NIDDK Multi-Center Clinical Trial Cooperative Agreement (U01 Clinical Trial Required) | PAR 18 415

Opportunity Information: Apply for PAR 18 415

The NIDDK Multi-Center Clinical Trial Cooperative Agreement (U01 Clinical Trial Required), PAR-18-415, is a National Institutes of Health funding opportunity designed to support investigator-initiated, hypothesis-driven clinical trials that are conducted across multiple sites. The core expectation is that the proposed study is a true multi-center clinical trial involving three or more clinical centers, with a research question and design strong enough to produce results that could realistically change clinical practice and/or meaningfully influence public health. Projects must fit within the mission areas of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which generally include diseases and conditions related to diabetes, endocrinology and metabolic disorders, digestive diseases, liver diseases, nutrition-related conditions, and kidney, urologic, and hematologic diseases.

This award uses the U01 cooperative agreement mechanism, which differs from a typical research project grant in that NIH (here, NIDDK) expects to have substantial scientific and/or programmatic involvement during the conduct of the study. In practical terms, applicants should anticipate a more collaborative relationship with NIDDK staff than under a standard grant, including coordination around trial oversight, milestones, and operational expectations that are common for large, complex, multi-site clinical trials. Because the FOA is explicitly labeled “Clinical Trial Required,” a clinical trial is not optional; the application must propose an actual clinical trial rather than observational work or purely mechanistic research without an interventional clinical trial component.

A key structural requirement of this FOA is that trial planning activities must already be completed before submitting the U01 application. The announcement makes clear that a planning phase is not allowed under this U01 FOA. If an applicant team still needs time and resources to finalize major planning elements (for example, refining the protocol, building site readiness, establishing data coordinating processes, finalizing recruitment strategies, or other foundational implementation details), NIDDK directs those applicants to first pursue a separate implementation planning cooperative agreement (the U34 mechanism, referenced as PAR-18-xxx). In addition, NIDDK strongly encourages prospective applicants to consult with NIDDK scientific/research staff before submitting either a U34 planning application or a U01 implementation application, which signals that early programmatic discussion is considered important for alignment with institute priorities and for ensuring the proposed trial is feasible and appropriately structured for a cooperative agreement.

Eligibility is broad and includes many common U.S.-based applicant types, such as state, county, and local 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional categories of eligible applicants, 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.

At the same time, the FOA draws clear boundaries around foreign participation. Non-domestic (non-U.S.) entities (foreign organizations/institutions) are not eligible to apply as the applicant organization, 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. This typically means a U.S. applicant institution can include certain elements of the work being performed outside the U.S. if they meet NIH’s definition and requirements for a foreign component, but the primary applicant organization must be domestic.

From an administrative standpoint, this is a discretionary federal funding opportunity under NIH with a cooperative agreement funding instrument. It is categorized under Food and Nutrition and Health activities and is associated with CFDA number 93.847. The opportunity was created on November 28, 2017, and the original closing date listed in the source data is December 23, 2020. The source information provided does not specify an award ceiling or the expected number of awards, so applicants would typically rely on the full FOA text and NIH discussions to understand likely budget ranges, funding levels, and competitiveness for particular trial types.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "NIDDK Multi-Center Clinical Trial 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): 93.847.
• This funding opportunity was created on 2017-11-28.
• Applicants must submit their applications by 2020-12-23. (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 18 415

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