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 participants reflect the rich diversity of America, including volunteers of many races and ethnicities, age groups, geographic regions, gender identities, sexual orientations, and health statuses. We aim to enroll one million or more participants over the course of the program.
- With All of Us, participants are 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 gathers blood, urine, and saliva samples; physical measurements; electronic health records; survey information about participants’ health histories, family medical histories, lifestyles, and communities; and wearable data to get a more complete picture of human health across many conditions.
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, in addition to discretionary appropriations the program receives, are subject to the annual appropriations process.
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. Then, after an initial period of infrastructure development and beta testing, the program opened enrollment nationwide in May 2018.
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 do participants go to provide physical measurements and biosamples?
Our participating health care provider organizations handle most of these participant visits.
In addition, the All of Us Participant Center, led by the Scripps Research Translational Institute, has established partnerships with Quest, QTC, 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, answers to the All of Us surveys they’ve taken, and information about how their answers compare to other participants. 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 genetics. This will 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 additional 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 more information about studies that use All of Us data. NIH will offer further updates as plans progress.
Reporters should contact our press team at AllofUsPress@mail.nih.gov for additional information about the program or to schedule an interview with program leadership at NIH.