Advancing Genomic Medicine Research (R01 Clinical Trial Optional)

This Notice of Funding Opportunity (NOFO), titled Advancing Genomic Medicine Research (R01 Clinical Trial Optional), is issued by the National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI) under the National Institutes of Health (NIH). The program aims to stimulate innovation and enhance understanding of how genomic information and technologies can be implemented effectively in clinical care for diverse populations. Research areas of interest include implementing genomic medicine, facilitating the analysis of clinical genomic data, and improving access to and sharing of genomic data. Specific emphasis is placed on projects with generalizable outcomes applicable to broader clinical settings rather than narrow disease- or gene-specific studies. The funding opportunity supports projects that address critical gaps in the field of genomic medicine. Example areas include studying the diffusion and sustainability of genomic medicine in various clinical settings, developing tools for clinical genomic data analysis, and assessing genomic data integration within health systems. NHGRI encourages projects involving diverse populations and underserved communities to address health disparities in genomic research. The NCI focuses on cancer-specific genomic data, including evaluating its implementation in underserved populations and exploring how genomic data contributes to cancer screening and outcomes. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, tribal governments, and other entities within the United States. Foreign institutions are not eligible, although foreign components of U.S. organizations are allowed. Applications can be submitted for new, renewal, or resubmission projects. Investigators are required to provide a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed during the peer review process. The funding is anticipated to support four awards in 2024, with NHGRI funding approximately three awards totaling $2.4 million and NCI funding one award at $700,000. Direct costs for individual applications are capped at $500,000 annually, and the maximum project duration is five years. The application process requires strict adherence to NIH’s application instructions and forms, including submission through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. Applications must include a Data Management and Sharing Plan and adhere to NHGRI’s data sharing expectations, which emphasize the use of standardized data collection protocols and timely sharing of data in public repositories. Participation in annual grantee meetings is required to promote collaboration and accelerate progress in genomic medicine research. Stakeholder engagement is encouraged, particularly in designing and conducting studies that address health disparities and involve diverse populations. The NOFO was posted on November 19, 2024, with the earliest submission date being January 11, 2025. Applications are due by February 11, 2025, and must be submitted by 5:00 PM local time. Scientific merit reviews will occur in July 2025, with advisory council reviews in October 2025 and award start dates as early as December 2025. Applicants are urged to begin the registration process early to meet submission deadlines.