December 12, 2022
All of Us Research Project, Office of The Director, National Institutes of Health (OD)
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.
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:
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:
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.
CLAD staffing expertise and capabilities are prioritized to include, but are not limited to, the following:
Applications are not being solicited at this time.
All of Us Research Program
Subject: CLAD Notice (NOT-PM-23-002)