The "All of Us" Research Program

Abstract

Knowledge gained from observational cohort studies has dramatically advanced the prevention and treatment of diseases. Many of these cohorts, however, are small, lack diversity, or do not provide comprehensive phenotype data. The All of Us Research Program plans to enroll a diverse group of at least 1 million persons in the United States in order to accelerate biomedical research and improve health. The program aims to make the research results accessible to participants, and it is developing new approaches to generate, access, and make data broadly available to approved researchers. All of Us opened for enrollment in May 2018 and currently enrolls participants 18 years of age or older from a network of more than 340 recruitment sites. Elements of the program protocol include health questionnaires, electronic health records (EHRs), physical measurements, the use of digital health technology, and the collection and analysis of biospecimens. As of July 2019, more than 175,000 participants had contributed biospecimens. More than 80% of these participants are from groups that have been historically underrepresented in biomedical research. EHR data on more than 112,000 participants from 34 sites have been collected. The All of Us data repository should permit researchers to take into account individual differences in lifestyle, socioeconomic factors, environment, and biologic characteristics in order to advance precision diagnosis, prevention, and treatment.

Figure 1.. Participant, Data, and Biospecimen Pathways in the All of Us Program.

Genome centers in the All of Us program generate genomic data from biosamples. The researcher workbench is the platform for data analysis in the program. EHR denotes electronic health record, HIPAA Health Insurance Portability and Accountability Act, and HPO health care provider organization.

Figure 2.. Planned Recruitment Sites and Network Partners in the All of Us Program.

Although most recruitment in the All of Us program is digital, in-person visits are required for physical measurements and collection of biospecimens. Currently, more than 340 recruitment sites have begun enrolling participants for these in-person assessments at HPOs and at the centers shown (QTC Medical Services–Leidos, Quest Diagnostics, EMSI Health, Walgreens clinics, and the National Blood Collaborative. The gray background of the map indicates population density, with one dot per person in the 2010 census.

Figure 3.. Timeline of the All of Us Program.

The Precision Medicine Initiative (PMI) Working Group of the Advisory Committee (ACD) to the National Institutes of Health (NIH) Director generated the initial blueprint for the structure and goals for the All of Us (AoU) program. The core participants count includes persons who have completed health surveys, agreed to share their EHR data, had physical measurements taken, and contributed biospecimens. Counts and dates after July 2019 are estimates. IRB denotes institutional review board.