Key Dates

Related Announcements

None

Issued by 

The All of Us Research Program https://allofus.nih.gov/

Office of The Director, National Institutes of Health (OD)

Purpose

This Request for Information (RFI) seeks input on datasets that, if linked to the All of Us Research Program’s data resource, would enable new avenues of research or address gaps in the resource’s current curated dataset. 

The All of Us Research Program

The All of Us Research Program seeks to accelerate health research and medical breakthroughs to enable individualized prevention, treatment, and care for all of us. To do this, the program will partner with one million or more participants nationwide and build one of the most diverse biomedical data resources of its kind. Researchers may leverage the All of Us platform for studies on a wide range of health conditions.

Diversity is one of the core values of the All of Us Research Program. The program aims to reflect the diversity of the United States and has a special focus on engaging communities that have been underrepresented in health research in the past. Participants are from different races, ethnicities, and age groups. They are diverse in terms of gender identity, sexual orientation, socioeconomic status, educational attainment, and health and disability status. Moreover, participants live in all parts of the United States (see map).

All of Us Research Program Data

When responding to this Request for Information, please review and consider the data that are currently available on the data platform, the All of Us Researcher Workbench. Data are available to researchers in several access tiers. You can refer to the data dictionary for details and use the All of Us Data Browser to explore publicly available, aggregate data and view outcomes of interest. Within the secured, cloud-based Researcher Workbench, researchers are able to make associations through the integrated dataset by cross-referencing data from these different data types:

• Participant Surveys. All of Us survey modules can be viewed here. Survey data are currently available for 500,000+ participants.
• Genomic Data. Whole genome sequencing data are currently available for over 245,000 participants and genotyping arrays for over 312,000.
• Electronic Health Record (EHR) Data. EHR data are currently available from 430,000+ participants, including a wide range of visit types, disease conditions, drug exposures, procedures, labs, and measurements.
• Physical Measurements. Physical measurement data are available for 337,000+ participants including height, weight, mean waist circumference, mean hip circumference, mean heart rate, mean blood pressure, wheelchair use, and pregnancy status at the time of study site visit.
• Wearables Data. Fitbit data are available for 15,000+ participants including heart rate and physical activity.

As the program grows, additional data types and sources will become available. The program has projected some of the anticipated data types and timelines for their acquisition, which can be found in the All of Us Research Program’s data roadmap.

In general, the scientific strategy by which new data types are prioritized by the program fall into the following categories that reflect the unique offerings of All of Us:

• Workbench & data: new methods toolbox and phenotype expansion
• Exposures & drivers of health and disease: lifestyle, substances and behavioral health; environment; health inequity; genetics and biology
• Causality & outcomes: prevalent common and rare health conditions; maternal and child health; healthy aging and resilience across the lifespan; return of results impact on individual and population health

Value of Linkages to All of Us

Currently, All of Us Research Program participants contribute a range of data for research use, including information from surveys, EHRs, physical measurements, wearable devices, and biosamples. Due to the scale of the All of Us Research Program, including the number of individuals enrolled and longitudinally retained, participant-level and contextual (e.g., air quality measures) data linkages are essential to minimize participant burden and enrich the data resource. By integrating linked data, the program aims to expand analytic pathways within and across lifestyle, environment, and biology. 

 Given the critical importance of linkages to the program, the All of Us Research Program recently funded the All of Us Center for Linkage and Acquisition of Data (CLAD). The intention of CLAD is to expand the type and research utility of program data by acquiring new passive data streams and providing additional methods to acquire data for existing data streams, such as electronic health records (EHRs). Though other factors will impact the initial set of linkages made through CLAD, fundamentally, data linkages will be selected based on the principles of expanding the understanding of a participant’s health, increasing research utility of the data, aligning data collection with the expectations of consented participants, ensuring quality, and increasing retention metrics. In general, the first set of linkages to be established before March 2025 will focus on mortality, residential history, geocoding, environmental, and health care claims data. Information gathered through this RFI may help the program determine the future linkages to be pursued.

Information Requested

This RFI invites comments from industry, government, scientific researchers, community-based organizations, consumer advocacy groups, service agencies, health care providers, policymakers, and the public. We are seeking input on potential data linkages that may add value to the All of Us Research Program’s data resource. Below is a list of linkage categories that may be of interest, as well as some examples for each category. Respondents are not limited to the listed categories or examples. Respondents may address one or more of the categories of data linkages or suggest their own given their understanding of the All of Us Research Program:

• Electronic health record (e.g., FHIR endpoints, HIEs, QHINs)
• Economic Factors / Indicators (e.g., Distressed Communities Index)
• Facility / Provider (e.g., information on facilities and providers of care)
• Geospatial
  • Environmental exposures (e.g., built / physical / structural, environment EPA air monitoring data, fluoridated water sources)
  • Social Determinants of Health
• Imaging / Waveform Databases (e.g., MIDRC)
• Pharmaceutical (e.g., prescribing information)
• Registries (e.g., Immunization, IRIS, SEER)
• Other Publicly Available Federal / State Datasets

Respondents may put forward any linkage that they think may be of value to the All of Us Research Program. Additionally, if Respondents wish to address multiple linkages, please denote their relative priority by assigning a consecutive numeric value to each one in your response. For example, if you choose to propose five linkages, each would be assigned a priority of 1, 2, 3, 4, or 5 with the lowest numeric value being the highest priority in the Respondent’s estimation.

In the response, for each linkage recommendation, please describe the following:

• Please provide a description of the linkage and source of the data
• What is the relative priority to others in your response if proposing multiple linkages (for example, 1 = highest priority, 5 = lowest priority)?
• Why should this be a priority for the All of Us Research Program?
• What research will be enabled with the addition to the All of Us data resource, and what impact could this research have on human health?
• To maintain its utility, what is the frequency of the linkage you would recommend?
• How well does the proposed linkage align with the All of Us Research Program’s focus on individuals underrepresented in biomedical research?
• Has this data resource been linked into other consented research studies that you are aware of and, if so, what were they?
• Which All of Us Research Program’s strategic scientific focus area will be fulfilled by the inclusion of data from this linkage?
  • Workbench & data
  • Exposures & drivers of health and disease
  • Causality & outcomes
• How should AoU participants be informed about data linkages after they have occurred?
• Should the data from the specific linkage you are recommending be returned to a participant? Why or why not?
• Are there any novel risks to participants created by these linkages, and if so, how can they be managed or mitigated?
• All of Us Research Program participants must sign a consent and authorization to share electronic health record information when enrolling in the program. How does the consent an authorization affect the data linkage(s) you are recommending?  (For more information please view https://allofus.nih.gov/about/protocol/all-us-consent-process)

How to Submit a Response

Responses to the RFI questions will be accepted through June 28, 2024. All RFI responses must be submitted electronically to: [email protected] . Electronic submissions through the portal received after the deadline may or may not be taken into consideration. There will be no extensions beyond the due date.

Responses are limited to a total of 8 pages. Shorter submissions are welcome. Responses should be formatted such that the margins are 1 inches wide on all sides and the font size is 12 points. Graphics may be included where they will help with addressing the bulleted questions noted above. Submissions that include marketing, business development, staff bios / CVs / resumes, or organizational capabilities information will not be used.

Responders are free to address any or all the questions listed above. All submitted information will be reviewed by NIH staff and contractor support personnel. Responses to this RFI are voluntary and may be submitted anonymously. You may voluntarily include your name, organization, and contact information with your response. If you choose to provide NIH with this information, NIH will not share your name and contact information outside of NIH unless required by law.

This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

No business proprietary information, copyrighted information, classified, or personally identifiable information (aside from that requested above) should be submitted in response to this RFI. Responses to this notice are not offers, and cannot be accepted by the Federal Government to form a binding contract. Additionally, those submitting responses are solely responsible for all expenses associated with response preparation.

Questions: Interested individuals and organizations who have questions about the RFI should submit these questions electronically to [email protected] . Please include “RFI Question: Potential Linkages for the All of Us Research Program” in the subject line of the email.

Inquiries

Please direct all inquiries to:

 All of Us Research Program 

Email: [email protected]