Immune Tolerance Network (UM1 Clinical Trial Required)

The National Institutes of Health, under the Department of Health and Human Services, is seeking applications through solicitation RFA-AI-28-005 to continue the Immune Tolerance Network (ITN). This cooperative agreement aims to develop tolerogenic therapies for immune-mediated disorders, specifically focusing on autoimmune diseases, allergic diseases and asthma, and the immune-mediated consequences of transplantation. The network operates through four integrated functional areas: Leadership, Clinical Operations, Core Laboratory, and Bioinformatics. Its primary objectives include designing and conducting clinical trials, performing integrated mechanistic studies, and sharing research results. Eligible applicants include small businesses and other for-profit organizations, though non-domestic entities are ineligible. Applications are evaluated based on scientific and technical merit, with a primary focus on significance and the likelihood of exerting a sustained influence on the research field. Key requirements include maintaining active registrations in SAM.gov, eRA Commons, and Grants.gov, as well as adhering to strict cybersecurity incident reporting and human subject protection protocols. The project requires a minimum effort of 3.6 person months per year for the PD/PI and mandates participation in a kick-off meeting in Bethesda, Maryland, and bi-annual steering meetings. Applications must follow specific page limits for the research strategy subsections and include detailed plans for clinical trial implementation, data management, and biorepository services.