The Advancing Genomic Medicine Research (R21 Clinical Trial Optional) funding opportunity, reissued as RFA-HG-25-003, is sponsored by the National Human Genome Research Institute and the National Cancer Institute under the National Institutes of Health. It invites exploratory and developmental research proposals to advance the implementation and sharing of genomic information in clinical care. Proposals should focus on improving health outcomes and addressing the policy implications of using genomic data in diverse populations, irrespective of racial, ethnic, or socioeconomic background.

This opportunity seeks innovative approaches to address gaps in genomic medicine. Research areas include understanding facilitators and barriers to the implementation of genomic medicine, developing frameworks for use in diverse clinical settings, creating analytical tools for assessing the clinical impact of genomic data, and improving access to and portability of genomic information. Studies must demonstrate broad applicability beyond single diseases or limited gene targets. Proposals are encouraged to address health disparities, include diverse populations, and incorporate community engagement where applicable.

Eligible applicants include higher education institutions, nonprofits, small businesses, for-profit organizations, and certain government entities. Foreign organizations and non-U.S. components of U.S. entities are not eligible to apply, but foreign components are allowed. Applicants must meet registration requirements in the System for Award Management, Grants.gov, and eRA Commons.

The funding anticipates up to four awards, with a total fiscal year 2024 budget of $1.5 million. Direct costs are limited to $250,000 per year, and projects may last up to three years. Applications must include detailed plans for data sharing and compliance with NIH genomic data management policies. A Plan for Enhancing Diverse Perspectives is also required to outline strategies for inclusivity.

Applications are evaluated based on scientific merit, innovation, feasibility, the significance of the proposed research, and the quality of the research environment. Additional considerations include compliance with NIH data sharing policies and the potential for broad application of findings in genomic medicine. Applications are due by February 11, 2025, at 5:00 PM local time of the applicant organization, with award decisions expected by December 2025.

For assistance, applicants are encouraged to contact the program’s scientific, grants management, or peer review staff as listed in the funding opportunity announcement. Full compliance with NIH application instructions is mandatory to ensure successful submission and review.