All of Us (initiative)

The initiative was announced during the 2015 State of the Union Address,{{cite news |last=Dvorsky |first=George |date=21 January 2015 |title=How Obama's Precision Medicine Initiative Will Revolutionize Healthcare |url=http://io9.com/how-obamas-precision-medicine-initiative-will-revolutio-1680866890 |newspaper=io9 }} and is run by the National Institutes of Health (NIH). The program is bilingual, with information and materials available in Spanish and English.

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{{cite web |title=Who Can Join? |url=https://www.joinallofus.org/en/who-can-join |access-date=3 May 2019}}

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. Children may also be able to enroll in the program.

By January 2018 an initial pilot project had enrolled about 10,000 people and 2022 was targeted for one million people.{{Cite news|url=https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2018/01/16/the-health-202-nih-wants-1-million-americans-to-contribute-to-new-pool-of-gene-data/5a5ba45a30fb0469e8840135/|title=The Health 202: NIH wants 1 million Americans to contribute to new pool of gene data|last=Cunningham|first=Paige Winfield|date=16 January 2018|newspaper=Washington Post|access-date=20 January 2018 |language=en-US|issn=0190-8286}} As of May 2019, enrollment numbers at the one-year launch anniversary are 187,000+ participants. More than 132,000 have already given biosamples.{{cite web |title=All of Us Research Hub |url=https://www.researchallofus.org/ |access-date=2 May 2019}}

The NIH reported in May 2018 that they were pleased with the 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.{{cite web |title=How The All of Us Research is Restoring Trust and Bringing A Much-Needed Diversity to Medical Research |url=https://www.radianthealthmag.com/health-wellness/how-the-all-of-us-research-is-restoring-trust-and-bringing-a-much-needed-diversity-to-medical-research/ |access-date=2 May 2019|date=2019-04-10 }}

File:Stanford 2022 Wellness Fair - 18.jpg

All of Us has more than 100 partners working to implement and support the mission and goals of the research.{{cite web |title=All of Us Program Partners |url=https://allofus.nih.gov/about/program-partners |access-date=2 May 2019}} Google life sciences startup Verily Life Sciences, a Google "moonshot" with a goal of "transform[ing] the way we detect, prevent, and manage disease"{{cite web |url=https://www.science.org/content/article/nih-s-1-million-volunteer-precision-medicine-study-announces-first-pilot-projects |title=NIH's 1-million-volunteer precision medicine study announces first pilot projects |last=Kaiser |first=Jocelyn |date=25 February 2016 |website=Science}}{{Cite web|url=https://www.statnews.com/2016/03/28/google-life-sciences-exodus/|title=Verily, Google's bold bid to transform medicine, hits turbulence under a divisive CEO|date=March 28, 2016}} is one partner. The initiative was identified by a 2019 review as involving the public in every stage of the research.{{Cite journal|last1=Lacaze|first1=Paul|last2=Fransquet|first2=Peter|last3=Tiller|first3=Jane|last4=Nunn|first4=Jack S.|date=2019|title=Public Involvement in Global Genomics Research: A Scoping Review|journal=Frontiers in Public Health|language=en|volume=7|pages=79|doi=10.3389/fpubh.2019.00079|pmid=31024880|pmc=6467093|issn=2296-2565|doi-access=free}}

The All of Us Research Program budget has increased every year since it launched: FY2016 - $130 million; FY2017 - $230 million; and FY2018 - $290 million.{{cite web |title=All of Us Research Program Backgrounder |url=https://allofus.nih.gov/news-events-media/media-toolkit/all-us-research-program-backgrounder |access-date=2 May 2019}}{{cite magazine |url=https://www.wired.com/story/all-of-us-launches/ |title=The NIH Launches Its Ambitious Million-Person Genetic Survey |last=Molteni |first=Megan |date=6 May 2018 |magazine=Wired}}

File:Summary of All of Us data resources.webp

The research program was launched for national enrollment on May 6, 2018.{{Cite web|url=https://www.statnews.com/2018/05/01/nih-precision-medicine-all-of-us-enrollment/|title=NIH opens nationwide enrollment for huge precision medicine initiative|first=Kathleen Flanagan-Olson|last=says|date=May 1, 2018}} 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.{{Cite web|url=https://www.clinicalomics.com/news-and-features/one-year-after-launch-nihs-all-of-us-hits-key-milestones/|title=One Year After Launch, NIH's All of Us Hits Key Milestones|date=19 August 2019}} By June 2020, enrollment reached approximately 350,000 individuals.{{Cite news|last=HealthITAnalytics|date=2020-06-01|title="All of Us" Opens Precision Medicine Data Platform for Beta Testing|url=https://healthitanalytics.com/news/all-of-us-opens-precision-medicine-data-platform-for-beta-testing|access-date=2020-06-17|website=HealthITAnalytics|language=en-US}}

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. 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.{{Cite web|title=All of Us Research Program Begins Beta Testing of Data Platform {{!}} National Institutes of Health (NIH) — All of Us|url=https://allofus.nih.gov/news-events-and-media/announcements/all-us-research-program-begins-beta-testing-data-platform|access-date=2020-06-17|website=allofus.nih.gov}}

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.{{Cite web|title=NIH launches COVID-19 tracking initiatives through 'All of Us' precision medicine program|url=https://www.beckershospitalreview.com/data-analytics/nih-launches-covid-19-tracking-initiatives-through-all-of-us-precision-medicine-program.html|access-date=2020-06-17|website=www.beckershospitalreview.com}} 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.{{Cite web|title=NIH Musters Million-Person Study to Track Covid's Spread|url=https://news.bloomberglaw.com/health-law-and-business/nih-musters-million-person-study-to-track-covids-spread|access-date=2020-06-17|website=news.bloomberglaw.com|language=en}}

The founding program director was Eric Dishman, who stepped down to become the Chief Innovation Officer.{{Cite web|date=2020-08-21|title=Statement from Eric Dishman on Changing Leadership at the NIH All of Us Research Program|url=https://allofus.nih.gov/news-events-and-media/announcements/statement-eric-dishman-changing-leadership-nih-all-us-research-program|access-date=2021-10-17|website=National Institutes of Health (NIH) — All of Us|language=en}} In 2019, Joshua Denny was selected to be the second director.{{Cite web|url=https://allofus.nih.gov/news-events-and-media/announcements/selection-dr-joshua-denny-chief-executive-officer-all-us-research-program|title=Selection of Dr. Joshua Denny as Chief Executive Officer of the All of Us Research Program {{!}} National Institutes of Health (NIH) — All of Us|website=allofus.nih.gov|access-date=2020-02-08}} In October 2016, the project was renamed "All of Us".{{Cite web|url=https://allofus.nih.gov/|title=All of Us (project web page)|date=2018|publisher=U.S. Department of Health & Human Services - National Institutes of Health|language=en|access-date=20 January 2018}}{{Cite news|url=http://www.mobihealthnews.com/content/fitbit-wearables-will-help-power-nihs-all-us-research-program|title=Fitbit wearables will help power NIH's All of Us Research Program|last=Muoio|first=Dave|date=7 November 2017 |work=MobiHealthNews |access-date=20 January 2018|language=en}}{{Cite news|url=https://www.genomeweb.com/research-funding/nih-partners-14-community-groups-healthcare-associations-outreach-all-us-program|title=NIH Partners With 14 Community Groups, Healthcare Associations on Outreach for All of Us Program|date=17 November 2017|work=GenomeWeb|access-date=20 January 2018|language=en}}

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The project published in Nature in 2024,{{Cite journal|url=https://www.nature.com/articles/s41586-023-06957-x|title=Genomic data in the All of Us Research Program|date=March 6, 2024|journal=Nature|volume=627|issue=8003|pages=340–346|via=www.nature.com|doi=10.1038/s41586-023-06957-x|pmc=10937371}} linking electronic health records to genomics data in some participants. The paper uses a uniform manifold approximation and projection algorithm.

Genetics of the participants were published in a 2025 Nature Communications article. The 2025 paper shows various principal components analysis projections of the biobank's genetic diversity.

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.{{Cite journal |last=Weiss |first=Kenneth M. |date=Fall 2017 |title=Is Precision Medicine Possible? |url=http://issues.org/34-1/is-precision-medicine-possible/ |journal=Issues in Science and Technology |language=en-US |volume=34 |issue=1 |access-date=20 January 2018}}

• 100,000 Genomes Project (UK)
• 21st Century Cures Act
• Baseline Study
• Precision medicine
• precisionFDA

{{notelist}}

• [https://www.joinallofus.org Join All of Us] homepage to join the All of Us research program
• [https://allofus.nih.gov All of Us] homepage at the National Institutes of Health
• [https://www.usaspending.gov/federal_account/075-5628 NIH Innovation] account on USAspending.gov

Category:American medical research

Category:Supercomputing

Category:Medical databases

Category:Biobank organizations

Category:Epidemiology