GREGoRi Innovation Projects (U01 Clinical Trial Optional)

The GREGoRi Innovation Projects funding opportunity is issued by the National Institutes of Health through the National Human Genome Research Institute. NHGRI serves as a leading federal entity focused on advancing genomics research and translating scientific discoveries into improvements in human health. Its broader mission includes developing genomic technologies, supporting foundational research, and addressing ethical, legal, and social implications associated with genomic science. This funding opportunity is part of the GREGoRi initiative, which builds on prior efforts to enhance the diagnosis of rare genetic diseases by fostering innovation in both experimental and computational methodologies. The purpose of this funding opportunity is to accelerate transformative advancements in rare disease diagnosis by supporting highly innovative approaches that go beyond current genomic sequencing techniques. While whole exome sequencing has become a standard diagnostic tool, a significant proportion of rare disease cases remain unresolved. This program seeks to address those gaps by encouraging the development of new molecular technologies, improved analytical methods, and integrated multi-omics approaches. Projects may focus on either technology innovation, involving experimental methods, or computational innovation, involving algorithm and tool development. Funding is provided through cooperative agreements, indicating substantial collaboration between award recipients and NIH staff. The program anticipates awarding approximately 8 to 10 grants, with a total funding pool of $7.5 million for the fiscal year. Each project may request up to $500,000 in direct costs per year, with a maximum project period of three years. Funds are intended to support research activities, personnel, data sharing infrastructure, and participation in consortium meetings. There is no cost-sharing or matching requirement associated with this opportunity. Eligible applicants include a broad range of organizations such as higher education institutions, nonprofits, for-profit entities, government agencies, and international organizations. Individuals with appropriate expertise may serve as principal investigators through their affiliated institutions. The program emphasizes inclusivity and allows multiple applications from the same organization provided they are scientifically distinct. However, restrictions apply to foreign subawards, and all applicants must complete required federal registrations prior to submission. The application process requires submission through federal systems such as Grants.gov or NIH ASSIST. Applicants must follow detailed NIH application guidelines, including preparation of research plans, data management and sharing plans, and compliance documentation. Projects are evaluated through a peer review process based on criteria such as significance, innovation, rigor, feasibility, and investigator expertise. Additional considerations include human subjects protections, data sharing plans, and overall alignment with program goals. Key dates for this opportunity include an application open date of September 30, 2026, and a submission deadline of October 30, 2026. Applications must be submitted by 5:00 PM local time. The review process is expected to occur in March 2027, followed by advisory council review in May 2027, with the earliest project start date in July 2027. This is a one-time funding announcement with a defined expiration date, and there is no indication of recurring cycles. Award recipients will become members of the GREGoRi Research Consortium and are expected to collaborate closely with other funded projects and NIH staff. Responsibilities include sharing data and resources, participating in consortium governance, and contributing to collective research goals. The program emphasizes open science principles, requiring data to be shared through platforms such as AnVIL. Applicants are encouraged to contact NHGRI staff for guidance and may participate in informational webinars prior to submission.

Focus on transformative innovation beyond current genomics methods; clearly demonstrate feasibility and rigorous study design; align with consortium collaboration and data sharing expectations