The All of Us Research Program (previously known as the Precision Medicine Initiative Cohort Program) is a research program created in 2015 during the tenure of
Barack Obama
Barack Hussein Obama II ( ; born August 4, 1961) is an American politician who served as the 44th president of the United States from 2009 to 2017. A member of the Democratic Party, Obama was the first African-American president of the U ...
with $130 million in funding that aims to make advances in tailoring medical care to the individual. The mission of All of Us is to accelerate health and medical breakthroughs, enabling individualized prevention, treatment and care.
The project aims to collect genetic and health data from one million volunteers. The initiative was announced during the
2015 State of the Union Address
The 2015 State of the Union Address was given by the 44th president of the United States, Barack Obama, on January 20, 2015, at 9:00 p.m. EST, in the chamber of the United States House of Representatives to the 114th United States Congress. It w ...
, and is run by the
National Institutes of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
(NIH). The program is currently bilingual, with information and materials available in Spanish and English.
Core Values
A set of ''All of Us'' core values 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.
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.
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
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.
6Children may also be able to enroll in the program.
4
By January 2018 an initial pilot project had enrolled about 10,000 people and 2022 was targeted for one million people. As of May 2019, enrollment numbers at the one-year launch anniversary are 187,000+ participants, with more than 132,000 who have given biosamples.
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.
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. Google life sciences startup
Verily Life Sciences
Verily Life Sciences, also known as Verily (formerly Google Life Sciences), is Alphabet Inc.'s research organization devoted to the study of life sciences. The organization was formerly a division of Google X, until August 10, 2015, when Sergey ...
, a Google "moonshot" with a goal of "transform
ngthe way we detect, prevent, and manage disease" is one partner.
The initiative was identified by a 2019 review as involving the public in every stage of the research.
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.
Responses to the Initiative
Professor
Kenneth Weiss from
Pennsylvania State University
The Pennsylvania State University (Penn State or PSU) is a Public university, public Commonwealth System of Higher Education, state-related Land-grant university, land-grant research university with campuses and facilities throughout Pennsylvan ...
, in a skeptical review of this project in 2017, suggested that the funding could be better spent elsewhere.
Program Progress
Enrollment
The research program was launched for national enrollment on May 6, 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. By June 2020, enrollment reached approximately 350,000 individuals.
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
Software testing is the act of examining the artifacts and the behavior of the software under test by validation and verification. Software testing can also provide an objective, independent view of the software to allow the business to apprecia ...
. 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.
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
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identif ...
. Blood samples collected from recent volunteers will be tested for
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a ...
antibodies
An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of the ...
in order to track prior infections within the US population. 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.
Administration
The founding program director was Eric Dishman, who stepped down to become the Chief Innovation Officer. In 2019,
Joshua Denny
Joshua Charles Denny is an American physician and medical researcher who is the chief executive officer of the All of Us research program at the National Institutes of Health, where he has worked since 2020. He previously served as Professor of Bio ...
was selected to be the second director. In October 2016, the project was renamed "All of Us".
[{{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]
See also
*
100,000 Genomes Project
The 100,000 Genomes Project is a now-completed UK Government project managed by Genomics England that is sequencing whole genomes from National Health Service patients. The project is focusing on rare diseases, some common types of cancer, and ...
(UK)
*
21st Century Cures Act
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health. The ...
*
Baseline Study
Project Baseline is a broad effort to map human health led by Verily Life Sciences (formerly Google Life Sciences), Alphabet, Inc.'s health sciences division, and was announced in the Wall Street Journal on July 24, 2014. It begins with the Projec ...
*
Precision medicine
Precision, precise or precisely may refer to:
Science, and technology, and mathematics Mathematics and computing (general)
* Accuracy and precision, measurement deviation from true value and its scatter
* Significant figures, the number of digit ...
*
precisionFDA
PrecisionFDA (stylized precisionFDA) is a secure, collaborative, high-performance computing platform that has established a growing community of experts around the analysis of biological datasets in order to advance precision medicine, inform reg ...
References
External links
Join All of Ushomepage to join the ''All of Us'' research program
All of Ushomepage at the
National Institutes of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
NIH Innovationaccount on
USAspending.gov ttp://www.usaspending.gov USASpending.govis a database of spending by the United States federal government.
History
Around the time of the Act's passage, OMB Watch, a government watchdog group, was developing a site that would do essentially eve ...
American medical research
Supercomputing
Biological databases
Biobank organizations
Epidemiology