NIDDK Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Not Allowed) | PAR 18 414

Opportunity Information: Apply for PAR 18 414

The NIDDK Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Not Allowed), Funding Opportunity Number PAR-18-414, is an NIH discretionary grant mechanism designed to support investigator-initiated, multi-center observational research. The core intent is to fund hypothesis-driven studies that address diseases and conditions within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), using a cooperative agreement structure (U01). Because it is a cooperative agreement, applicants should expect substantial scientific and programmatic involvement from NIDDK staff during the conduct of the project, beyond what is typical for a standard research project grant.

A central requirement is that proposed projects must be multi-center observational studies involving three or more clinical centers. In practical terms, the FOA is aimed at research questions that genuinely require multiple sites to achieve sufficient participant numbers, increase population diversity, enhance generalizability, or ensure feasibility within a reasonable timeframe. The "Clinical Trial Not Allowed" designation means the application cannot propose an interventional clinical trial where participants are prospectively assigned to receive one or more interventions to evaluate effects on health-related outcomes. Instead, the focus should be on observational designs, such as cohort studies, registries, natural history studies, or other non-interventional clinical research approaches, as long as they are clearly hypothesis-driven and aligned with NIDDK-relevant diseases.

Another key point is that planning work must be completed before submitting a U01 under this announcement. The FOA explicitly does not allow applicants to use the U01 period to conduct early-stage organizational or feasibility planning activities that would normally precede a large multi-center effort, such as finalizing the protocol, building governance structures from scratch, developing common data elements, negotiating site agreements, or other foundational start-up work. Applicants who still need a structured planning phase are directed to first pursue an implementation planning cooperative agreement (U34; referenced as PAR-18-xxx in the text), and then follow with a U01 once the study is ready for execution. Related to that, NIDDK strongly encourages consultation with NIDDK scientific/research staff prior to submitting either a U34 or a U01, signaling that program input on fit, scope, readiness, and design is an important part of a competitive and compliant application.

Eligibility is broad and spans many organization types commonly permitted under NIH opportunities. Eligible applicants include state, county, 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; public housing authorities/Indian housing authorities; and Native American tribal organizations other than federally recognized tribal governments. The FOA also permits nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education in those categories), for-profit organizations other than small businesses, small businesses, and other eligible entities. In addition, the opportunity explicitly highlights a range of "other eligible applicants" often emphasized by NIH to encourage broad participation, 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, and U.S. territories or possessions.

Foreign eligibility is more restrictive. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" as defined in the NIH Grants Policy Statement are allowed, meaning a U.S.-based applicant can include certain international elements or collaborations if they meet NIH’s definition and are appropriately justified and structured within the application.

From an administrative perspective, the listing identifies the agency as the National Institutes of Health and classifies the activity under the broad category of Food and Nutrition, Health, with CFDA number 93.847. The original closing date shown is December 23, 2020, and the creation date is November 28, 2017. The posted excerpt does not specify an award ceiling or expected number of awards, so applicants typically would need to consult the full FOA text and any linked NIH budget guidance to understand anticipated award sizes, project periods, and portfolio priorities. Overall, the opportunity is best suited for research teams that already have a well-developed, execution-ready, multi-site observational protocol and infrastructure, and that can work effectively within NIH’s cooperative agreement model with active NIDDK engagement.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "NIDDK Multi-Center Clinical Study Cooperative Agreement (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 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 18 414

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