Clinical Research Network on Antimicrobial Resistance (UM1 Clinical Trial Required)

The National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health within the U.S. Department of Health and Human Services, is offering the Clinical Research Network on Antimicrobial Resistance (UM1 Clinical Trial Required) under funding opportunity RFA-AI-27-005. The purpose is to support a coordinated and integrated Clinical Research Network that designs, implements, and manages clinical research addressing pivotal questions related to antimicrobial resistance. The network will consist of four interconnected centers: a Scientific Leadership Center, Clinical Operations Center, Laboratory Center, and Statistics and Data Coordination Center. The research agenda is intended to advance prevention, diagnosis, and treatment of antimicrobial-resistant infections and develop the next generation of clinical researchers specializing in antimicrobial resistance. Supported research may include clinical trials and studies evaluating innovative antimicrobial treatments, drug combinations, targeted interventions, alternative therapies, diagnostic approaches, biomarkers, clinical informatics, molecular epidemiology, and pharmacokinetic and pharmacodynamic studies. Priority areas include difficult-to-treat infections and major bacterial and fungal antimicrobial resistance threats identified by the Centers for Disease Control and Prevention. Studies focused solely on infection control programs or broad antimicrobial stewardship interventions without evaluation of targeted antimicrobial-use strategies are non-responsive. Research directed toward parasitic, viral, mycobacterial infections, Streptococcus pneumoniae, specified food- and water-borne pathogens, and microorganisms not identified on CDC antimicrobial resistance threat lists is also non-responsive. Applications must propose one or more clinical trials. NIAID intends to commit 18 million dollars in fiscal year 2027 to fund one award. Application budgets are not expected to exceed 12 million dollars in direct costs per year, should reflect actual project needs, and the required project period is seven years. 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 governments, county governments, city or township governments, 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 may not apply. Foreign components are allowed subject to NIH policy, but applications involving foreign subawards or subcontracts are noncompliant and will not be considered for funding. The opportunity does not require cost sharing. Applicant organizations must maintain the required SAM, eRA Commons, and Grants.gov registrations, and PDs and PIs must have eRA Commons accounts and valid ORCID IDs linked to their eRA Commons profiles. Applications must follow the Research instructions in the NIH How to Apply Application Guide and all program-specific requirements in the NOFO. Applications may be prepared and submitted through NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace, with application status tracked through eRA Commons. The Research Strategy requires five subsections: a six-page CRN Overview, a 30-page Scientific Leadership Center section, a 30-page Clinical Operations Center section, a 12-page Laboratory Center section, and a 12-page Statistics and Data Coordination Center section. Additional requirements include Specific Aims, appropriate budget materials, human subjects and clinical trials information, a Resource Sharing Plan, and a Data Management and Sharing Plan. The budget must distinguish Core Funds from Protocol Funds, and it must include required travel for a kickoff meeting and annual program progress meetings. Clinical trial applications must address applicable recruitment and retention, safety oversight, study design, statistical design, regulatory, dissemination, and other NIH requirements. Applications will undergo NIH scientific peer review based on overall impact and the scored criteria of Significance, Investigators, Innovation, Approach, and Environment, together with applicable clinical trial and NOFO-specific considerations. Reviewers will examine the ability of the Scientific Leadership Center to provide effective governance and scientific leadership, the Clinical Operations Center to manage clinical sites and trials, the Laboratory Center to manage assays, quality, and specimens, and the Statistics and Data Coordination Center to provide effective statistics, data management, quality control, security, and regulatory compliance. Funding decisions will also consider availability of funds and relevance to program priorities, particularly investigational randomized controlled clinical trials involving therapeutics, including non-traditional approaches, and diagnostics for difficult-to-treat infections caused by Gram-negative pathogens. Recommended applications receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The opportunity was posted September 1, 2026, and the earliest submission date is October 10, 2026. Applications are due November 10, 2026, by 5:00 PM local time of the applicant organization, and the opportunity expires November 11, 2026. Scientific merit review is anticipated in March 2027, Advisory Council review in May 2027, and the earliest project start date is July 2027. The required project period is seven years, with awards incrementally funded and progress and financial reporting reviewed annually. Automatic carryover and automatic extension of the final budget period are not authorized under this NOFO, and all funds must be expended within the approved project period. No recurring application cycle is stated in the source. Questions about the scientific or research aspects of the opportunity may be directed to the National Institute of Allergy and Infectious Diseases at AMRClinicalResearchNetworkContact@mail.nih.gov. Financial and grants management questions may be directed to NIAIDFinancial-GrantsContact@mail.nih.gov. Application submission assistance is available through the eRA Service Desk and Grants.gov Support Center. No named individual program contact or telephone number is provided. Applicant organizations may submit more than one application if each is scientifically distinct, but NIH will not accept duplicate or highly overlapping applications under review at the same time.

Build a highly integrated CRN plan showing clear governance and coordination among the SLC, COC, LC, and SDCC. Demonstrate strong experience with IND and IDE submissions, IRB and single IRB processes, and safety oversight reporting. Provide feasible clinical site selection, trial management, recruitment, data quality, laboratory quality, statistical, security, and contingency plans with realistic benchmarks. Clearly establish innovation and feasibility for each proposed clinical project. Align the clinical research agenda with NIAID AMR priorities, particularly investigational randomized controlled clinical trials for therapeutics, including non-traditional approaches, and diagnostics for difficult-to-treat Gram-negative infections. Follow all application instructions and page limits strictly because incomplete, noncompliant, or nonresponsive applications will not be reviewed.