Partnered research studies are collaborative initiatives funded by an external study sponsor, not the All of Us Research Program, to collect data from program’s participants or stored biospecimens for integration into the All of Us dataset. Leveraging the All of Us core protocol and infrastructure, partnered research studies deliver additional value to participants and add data to the Researcher Workbench. To learn more about All of Us partnered research studies, click here.

An X01 Resource Access Award is a mechanism used by the National Institutes of Health (NIH) to invite eligible investigators to seek access to NIH research resources, rather than direct research funding. The All of Us Research Program intends to make processed and stored biospecimens available to meritorious applicants using this mechanism. Please review the Cost Considerations for X01 Applicants section on this webpage for detailed cost estimates and resource allocation planning. For detailed information on eligibility and application requirements, please visit the X01 Notice of Funding Opportunity (NOFO). 

Applications that propose to generate data applicable to a broad range of future scientific questions will be prioritized. Applicants must propose using assays with demonstrated, repeated analytic validity in large cohorts; proposals relying on unvalidated methods will be deemed non-responsive. All proposed assays should be robust, reproducible, and cited in peer-reviewed publications. For each proposed assay, please include the following information in your application: 

1. 1. Relevant preliminary data or proficiency testing demonstrating experience with the assay, and accuracy and robustness of the proposed assays.
   2. Description of the analytical method and reference(s), such as the URL for a standard method or publication(s) that describe the assay(s) and quality control methods;
   3. Methodologies and instrumentation, including the detailed descriptions of assay platforms, key equipment, and specific assay kit name if a commercial kit is employed;
   4. Analyte stability under known storage conditions and performance and analytic validity for type of biospecimen requested, including assay performance metrics, such as precision, sensitivity, specificity, accuracy, limits of detection, etc.

For more information, please visit the X01 Notice of Funding Opportunity (NOFO).

Yes, foreign organizations and non-domestic components of U.S. organizations are eligible to apply and/or collaborate on listed proposed activities as part of an application to PAR-27-069. Projects awarded to a domestic institution with a foreign component are also allowable under this notice of funding opportunity. Foreign (non-U.S.) organizations must follow current NIH policies, policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

Biospecimens may only be shipped to X01 awardees once material transfer and data use agreements are finalized between the All of Us research program, the All of Us Biobank, and the investigator’s institution. Once these agreements are in place, the All of Us Biobank will work with the investigator to finalize all aspects of the biospecimen request, including the funding and time needed for shipment.

The All of Us Research Program reserves the right to make final cohort decisions and/or withhold the release of biospecimens. This includes, but may not be limited to, withholding the release of self-identified American Indian/Alaska Native (AI/AN) biospecimens. 

Yes, biospecimens can be shipped internationally. However, courier costs, time for shipping, and regulations for specimen handling may vary. For detailed cost estimates and resource allocation planning, please review the Cost Considerations for X01 Applicants section on this webpage. The All of Us staff will collaborate closely with successful applicants to finalize the costs of all study activities, including the shipment of biospecimens from the All of Us Biobank to the assay laboratory.

Prospective applicants should create their cohort on the Researcher Workbench 2.0 Controlled Tier using the All of Us dataset and biospecimen availability data table to determine cohort criteria, assess the feasibility of their proposed study, and perform preliminary analyses. These data will allow prospective applicants to assess the feasibility of proposed analyses by providing the availability of blood DNA, saliva DNA, serum, and plasma samples, and sample collection dates for all eligible participants. Use the new Data Explorer to learn more about how to create cohorts and datasets in Researcher Workbench 2.0. 

A tutorial walkthrough of accessing and using the biospecimen availability data table can be found in the workspace All of Us Tutorial Workspace: A Guide to Using Biospecimen Tables (v8). Please note, other biospecimen data types may be included in future Researcher Workbench releases, but only these select sample types are eligible for X01 applications. 

To support the feasibility of proposals, we recommend oversampling all cohorts by 10% to help ensure biospecimen availability at the Biobank. Sample availability may vary over time, as biospecimens are released on a rolling basis and may already be in use by other study teams.

For more resources and guides to access the biospecimen data, check out our Using the All of Us Biospecimen Table support article in our User Support Hub.

After you submit your X01 application, please email our team at AoUAncillaryStudies@od.nih.gov. You will receive detailed instructions on how to share your workspace with program personnel.

Thank you for being a part of All of Us and sharing your time, data, and samples. We value your feedback and appreciate the important role you play in guiding the program. To learn more about the X01 and partnered research studies, you can contact the All of Us Support Center.

All of Us program staff will host live office hours to address questions from prospective applicants that were not covered in the TAW. 

The All of Us Data and Resource Center hosts weekly office hours for registered Researcher Workbench users to ask questions in real time about the All of Us dataset, tools on the Researcher Workbench, and technical inquiries about data wrangling. If you have questions about how to build a cohort, how to access and use the biospecimen table, or questions about the All of Us dataset, please consider attending office hours or contact the Help Desk.

For specific application eligibility requirements, please refer to the X01 NOFO. Applicants may find it useful to review the NIH Grants Policy Statement for current policy requirements, including the terms and conditions of NIH grant awards. Other helpful resources may include NOT-OD-25-132: Supporting Fairness and Originality in NIH Research Applications and Notices of NIH Policy Changes published in the NIH Guide for Grants and Contracts.