Infectious Diseases Clinical Trials Network (IDCTN) (UM1 Clinical Trial Required)

The National Institutes of Health, through the National Institute of Allergy and Infectious Diseases, is offering the Infectious Diseases Clinical Trials Network funding opportunity under the UM1 Research Project with Complex Structure Cooperative Agreement mechanism. The purpose is to establish an Infectious Diseases Clinical Trials Network composed of multiple Clinical Trial Evaluation Units and one Network Coordination Center associated with one of the funded CTEUs. The network will evaluate therapeutics, vaccines, biologics, diagnostics, and devices targeting emerging and chronic infectious diseases. Its clinical research capabilities are expected to span Phase I through Phase IV research and scientific areas including malaria and neglected tropical diseases, sexually transmitted infections, respiratory infections, enteric diseases, emerging infectious diseases, and other infectious disease considerations. The network will also create opportunities for investigators early in their careers and investigators who are new to the field. Each application must propose exactly one CTEU. Required CTEU components are CTEU Administration, a Clinical Trial Site, a Clinic, a Clinical Laboratory, a Pharmacy, and IDCTN Collaboration. A Research Laboratory is optional. Applicants may also propose the single NCC, although inclusion of an NCC is optional for an individual application. If proposed, the NCC must address administration, governance, scientific working groups, and clinical oversight. The NCC will provide scientific leadership and an operational framework for the network, establish and revise the research agenda, identify scientific priorities, solicit and develop clinical concepts, and oversee IDCTN clinical trials. Applications proposing more than one CTEU, lacking Registry/Screening and Specimen Sampling protocols, lacking delayed onset clinical trials, or otherwise meeting the stated non-responsive conditions will not be reviewed. NIAID intends to commit up to $10 million in fiscal year 2027 to fund 7 to 11 CTEU awards, with one award for a CTEU that includes the NCC. CTEU budgets may request up to $450,000 in direct costs per year. An application that includes the NCC may request an additional $2,000,000 in direct costs for NCC funds. The required project period is seven years, and budgets must reflect the actual needs of the proposed project. CTEU and NCC funding constitutes Core Funds. Applicants must not request funds for specific clinical trial protocols in response to this opportunity; Protocol Funds will instead be determined and provided as needed based on funding availability. Awards will be incrementally funded, automatic carryover is excluded, progress and financial reporting are required annually, and all funds must be expended within the approved project period. Cost sharing is not required. Eligible applicants include public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; small businesses and other for-profit organizations; state, county, city or township, and special district governments; federally recognized and other tribal governments; eligible federal agencies; U.S. territories or possessions; independent school districts; public and Indian housing authorities; Native American tribal organizations; faith-based or community-based organizations; and regional organizations. Foreign organizations and non-U.S. components of U.S. organizations are not eligible. Foreign components are allowed, but applications involving foreign subawards or subcontracts are noncompliant and will not be considered for funding. At least one PD/PI must be a physician holding an M.D. or D.O. An investigator may serve as a PD/PI on only one application, although that person may collaborate on other applications if there is no scientific overlap. Applicant organizations may submit more than one application when each application is scientifically distinct. Applications must follow the Research Instructions in the NIH How to Apply Application Guide together with the program-specific requirements of this notice. Required materials include the applicable SF424(R&R) components, Senior/Key Person Profile and biosketch information, detailed R&R Budget materials, PHS 398 Research Plan, Resource Sharing Plan, Data Management and Sharing Plan when scientific data will be generated, and applicable human subjects and clinical trials information. The Research Strategy must address CTEU subsections 1A through 1H, subject to the specified page limits, and applicants proposing the NCC must also address NCC subsections 2A through 2E within the stated 30-page maximum. Applicants must enter at least one delayed onset study record, check Anticipated Clinical Trial, use the study title CTEU Delayed Onset Clinical Trial, and provide the specified justification. Applications may be prepared and submitted through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution, with submission status tracked through eRA Commons. Peer review will consider overall impact and the scored criteria of Significance, Investigators, Innovation, Approach, and Environment, together with applicable clinical trial criteria and additional review considerations. Reviewers will examine clinical trial preparedness, including safety and protocol oversight, IRB approvals, monitoring, staff training, data management, recruitment and retention, laboratory and pharmacy capabilities, quality processes, and the feasibility of the study timeline. If an NCC is proposed, reviewers will consider whether its governance, scientific working groups, and priority-setting processes can achieve IDCTN goals and support generation of at least four prioritized clinical concepts each year. Funding decisions will consider scientific and technical merit, availability of funds, and relevance to program priorities. The application opens October 10, 2026 and is due November 10, 2026 by 5:00 PM local time of the applicant organization. Scientific merit review is anticipated in March 2027, advisory council review in May 2027, and the earliest start date is July 2027. The opportunity expires November 11, 2026. Scientific and research questions may be directed to IDCTN_NOFO@mail.nih.gov, while financial and grants management questions may be directed to NIAIDFinancial-GrantsContact@mail.nih.gov.

Propose exactly one CTEU and ensure all Clinical Trial Site facilities are part of the applicant organization except fee-for-service commercial laboratories. Include Registry/Screening and Specimen Sampling protocols and at least one delayed onset clinical trial. Demonstrate readiness for high-quality clinical trials through safety oversight, IRB approvals, monitoring, staff training, data management, and timely dissemination. If proposing the NCC, show governance and scientific working group processes capable of generating at least four prioritized clinical concepts per year. Align the budget with actual project needs, separate CTEU and NCC core funds, and do not request protocol-specific clinical trial funds. Submit early enough to correct electronic submission errors before the deadline.