Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)

The Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional) is a federal funding initiative by the National Institutes of Health (NIH), reissued under Funding Opportunity Number PAR-26-116. Administered by multiple NIH components, including the Office of the Director and key Institutes like NEI, NCI, NIAID, NIMH, and others, this grant supports collaborative translational research projects that integrate basic and clinical science. The overarching goal is to convert fundamental biological insights into tangible health improvements through diagnostics, therapeutics, and prevention strategies. This program uniquely promotes partnerships between NIH intramural researchers and external extramural investigators, leveraging the NIH Clinical Center’s infrastructure to conduct patient-centric clinical studies. To be eligible, applications must include at least one NIH intramural scientist as a co-Program Director/Principal Investigator and must conduct a portion of their research at the NIH Clinical Center. Projects must substantially utilize Clinical Center resources—simply accessing banked data or samples is insufficient. The Clinical Center offers specialized resources including rare disease cohorts, PET imaging, blood product access, long-term patient housing, and clinical research infrastructure. Studies that propose meaningful patient enrollment and use of unique Clinical Center assets will be prioritized. Applications can be submitted by a wide range of eligible U.S. and foreign entities, including public and private higher education institutions, nonprofits, small businesses, state and local governments, and more. Foreign components are permitted, but foreign subawards/subcontracts are not allowed. Applications must include detailed collaboration and budget plans that outline costs for the extramural applicant, intramural collaborator, and Clinical Center components. NIH will provide intramural and Clinical Center support directly, outside of the applicant's award. The maximum budget is $500,000 in direct costs per year, inclusive of all project costs except those handled separately for intramural and Clinical Center work. Projects may span up to four years, or five years if a planning year is proposed. The application process is competitive, with standard NIH review cycles applying. Required components include a Collaboration Plan, specific budget justifications, and Letters of Support from the Clinical Center and the relevant NIH Institute or Center. Applications open January 5, 2026, with recurring deadlines annually on February 5 (new applications) and March 5 (renewals/resubmissions). The program supports recurring cycles through March 2027. The review process involves rigorous evaluation of the significance, approach, feasibility, and expertise involved. Awards are expected to begin by December of each cycle year. Applicants must follow the detailed instructions provided in the NIH Application Guide and are strongly encouraged to consult with NIH contacts early in the process for guidance and coordination of collaborative logistics.

Ensure full integration of intramural collaborator; utilize Clinical Center resources meaningfully; contact NIH staff early for guidance; inadequate Clinical Center usage leads to disqualification.