All of Us (initiative)

{{Short description|United States NIH research program}} {{use mdy dates|date=March 2026}} {{Infobox organization | name = All of Us | logo = All_of_us_initiative_logo.png | logo_size = | logo_alt = Logo composed of the words All Of Us Research Program | logo_caption = | headquarters = Bethesda, Maryland, United States | parent_organization = National Institutes of Health (NIH) | website = [https://allofus.nih.gov/ allofus.nih.gov] }}

The '''All of Us''' Research Program (previously known as the '''Precision Medicine Initiative Cohort Program'''<ref>{{cite web |title=FACT SHEET: President Obama's Precision Medicine Initiative |url=https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative |access-date=2019-05-02 |via=National Archives |work=whitehouse.gov |date=2015-01-30}}</ref>) is a precision medicine research program created in 2015 under the Obama Administration with $130 million<ref>{{cite web |title=About the All of Us Research Program |url=https://allofus.nih.gov/article/program-overview |access-date=2019-05-02}}</ref> in funding to accelerate health and medical breakthroughs, enable individualized prevention, treatment and care.<ref>{{cite web |author= |date=2015-01-30 |title=FACT SHEET: President Obama's Precision Medicine Initiative |url=https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative |access-date=2016-07-26 |publisher=whitehouse.gov |via=National Archives}}</ref>

The project aimed to collect genetic and health data from one million volunteers,<ref>{{cite news |last=Reardon |first=Sara |date=2015-09-01 |title=Giant study poses DNA data-sharing dilemma |url=http://www.nature.com/news/giant-study-poses-dna-data-sharing-dilemma-1.18275 |newspaper=Nature}}</ref> and recruited around 297,549 participants.<ref name="naturecomms2025">{{Cite journal|title=Genetic ancestry and population structure in the All of Us Research Program cohort|first1=Shivam|last1=Sharma|first2=Shashwat Deepali|last2=Nagar|first3=Priscilla|last3=Pemu|first4=Stephan|last4=Zuchner|first5=Leonardo|last5=Mariño-Ramírez|first6=Robert|last6=Meller|first7=I. King|last7=Jordan|date=May 3, 2025|journal=Nature Communications|volume=16|issue=1|pages=4123|doi=10.1038/s41467-025-59351-8|pmc=12049439}}</ref> The project says its data is analyzed by 2,300 researchers.<ref>{{Cite journal|title=The All of Us Data and Research Center: Creating a Secure, Scalable, and Sustainable Ecosystem for Biomedical Research|first1=Kelsey R.|last1=Mayo|first2=Melissa A.|last2=Basford|first3=Robert J.|last3=Carroll|first4=Moira|last4=Dillon|first5=Heather|last5=Fullen|first6=Jesse|last6=Leung|first7=Hiral|last7=Master|first8=Shimon|last8=Rura|first9=Lina|last9=Sulieman|first10=Nan|last10=Kennedy|first11=Eric|last11=Banks|first12=David|last12=Bernick|first13=Asmita|last13=Gauchan|first14=Lee|last14=Lichtenstein|first15=Brandy M.|last15=Mapes|first16=Kayla|last16=Marginean|first17=Steve L.|last17=Nyemba|first18=Andrea|last18=Ramirez|first19=Charissa|last19=Rotundo|first20=Keri|last20=Wolfe|first21=Weiyi|last21=Xia|first22=Romuladus E.|last22=Azuine|first23=Robert M.|last23=Cronin|first24=Joshua C.|last24=Denny|first25=Abel|last25=Kho|first26=Christopher|last26=Lunt|first27=Bradley|last27=Malin|first28=Karthik|last28=Natarajan|first29=Consuelo H.|last29=Wilkins|first30=Hua|last30=Xu|first31=George|last31=Hripcsak|first32=Dan M.|last32=Roden|first33=Anthony A.|last33=Philippakis|first34=David|last34=Glazer|first35=Paul A.|last35=Harris|date=August 10, 2023|journal=Annual Review of Biomedical Data Science|volume=6|pages=443–464|doi=10.1146/annurev-biodatasci-122120-104825|pmid=37561600|pmc=11157478}}</ref>

==Program== The initiative was announced during the 2015 State of the Union Address,<ref>{{cite news |last=Dvorsky |first=George |date=2015-01-21 |title=How Obama's Precision Medicine Initiative Will Revolutionize Healthcare |url=http://io9.com/how-obamas-precision-medicine-initiative-will-revolutio-1680866890 |newspaper=io9}}</ref> and is run by the National Institutes of Health (NIH). The program is bilingual, with information and materials available in Spanish and English.

=== Enrollment === 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<ref>{{cite web |title=Who Can Join? |url=https://www.joinallofus.org/en/who-can-join |access-date=2019-05-03 |archive-date=2019-05-03 |archive-url=https://web.archive.org/web/20190503041701/https://www.joinallofus.org/en/who-can-join |url-status=dead}}</ref> 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.<ref name="vg"/> Children may also be able to enroll in the program.<ref name="rt"/>

By January 2018 an initial pilot project had enrolled about 10,000 people and 2022 was targeted for one million people.<ref>{{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=2018-01-16 |newspaper=Washington Post|access-date=2018-01-20 |language=en-US|issn=0190-8286}}</ref> As of May 2019, enrollment numbers at the one-year launch anniversary are 187,000+ participants. More than 132,000 have already given biosamples.<ref>{{cite web |title=All of Us Research Hub |url=https://www.researchallofus.org/ |access-date=2019-05-02}}</ref>

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.<ref name="no"/><ref name="rt">{{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=2019-05-02 |date=2019-04-10}}</ref>

=== Program partners === thumb|alt=People in the Koret Plaza at Stanford University, with a man at a table with the All of Us service marks.

''All of Us'' has more than 100 partners working to implement and support the mission and goals of the research.<ref>{{cite web |title=All of Us Program Partners |url=https://allofus.nih.gov/funding-and-program-partners |access-date=2019-05-02}}</ref> Google life sciences startup Verily Life Sciences, a Google "moonshot" with a goal of "transform[ing] the way we detect, prevent, and manage disease"<ref>{{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=2016-02-25 |website=Science}}</ref><ref name="vg">{{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}}</ref> is one partner. The initiative was identified by a 2019 review as involving the public in every stage of the research.<ref>{{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}}</ref>

=== Program budget === The ''All of Us'' Research Program budget has increased every year since it launched: FY2016 - $130 million; FY2017 - $230 million; and FY2018 - $290 million.<ref>{{cite web |title=All of Us Research Program Backgrounder |url=https://allofus.nih.gov/news-events-media/media-toolkit/all-us-research-program-backgrounder |archive-url=https://web.archive.org/web/20180502022714/https://allofus.nih.gov/news-events-media/media-toolkit/all-us-research-program-backgrounder |url-status=dead |archive-date=May 2, 2018 |access-date=2019-05-02}}</ref><ref name=wired>{{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=2018-05-06 |magazine=Wired}}</ref>

== Program progress == === Enrollment === thumb|Summary of All of Us data resources{{efn|"a, The All of Us Research Hub contains a publicly accessible Data Browser for exploration of summary phenotypic and genomic data. The Researcher Workbench is a secure cloud-based environment of participant-level data in a Controlled Tier that is widely accessible to researchers. b, All of Us participants have rich phenotype data from a combination of physical measurements, survey responses, EHRs, wearables and genomic data. Dots indicate the presence of the specific data type for the given number of participants. c, Overall summary of participants under-represented in biomedical research (UBR) with data available in the Controlled Tier."}}<ref>{{cite journal |last1=Bick |first1=Alexander G. |last2=Metcalf |first2=Ginger A. |display-authors=et al. |title=Genomic data in the All of Us Research Program |journal=Nature |date=March 2024 |volume=627 |issue=8003 |pages=340–346 |doi=10.1038/s41586-023-06957-x |language=en |issn=1476-4687|pmc=10937371}}</ref> The research program was launched for national enrollment on May 6, 2018.<ref name="no">{{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}}</ref> 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.<ref>{{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=2019-08-19}}</ref> By June 2020, enrollment reached approximately 350,000 individuals.<ref name="pm">{{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}}</ref>

=== 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.<ref name="pm"/> 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.<ref>{{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|archive-url=https://web.archive.org/web/20200609054052/https://allofus.nih.gov/news-events-and-media/announcements/all-us-research-program-begins-beta-testing-data-platform|url-status=dead|archive-date=June 9, 2020|access-date=2020-06-17|website=allofus.nih.gov}}</ref>

=== 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.<ref>{{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}}</ref> 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.<ref>{{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}}</ref>

===Administration=== The founding program director was Eric Dishman, who stepped down to become the Chief Innovation Officer.<ref>{{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|archive-url=https://web.archive.org/web/20191008204256/https://allofus.nih.gov/news-events-and-media/announcements/statement-eric-dishman-changing-leadership-nih-all-us-research-program|url-status=dead|archive-date=October 8, 2019|access-date=2021-10-17 |website=National Institutes of Health (NIH) — All of Us|language=en}}</ref> In 2019, Joshua Denny was selected to be the second director.<ref>{{Cite web|url=https://allofus.nih.gov/news-events-and-media/announcements/selection-dr-joshua-denny-chief-executive-officer-all-us-research-program|archive-url=https://web.archive.org/web/20200108210224/https://allofus.nih.gov/news-events-and-media/announcements/selection-dr-joshua-denny-chief-executive-officer-all-us-research-program|url-status=dead|archive-date=January 8, 2020|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}}</ref> In October 2016, the project was renamed "All of Us".<ref>{{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=2018-01-20}}</ref><ref name= wearable>{{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=2017-01-07 |work=MobiHealthNews |access-date=2018-01-20 |language=en}}</ref><ref>{{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=2017-11-17 |work=GenomeWeb|access-date=2018-01-20 |language=en}}</ref>

==Publications== {{external media | float = | width = | topic =  | caption =  | headerimage=  | title = All of us Continental genetic ancestry | image1 = [https://media.springernature.com/full/springer-static/image/art%3A10.1038%2Fs41467-025-59351-8/MediaObjects/41467_2025_59351_Fig2_HTML.png Figure 2 with Principal Components Analysis] | image2 = | image3 = | audio1 = | audio2 = | audio3 = | video1 = | video2 = | video3 = | model1 = | model2 = | model3 = }} The project published in ''Nature'' in 2024,<ref>{{Cite journal|last1=Bick |first1=Alexander G. |last2=Metcalf |first2=Ginger A. |last3=Mayo |first3=Kelsey R. |last4=Lichtenstein |first4=Lee |last5=Rura |first5=Shimon |last6=Carroll |first6=Robert J. |last7=Musick |first7=Anjene |last8=Linder |first8=Jodell E. |last9=Jordan |first9=I. King |last10=Nagar |first10=Shashwat Deepali |last11=Sharma |first11=Shivam |last12=Meller |first12=Robert |last13=Basford |first13=Melissa |last14=Boerwinkle |first14=Eric |last15=Cicek |first15=Mine S. |last16=Doheny |first16=Kimberly F. |last17=Eichler |first17=Evan E. |last18=Gabriel |first18=Stacey |last19=Gibbs |first19=Richard A. |last20=Glazer |first20=David |last21=Harris |first21=Paul A. |last22=Jarvik |first22=Gail P. |last23=Philippakis |first23=Anthony |last24=Rehm |first24=Heidi L. |last25=Roden |first25=Dan M. |last26=Thibodeau |first26=Stephen N. |last27=Topper |first27=Scott |last28=Blegen |first28=Ashley L. |last29=Wirkus |first29=Samantha J. |last30=Wagner |first30=Victoria A. |display-authors=1 |title=Genomic data in the All of Us Research Program|date=March 6, 2024|journal=Nature|volume=627|issue=8003|pages=340–346|doi=10.1038/s41586-023-06957-x|pmc=10937371}}</ref> 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.<ref name="naturecomms2025"/> The 2025 paper shows various principal components analysis projections of the biobank's genetic diversity.

== Criticism == 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.<ref>{{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=2018-01-20}}</ref>

===Joseph Yracheta=== '''Joseph M. Yracheta''' is a researcher studying health disparities,<ref name="cbc">{{cite news |last1=Gismondi |first1=Melissa |title=How Indigenous scientists are using biomedical research to seek 'genomic justice' {{!}} CBC Radio |url=https://www.cbc.ca/radio/ideas/how-indigenous-scientists-are-using-biomedical-research-to-seek-genomic-justice-1.6190855 |access-date=2025-10-23 |publisher=CBC |date=2021-09-28}}</ref> and a co-founder<ref name="cbc"/> and executive director<ref name="ns">{{cite news |title=These Native Scientists Are Taking Control Of Their Biological Samples |url=https://www.sciencefriday.com/segments/indigenous-biology-communities/#segment-transcript |access-date=2025-10-23 |work=Science Friday |date=2021-10-15}}</ref> of the '''Native BioData Consortium''' (NBDC), a biobank containing samples collected from indigenous people and led by indigenous scientists.<ref name="ns"/><ref>{{Cite web |date=2024-01-10 |title=Listener Picks: Indigenous communities want sovereignty over their data |url=https://the1a.org/segments/listener-picks-indigenous-communities-want-sovereignty-over-their-data/ |access-date=2025-10-23 |website=1A |language=en}}</ref> Himself a member of the Pūrepecha Indigenous group,<ref>{{cite web |last1=Cruz |first1=Alexandria |title=Indigenous Bio-Medical Researcher Joseph Yracheta, Meets with the Borikua Taino Foundation to Discuss Native Data Sovereignty |url=https://www.naciontainodeboriken.org/post/indigenous-bio-medical-researcher-joseph-yracheta-meets-with-the-borikua-taino-foundation-to-discus |website=Nacion Taino Borikua |access-date=2025-10-23 |language=en |date=2023-08-16}}</ref><ref>{{cite web |title=Collaboration on the Design of a Blockchain System to Advance Indigenous Data Sovereignty |url=https://usindigenousdatanetwork.org/2024/02/collaboration-on-the-design-of-a-blockchain-system-to-advance-indigenous-data-sovereignty/ |website=U.S. Indigenous Data Sovereignty Network |access-date=2025-10-23 |date=2024-02-14}}</ref> he is a noted skeptic of the 'All of Us' initiative and its benefit to Native American tribes.<ref name="science">{{cite news |last1=Kaiser |first1=Jocelyn |title=Million-person U.S. study of genes and health stumbles over including Native American groups |url=https://www.science.org/content/article/million-person-us-study-genes-and-health-stumbles-over-including-native-american-groups |access-date=2025-10-23 |work=www.science.org |publisher=American Association for the Advancement of Science |date=2019-05-29 |language=en}}</ref> As part of his work with the NBDC, he has collectedgenetic samples from members of a Native American tribe in the Northern Plains.<ref>{{cite news |title=How indigenous scientists are taking control of their data |url=https://www.illumina.com/company/news-center/feature-articles/how-indigenous-scientists-are-taking-control-of-their-data.html |access-date=2025-10-23 |work=Illumina News Center |publisher=Illumina |date=2021-08-06|language=en}}</ref>

== References == <references />

==Notes== {{notelist}}

== External links == * [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