All of Us (initiative)

The All of Us Research Program (previously known as the Precision Medicine Initiative Cohort Program[1]) is a research program created in 2015 during the tenure of Barack Obama with $130 million[2] in funding that aims to make advances in tailoring medical care to the individual.[3] The mission of AoU is to accelerate health and medical breakthroughs, enabling individualized prevention, treatment and care from all of us.

All of Us
HeadquartersBethesda , Maryland, United States
Key people
Joshua Denny (Chief Executive Officer)

Stephanie Devaney (Chief Operating Officer)

Eric Dishman (Chief Innovation Officer)
Parent organization
National Institutes of Health
Websitehttps://allofus.nih.gov/

The project aims to collect genetic and health data from one million volunteers.[4] The initiative was announced during the 2015 State of the Union Address,[5] and is run by the National Institutes of Health (NIH). The founding program director was Eric Dishman, who stepped down to become the Chief Innovation Officer. In 2019, Joshua Denny was selected to be the second director.[6]

In October 2016, the project was renamed "All of Us".[7][8][9]

The research program was launched for national enrollment on May 6, 2018.[10]

The Program is currently bilingual, with information and materials available in Spanish and English. Additional languages will be added in the future.

Core Values

A set of All of Us core values[11] are guiding the development and implementation of the All of Us Research Program:

  • Participation is open to all.
  • Participants reflect the rich diversity of the U.S.
  • Participants are partners.
  • Trust will be earned through transparency.
  • Participants have access to their information.
  • Data will be accessed broadly for research purposes.
  • Security and privacy will be of the highest importance.
  • The program will be a catalyst for positive change in research.

What Data is Collected

When you sign up for the All of Us Research Program, you are asked to take a survey that gathers information about your lifestyle and environment. Participants in All of Us can choose to give researchers access to their electronic health records (EHR), which includes information about their individual health problems and treatment they have received. They may also be asked to provide blood and urine samples and your physical measurements.[12]

Participants may also share data gathered by wearable devices (Fitbit) and in the future be asked to participate in clinical trials.

Program leaders plan to capture genomic data from select participants in 2019.[13]

Who Can Enroll

Eligible adults (18 and over) can enroll with the program. People who are not eligible are those in prison or people who cannot consent on their own[14] According to a sample consent form released in June 2018, participation in All of Us is voluntary and does not affect a participant's medical care. The form explains that if a participant quits the program, their samples will be destroyed.[16] Children may also be able to enroll in the program.[14]

By January 2018 an initial pilot project had enrolled about 10,000 people and 2022 was targeted for one million people.[15] As of May 2019, enrollment numbers at 1-year launch anniversary are 187,000+ participants, with more than 132,000 who have given biosamples. [16]

The NIH reported in May 2018 that they were pleased with high enrollment by underrepresented groups including communities of color and individuals with lower incomes. Up to three-quarters of beta phase participants came from those communities.[10] [17]

Program Partners

All of Us has more than 100 partners and champions working together to implement and support the mission and goals of the research program.[18] Google life sciences startup Verily Life Sciences, a Google "moonshot" with a goal of "transform[ing] the way we detect, prevent, and manage disease"[19][20] is one partner.

The initiative was identified by a 2019 review as involving the public in every stage of the research.[21]

Program Budget

The All of Us Research Program budget has increase every year since it launched: FY2016 - $130 million; FY2017 - $230 million; and FY2018 - $290 million.[22][23]

Responses to the Initiative

Professor Kenneth Weiss from Pennsylvania State University, in a skeptical review of this project in 2017, suggested that the funding could be better spent elsewhere.[24]

Program Progress

Enrollment

In the summer of 2019, one year after its official launch, All of Us had enrolled 230,000 participants, which represents almost one quarter of the program's goal of 1,000,000 individuals. Approximately 80% of those people are from groups that have been traditionally underrepresented in biomedical research. One of All of US's main goals is to include many people from diverse ancestries.[25] By June 2020, enrollment reached approximately 350,000 individuals.[26]

All of Us Researcher Workbench

On May 27, 2020, the All of Us research program announced the launch of their research platform, the All of Us Researcher Workbench, for beta testing. Select data collected by the initiative, including electronic health records and survey responses from the first 225,000 program participants, will be available to approved researchers through the workbench.[27] Researchers may apply for access to the data if they have an NIH eRA Commons account (for identity verification) and are affiliated with an institution that has signed a data use agreement with All of Us.[28]

Response to COVID-19 Pandemic

In June 2020, the NIH announced that research materials collected as part of the All of Us initiative will be used to address the COVID-19 pandemic. Blood samples collected from recent volunteers will be tested for SARS-CoV-2 antibodies in order to track prior infections within the US population.[29] Electronic health records shared by All of Us participants will also be evaluated for potential patterns associated with SARS-CoV-2 infection. All of Us also added monthly participant surveys with questions about the physical, mental, and socioeconomic impacts of the COVID-19 pandemic.[30]

gollark: (How would that even work?)
gollark: There does not have to be some sort of objective universe-y backing behind "ought"-ish/moral statements.
gollark: * I think so → my moral belief set says so
gollark: I think so, but this is *definitely* not some sort of objective universal truth.
gollark: I did not mean that they're true statements describing the entire universe. Go with "unconditional truth" if you mean something different by "universal" too.

See also

References
  1. "FACT SHEET: President Obama's Precision Medicine Initiative". 2015-01-30. Retrieved 2 May 2019.
  2. "About the All of Us Research Program". Retrieved 2 May 2019.
  3. "FACT SHEET: President Obama's Precision Medicine Initiative". whitehouse.gov. 30 January 2015. Retrieved 26 July 2016.
  4. Reardon, Sara (1 September 2015). "Giant study poses DNA data-sharing dilemma". Nature.
  5. Dvorsky, George (21 January 2015). "How Obama's Precision Medicine Initiative Will Revolutionize Healthcare". io9.
  6. "Selection of Dr. Joshua Denny as Chief Executive Officer of the All of Us Research Program | National Institutes of Health (NIH) — All of Us". allofus.nih.gov. Retrieved 2020-02-08.
  7. "All of Us (project web page)". U.S. Department of Health & Human Services - National Institutes of Health. 2018. Retrieved 20 January 2018.
  8. Muoio, Dave (7 November 2017). "Fitbit wearables will help power NIH's All of Us Research Program". MobiHealthNews. Retrieved 20 January 2018.
  9. "NIH Partners With 14 Community Groups, Healthcare Associations on Outreach for All of Us Program". GenomeWeb. 17 November 2017. Retrieved 20 January 2018.
  10. says, Kathleen Flanagan-Olson (May 1, 2018). "NIH opens nationwide enrollment for huge precision medicine initiative".
  11. "Core Values – All of Us | National Institutes of Health". allofus.nih.gov. Retrieved 2020-06-17.
  12. "Next Steps". Retrieved 3 May 2019.
  13. "NIH Launches Historic All of Us Initiative". news.aamc.org.
  14. "Who Can Join?". Retrieved 3 May 2019.
  15. Cunningham, Paige Winfield (16 January 2018). "The Health 202: NIH wants 1 million Americans to contribute to new pool of gene data". Washington Post. ISSN 0190-8286. Retrieved 20 January 2018.
  16. "All of Us Research Hub". Retrieved 2 May 2019.
  17. "How The All of Us Research is Restoring Trust and Bringing A Much-Needed Diversity to Medical Research". 2019-04-10. Retrieved 2 May 2019.
  18. "All of Us Program Partners". Retrieved 2 May 2019.
  19. Kaiser, Jocelyn (25 February 2016). "NIH's 1-million-volunteer precision medicine study announces first pilot projects". Science.
  20. "Verily, Google's bold bid to transform medicine, hits turbulence under a divisive CEO". March 28, 2016.
  21. Lacaze, Paul; Fransquet, Peter; Tiller, Jane; Nunn, Jack S. (2019). "Public Involvement in Global Genomics Research: A Scoping Review". Frontiers in Public Health. 7: 79. doi:10.3389/fpubh.2019.00079. ISSN 2296-2565. PMC 6467093. PMID 31024880.
  22. "All of Us Research Program Backgrounder". Retrieved 2 May 2019.
  23. Molteni, Megan (6 May 2018). "The NIH Launches Its Ambitious Million-Person Genetic Survey". Wired.
  24. Weiss, Kenneth M. (Fall 2017). "Is Precision Medicine Possible?". Issues in Science and Technology. 34 (1). Retrieved 20 January 2018.
  25. https://www.clinicalomics.com/news-and-features/one-year-after-launch-nihs-all-of-us-hits-key-milestones/
  26. HealthITAnalytics (2020-06-01). ""All of Us" Opens Precision Medicine Data Platform for Beta Testing". HealthITAnalytics. Retrieved 2020-06-17.
  27. HealthITAnalytics (2020-06-01). ""All of Us" Opens Precision Medicine Data Platform for Beta Testing". HealthITAnalytics. Retrieved 2020-06-17.
  28. "All of Us Research Program Begins Beta Testing of Data Platform | National Institutes of Health (NIH) — All of Us". allofus.nih.gov. Retrieved 2020-06-17.
  29. "NIH launches COVID-19 tracking initiatives through 'All of Us' precision medicine program". www.beckershospitalreview.com. Retrieved 2020-06-17.
  30. "NIH Musters Million-Person Study to Track Covid's Spread". news.bloomberglaw.com. Retrieved 2020-06-17.
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