GREGoRi Innovation Projects (U01 Clinical Trial Optional)

The GREGoRi Innovation Projects (U01 Clinical Trial Optional) is a forecasted funding opportunity from the National Institutes of Health under the U.S. Department of Health and Human Services. The program is managed specifically through the National Human Genome Research Institute (NHGRI). This initiative is part of the federal government’s ongoing commitment to advancing genetic research and developing new strategies to address rare genetic disorders. The funding instrument for this opportunity will be a cooperative agreement, which means that NIH staff will have substantial programmatic involvement during the course of the funded projects. The primary purpose of this program is to promote proof of concept research studies that test innovative approaches for identifying the gene or genetic variant underlying rare genetic conditions. Unlike current practices that begin primarily with DNA sequencing, this initiative encourages applicants to develop methods that use alternative or complementary molecular technologies. Examples of acceptable projects include those employing multi-omics strategies, or studies that investigate RNA sequencing, methylation, or other emerging molecular methods as the first step in gene discovery. Projects that demonstrate effectiveness may later be integrated into the activities of the NHGRI Technology Integration Center to enhance broader genomic research programs. The scope of funding focuses on early-stage, pilot-level studies. This is not intended for large-scale clinical trials but rather for smaller exploratory efforts designed to test the feasibility of these new technologies. Since the activity code is U01, the opportunity may support clinical trials if applicants propose them, though they are not required. The notice emphasizes innovation and proof of concept rather than continuation of existing DNA sequencing approaches. The long-term aim is to accelerate discovery for rare genetic disorders by providing new tools and approaches that may improve the efficiency and accuracy of diagnosis. Eligibility for this opportunity is broad and includes a wide range of entities. Eligible applicants include state governments, county governments, independent school districts, city and township governments, federally recognized and non-federally recognized Native American tribal governments and organizations, nonprofit organizations with 501(c)(3) status, public housing authorities, higher education institutions (both public and private), as well as for-profit organizations, including small businesses. This broad eligibility is intended to attract researchers from diverse backgrounds and institutional settings, allowing for a wide variety of perspectives and approaches to the scientific questions posed. The forecasted timeline indicates that the Notice of Funding Opportunity is expected to be officially published on September 4, 2025. Applications will be due by November 4, 2025. Awards are anticipated to be announced on July 6, 2026, with funded projects beginning on the same date. No pre-application requirements such as a letter of intent are specified in the forecast. The funding is categorized under human genome research, specifically Assistance Listing 93.172, which is administered by NIH. Information on award ceiling, floor, and total funding has not yet been published in this forecast notice and would require verification upon release of the final NOFO. Applications will be evaluated based on scientific merit, alignment with the goals of the NHGRI, and the potential to advance novel molecular methods for identifying disease-causing genes. Because this is a cooperative agreement, funded investigators will collaborate closely with NIH program staff to ensure scientific progress and adherence to program goals. Additional details on review criteria, specific application requirements, and allowable costs will be provided when the official funding announcement is released. For further information, applicants may contact Lisa H. Chadwick at the National Human Genome Research Institute. She can be reached at 301-435-7275 or via email at lisa.chadwick@nih.gov. Interested applicants are encouraged to begin forming research teams and collaborations now to be well prepared for the anticipated publication of the full NOFO in September 2025.