All of Us Research Program Backgrounder
Answers to many frequently asked questions about the All of Us Research Program are available online at NIH’s All of Us website FAQ and our participant website FAQ. For more in-depth background information, please see below:
What makes this program different from other research programs, cohorts, or biobanks?
While many programs share one or two characteristics of All of Us, it is the combination of all the elements below that makes All of Us a unique and unprecedented research effort:
- Our one million or more participants will reflect the rich diversity of America, including volunteers of many races and ethnicities, age groups, geographic regions, gender identities, sexual orientations, and health statuses.
- With All of Us, participants will be true partners—not subjects—with ongoing opportunities to help shape the program with their input. Further, data will be shared with both researchers and participants.
- As a government-funded program committed to open data and science, All of Us will make data broadly accessible to researchers of all kinds, including citizen scientists, to support thousands of studies across a wide range of different health topics.
- Other large research programs collect limited types of samples or data, often focused on a specific disease. All of Us will combine blood and urine samples; physical measurements; electronic health records; surveys about participants’ health histories, family medical histories, lifestyles, and communities; and eventually wearable data to get a more complete picture of human health across many conditions.
Also, while many people may think of All of Us as a biobank because we store and manage access to participant samples, that’s just one of our many components. Our large and growing database will include many other types of information useful in health research.
How is the program funded?
The All of Us Research Program is publicly funded, with resources appropriated each year by the U.S. Congress. The 21st Century Cures Act, passed in December 2016, authorized a total of $1.5 billion over ten years for the program. These funds are subject to the annual appropriations process.
History of annual appropriations for the All of Us Research Program:
$230 million, including $40 million from the 21st Century Cures Act
$290 million, including $100 million from the 21st Century Cures Act
If you have questions about future budget projections, please contact the White House Office of Management and Budget: [email protected] or 202-395-7254.
When did work on the program begin?
In 2015, NIH formed a special working group to develop a framework for the program. In 2016, NIH made its first awards to begin building a nationwide consortium of partners to implement the program. Since the group’s kickoff meeting that July, the program has reached many milestones leading up to its national launch:
- Developed the first version of its research protocol and received approval from the All of Us Institutional Review Board
- Expanded its consortium to include more than 100 academic, provider, technology, and community partners
- Developed a participant-friendly and bilingual website and participant portal for online education and enrollment
- Established a bilingual Support Center to answer questions from the public via phone, email, and Web chat
- Constructed a new biobank building, with robotic capability and a 24-hour shipping process, currently storing more than 710,000 vials and with a capacity to store more than 35 million
- Developed a data warehouse with the infrastructure to collect, clean, curate, de-identify, and eventually share program data
- Completed end-to-end security and usability testing on the program’s technology systems
- Launched more than 125 sites across the country to begin gathering participants’ physical measurements and biosamples
- Enrolled more than 26,000 beta testers who have completed the entire protocol
How may people enroll in the program?
To enroll in the program, people should visit JoinAllofUs.org, which provides in-depth information about the program and what will be involved. From there, they will be able to sign up for an account online through the participant portal or download the program’s free app from the Apple store or Google Play.
After people create their account, they can begin their enrollment online by going through the consent process, agreeing to share their electronic health records, and completing an initial set of surveys. If they receive health care through a participating health care provider organization, they may link their account and may be invited to make an appointment for an in-person enrollment visit.
Most participants will not have a connection to one of our health care provider organizations; we have additional partners in place to support their involvement. These participants also may create their account and begin enrollment online or perhaps at a community event, library, or health fair near them.
Who will be invited to give physical measurements and blood and urine samples?
We will invite many different kinds of people to provide physical measurements and samples.
To build a valuable scientific resource, All of Us must gather information from a very large and diverse group of people. Our goal is one million or more participants with a wide range of backgrounds (demographic diversity), from many kinds of places (geographic diversity), and with a variety of health conditions (medical diversity). Over time, as we start to understand how we’re doing with those diversity goals, we may limit the physical measurement/biosample invitations to certain groups of people where we have a gap.
At a minimum, participants will be able to complete surveys and share their electronic health records. Involvement at any level is highly valuable to advance research.
Where will participants go to provide physical measurements and blood and urine samples?
Our participating health care provider organizations will handle many of these participant visits—initially for their own patients and later for other All of Us participants in their surrounding areas as well.
In addition, the All of Us Participant Center, led by the Scripps Research Translational Institute, has established partnerships with Walgreens, Quest, QTC, EMSI, the National Blood Collaborative/San Diego Blood Bank, and other organizations. Over time, we will be able to provide more convenient locations to collect participants’ biosamples and physical measurements—expanding our reach far beyond participating health care provider organizations.
And as we see increasing clusters of participants in different communities, our partners will be able to open temporary centers nearby for several months at a time, or even quicker “pop-up” locations, to make it easy for volunteers to provide biosamples and physical measurements.
Scheduling appointments for one million participants will take time. It may take weeks, months, or even years before a participant is invited for one of these appointments.
What information will participants receive about their own health?
All of Us participants will be able to decide how much data and information they want. The longer participants take part in the program, the more they may contribute and learn about their health. Right now, participants receive their physical measurements and answers to the All of Us surveys they’ve taken. In the future, participants will be able to access information we have collected from their electronic health records. We anticipate being able to assemble more complete EHR information over time.
If participants provide samples, they will be able to choose whether to receive the results of tests performed on their samples, including information about their DNA. This may include, for example, information about traits and ancestry, risks for certain diseases, or the likelihood of some drugs being harmful or helpful.
They also may be able to receive other data as well, such as through wearable devices or special apps.
What features will be added to the program over time?
The All of Us Research Program is planning future enhancements over time to make the program more useful for both participants and researchers. For researchers, these may include additional surveys, real-time data collection through wearable devices, more in-depth EHR data (such as images and claims data), and linkages to other large datasets. For participants, these may include additional insights about the data they have provided and the ability to compare their answers to other participants in the study. NIH will offer further updates as plans progress.
Reporters should contact our press team at [email protected] for additional information about the program or to schedule an interview with program leadership at NIH.