Accelerating Discovery through Partnered Research with All of Us to Analyze Participant Biospecimens (X01 Clinical Trial Not Allowed)

The Accelerating Discovery through Partnered Research with All of Us to Analyze Participant Biospecimens funding opportunity is administered by the National Institutes of Health under the U.S. Department of Health and Human Services. It is part of the All of Us Research Program, a large-scale national initiative designed to collect health data and biospecimens from one million or more participants across the United States. The program’s mission is to advance precision medicine by enabling researchers to better understand how biological, environmental, and lifestyle factors influence health outcomes. This opportunity specifically supports access to biospecimens housed in the All of Us Biobank, including plasma, serum, and extracted DNA, to facilitate high-impact research that contributes to this mission. The primary objective of this announcement is to enable researchers to conduct advanced assays and analyses using existing biospecimens and integrated datasets within the All of Us Researcher Workbench. Applicants are expected to propose large-scale, scientifically rigorous studies that generate new data and return those data to the program for broader use. Priority is given to projects that involve multiomics approaches, biomarker discovery, early disease detection, and development of predictive models for disease risk and treatment response. The opportunity emphasizes generating broadly applicable findings that enhance understanding across multiple disease areas and populations. This funding mechanism is an X01 Resource Access Award, which does not provide direct financial support. Instead, it grants approved investigators access to valuable research resources. Applicants must secure external funding independently to cover all project-related costs, including personnel, laboratory analysis, biospecimen handling, data generation, and dissemination activities. The program requires detailed justification of biospecimen usage and mandates adherence to strict data quality, security, and privacy standards. Additionally, awardees must return all generated data to the All of Us platform, where it becomes available to the broader research community after a limited exclusive access period. Eligibility for this opportunity is broad and includes a wide range of domestic and international organizations such as higher education institutions, nonprofits, for-profit entities, and government agencies. Investigators must demonstrate the capability to conduct large-scale analyses and familiarity with the All of Us Researcher Workbench. Registration with required federal systems such as SAM, Grants.gov, and eRA Commons is mandatory prior to submission. Applicants must also include evidence of secured funding or a credible plan to obtain funding within one year of receiving a provisional approval. The application process requires submission through Grants.gov or NIH systems such as ASSIST or Workspace. Applicants must follow NIH application guidelines and include detailed research strategies, biospecimen justifications, laboratory capabilities, statistical plans, and data return strategies. Applications undergo peer review based on scientific merit, significance, innovation, and feasibility. Special emphasis is placed on alignment with All of Us program priorities and the potential to generate high-value, reusable data resources. Key dates for this opportunity include an opening date of June 1, 2026, and multiple submission deadlines, including July 1, 2026, October 30, 2026, and March 1, 2027. Applications must be submitted by 5:00 PM local time on the due date. Peer review cycles occur periodically, with earliest project start dates beginning as early as November 2026. The opportunity expires on March 2, 2027, and does not accept late submissions. This program is recurring in nature with multiple submission cycles within its active window. While no direct funding is provided, successful applicants gain access to one of the most comprehensive biomedical datasets available, enabling transformative research opportunities. The program also requires applicants to include plans for returning value to participants through accessible communication and educational materials, reinforcing its commitment to participant engagement and transparency.

Propose large scale validated assays with strong analytic validity; align with All of Us priorities such as multiomics and biomarker discovery; ensure clear plans for data return and participant value; demonstrate capability with large datasets