National Institutes of Health (NIH)
.
All of Us Research Program, Office of the Director, National Institutes of Health (PRECMED)
X01 Resource Access Award
See Section III. 3. Additional Information on Eligibility.
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.
To provide support for initiatives funded under the 21st Century Cures Act, the All of Us Research Program will gather data from one million or more people living in the United States to accelerate research and improve health. By taking into account individual differences in lifestyle, environment, and biology, researchers will uncover paths toward delivering precision medicine.
The All of Us Research Program’s mission is to accelerate health research and medical breakthroughs, enabling individual prevention, treatment, and care for all of us. To carry out its mission, All of Us is collecting a wide range of data from participants across the country to drive discoveries that may improve overall health and the early detection, treatment, and prevention of a broad variety of diseases, while delivering one of the largest and richest biomedical datasets broadly available to the research community.
New (Resubmissions Not Applicable): July 1, 2026
New and Resubmissions: October 30, 2026
New and Resubmissions: March 1, 2027
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).
Not Applicable
October 2026
February 2027
June 2027
Not Applicable
November 2026
March 2027
July 2027
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Purpose
The purpose of this Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR) is to solicit applications to access the processed and stored biospecimens 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.
This opportunity allows eligible investigators across the scientific community to access biospecimens from the All of Us Biobank to generate new assay data for subsequent analysis and to return newly generated data to the All of Us Researcher Workbench and create opportunities for engaging All of Us participants, building on All of Us resources to create rich opportunities for future research.
All of Us partnered research studies are collaborative initiatives funded by a sponsor external to All of Us to collect new biospecimens or 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. No funds are associated with awards from this announcement. The X01 will allow the NIH All of Us Research Program to prioritize applications that fit within programmatic priorities, consider collaborative opportunities between applicants, and oversee awardees’ adherence to NIH and All of Us policies and procedures during performance of All of Us partnered research studies.
Background
The All of Us Research Program is a historic effort to collect data and biospecimens from at least one million people living in the United States and its territories, to accelerate health research and medical breakthroughs, and enable individualized prevention, treatment, and care. Built in partnership with participants spanning varied demographics, health statuses, and regions of the country, the All of Us dataset provides unprecedented opportunities for a wide range of studies to understand how biological, social, behavioral, and environmental factors influence health and a broad range of diseases and conditions.
As of December 2025, the All of Us Research Program has consented more than 872,000 participants, with over 613,000 participants providing biospecimens for research. At this time, only biospecimens collected at a single time point are available through this PAR.
The All of Us Researcher Workbench hosts the program’s dataset and serves as an international research resource to tens of thousands of studies, covering a wide range of health conditions. This scientific resource provides the data, tools, and cloud-based analysis infrastructure that enables interdisciplinary scientific teams to investigate complex, multidimensional, and intersecting influences on human health in collaborative workspaces.
For more information on different data types and participant characteristics including health conditions, aggregate-level data contributed by All of Us participants can be searched publicly through the All of Us Data Browser at databrowser.researchallofus.org. All of Us Researcher Workbench data is curated and updated regularly to align with the program’s data protection safeguards. Information on planned additions to the dataset is available on the All of Us Data Roadmap. With access to All of Us biospecimens, successful investigators will be able to generate new data and in combination with currently available data on the Researcher Workbench investigate how a broad range of biological, genetic, environmental, behavioral, and social factors influence health outcomes. At the time of this announcement, the All of Us Biobank manages and stores over 14.7 million aliquoted biospecimens donated by over 613,000 participants. A subset of these aliquots will be made available for this X01 opportunity.
Biospecimen Partnered Research Study Overview
Investigators interested in accessing biospecimens through this partnered research study opportunity should access the All of Us Researcher Workbench to create a workspace to query existing data, develop a research question, and select a cohort of eligible participants in support of their application. See Research Strategy section for additional application information.
Applicants conditionally approved to obtain access to biospecimens will receive a provisional letter of support from All of Us, which may be utilized to secure funding for the proposed project. If funding for the proposed project is secured, All of Us will execute final partnered research study requirements in collaboration with investigators and its program partners to obtain final approval for release of de-identified biospecimens. Next, the All of Us Biobank will securely ship de-identified biospecimens to the investigator(s) and/or approved laboratory in order to carry out the approved analyses and for the generation of novel data.
As required of all partnered research studies, the investigator(s), laboratory, and/or collaborator(s), must appropriately curate and share all generated data with the All of Us Data and Research Center for privacy assessment and linkage to existing All of Us participant data in the Researcher Workbench. The investigator(s) and/or collaborator(s) will then receive exclusive access to their generated data linked to All of Us participant data, such as genomic data or electronic health records, for up to 9 months in order to conduct their proposed analyses. Following that period or at the conclusion of the proposed analyses, the All of Us Data and Research Center will release the generated data to the All of Us Researcher Workbench for all registered researchers to access in support of the mission to accelerate discovery for all.
Research Scope
For this X01 announcement, the eligible cohort of All of Us participants will include those with available electronic health records, genomic data, physical measurements, baseline survey data (i.e., The Basics, Overall Health, and Lifestyle), and stored biospecimens, including plasma, serum, and/or extracted genomic DNA from blood or saliva. Applicants must propose using assays with demonstrated, repeated analytic validity in large cohorts; proposals relying on unvalidated methods will be deemed non-responsive. Applicants should propose large-scale projects that make optimal use of stored plasma, serum, and/or extracted DNA biospecimens by yielding the highest scientific value to the All of Us Research Program, with broad impacts such as advancing precision medicine, enhancing prevention and treatment strategies, and narrowing health disparities. Proposals that generate data on the entire population or large subsets will be prioritized. Applications that propose broadly applicable assays with the potential to provide insights into biological pathways that underlie common, chronic, or pressing health conditions will also be prioritized. Ideal projects will include assays that generate data that are applicable to a broad range of future scientific questions. Investigations of rare diseases will be evaluated on a case by case basis. Applications that propose adding a new biospecimen-derived data type to the All of Us dataset and/or propose expanding a data type currently available only on a small subset of All of Us participants (see All of Us Data Roadmap) are permitted. Proposals for expanding currently available data types must be compatible or compliant with those existing data.
Specific areas of interest to advance precision medicine include, but are not limited to:
Details on All of Us Biospecimen Access
Up to three types of biospecimens from each participant may be made available for this X01: serum collected by Becton Dickson (BD) vacutainer serum separation tubes (SST), plasma collected by BD vacutainer plasma separation tubes (PST) or BD vacutainer EDTA tubes, and genomic DNA extracted from blood or saliva.
All of the collected biospecimens by the All of Us Research Program are processed and stored in a centralized, standardized manner at the All of Us Biobank (located in Rochester, MN) to ensure consistency and quality.
For more information on standardized sample collection processes, procedures, and storage conditions applicants may visit the All of Us X01 Partnered Research Studies Resource webpage (https://www.researchallofus.org/biospecimen-announcement/).
All biospecimens stored at the All of Us Biobank are de-identified and will be shared with successful applicants without other participant level information (e.g., age group, sex, race). If basic participant-level information is essential to the proposed assay, the investigators must provide justification as part of their proposal.
Applicants should acknowledge in their proposals that the All of Us Research Program does not release biospecimens until material transfer and data use agreements are in place.
To ensure adherence to program policies and participant protections, the All of Us Research Program reserves the right to make final cohort decisions and/or withhold the release of any biospecimen type.
Specific Application Requirements and Expectations
Evidence of Funding
All of Us partnered research studies require support from funding sources external to All of Us. This announcement does not provide funds for any costs related to the proposed research project. Applicants are responsible for providing their own funding to cover all costs associated with conducting the proposed research under the auspices of All of Us partnered research studies, including but not limited to:
Other costs will be specific to the needs of each study. For assistance with budget planning associated with partnered research studies, applicants are encouraged to visit the All of Us X01 Partnered Research Studies Resource webpage. Applicants who cannot provide evidence of existing funding to support the proposed research must describe a plan to secure funding within one year of receiving a provisional letter of support from All of Us. The letter of support from the All of Us Research Program may be used for securing funding. Meritorious applicants may request additional time to secure funding with appropriate justification.
Biospecimen and Assay Data Quality and Security Measures
Only proposals utilizing assays that have been rigorously validated in large cohorts (i.e. data demonstrating reproducible sensitivity and/or specificity under population-scale use and robust to biobank style collection procedures) and are applicable to multiple research areas will be considered. All other applications will be deemed non-responsive. Applications must include detailed information about the proposed analytical laboratory, planned assays, and plans for implementing biospecimen and assay data quality and security measures. Investigators must adhere to the All of Us Biospecimen Access Policy. To access the policy, please visit All of Us X01 Partnered Research Studies Resource webpage. For more details, see Section IV below.
All of Us Researcher Workbench Controlled Tier Access
To be eligible for this funding opportunity, applicants must register for access to the All of Us Researcher Workbench Controlled Tier. After registration, applicants will be able to access the cohort of participants with available serum, plasma, and DNA biospecimens to perform cohort selection and sample size/power calculations. For assistance with identifying cohorts with eligible biospecimens, applicants are encouraged to visit All of Us X01 Partnered Research Studies Resource webpage.
Requirement of Returning Newly Generated Biospecimen Assay Data to All of Us
Newly generated assay data from approved All of Us biospecimens must be returned to All of Us Research Program. Investigators will then receive exclusive access to the data linked to requested participant data through the All of Us Researcher Workbench for up to 9 months to complete the proposed specific aims. After this embargo period, the curated, research-ready data will be released to all registered users of the All of Us Researcher Workbench.
Project proposals must include plans to return curated, release-ready biospecimen assay data to the All of Us Researcher Workbench to support broad researcher use and maximize scientific impact through publications and other outputs. Along with returning assay data, awardees will be required to create or support researcher-facing materials, such as support articles (e.g., Exploring the Mind; Physical Measurements), a featured Researcher Workbench workspace, data dictionaries, and approved code, and when appropriate, generate publications.
Requirement of Returning Value to All of Us Participants
The All of Us Research Program seeks to promote and maintain long-term trust with participants as partners in All of Us. Partnered research study investigators are expected to propose return of value (ROV) plans including creation of materials, engagement and outreach techniques, or communications strategies to ensure participants receive meaningful information that engages them in the program. These plans are finalized and implemented in close coordination with All of Us.
Return of Value in the All of Us Research Program means:
In order to uphold this commitment, applicants are required to submit a ROV plan to outline strategies for meaningful contributions to All of Us participants.
Examples of ROV include but are not limited to:
To the extent possible, each ROV plan should follow the guidelines listed below in documenting the plans for return of information to participants. Given the nature of the de-identified biospecimens awarded under this X01, returning results to All of Us participants individually, i.e., contacting All of Us participants, will not be permitted. ROV materials will be limited to generalized information (i.e. not based on individual participant data). Applicants should include collaboration with All of Us as a part of their plan to coordinate interactions or communication with participants. Innovative plans for ROV are highly encouraged. Applicants must include ROV activities, including staff time, design, and dissemination in their proposed budgets and evidence of funding. Applications should consider the following guidelines in their proposals:
See Section VIII. Other Information for award authorities and regulations.
Other: A financial assistance mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications.
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
These awards do not provide funding. The number of awards is contingent upon the number of meritorious applications and the capacity of the All of Us Research Program.
Not Applicable. X01 resource access awards do not provide funding.
The scope of the proposed project should determine the project period. The maximum project period is 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.
Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.
For this specific NOFO, the Research Strategy section is limited to 6 pages.
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
Total Federal Funds Requested: Enter $0.
Total Federal & Non-Federal Funds: Enter $0.
Estimated Program Income: Enter $0.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Specific Aims
The Specific Aims should refer directly to the X01 request and should clearly and concisely describe the potential impact of the proposed research.
Research Strategy
Applicants should propose large-scale, innovative projects that take advantage of the unique opportunities inherent in partnering with All of Us. This section should address the project's:
Significance
Investigator(s)
Approach
Applications should also address the following requirements of the announcement.
Evidence of Funding
Because this announcement does not provide funding for the research project, applicants must provide evidence of existing funding or a plan to secure funding within one year of receiving a provisional letter of support sufficient to cover the following budget items:
Biospecimen and Assay Data Quality and Security Measures
Requirement of Returning Biospecimen Assay Data to All of Us
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply Application Guide.
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the All of Us Research Program, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular NOFO, note the following:
The X01 Resource Access Program invites eligible institutions to seek access to NIH research resources, which are specified in each X01 NOFO. This includes programs where institutions will request access to submit to the resource (e.g., high throughput screening assays) as well as programs where access to a specific NIH research resource is needed to conduct certain research. Important factors in the peer review of X01 applications are the need for, and potential benefit of, gaining access to the resource, specifications for any assays proposed, timelines for completion.
Reviewers will provide a brief written summary to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this NOFO:
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?
Specific to this NOFO:
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does it combine other fields or practices (i.e. incorporate bioinformatics and artificial intelligence)?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO:
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this NOFO:
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing a brief written summary, but will not give separate scores for these items.
Specific to this NOFO:
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Not Applicable
Not Applicable
For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Not Applicable
Not Applicable
Not Applicable
While this mechanism will not provide funding, reviewers will assess whether the requested period of support is fully justified and reasonable in relation to the proposed research.
X01 applications will undergo an internal administrative evaluation by NIH staff. Applications submitted for this funding opportunity will be evaluated using the criteria shown above.
As part of the scientific peer review, all applications will receive a brief written summary.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed.
As X01 applications are reviewed by a federal review panel, they will not undergo Advisory Council review. The following will be considered in making award decisions:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
An X01 does not result in a Notice of Award (NoA). Rather, selected applicants will receive access to resources described in this NOFO. Successful applicants will receive instructions for next steps.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
An X01 does not result in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.
Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.”
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.
Not Applicable
A Data Management and Sharing Plan is not applicable for this NOFO.
Not applicable. An X01 does not result in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
Office of the Director, NIH
Division of Program Coordination, Planning, and Strategic Initiatives, All of Us Research Program
Innovative Collaborations and Ancillary Studies Branch
Email: AoUAncillaryStudies@od.nih.gov
Email subject: AllofUsX01
The NIH awarding component is responsible for review. Please contact the Scientific/Research Contact mailbox (AoUAncillaryStudies@od.nih.gov, subject: AllofUsX01) for questions.
Office of the Director, NIH
Division of Program Coordination, Planning, and Strategic Initiatives, All of Us Research Program
Innovative Collaborations and Ancillary Studies Branch
Email: AoUAncillaryStudies@od.nih.gov
Email subject: AllofUsX01
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.