Expanding Extramural Research Opportunities at the NIH Clinical Center (U01 Clinical Trial Optional) | PAR 18 879

Opportunity Information: Apply for PAR 18 879

The grant opportunity titled "Expanding Extramural Research Opportunities at the NIH Clinical Center (U01 Clinical Trial Optional)" (Funding Opportunity Number PAR-18-879) is a National Institutes of Health (NIH) discretionary funding announcement that uses the cooperative agreement mechanism (U01). Its central goal is to bring outside (extramural) researchers together with NIH’s in-house (intramural) investigators to run investigator-initiated clinical research projects at the NIH Clinical Center in Bethesda, Maryland. The overall emphasis is on accelerating translation from lab findings to early clinical testing, specifically for therapies and interventions relevant to allergy, asthma, autoimmune disease, and transplantation, aligned with priorities of the National Institute of Allergy and Infectious Diseases (NIAID).

A defining feature of this opportunity is access to the NIH Clinical Center’s extensive infrastructure and specialized capabilities, which are often difficult to assemble at a single academic or community site. Projects funded under this FOA can leverage both inpatient and outpatient clinical research resources, including experienced clinical and research staff, dedicated nursing support, hospital beds, critical care services, ambulatory care services, advanced laboratories, imaging platforms, biostatistics support, and hands-on expertise in protocol development. It also highlights regulatory guidance, clinical trials management, and safety oversight as built-in strengths of the Clinical Center environment. The intent is that these resources reduce common bottlenecks in launching and conducting complex translational studies, especially when the work requires intensive phenotyping, specialized assays, close monitoring, or highly controlled clinical research conditions.

In terms of the science supported, the FOA is geared toward hypothesis-driven mechanistic research, either as standalone mechanistic studies or embedded within clinical projects. The clinical work is framed around small, early-stage trial designs, specifically Phase 0, Phase 1, and/or Phase 2a studies. While the title notes "Clinical Trial Optional," the scope clearly accommodates applications that include early clinical trials when they are appropriate to test feasibility, safety, pharmacodynamics, or early signals of biological activity, particularly when paired with mechanistic endpoints that help explain how and why an intervention works (or does not). The Clinical Center setting is especially suited to this type of deeply characterized, mechanistically rich early clinical investigation.

Because the funding instrument is a cooperative agreement, applicants should expect a more collaborative relationship with NIH than a standard research grant. In practical terms, this typically means NIH staff and intramural collaborators may have substantial involvement in project planning and execution, and the work is meant to be carried out in true partnership with the NIH Clinical Center’s intramural ecosystem. This collaborative structure is consistent with the FOA’s emphasis on pairing extramural innovation with the Clinical Center’s operational and scientific assets to speed translation.

Eligibility is broad and includes many types of domestic applicant organizations, such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; and a wide range of nonprofit organizations (including those with or without 501(c)(3) status). It also permits applications from for-profit organizations (other than small businesses) as well as small businesses. Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments) are listed as eligible, along with public housing authorities/Indian housing authorities and other eligible entities. In addition, the FOA explicitly calls out a set of additional eligible applicant categories that reflect an interest in expanding participation and partnerships, including 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 even non-U.S. (foreign) organizations.

Administratively, the opportunity is listed under CFDA number 93.855, with NIH as the sponsoring agency. The FOA record indicates it was created on July 26, 2018, and shows an original closing date of December 3, 2020. The publicly provided snippet does not specify an award ceiling or the expected number of awards, which means applicants would normally need to consult the full FOA text for budget parameters, project period limits, and any special submission or review considerations tied to doing research at the NIH Clinical Center. Overall, the opportunity is best understood as a pathway for extramural investigators to conduct high-impact, early-stage translational and mechanistic clinical research by directly integrating their scientific ideas with the Clinical Center’s highly specialized clinical research environment and NIAID-relevant disease priorities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Expanding Extramural Research Opportunities at the NIH Clinical Center (U01 Clinical Trial Optional)" 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 2018-07-26.
• Applicants must submit their applications by 2020-12-03. (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 18 879

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