NLM Research Grants in Biomedical Informatics and Data Science (R01 Clinical Trial Optional)

The National Institutes of Health (NIH), through the National Library of Medicine (NLM), offers the Research Grants in Biomedical Informatics and Data Science (R01, PAR-23-034) to support innovative research that uses biomedical informatics and data science to improve human health and advance the field of informatics. This grant encourages projects focused on data-driven biomedical discovery, public health practice, and clinical care innovations, using integrative, interdisciplinary approaches across complex data sources. The program promotes novel, scalable, and reproducible methods that adhere to FAIR (Findable, Accessible, Interoperable, Reusable) data standards, enabling scientific insights applicable to various health domains. Award budgets are limited to $250,000 annually in direct costs, with a project period of up to four years. Research areas eligible for funding include methods to analyze and interpret large-scale biomedical data, tools for public health decision-making, techniques addressing data bias and fairness, and models enhancing data security and accessibility. Specific areas of interest range from advanced data retrieval, natural language processing of health records, and simulation modeling to approaches for integrating and curating data from diverse sources. Projects may involve computational methods for translational research, patient decision support, or algorithmic innovations addressing health equity. While clinical trials are optional under this FOA, projects that include them must adhere to NIH’s trial policies, and applicants should consult NLM contacts for guidance on trial design. Eligible applicants include public or private higher education institutions, nonprofits, small businesses, local governments, and other qualifying entities, both U.S.-based and foreign. Key individuals, such as Principal Investigators, must hold eRA Commons accounts, and applicant organizations must maintain active registrations with SAM, NCAGE (for foreign applicants), eRA Commons, and Grants.gov. Applicants may submit multiple applications if they are scientifically distinct. This FOA does not require cost-sharing, but applicants must comply with NIH application standards, as outlined in the SF424 (R&R) Application Guide. Applications are due on standard NIH dates through January 2026, with initial submissions required at least five months before anticipated project start dates. Applications are evaluated on significance, investigator expertise, innovation, methodological approach, and the project environment. For clinical trials, review criteria also cover study design, data management, recruitment strategies, and adherence to ethical standards. Notably, proposals centered solely on software development or data infrastructure are non-responsive, as this FOA emphasizes groundbreaking methods rather than products. Applications must include a Resource Sharing Plan detailing data and tool dissemination practices, particularly around software usability, open-source licensing, and version control. Where possible, NLM encourages public access to project outputs, which should be documented and hosted on appropriate, version-controlled platforms for easy adaptation by the broader research community. Resource-sharing expectations emphasize reproducibility, long-term access, and documentation of software, data, and methods. Following peer review, applications undergo an NLM Board of Regents review. Decisions consider scientific merit, innovation, programmatic relevance, and budget considerations, with final announcements anticipated post-review. Projects aligning with NLM’s data science priorities in biomedical discovery, clinical practice, and health informatics stand to make a sustained impact on the informatics field and may address critical health challenges through innovative data methodologies.