NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)
National Institutes of Health (NIH)
Maximum funding amount: $225,000 per year
Maximum project period: 2 years
Support investigator-initiated, high-risk multi-center clinical studies.
Facilitate early peer review, assessment of study design, and development of essential documents.
Investigators conducting clinical studies.
Participants in clinical studies.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, local and state governments, and tribal governments.
Non-domestic (non-U.S.) entities are not eligible to apply.
Applications must be from U.S.-based organizations.
Non-domestic components of U.S. organizations are not eligible.
Projects must focus on high-risk clinical studies.
Studies should be hypothesis-driven and align with NIDDK's mission.
Budgets for direct costs of up to $225,000 per year are allowed.
No cost-sharing is required.
Application due date: June 10, 2027.
Earliest submission date: May 09, 2025.
Applicants may submit more than one application if each is scientifically distinct.
Duplicate applications will not be accepted.
Applications must include a detailed study protocol, milestone plan, and organization plan.
Applications will be evaluated based on significance, innovation, rigor, and feasibility.
Applications will undergo peer review and a second level of review by the Advisory Council.
Scientific and technical merit, availability of funds, and relevance to program priorities will be considered.
Consultation with NIDDK staff is strongly encouraged prior to submission.
Non-responsive applications will be withdrawn from consideration.
Engagement with affected individuals and communities is encouraged.
Strong emphasis on collaboration and substantial involvement from NIH staff.
Early consultation with NIDDK staff.
Clear articulation of study significance and design.
Failure to comply with application instructions may lead to delays or rejection.
Ensure all required registrations are completed before application submission.
Highlight the innovative aspects of the proposed study.