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

Open Posted

Opportunity number
PAR-27-069
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Not on record
Category
  • Health
Eligible applicants
  • Other
  • Small Businesses
  • State Governments
  • Higher Education Inst. (Public)
  • Tribal Organizations (Not Federally Recognized)
  • Special District Governments
  • 501(c)(3) Nonprofits
  • Non-501(c)(3) Nonprofits
  • Higher Education Inst. (Private)
  • For Profit Organizations
  • County Governments
  • Tribal Governments (Federally Recognized)
  • City/Township Governments
  • Independent School Districts
  • Public or Indian Housing Auth.
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

The National Institutes of Health is soliciting applications for X01 Resource Access Awards to enable researchers to access biospecimens from the All of Us Research Program Biobank by March 1, 2027. This opportunity does not provide federal funding; applicants must secure external funding to cover all research costs, including assay development, biospecimen retrieval and shipping, and data generation.

Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, state and local governments, tribal organizations (federally recognized and not federally recognized), special district governments, independent school districts, public or Indian housing authorities, and foreign organizations. Foreign components of U.S. organizations and non-domestic entities are eligible.

Researchers gain access to stored blood plasma, blood serum, and extracted DNA from over 613,000 participants. Applications must demonstrate evidence of existing or planned funding and propose large-scale projects using validated assays. Applicants must register in the All of Us Researcher Workbench Controlled Tier to develop their research question and select cohorts. Required elements include detailed laboratory quality management plans, sample size and power calculations, material transfer and data use agreements, and commitment to returning curated assay data to the All of Us Researcher Workbench within a nine-month exclusive access period followed by public release. Projects must propose meaningful return-of-value plans to participants through accessible educational materials at a seventh-grade reading level in English and Spanish.

High-priority research areas include integrated multiomics analyses, early disease detection, biomarker discovery or validation, novel risk models for incident disease, and novel disease stratification for chronic disease risk, diagnosis, and prognosis in support of precision medicine. Clinical trials are not allowed under this announcement.

Applications are due July 1, 2026, October 30, 2026, and March 1, 2027, with earliest start dates of November 2026, March 2027, and July 2027. The program operates under CFDA 93.368 (21st Century Cures Act – Precision Medicine Initiative) and is administered by the NIH Office of the Director All of Us Research Program.

Synopsis

The purpose of this Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR) is to solicit applications to access stored blood plasma, blood serum, and extracted DNA from the All of Us Research Program supported Biobank to advance the program's mission of accelerating health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us.All of Us partnered research studies are collaborative initiatives funded by a study sponsor external to All of Us to collect and add new data to the All of Us Researcher Workbench in accordance with All of Us" best practices. All of Us partnered research studies are open to the broad scientific community and require investigators to apply for and receive an X01 award under this announcement.This will enable longitudinal follow‐up and repeat sampling, and provide multiomic data (genomics, proteomics, metabolomics, and other high‐dimensional molecular profiles), integrated clinical, environmental, and life‐course data, infrastructure designed to support future clinical‐trial recruitment, and public‐private partnership pathways.This opportunity will enable researchers to conduct assays to evaluate associations between newly collected and existing All of Us data and add new data to the All of Us dataset for broad use by the research community. High-priority areas for biospecimen analyses may include, but are not limited to, large scale projects that propose integrated multiomics analyses, early disease detection, biomarker discovery or validation, novel risk models for incident disease, and/or novel disease stratification for chronic disease risk, diagnosis, and prognosis, in support of advancing precision medicine. For more information, please visit the All of Us X01 Partnered Research Studies Resource webpage.

Eligibility

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/Foreign Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Files

File Type Posted
PKG00292849.pdf PDF
PAR-27-069-Full-Announcement.html HTML file

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