Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional) | PAR 26 116

Opportunity Information: Apply for PAR 26 116

Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional) is an NIH cooperative agreement program designed to speed up translational science by linking strong basic biology to real-world clinical applications. The central aim is to support collaborative projects that can credibly move discoveries toward improvements in human health, such as clarifying key disease mechanisms or producing tangible next steps toward new therapeutics, diagnostics, or prevention approaches. Projects are expected to be closely aligned with the scientific missions and priorities of the participating NIH Institutes and Centers, and the overall emphasis is on high-quality, clinically relevant science with clear potential to advance understanding or treatment of important diseases.

A defining feature of this opportunity is the requirement for meaningful collaboration between NIH intramural investigators and extramural investigators. Intramural investigators are NIH-based scientists and clinician-researchers working in NIH laboratories and clinics, while extramural investigators are based outside NIH (universities, hospitals, nonprofits, companies, and other eligible organizations). The program is built to broaden and strengthen these partnerships by enabling external teams to make use of the NIH Clinical Center, which is a unique federal clinical research hospital with specialized infrastructure, patient access in certain rare or complex conditions, and integrated clinical research capabilities. In practice, applicants should be prepared to structure a joint translational research plan where the Clinical Center setting and the NIH intramural partnership are essential to the work, not just an added convenience.

The award mechanism is a U01 cooperative agreement, which generally means NIH staff will have substantial programmatic involvement compared with a standard research grant. While the specific oversight and collaboration expectations are laid out in the full notice of funding opportunity (NOFO), applicants should anticipate active coordination with NIH program staff and intramural collaborators, and should plan for a project management approach that supports shared milestones, data flows, and operational decision-making across institutions. Clinical trials are optional under this NOFO, so proposals may include a clinical trial if it fits the translational pathway, but they do not have to.

Eligibility is broad and spans many organization types, including state, county, and local governments; tribal governments and certain tribal organizations; public housing authorities; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses and other than small businesses); and other eligible entities as described in the NOFO. Importantly, non-U.S. organizations are eligible to apply, and foreign components as defined by NIH policy are allowed, meaning certain parts of the work can be conducted outside the United States when properly justified and structured within NIH rules. Non-U.S. components of U.S. organizations are also eligible.

At the same time, there is a major restriction on funded international collaborations that applicants need to plan around. NIH policy effective May 1, 2025 states that NIH will not issue awards to domestic or foreign entities if the project includes foreign subawards or subcontracts, unless the application is submitted under a funding opportunity specifically designated for funded international collaborations. For this particular NOFO, any application that includes foreign subawards or subcontracts will be deemed noncompliant and will not be reviewed for funding. This restriction applies to monetary international collaborations that would create foreign subaward or subcontract arrangements, but it does not necessarily prohibit all international involvement. The policy allows certain alternatives such as unfunded international collaborations, inclusion of a foreign component (as defined and approved under NIH policy), paying foreign consultants, or purchasing unique equipment or supplies from foreign vendors, as long as those arrangements do not constitute a foreign subaward or subcontract.

From an administrative standpoint, the opportunity is listed as PAR-26-116 under the NIH, categorized as discretionary funding, and uses the Health activity category (CFDA 93.313). The stated award ceiling is $500,000. The original closing date is March 6, 2027, indicating a multi-year window in which applications may be accepted according to the submission schedule in the NOFO. The program is positioned for applicants who have a strong translational concept and who can build an integrated, operationally realistic partnership with an NIH intramural team to carry out clinical research activities at or through the NIH Clinical Center in a way that accelerates movement from discovery to patient impact.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Opportunities for Collaborative Research 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): 93.313.
• This funding opportunity was created on 2025-12-08.
• Applicants must submit their applications by 2027-03-06.
• Each selected applicant is eligible to receive up to $500,000.00 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 PAR 26 116

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