Single Source for the Continuation of the Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center (Collaborative U01 Clinical Trial Not Allowed)

The National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health within the Department of Health and Human Services, is offering the Single Source for the Continuation of the Epidemiology of Diabetes Interventions and Complications EDIC Study Research Center Collaborative U01 Clinical Trial Not Allowed opportunity. This cooperative agreement is a reissue of RFA-DK-21-503 and is specifically intended to continue the long-term follow-up of the EDIC cohort. The program supports the NIDDK mission of advancing biomedical research that improves understanding of disease management and contributes to improved prevention, diagnosis, and treatment of diabetes, digestive, kidney, and related diseases. The opportunity will support continued research involving approximately 1,000 active EDIC participants who have lived with type 1 diabetes for more than 40 years. Research objectives include examining how type 1 diabetes affects memory, physical ability, and frailty with aging; studying overweight, obesity, liver disease, and obstructive sleep apnea; using continuous glucose monitors, cardiac imaging, and artificial intelligence to predict health outcomes; applying multiomic approaches involving genomic, transcriptomic, and metabolomic data; examining quality of life and health economics associated with newer diabetes treatments and devices; and maximizing scientific use of the extensive DCCT and EDIC data and biospecimen resources. The Research Center is also expected to support cohort infrastructure, continued participant follow-up, ongoing core assessments, new core study activities, and ancillary studies. NIDDK intends to commit up to 6.5 million dollars in Fiscal Year 2027 to support continuation of EDIC under this opportunity and expects to make one Research Center award. The application budget is limited to 6.3 million dollars per year in direct costs, and the maximum project period is five years. Budgets must reflect the actual needs of the proposed project. Cost sharing is not required. NIH grants policies, applicable cost principles, and the funding restrictions contained in the NIH Grants Policy Statement apply. Pre-award costs are allowable only as permitted by NIH policy. Foreign subawards and subcontracts are not permitted under this opportunity, although qualifying foreign components, foreign consultants, unfunded international collaborations, and procurement of unique equipment or supplies from foreign vendors may be permitted under the stated policies. Eligibility is highly restricted because this is a single-source opportunity. Only the current recipient under RFA-DK-21-503 is eligible to apply, and only one application is allowed. Non-U.S. organizations and non-U.S. components of U.S. organizations are not eligible. Applicant organizations must maintain the required SAM, UEI, eRA Commons, and Grants.gov registrations, while all Program Directors and Principal Investigators must have eRA Commons accounts and valid ORCID registrations linked to their profiles. The application must follow the Research instructions in the NIH How to Apply Application Guide together with the program-specific requirements in the announcement. Applications may be prepared and submitted through NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace, with subsequent tracking through eRA Commons. Required application material includes a Clinical Protocol Synopsis describing the study population, site characteristics, participant retention and engagement, proposed clinical and laboratory assessments, secure data handling, and data quality controls. A Statistical Analysis Plan must describe statistical methods, sample size and power calculations, primary and secondary analyses, and applicable interim analyses; applications lacking this plan are incomplete and will not be peer reviewed. The Research Strategy must address significance, methodology, analyses, prior EDIC findings, the specified research goals, participant engagement, study organization, committee structures, coordination of clinical and biostatistical centers and other central entities, core project support, and ancillary study support. A Data Management and Sharing Plan is required. Applications involving human subjects must also provide the applicable PHS Human Subjects and Clinical Trials Information records. This opportunity does not permit proposed clinical trials. Peer review will evaluate the importance of the research, including significance and innovation; rigor and feasibility of the approach; and investigator expertise and institutional resources. Reviewers will consider experimental rigor, sample size, analytical plans, relevant biological variables, human subjects protections, recruitment and retention where applicable, and whether the proposed work can be completed within the proposed timeframe. Budget and period of support will also be evaluated for justification and reasonableness. Following initial scientific peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Funding decisions will consider scientific and technical merit, availability of funds, and relevance to program priorities. The opportunity was posted August 31, 2026, and opens for submission October 9, 2026. The application deadline is November 9, 2026, at 5:00 PM local time of the applicant organization, and the opportunity expires November 10, 2026. Scientific merit review is anticipated in March 2027, Advisory Council review in May 2027, and the earliest anticipated start date is July 2027. Applicants are encouraged to submit early so that submission errors can be corrected before the deadline. Scientific and research questions may be directed to NIDDK_DEM@nih.gov, while grants management questions may be directed to NIDDKGMBManagementTeam@niddk.nih.gov. No recurring application cycle is stated for this single-source continuation opportunity.

Ensure the Statistical Analysis Plan is included because applications lacking it are incomplete and will not be peer reviewed; clearly demonstrate the significance and potential impact of the research; provide rigorous and feasible methodology, justified sample size and analysis plans, and appropriate consideration of biological variables; directly address the specified EDIC research goals; provide strong participant retention and engagement strategies; clearly explain study organization, site coordination, quality control, and data management; ensure the budget and requested period are fully justified and reasonable; submit early enough to correct electronic submission errors before the deadline.