NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement
National Institutes of Health (NIH)
Funding amount is not limited but must reflect the actual needs of the proposed project.
Maximum project period is 5 years.
To support investigator-initiated, high-risk multi-center observational studies.
Focus on diseases relevant to the mission of NIDDK.
Researchers in the fields of diabetes, digestive diseases, and kidney diseases.
Patients and communities affected by these diseases.
Eligible organizations include higher education institutions, nonprofits, for-profit organizations, local 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.
Proposed studies must be hypothesis-driven and focus on diseases relevant to NIDDK.
Planning activities must be completed prior to submission.
Application budgets are not limited but must reflect the actual needs of the proposed project.
Applications are due by 5:00 PM local time of the applicant organization.
Key dates include application due dates and review cycles.
The NIH will not accept duplicate or overlapping applications under review at the same time.
Applications must include a Clinical Protocol Synopsis, Statistical Analysis Plan, Milestone Plan, and Planning Activities.
Applications will be evaluated based on significance, innovation, rigor, and feasibility.
Applications will undergo peer review and a second level of review by the appropriate national Advisory Council or Board.
Scientific and technical merit of the proposed project will be the primary consideration.
Engagement with affected individuals and communities is essential.
Applications for clinical trials will not be accepted.
Consultation with NIDDK staff is encouraged prior to submission.
Strong community engagement may enhance the competitiveness of applications.
Demonstrating substantial engagement with community stakeholders.
Submitting applications that do not comply with the specific instructions outlined in the NOFO.
Engage with NIDDK staff early in the application process.
Highlight the potential clinical impact of the proposed study.