Key Dates

Related Announcements

None

Issued by

All of Us Research Project, Office of The Director, National Institutes of Health (OD)

Purpose

The National Institutes of Health is issuing this Notice to alert the community about an upcoming Research Opportunity Announcement (ROA) from the All of Us Research Program, a historic effort to gather data from at least 1 million people who reflect the diversity of the United States, with the goal of accelerating health research and medical breakthroughs, and enabling individualized prevention, treatment, and care.

The purpose of the ROA will be to solicit the development and implementation of the Center for Linkage and Acquisition of Data (CLAD). CLAD will expand All of Us Research Program research and analyses by acquiring new passive data streams and providing support, as needed, for existing data streams such as electronic health records.

The ROA is expected to be published in January 2023, and will be available via www.sam.gov. NIH acceptance of applications will depend on the time frame outlined in the published opportunity announcement but is estimated to be March 2023. The goal is to make an award as early as July 2023. The anticipated award will be made utilizing the Other Transaction Authority (OTA) under Section 402(n) of the Public Health Service Act (PHSA), 42 U.S.C. 282(n). Proposed technology systems and data acquisition services must be capable of integrating with All of Us platform partners, particularly the Data and Research Center. A centralized cloud-based data curation and linkage platform will be a principal component of this effort; it must be ready for production launch within 6-12 months from the time of the award. This includes meeting all of the All of Us and NIH security and privacy requirements, including compliance with a Federal Information Security Modernization Act (FISMA) moderate level.

This Notice is being provided to allow potential offerors time to engage with the All of Us Research Program in advance of the release of the ROA.

This Notice does not commit the Government to award an agreement. This Notice is for informational purposes only. It is not a formal ROA or Request for Application. Do not submit any formal proposals or applications to this Notice. All information contained in this Notice is subject to change at any time.

Research Initiative Details

All of Us Research Program

The All of Us Research Program is a historic effort to gather data from at least 1 million people living in the United States, with the goal of accelerating research and medical breakthroughs, and enabling individualized prevention, treatment, and care. The program is guided by a set of core values, including diversity, transparency, and accessibility. The program is creating a national research resource to inform thousands of studies, covering a wide variety of health conditions.

Registered researchers use data from the program to learn more about how individual differences in lifestyle, environment, and biological makeup can influence health and disease. The All of Us Research Program is committed to enrolling a cohort of participants who reflect the diversity of the U.S., including groups historically underrepresented in biomedical research. The program characterizes populations that are underrepresented in biomedical research as groups that historically have low representation rates in biomedical research studies (including clinical trials). Groups underrepresented in biomedical research include (1) individuals identifying as from racial and ethnic minority groups and/or (2) sexual and gender minority groups; (3) children and older adults; and people with (4) disabilities, (5) barriers to accessing healthcare, (6) lower incomes, or (7) limited educational attainment; and/or (8) residents of rural areas.

The All of Us Research Program has enrolled more than 555,000 adult participants since 2017, and assembled a partner network of more than 100 organizations supporting community outreach and engagement, participant enrollment and retention, program operations, and longitudinal cohort management. The majority of program participants have enrolled in the All of Us Research Program with support from a network of Health Care Provider Organization partners, including Regional Medical Centers, Federally Qualified Health Centers, and U.S. Department of Veterans Affairs Medical Centers.

In addition to a strong facility-based enrollment network, the All of Us Research Program supports nationwide enrollment of eligible adults, ages 18 and up. These nationwide participants can complete initial protocol activities through responsive web and native application-based digital participant experiences and provide biosamples remotely from 50 states and most U.S. territories. The demographic diversity and geographic distribution of program participants further highlight the need and value of expanding capabilities to acquire passive data streams across multiple domains, including environmental data. A recent version of All of Us Research Program’s protocol is available for additional information.

Research Objectives

Currently, participants contribute a range of data, including information from surveys, electronic health records, physical measurements, wearable devices, and genomic analyses. The program plans to integrate additional information. Due to the scale of the All of Us Research Program, including the number of individuals enrolled and longitudinally retained, data linkages are required to minimize participant burden and enrich the data resource. Thus, a partner is needed to acquire, harmonize, and standardize data, and link it to All of Us program participants without recontact (passive means). This work must be done consistent with the All of Us Research Program’s informed consent, privacy, and security policies and regulations.

It is anticipated that expanding data streams through passive means will increase research opportunities and scientific discovery through the use of the All of Us Researcher Workbench. Consequently, the purpose of the Center for Linkage and Acquisition of Data (CLAD) is to expand the research utility of the All of Us Research Program by acquiring new passive data streams and providing support, as needed, to acquire data for existing data streams such as electronic health records.

The CLAD ROA will solicit the development of a technology platform for the acquisition, ingestion, curation, and documentation of data streams to enhance the research utility of the All of Us Research Program’s Researcher Workbench. Associated services to support these activities will be part of the ROA. Particular attention to system security and protection of participant data will be of the highest priority. Data collected through passive data streams will be transmitted to the All of Us Research Program Data and Research Center (DRC) for inclusion in the Researcher Workbench. Through CLAD, the program aims to advance research to understand how biology, lifestyle, and environmental influences affect health.

Platforms and teams awarded under this ROA will provide an essential foundation supporting program objectives to:

• Implement a secure data linkage and integration platform to acquire, link, and curate passive data streams with existing All of Us program participant data, and manage related metadata and paradata.
• Acquire and link new high-quality contextual (e.g., community-level indicators) or individual-level data (e.g., occupational or residential history) on All of Us program participants through methodological innovation, while protecting participant privacy and data security and preventing disclosure.
• Acquire data from All of Us Health Care Provider Organizations (HPO) through supportive tools and services, for those HPOs that need additional support to curate and transmit data to All of Us or are no longer active awardees of the program.
• Create thorough and high-quality documentation on the methods, provenance, and procedures used to acquire, link, and curate data, and related tools. This will be produced in open and researcher-accessible analytic notebooks, notes, and reusable code with adherence to Findability, Accessibility, Interoperability, and Reuse of digital assets (FAIR) principles.
• Investigate and implement procedures for disclosure review to prevent identifiability of All of Us Research Program participants within the linked data.
• Develop analytic tools to encourage, expand, and provide an analytic jumpstart in using these new passively acquired data streams on the All of Us Researcher Workbench.
• Provide training and technical assistance on the use of these data and tools to All of Us partners and external researchers through the development of efforts such as cooperative learning networks, online continuing education, and other methods.

ROA Summary

Offerors may propose partnerships within their proposal to provide technology and services expertise across the research objectives and anticipated award milestones. It is anticipated that NIH will make one award for CLAD. The award is anticipated to have a base period of 18 months, with four optional one-year periods. The estimated budget is $30 million (total costs) over the base period of this project and anticipated milestones. The selected awardee is expected to work collaboratively with program partners, particularly the DRC, to achieve CLAD and program objectives. The ROA will be open to Higher Education Institutions (public and private), Non-profit Organizations, and For-profit Organizations (including small and large businesses).

Planned milestones to be successfully completed during the base period of this award include:

• Implementation of a cloud-based data platform shall:
  • Incorporate all functionalities required to ingest, curate, and link passive data streams to All of Us Research Program participant data
  • Incorporate tools and methods to ensure personally identifiable information and protected health information is appropriately protected when data matching or transfer is undertaken.
  • Utilize a well-defined technology stack
  • Incorporate a Master Study Participant Index (MSPI) that tracks metadata such as data provenance, source, and type
  • Protect data from security threats and disclosure
  • Exchange data securely with data providers and All of Us Research Program partners such as the Data and Research Center and HPOs
• Data Linkages
  • Conduct specific data linkages that serve as endpoints for research, provide necessary foundational data for exposure science, and help fill in the gaps in program participants longitudinal health records across their life-course. Where needed, each linkage will be guided by methodological innovation. Moreover, documentation, analytic tools, and training and technical assistance shall be developed and provided. For each data linkage the acquired data will be curated and prepared for release to the DRC for use in the Researcher Workbench. Potential passive data stream linkages during the base period include:

1. Mortality Data: Acquire the mortality status for each All of Us Research Program participant, including the location, date, and underlying causes of death.

2. Occupational History Data: Acquire the occupational history for each All of Us Research Program participant. Incorporating data on occupational history will allow the researchers to assess exposures during a participant’s employment, as well as the potential stressors of employment and unemployment. Occupational history will be coded to specific occupational standards.

3. Residential History Data: Acquire the residential history of each All of Us Research Program participant. Acquiring residential history data will enable linkage to environmental (built, physical, social) and other data to assess exposures during a participant’s life course.

4. Geocoding: Residential addresses will be geocoded to the latitude and longitude level, along with various other levels of geography to enable multi-level linkages.

5. Environmental Data: Acquire geomarkers related to air pollution (e.g., PM2.5, PM10, O3, CO, SO2, air toxics risk) and environmental exposures (e.g., air temperature, relative humidity, precipitation) to allow researchers to assess the impact of environmental exposures on health and disease.

6. Health Information Networks / Health Information Exchange Pilot: Implement secure data linkages with priority Health Information Networks (HIN) / Health Information Exchanges (HIE) that provide the greatest overlap with All of Us participants to develop a more complete record of participants clinical encounters and to demonstrate the breadth and depth of electronic health record (EHR) data available from these sources.

7. Data Acquisition from Partners: Establish methods and agreements to support processing EHRs from program partners, as required. Incoming data from partners may be operationalized through a variety of mechanisms, such as application program interfaces (APIs) and secure file transfer of data extracts. Data exchange may be built on standards such as Observational Medical Outcomes Partnership (OMOP), HL7 Fast Healthcare Interoperability Resources (FHIR ), or Bulk FHIR. It may incorporate data standards such as United States Core Data for Interoperability (USCDI).

• Documentation: Prepare substantive reports for each data linkage describing the methodology used to acquire and curate the data, characterization of the linked data, and related disclosure risk.

• Tools: Develop analytic tools to expand and encourage use of each newly linked data stream while improving the researcher experience on the Researcher Workbench. The expectation is that these tools will provide basic analytic functionality for descriptive statistics and modeling, as necessary, to demonstrate the use of the newly linked data stream. These tools should be prepared and tested before delivery to the DRC. The DRC may conduct further assessment prior to release on the Researcher Workbench. The awardee shall work with the DRC on any issues with the tools before, during, or after it has been released to the Researcher Workbench.

ROA Optional One-Year Periods

Four optional one-year periods are envisioned after the base period. Additional funding will be provided for the optional periods. During optional periods the awardee is expected to maintain and enhance the data linkage platform; the awardee shall continue to acquire and link data one or two times each year, for those data assets acquired during the base period. In addition, as the All of Us scientific and data roadmaps evolve and program priorities and funding change, new streams of data may be acquired under CLAD. Examples of such data include health insurance claims, cancer registry information, immunization registry information, imagery and signals, and the social determinants of health. Data streams will be selected based on the value of each in advancing baseline ROA objectives, scientific utility, and the potential for returning information to program participants.

ROA Staffing

CLAD staffing expertise and capabilities are prioritized to include, but are not limited to, the following:

• Cloud-based platform development and engineering
• Scientific research methods
• Data linkages
• Environmental data
• Biomedical, EHR, social and behavioral health data
• De-identification, disclosure, and privacy
• Data architecture
• Data analytics implementation, including reporting and dashboards for internal program use
• Data science and visualization for data curation, quality assurance and quality control
• HL7 , HL7 Fast Healthcare Interoperability Resources
• Medical / clinical standards, terminologies and vocabularies
• Observational Medical Outcomes Partnership (OMOP) data structure
• Partnership liaison / development
• Program, product, and project management
• Quality assurance and quality control
• Technical documentation
• Software quality
• Staffing models to support scientific and technical domain expertise necessary to meet both short and long term needs of CLAD
• System security

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

All of Us Research Program
Subject: CLAD Notice (NOT-PM-23-002)
Email: [email protected]