cellular reprogramming, and immune-environment shielding, while staying firmly on the non-clinical-trial side of translational research.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Human Islet Research Network - Consortium on Targeting and Regeneration (HIRN-CTAR) (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): 93.847.
• This funding opportunity was created on 2018-10-31.
• Applicants must submit their applications by 2019-02-26. (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 $550,000.00 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 DK 18 014

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: