NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) | PAR 18 633

Opportunity Information: Apply for PAR 18 633

The NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required), Funding Opportunity Number PAR-18-633, is a National Institutes of Health discretionary funding program in the health area (CFDA 93.855) designed to support the implementation of investigator-initiated clinical trials that are considered high-risk, along with mechanistic studies that are directly tied to those trials. In practical terms, NIAID is looking for applicants who already have a strong, well-justified clinical trial concept and are ready to carry it out, especially when the trial involves higher uncertainty, complexity, or potential for both meaningful impact and meaningful challenges. The FOA highlights mechanistic work as a key value-add, because collecting mechanistic data during a clinical trial can help explain why an intervention works or fails, clarify disease biology in humans, and lay the groundwork for future therapies and better-designed studies.

This award uses the cooperative agreement mechanism (U01), which typically means the project is not purely investigator-directed in the way a standard research grant might be. Instead, the NIH (through NIAID) expects to have substantial scientific or programmatic involvement during the life of the award, often through collaboration on milestones, oversight of trial progress, and coordination around regulatory, operational, and reporting expectations. The scope is tightly defined in one important way: only one clinical trial may be proposed per application. Applicants therefore need to focus their proposal on a single, clearly articulated clinical study and, if included, the associated mechanistic components that complement and enhance the main trial rather than drifting into multiple trial concepts.

The scientific emphasis is aligned with NIAIDs broader mission and priority research areas, and the FOA explicitly encourages investigators to consult NIAIDs online resources describing its research role and priorities (https://www.niaid.nih.gov/research/role). That signal matters because, while the FOA supports investigator-initiated work, projects still need to fit within NIAIDs scientific remit to be competitive and programmatically appropriate.

Eligibility is broad and includes many types of domestic U.S. organizations and government entities. Eligible applicants listed include 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; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other applicant types. The FOA also specifically calls out additional eligible applicant categories, reflecting an interest in inclusive participation across institution types and communities. These include 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; Indian/Native American tribal governments other than federally recognized; and non-U.S. entities (foreign organizations).

Key administrative details from the posted record include the original posting date (creation date) of February 6, 2018, and an original closing date of January 13, 2021. The public listing does not specify an award ceiling or expected number of awards in the provided fields, so applicants would typically need to consult the full FOA text and current NIH guidance to understand budget expectations, project period norms, and any institute-specific limits or benchmarking information.

Overall, this opportunity is aimed at teams prepared to run a single, potentially high-impact but higher-uncertainty clinical trial within NIAIDs mission space, ideally strengthened by mechanistic investigations that can translate trial outcomes into deeper biological understanding and clearer next steps for future therapeutic development.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)" 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 2018-02-06.
• Applicants must submit their applications by 2021-01-13. (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 18 633

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